A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants With Severe Alopecia Areata (Up-AA)

May 11, 2026 updated by: AbbVie

A Phase 3 Randomized, Placebo-controlled, Double-blind Program to Evaluate Efficacy and Safety of Upadacitinib in Adult and Adolescent Subjects With Severe Alopecia Areata

Alopecia areata (AA) is a disease that happens when the immune system attacks hair follicles and causes hair loss. AA usually affects the head and face, but hair loss can happen on any part of the body. The purpose of this study is to assess how safe, effective, and tolerable upadacitinib is in adolescent and adult participants with severe AA.

Upadacitinib is an approved drug being investigated for the treatment of AA. In Study 1 and Study 2 and Study 4 Period A, participants are placed in 1 of 3 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 5 chance that participants will be assigned to placebo. In Study 1 and Study 2 and Study 4 Period B, participants originally randomized to upadacitinib dose group in Period A will continue their same treatment in Period B. Participants originally randomized to Placebo in Period A will either remain on placebo in Period B, or be randomized in 1 of 2 groups, based off of their Severity of Alopecia Tool (SALT) score. Participants who complete Study 1, Study 2 or Study 4, can join Study 3 and may be re-randomized to receive 1 of 2 doses of upadacitinib for up to 108 weeks. Around 1500 participants with severe AA will be enrolled in the study at approximately 280 sites worldwide.

Participants will receive oral tablets of either upadacitinib or placebo once daily for up to 160 weeks with the potential of being re-randomized into a different treatment group at Weeks 24 and 52. Participants will be followed up for up to 30 days after last study drug dose.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1500

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1061
        • Active, not recruiting
        • Centro de Investigacion y Prevencion Cardiovascular (CIPREC) /ID# 258639
    • Buenos Aires F.D.
      • Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina, 1055
        • Active, not recruiting
        • Buenos Aires Skin /ID# 258297
      • Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina, 1425
        • Active, not recruiting
        • Instituto de Neumonologia y Dermatologia /ID# 258640
      • Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina, 1425
        • Active, not recruiting
        • Psoriahue Med Interdisciplinar /ID# 258641
    • Córdoba Province
      • Córdoba, Córdoba Province, Argentina, 5000
        • Active, not recruiting
        • Instituto De Investigaciones Clínicas Córdoba /ID# 260244
  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • Active, not recruiting
        • Momentum Clinical Research /ID# 258571
      • Kogarah, New South Wales, Australia, 2217
        • Active, not recruiting
        • St George Dermatology & Skin Cancer Centre /ID# 258567
    • Queensland
      • Coorparoo, Queensland, Australia, 4151
        • Active, not recruiting
        • Cornerstone Dermatology /ID# 258769
      • Woolloongabba, Queensland, Australia, 4102
        • Active, not recruiting
        • Veracity Clinical Research /ID# 258566
    • Victoria
      • Carlton, Victoria, Australia, 3053
        • Active, not recruiting
        • Skin Health Institute Inc /ID# 258570
      • East Melbourne, Victoria, Australia, 3002
        • Active, not recruiting
        • Sinclair Dermatology - Melbourne /ID# 258565
      • Parkville, Victoria, Australia, 3050
        • Active, not recruiting
        • The Royal Melbourne Hospital /ID# 258770
    • Western Australia
      • Fremantle, Western Australia, Australia, 6160
        • Active, not recruiting
        • Fremantle Dermatology /ID# 260207
  • Belgium
      • Liège, Belgium, 4000
        • Completed
        • CHU de Liege /ID# 257316
    • Brussels Capital
      • Anderlecht, Brussels Capital, Belgium, 1070
        • Recruiting
        • Universite Libre de Bruxelles - Hopital Erasme /ID# 257314
      • Brussels, Brussels Capital, Belgium, 1200
        • Recruiting
        • Cliniques Universitaires UCL Saint-Luc /ID# 257320
      • Jette, Brussels Capital, Belgium, 1090
        • Recruiting
        • Universitair Ziekenhuis Brussel /ID# 257325
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgium, 9000
        • Recruiting
        • UZ Gent /ID# 257317
    • West-Vlaanderen
      • Torhout, West-Vlaanderen, Belgium, 8820
        • Active, not recruiting
        • AZ Delta - campus Torhout /ID# 257321
  • Brazil
      • Rio de Janeiro, Brazil, 20241-180
        • Active, not recruiting
        • Instituto Brasil de Pesquisa Clinica S.A - IBPClin /ID# 258750
      • São Paulo, Brazil, 01323-020
        • Active, not recruiting
        • Hospital Alemao Oswaldo Cruz /ID# 258104
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90020-090
        • Active, not recruiting
        • Irmandade da Santa Casa de Misericordia de Porto Alegre /ID# 258045
    • São Paulo
      • Botucatu, São Paulo, Brazil, 18618-686
        • Active, not recruiting
        • Upeclin Fmb - Unesp /Id# 258046
      • Campinas, São Paulo, Brazil, 13034-685
        • Active, not recruiting
        • Hospital e Maternidade Celso Pierro - PUC-Campinas /ID# 258105
  • Bulgaria
      • Plovdiv, Bulgaria, 4002
        • Active, not recruiting
        • UMHAT Sveti Georgi /ID# 257548
      • Sofia, Bulgaria, 1407
        • Completed
        • Duplicate_Ambulatory for Specialized Medical Care-IPSMC-skin and venereal diseas /ID# 257047
      • Stara Zagora, Bulgaria, 6000
        • Active, not recruiting
        • UMHAT Professor Stoyan Kirkovich /ID# 257051
    • Sofia
      • Sofiya, Sofia, Bulgaria, 1431
        • Active, not recruiting
        • Diagnostic Consultative Center Aleksandrovska /ID# 257049
      • Sofiya, Sofia, Bulgaria, 1463
        • Active, not recruiting
        • Diagnostic Consultative Centre (Dcc) - Foкus 5 /ID# 257048
      • Sofiya, Sofia, Bulgaria, 1618
        • Active, not recruiting
        • Diagnosis - Consult Centre 20 - Sofia /ID# 257273
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2J 7E1
        • Active, not recruiting
        • Dermatology Research Institute - Blackfoot Trail /ID# 258818
      • Calgary, Alberta, Canada, T3A 2N1
        • Active, not recruiting
        • Beacon Dermatology Inc /ID# 258817
      • Edmonton, Alberta, Canada, T5J 3S9
        • Active, not recruiting
        • Rejuvenation Dermatology - Edmonton Downtown /ID# 258816
    • British Columbia
      • Surrey, British Columbia, Canada, V3R 6A7
        • Active, not recruiting
        • Dr. Chih-ho Hong Medical Inc. /ID# 258814
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3M 3Z4
        • Active, not recruiting
        • Wiseman Dermatology Research /ID# 258819
    • Ontario
      • Barrie, Ontario, Canada, L4M 7G1
        • Active, not recruiting
        • SimcoDerm Medical and Surgical Dermatology Center /ID# 258820
      • Greater Sudbury, Ontario, Canada, P3C 1X3
        • Active, not recruiting
        • Medicor Research Inc /ID# 258810
      • Hamilton, Ontario, Canada, L8L 3C3
        • Active, not recruiting
        • Leader Research /ID# 267028
      • Markham, Ontario, Canada, L3P 1X2
        • Active, not recruiting
        • Lynderm Research Inc /ID# 258815
      • Ottawa, Ontario, Canada, K1H 7X3
        • Active, not recruiting
        • JRB Research /ID# 259248
      • Peterborough, Ontario, Canada, K9J 5K2
        • Active, not recruiting
        • SKiN Centre for Dermatology /ID# 258813
      • Richmond Hill, Ontario, Canada, L4C 9M7
        • Active, not recruiting
        • York Dermatology Clinic & Research Centre /ID# 267026
      • Waterloo, Ontario, Canada, N2J 1C4
        • Active, not recruiting
        • Private Practice - Dr. Kim Papp Clinical Research /ID# 259249
    • Quebec
      • Montreal, Quebec, Canada, H2X 2V1
        • Active, not recruiting
        • Innovaderm Research Inc. /ID# 258812
      • Québec, Quebec, Canada, G1V 4X7
        • Active, not recruiting
        • Centre de Recherche dermatologique du Quebec Metropolitain /ID# 258811
      • Saint-Jérôme, Quebec, Canada, J7Z 7E2
        • Active, not recruiting
        • Private Practice - Dr. Angelique Gagne-Henley /ID# 267027
  • Chile
    • Region Metropolitana Santiago
      • Las Condes, Region Metropolitana Santiago, Chile, 7580206
        • Active, not recruiting
        • Centro Medico Skin Med SPA /ID# 259314
      • Santiago, Region Metropolitana Santiago, Chile, 8420383
        • Active, not recruiting
        • Centro Internacional de Estudios Clinicos - CIEC /ID# 259312
      • Vitacura, Region Metropolitana Santiago, Chile, 7640881
        • Active, not recruiting
        • Clinica Dermacross /ID# 259311
    • Santiago Metropolitan
      • Independencia, Santiago Metropolitan, Chile, 8380465
        • Active, not recruiting
        • Fundacion Innovacion Cardiovascular /ID# 259313
  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100020
        • Recruiting
        • Beijing Chaoyang Hospital,Capital Medical University /ID# 258912
        • Contact:
          • Site Coordinator
          • Phone Number: +86 010-85231777
      • Beijing, Beijing Municipality, China, 100029
        • Active, not recruiting
        • China-Japan Friendship Hospital /ID# 258941
      • Beijing, Beijing Municipality, China, 100044
        • Recruiting
        • Peking University People's Hospital /ID# 258940
        • Contact:
          • Site Coordinator
          • Phone Number: +86 010-88326666
      • Beijing, Beijing Municipality, China, 100730
        • Active, not recruiting
        • Beijing Tongren Hospital Affiliated To Capital Medical University /ID# 266715
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400010
        • Active, not recruiting
        • The Second Affiliated Hospital of Chongqing Medical University /ID# 260254
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Active, not recruiting
        • The First Affiliated Hospital, Sun Yat-sen University /ID# 257367
      • Guangzhou, Guangdong, China, 510091
        • Active, not recruiting
        • Dermatology Hospital of Southern Medical University /ID# 257118
      • Guangzhou, Guangdong, China, 510163
        • Active, not recruiting
        • The First Affiliated Hospital Of Guangzhou Medical University /ID# 258663
      • Guangzhou, Guangdong, China, 510280
        • Active, not recruiting
        • Zhujiang Hospital of Southern Medical University /ID# 258485
      • Shenzhen, Guangdong, China, 518020
        • Active, not recruiting
        • Shenzhen People's Hospital /ID# 258208
      • Shenzhen, Guangdong, China, 518039
        • Active, not recruiting
        • Shenzhen Second Peoples Hospital /ID# 258060
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Recruiting
        • Union Hospital - Tongji Medical College /ID# 266737
        • Contact:
          • Site Coordinator
          • Phone Number: +86 027-85726114
      • Wuhan, Hubei, China, 430060
        • Active, not recruiting
        • Renmin Hospital of Wuhan University /ID# 260260
    • Jiangxi
      • Nanchang, Jiangxi, China, 330030
        • Active, not recruiting
        • Dermatology Hospital of Jiangxi Provincial /ID# 259488
    • Jilin
      • Changchun, Jilin, China, 130021
        • Recruiting
        • The First Hospital of Jilin University /ID# 257496
    • Shaanxi
      • Xi'an, Shaanxi, China, 710004
        • Active, not recruiting
        • Second Affiliated Hospital of Xian Jiaotong University /ID# 257497
    • Shandong
      • Jinan, Shandong, China, 250022
        • Recruiting
        • Shandong Dermatological Hospital /ID# 267520
        • Contact:
          • Site Coordinator
          • Phone Number: +86 0531-87298808
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200040
        • Active, not recruiting
        • Huashan Hospital, Fudan University /ID# 257758
    • Shanxi
      • Taiyuan, Shanxi, China, 030001
        • Active, not recruiting
        • First Affiliated Hospital of Shanxi Medical University /ID# 259647
    • Sichuan
      • Chengdu, Sichuan, China, 610017
        • Active, not recruiting
        • Chengdu Second Municipal People's Hospital /ID# 259492
      • Chengdu, Sichuan, China, 610041
        • Completed
        • West China Hospital, Sichuan University /ID# 259560
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300052
        • Active, not recruiting
        • Tianjin Medical University General Hospital /ID# 259525
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Active, not recruiting
        • The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 257260
      • Hangzhou, Zhejiang, China, 310020
        • Active, not recruiting
        • Sir Run Run Shaw Hospital Zhejiang University School of Medicine /ID# 257119
      • Wenzhou, Zhejiang, China, 325000
        • Active, not recruiting
        • The First Affiliated Hospital of Wenzhou Medical University /ID# 257739
  • Croatia
    • City of Zagreb
      • Zagreb, City of Zagreb, Croatia, 10000
        • Active, not recruiting
        • DermaPlus - Poliklinika za dermatologiju i venerologiju /ID# 257151
      • Zagreb, City of Zagreb, Croatia, 10000
        • Active, not recruiting
        • Klinicki bolnicki centar Zagreb /ID# 257630
      • Zagreb, City of Zagreb, Croatia, 10000
        • Active, not recruiting
        • Poliklinika Solmed /ID# 257651
    • Primorje-Gorski Kotar County
      • Rijeka, Primorje-Gorski Kotar County, Croatia, 51000
        • Active, not recruiting
        • Specialty Hospital Medico /ID# 257629
    • Split-Dalmatia County
      • Split, Split-Dalmatia County, Croatia, 21000
        • Active, not recruiting
        • Klinicki Bolnicki Centar (KBC) Split /ID# 257632
  • France
      • Brest, France, 29200
        • Active, not recruiting
        • CHRU de Brest - Hopital Morvan /ID# 256979
      • Paris, France, 75010
        • Active, not recruiting
        • Centre de Sante Sabouraud /ID# 257213
      • Rouen, France, 76000
        • Active, not recruiting
        • Hôpital Charles-Nicolle /ID# 256981
    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, France, 06202
        • Active, not recruiting
        • Chu de Nice-Hopital Larchet Ii /Id# 256978
    • Brittany Region
      • Rennes, Brittany Region, France, 35000
        • Completed
        • Hopital Ponchaillou /ID# 257520
    • Gironde
      • Bordeaux, Gironde, France, 33000
        • Active, not recruiting
        • Centre Hospitalier Universitaire de Bordeaux - Groupe Hospitalier Saint-Andre /ID# 257519
    • Haute-Garonne
      • Toulouse, Haute-Garonne, France, 31400
        • Active, not recruiting
        • CHU Toulouse - Hopital Larrey /ID# 256980
    • Marne
      • Reims, Marne, France, 51100
        • Active, not recruiting
        • Polyclinique Courlancy /ID# 256977
    • Pays de la Loire Region
      • Nantes, Pays de la Loire Region, France, 44000
        • Active, not recruiting
        • Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 256982
    • Rhone
      • Lyon, Rhone, France, 69003
        • Active, not recruiting
        • HCL - Hopital Edouard Herriot /ID# 256983
  • Germany
      • Berlin, Germany, 10117
        • Recruiting
        • Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 257310
        • Contact:
          • Site Coordinator
          • Phone Number: +4930450518176
    • Bavaria
      • Munich, Bavaria, Germany, 81675
        • Recruiting
        • TUM Klinikum rechts der Isar /ID# 257609
    • Lower Saxony
      • Bad Bentheim, Lower Saxony, Germany, 48455
        • Recruiting
        • Fachklinik Bad Bentheim /ID# 257741
    • North Rhine-Westphalia
      • Düsseldorf, North Rhine-Westphalia, Germany, 40225
        • Active, not recruiting
        • Universitaetsklinikum Duesseldorf /ID# 257307
      • Münster, North Rhine-Westphalia, Germany, 48149
        • Recruiting
        • Universitaetsklinikum Muenster /ID# 257306
        • Contact:
          • Site Coordinator
          • Phone Number: +49 251 8356558
    • Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Germany, 23538
        • Active, not recruiting
        • Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 257305
  • Greece
      • Thessaloniki, Greece, 54643
        • Active, not recruiting
        • Hospital of Skin and Venereal Diseases- Thessaloniki /ID# 257263
      • Thessaloniki, Greece, 56429
        • Active, not recruiting
        • Papageorgiou General Hospital /ID# 257258
    • Attica
      • Athens, Attica, Greece, 16121
        • Active, not recruiting
        • General Hospital Andreas Syggros /ID# 257259
      • Athens, Attica, Greece, 16121
        • Active, not recruiting
        • General Hospital Andreas Syggros /ID# 257262
  • Hungary
      • Debrecen, Hungary, 4031
        • Completed
        • DERMA-B Egeszsegugyi es Szolgaltato - Debrecen - Gyepusor Utca /ID# 257469
    • Baranya
      • Pécs, Baranya, Hungary, 7624
        • Recruiting
        • Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 257468
    • Bács-Kiskun county
      • Kecskemét, Bács-Kiskun county, Hungary, 6000
        • Active, not recruiting
        • Bacs-Kiskun Varmegyei Oktatokorhaz /ID# 257472
      • Kecskemét, Bács-Kiskun county, Hungary, 6000
        • Completed
        • Bagoly Egeszseghaz (Meditres Kft.) /ID# 258032
    • Csongrád megye
      • Szeged, Csongrád megye, Hungary, 6725
        • Active, not recruiting
        • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 258552
    • Hajdú-Bihar
      • Debrecen, Hajdú-Bihar, Hungary, 4032
        • Recruiting
        • Debreceni Egyetem-Klinikai Kozpont /ID# 257465
  • Israel
      • Haifa, Israel, 3109601
        • Active, not recruiting
        • Rambam Health Care Campus- Haifa /ID# 257769
    • Central District
      • Petah Tikva, Central District, Israel, 4941492
        • Completed
        • Rabin Medical Center. /ID# 257772
    • Jerusalem
      • Jerusalem, Jerusalem, Israel, 91120
        • Active, not recruiting
        • Hadassah Medical Center-Hebrew University /ID# 257946
    • Tel Aviv
      • Ramat Gan, Tel Aviv, Israel, 5265601
        • Active, not recruiting
        • The Chaim Sheba Medical Center /ID# 257770
      • Tel Aviv, Tel Aviv, Israel, 6423906
        • Completed
        • Tel Aviv Sourasky Medical Center /ID# 257771
  • Italy
      • Bologna, Italy, 40138
        • Active, not recruiting
        • IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 257499
      • Brescia, Italy, 25123
        • Active, not recruiting
        • ASST degli Spedali Civili di Brescia /ID# 257508
      • Catania, Italy, 95123
        • Active, not recruiting
        • AOU Policlinico G. Rodolico - San Marco /ID# 257507
      • Milan, Italy, 20122
        • Active, not recruiting
        • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 257503
    • Firenze
      • Florence, Firenze, Italy, 50122
        • Completed
        • AZIENDA USL TOSCANA CENTRO - Ospedale Piero Palagi /ID# 257501
    • L Aquila
      • L’Aquila, L Aquila, Italy, 67100
        • Active, not recruiting
        • ASL 1 Abruzzo - Ospedale regionale San Salvatore /ID# 257506
    • Lombardy
      • Rozzano, Lombardy, Italy, 20089
        • Active, not recruiting
        • IRCCS Istituto Clinico Humanitas /ID# 257500
    • Napoli
      • Naples, Napoli, Italy, 80138
        • Active, not recruiting
        • Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 258585
      • Naples, Napoli, Italy, 80131
        • Active, not recruiting
        • Azienda Ospedaliera Universitaria Federico II - Naples /ID# 257504
    • Roma
      • Rome, Roma, Italy, 00161
        • Active, not recruiting
        • Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 257513
      • Rome, Roma, Italy, 00168
        • Active, not recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 257505
      • Rome, Roma, Italy, 00133
        • Completed
        • Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 257502
  • Japan
    • Fukuoka
      • Kurume-shi, Fukuoka, Japan, 830-0011
        • Active, not recruiting
        • Kurume University Hospital /ID# 257255
    • Kanagawa
      • Sagamihara-shi, Kanagawa, Japan, 252-0375
        • Active, not recruiting
        • Kitasato University Hospital /ID# 257285
    • Niigata
      • Niigata, Niigata, Japan, 951-8520
        • Active, not recruiting
        • Niigata University Medical & Dental Hospital /ID# 259425
    • Osaka
      • Osaka, Osaka, Japan, 545-8586
        • Active, not recruiting
        • Osaka Metropolitan University Hospital /ID# 257256
    • Shizuoka
      • Hamamatsu, Shizuoka, Japan, 431-3192
        • Active, not recruiting
        • Hamamatsu University Hospital /ID# 257253
    • Tokyo
      • Mitaka-shi, Tokyo, Japan, 181-8611
        • Active, not recruiting
        • Kyorin University Hospital /ID# 257283
      • Shinjuku-ku, Tokyo, Japan, 160-0023
        • Active, not recruiting
        • Tokyo Medical University Hospital /ID# 258132
    • Yamaguchi
      • Ube-shi, Yamaguchi, Japan, 755-8505
        • Active, not recruiting
        • Yamaguchi University Hospital /ID# 257252
  • New Zealand
      • Auckland, New Zealand, 2025
        • Active, not recruiting
        • Aotearoa Clinical Trials. /ID# 258562
      • Wellington, New Zealand, 6021
        • Active, not recruiting
        • P3 Research Ltd /ID# 259846
    • Auckland
      • Epsom, Auckland, New Zealand, 1051
        • Active, not recruiting
        • Greenlane Clinical Centre /ID# 258563
    • Waikato Region
      • Hamilton, Waikato Region, New Zealand, 3204
        • Active, not recruiting
        • Clinical Trials New Zealand /ID# 258564
  • Poland
      • Cracow, Poland, 30-033
        • Active, not recruiting
        • Centrum Medyczne ALL-MED Badania Kliniczne /ID# 257590
    • Kuyavian-Pomeranian Voivodeship
      • Osielsko, Kuyavian-Pomeranian Voivodeship, Poland, 86-031
        • Completed
        • Dermodent Centrum Medyczne Aldona Czajkowska Rafał Czajkowski /ID# 258242
      • Torun, Kuyavian-Pomeranian Voivodeship, Poland, 87-100
        • Active, not recruiting
        • MICS Centrum Medyczne Torun /ID# 257740
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Poland, 30-002
        • Active, not recruiting
        • Specjalistyczny Gabinet Dermatologiczny Aplikacyjno Badawczy /ID# 257534
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 00-716
        • Active, not recruiting
        • Klinika Osipowicz & Turkowski sp.z.o.o /ID# 257598
      • Warsaw, Masovian Voivodeship, Poland, 02-962
        • Active, not recruiting
        • Royalderm Agnieszka Nawrocka /ID# 257536
    • Podlaskie Voivodeship
      • Bialystok, Podlaskie Voivodeship, Poland, 15-351
        • Active, not recruiting
        • Osteo Medic s.c. Artur Racewicz Jerzy Supronik /ID# 257531
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Poland, 80-546
        • Active, not recruiting
        • Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 257535
    • Silesian Voivodeship
      • Katowice, Silesian Voivodeship, Poland, 40-615
        • Active, not recruiting
        • Centrum Medyczne Angelius Provita /ID# 257916
    • Warmian-Masurian Voivodeship
      • Elblag, Warmian-Masurian Voivodeship, Poland, 82-300
        • Active, not recruiting
        • Centrum Kliniczno-Badawcze J.Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka /ID# 257537
  • Portugal
      • Lisbon, Portugal, 1998-018
        • Active, not recruiting
        • Hospital CUF Descobertas /ID# 257419
      • Porto, Portugal, 4099-003
        • Active, not recruiting
        • Unidade Local de Saude de Santo Antonio, E.P.E. /ID# 258554
    • Setúbal District
      • Almada, Setúbal District, Portugal, 2805-267
        • Active, not recruiting
        • Unidade Local de Saude de Almada-Seixal, EPE /ID# 257425
  • Puerto Rico
      • Bayamón, Puerto Rico, 00961-6910
        • Completed
        • Santa Cruz Behavioral (SCB) Research Center /ID# 259350
      • Caguas, Puerto Rico, 00727
        • Active, not recruiting
        • Dr. Samuel Sanchez PSC /ID# 259359
      • San Juan, Puerto Rico, 00909-1711
        • Active, not recruiting
        • Clinical Research Puerto Rico /ID# 259355
      • San Juan, Puerto Rico, 00918-3756
        • Completed
        • Mindful Medical Research /ID# 260113
      • San Juan, Puerto Rico, 00917-3104
        • Active, not recruiting
        • GCM Medical Group /ID# 258013
  • Slovakia
      • Topoľčany, Slovakia, 955 01
        • Active, not recruiting
        • Kaderma Majtan s.r.o. /ID# 257596
    • Bratislava Region
      • Bratislava, Bratislava Region, Slovakia, 811 07
        • Active, not recruiting
        • Univerzitna nemocnica Bratislava, Nemocnica Stare mesto /ID# 257594
      • Bratislava, Bratislava Region, Slovakia, 851 01
        • Active, not recruiting
        • Derma therapy spol /ID# 257595
    • Presov
      • Prešov, Presov, Slovakia, 081 01
        • Active, not recruiting
        • Fakultna nemocnica s poliklinikou J.A. Reimana Presov /ID# 257593
  • South Korea
      • Seoul, South Korea, 05355
        • Active, not recruiting
        • Hallym University Kangdong Sacred Heart Hospital /ID# 257905
    • Busan Gwang Yeogsi
      • Busan, Busan Gwang Yeogsi, South Korea, 49241
        • Active, not recruiting
        • Pusan National University Hospital /ID# 257910
    • Daegu Gwang Yeogsi
      • Daegu, Daegu Gwang Yeogsi, South Korea, 41944
        • Active, not recruiting
        • Kyungpook National University Hospital /ID# 257908
    • Daejeon Gwang Yeogsi
      • Daejeon, Daejeon Gwang Yeogsi, South Korea, 35015
        • Active, not recruiting
        • Chungnam National University Hospital /ID# 267151
    • Gyeonggido
      • Seongnam-si, Gyeonggido, South Korea, 13620
        • Active, not recruiting
        • Seoul National University Bundang Hospital /ID# 257906
    • Incheon Gwang Yeogsi
      • Incheon, Incheon Gwang Yeogsi, South Korea, 21565
        • Active, not recruiting
        • Inha University Hospital /ID# 257904
    • Jeonrabugdo
      • Jeonju, Jeonrabugdo, South Korea, 54907
        • Active, not recruiting
        • Jeonbuk National University Hospital /ID# 267154
    • Seoul Teugbyeolsi
      • Dongjak-gu, Seoul Teugbyeolsi, South Korea, 06973
        • Completed
        • Chungang University Hospital /ID# 267155
      • Seoul, Seoul Teugbyeolsi, South Korea, 03080
        • Active, not recruiting
        • Seoul National University Hospital /ID# 257903
      • Seoul, Seoul Teugbyeolsi, South Korea, 05030
        • Active, not recruiting
        • Konkuk University Medical Center /ID# 257900
      • Seoul, Seoul Teugbyeolsi, South Korea, 05278
        • Active, not recruiting
        • Kyung Hee University Hospital at Gangdong /ID# 257907
  • Spain
      • Barcelona, Spain, 08041
        • Active, not recruiting
        • Hospital Santa Creu i Sant Pau /ID# 257034
      • Córdoba, Spain, 14004
        • Completed
        • Hospital Universitario Reina Sofia /ID# 257035
      • Madrid, Spain, 28046
        • Active, not recruiting
        • Hospital Universitario La Paz /ID# 257333
      • Valencia, Spain, 46017
        • Recruiting
        • Hospital Universitario Dr. Peset /ID# 257036
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Active, not recruiting
        • Hospital Universitari de Bellvitge /ID# 257332
    • Madrid
      • Fuenlabrada, Madrid, Spain, 28942
        • Active, not recruiting
        • Hospital Universitario de Fuenlabrada /ID# 257334
  • Sweden
    • Stockholm County
      • Solna, Stockholm County, Sweden, 171 64
        • Active, not recruiting
        • Karolinska University Hospital Solna /ID# 257094
      • Stockholm, Stockholm County, Sweden, 111 37
        • Active, not recruiting
        • Diagnostiskt Centrum Hud /ID# 257229
    • Västra Götaland County
      • Mölndal, Västra Götaland County, Sweden, 431 53
        • Active, not recruiting
        • CTC GoCo /ID# 257714
  • Taiwan
      • Kaohsiung City, Taiwan, 833
        • Active, not recruiting
        • Kaohsiung Chang Gung Memorial Hospital /ID# 258726
      • Tainan, Taiwan, 704
        • Active, not recruiting
        • National Cheng Kung University Hospital /ID# 257409
      • Taipei, Taiwan, 11217
        • Active, not recruiting
        • Taipei Veterans General Hosp /ID# 257413
      • Taipei, Taiwan, 100
        • Active, not recruiting
        • National Taiwan University Hospital /ID# 257407
      • Taoyuan City, Taiwan, 333
        • Active, not recruiting
        • Linkou Chang Gung Memorial Hospital /ID# 258725
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06800
        • Active, not recruiting
        • Ankara City Hospital /ID# 257417
      • Gaziantep, Turkey (Türkiye), 27310
        • Active, not recruiting
        • Gaziantep Universitesi /ID# 257418
      • Istanbul, Turkey (Türkiye), 34214
        • Active, not recruiting
        • Bagcilar Medipol Mega Universite Hastanesi /ID# 257449
      • Kayseri, Turkey (Türkiye), 38039
        • Active, not recruiting
        • Erciyes University Medical Faculty /ID# 259034
    • Antalya
      • Ankara, Antalya, Turkey (Türkiye), 06010
        • Active, not recruiting
        • Gulhane Egitim ve Arastirma Hastanesi /ID# 257509
  • United Kingdom
      • Harrow, United Kingdom, HA1 3UJ
        • Active, not recruiting
        • London North West University Healthcare NHS Trust /ID# 257914
      • Salford, United Kingdom, M6 8HD
        • Active, not recruiting
        • Northern Care Alliance NHS Group /ID# 257952
    • Buckinghamshire
      • High Wycombe, Buckinghamshire, United Kingdom, HP11 2QW
        • Active, not recruiting
        • Velocity Clinical Research Ltd /ID# 257925
    • East Sussex
      • Brighton, East Sussex, United Kingdom, BN2 5BE
        • Active, not recruiting
        • Royal Sussex County Hospital /ID# 257912
    • Gloucestershire
      • Gloucester, Gloucestershire, United Kingdom, GL1 3NN
        • Active, not recruiting
        • Gloucestershire Royal Hospital /ID# 257953
    • Greater London
      • London, Greater London, United Kingdom, SW10 9NH
        • Active, not recruiting
        • Chelsea and Westminster Hospital /ID# 259128
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 9DU
        • Active, not recruiting
        • Oxford University Hospitals NHS Foundation Trust /ID# 257948
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Active, not recruiting
        • Total Skin and Beauty Dermatology Center /ID# 259539
    • Arizona
      • Glendale, Arizona, United States, 85308
        • Completed
        • Duplicate_Advanced Research Associates - Glendale /ID# 259108
      • Phoenix, Arizona, United States, 85018-3953
        • Completed
        • Southwest Skin Specialists /ID# 258234
      • Phoenix, Arizona, United States, 85032
        • Active, not recruiting
        • Alliance Dermatology and Mohs Center /ID# 258111
    • Arkansas
      • Fort Smith, Arkansas, United States, 72916-6103
        • Active, not recruiting
        • Johnson Dermatology Clinic /ID# 259103
    • California
      • Encino, California, United States, 91436
        • Completed
        • Duplicate_JOSEPH RAOOF MD,INC /ID# 258031
      • Fountain Valley, California, United States, 92708
        • Recruiting
        • First OC Dermatology /ID# 259220
      • Irvine, California, United States, 92697-1385
        • Active, not recruiting
        • University of California Irvine /ID# 259096
      • Los Angeles, California, United States, 90045
        • Recruiting
        • Dermatology Research Associates /ID# 258033
      • Redwood City, California, United States, 94063
        • Completed
        • Stanford University School of Medicine - Redwood City /ID# 259542
      • Sacramento, California, United States, 95815
        • Recruiting
        • Integrative Skin Science and Research /ID# 258114
        • Contact:
          • Site Coordinator
          • Phone Number: (916) 524-1216
      • Sacramento, California, United States, 95817
        • Recruiting
        • University of California Davis Health /ID# 258112
        • Contact:
          • Site Coordinator
          • Phone Number: 916-551-2635
      • Thousand Oaks, California, United States, 91320-2130
        • Recruiting
        • Clinical Trials Research Institute /ID# 258021
    • Florida
      • Boca Raton, Florida, United States, 33486-2269
        • Recruiting
        • Skin Care Research Boca Raton /ID# 258012
        • Contact:
          • Site Coordinator
          • Phone Number: +1-561-948-3116
      • Brandon, Florida, United States, 33511
        • Active, not recruiting
        • Apex Clinical Trials /ID# 259205
      • Coral Gables, Florida, United States, 33146-1837
        • Completed
        • Skin Research Institute LLC /ID# 259207
      • Coral Gables, Florida, United States, 33134-5755
        • Active, not recruiting
        • Florida Academic Dermatology Center /ID# 259353
      • Doral, Florida, United States, 33122-1902
        • Completed
        • Revival Research /ID# 259213
      • Hollywood, Florida, United States, 33021-6748
        • Recruiting
        • Skin Care Research - Hollywood /ID# 259210
        • Contact:
          • Site Coordinator
          • Phone Number: +1-561-948-3116
      • Margate, Florida, United States, 33063
        • Recruiting
        • GSI Clinical Research, LLC /ID# 259352
      • Margate, Florida, United States, 33063
        • Active, not recruiting
        • Life Clinical Trials - N State Rd - Margate /ID# 259358
      • Miami, Florida, United States, 33172
        • Recruiting
        • Lenus Research and Medical Group /ID# 259356
      • Sanford, Florida, United States, 32771
        • Completed
        • International Clinical Research - Sanford /ID# 259547
      • Tamarac, Florida, United States, 33321-2931
        • Completed
        • FWD Clinical Research /ID# 266687
      • Tampa, Florida, United States, 33613-1825
        • Completed
        • Avita Clinical Research /ID# 258011
      • Tampa, Florida, United States, 33607
        • Recruiting
        • Advanced Clinical Research Institute - Tampa /ID# 259204
        • Contact:
          • Site Coordinator
          • Phone Number: 1-813-362-1037
    • Georgia
      • Dawsonville, Georgia, United States, 30534
        • Active, not recruiting
        • Cleaver Medical Group Dermatology /ID# 259801
      • Marietta, Georgia, United States, 30060
        • Active, not recruiting
        • Marietta Dermatology /ID# 259818
    • Illinois
      • Chicago, Illinois, United States, 60611-2927
        • Completed
        • Northwestern University Feinberg School of Medicine /ID# 259555
      • Skokie, Illinois, United States, 60077
        • Active, not recruiting
        • NorthShore University HealthSystem - Skokie /ID# 266684
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University Health University Hospital /ID# 259827
    • Kansas
      • Leawood, Kansas, United States, 66211-1453
        • Completed
        • U.S. Dermatology Partners Leawood /ID# 259203
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • Tulane University School of Medicine /ID# 259799
        • Contact:
          • Site Coordinator
          • Phone Number: 504-988-5135
    • Maryland
      • Marriottsville, Maryland, United States, 21104
        • Completed
        • Raven Clinical Research /ID# 268453
    • Massachusetts
      • Boston, Massachusetts, United States, 02135-3511
        • Active, not recruiting
        • MetroBoston Clinical Partners /ID# 259559
      • Burlington, Massachusetts, United States, 01805
        • Completed
        • Lahey Hospital & Medical Center /ID# 260484
    • Michigan
      • Bay City, Michigan, United States, 48706
        • Completed
        • Great Lakes Research Group - Bay City /ID# 259100
      • Canton, Michigan, United States, 48187
        • Completed
        • Hamzavi Dermatology - Canton /ID# 260115
      • Chesterfield, Michigan, United States, 48047
        • Active, not recruiting
        • Clin Res Inst of Michigan, LLC /ID# 259802
      • Clarkston, Michigan, United States, 48346
        • Recruiting
        • Clarkston Dermatology /ID# 258018
      • Detroit, Michigan, United States, 48202-3046
        • Active, not recruiting
        • Henry Ford Medical Center - New Center One /ID# 258067
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Active, not recruiting
        • M Health Fairview University of Minnesota Medical Center - East Bank /ID# 260122
      • New Brighton, Minnesota, United States, 55112
        • Completed
        • Minnesota Clinical Study Center /ID# 259218
    • Missouri
      • Lee's Summit, Missouri, United States, 64064-2301
        • Completed
        • Dermatology and Skin Center of Lees Summit /ID# 259206
    • Nebraska
      • Lincoln, Nebraska, United States, 68516
        • Active, not recruiting
        • Physician Research Collaboration, LLC /ID# 259354
      • Omaha, Nebraska, United States, 68144
        • Recruiting
        • Skin Specialists /ID# 259237
        • Contact:
          • Site Coordinator
          • Phone Number: 402-697-6599
    • Nevada
      • Las Vegas, Nevada, United States, 89144
        • Recruiting
        • Las Vegas Dermatology /ID# 279317
        • Contact:
          • Site Coordinator
          • Phone Number: 702 456 3120
      • Reno, Nevada, United States, 89509
        • Recruiting
        • Skin Cancer and Dermatology Institute - Reno /ID# 259208
        • Contact:
          • Site Coordinator
          • Phone Number: 775-336-3665
    • New York
      • New City, New York, United States, 10956-7153
        • Active, not recruiting
        • The Skin Center Dermatology Group /ID# 266748
      • New York, New York, United States, 07044-2946
        • Completed
        • Schweiger Dermatology, P.C. /ID# 258007
      • New York, New York, United States, 10023-7340
        • Recruiting
        • Equity Medical, LLC /ID# 266680
      • New York, New York, United States, 10075
        • Recruiting
        • Sadick Research Group LLC /ID# 266790
      • New York, New York, United States, 07044-2946
        • Completed
        • Schweiger Dermatology, P.C. /ID# 259531
      • New York, New York, United States, 10029
        • Active, not recruiting
        • Icahn School of Medicine at Mount Sinai /ID# 259808
    • North Carolina
      • Huntersville, North Carolina, United States, 28078-7961
        • Completed
        • Piedmont Plastic Surgery and Dermatology - Huntersville /ID# 258206
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic - Cleveland /ID# 258113
        • Contact:
        • Contact:
          • Site Coordinator
          • Phone Number: 847-707-6452
      • Columbus, Ohio, United States, 43215
        • Active, not recruiting
        • Remington-Davis Clinical Research /ID# 258106
      • Mason, Ohio, United States, 45040-4520
        • Recruiting
        • Dermatologists of Southwest Ohio, Inc /ID# 260116
        • Contact:
          • Site Coordinator
          • Phone Number: 513-701-5526
      • Springfield, Ohio, United States, 45505
        • Completed
        • Dermatologist of Central States (DOCS) Clinical Research - Springfield /ID# 266746
    • Oregon
      • Portland, Oregon, United States, 97210
        • Recruiting
        • Oregon Dermatology and Research Center /ID# 258243
      • Portland, Oregon, United States, 97223
        • Active, not recruiting
        • Oregon Medical Research Center /ID# 258107
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Active, not recruiting
        • University of Pittsburgh Medical Center /ID# 266681
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Active, not recruiting
        • Medical University of South Carolina /ID# 259828
      • Spartanburg, South Carolina, United States, 29307
        • Recruiting
        • Advanced Dermatology And Cosmetic Surgery - Spartanburg /ID# 278359
        • Contact:
          • Site Coordinator
          • Phone Number: 864 574-0017 ext 8
    • South Dakota
      • Rapid City, South Dakota, United States, 57702
        • Active, not recruiting
        • Health Concepts /ID# 266678
    • Tennessee
      • Murfreesboro, Tennessee, United States, 37130-2450
        • Recruiting
        • International Clinical Research - Tennessee LLC /ID# 259552
    • Texas
      • Arlington, Texas, United States, 76011
        • Recruiting
        • Arlington Research Center, Inc /ID# 258028
      • Bellaire, Texas, United States, 77401
        • Recruiting
        • Bellaire Dermatology Associates /ID# 259360
      • Cedar Park, Texas, United States, 78613
        • Recruiting
        • U.S. Dermatology Partners - Cedar Park /ID# 259367
        • Contact:
          • Site Coordinator
          • Phone Number: 512-260-5860
      • Dallas, Texas, United States, 75230
        • Recruiting
        • Dermatology Treatment and Research Center /ID# 259357
      • Dallas, Texas, United States, 75231
        • Active, not recruiting
        • Modern Research Associates, PLLC /ID# 259349
      • Dallas, Texas, United States, 75235
        • Completed
        • Reveal Research Institute - Dallas /ID# 259361
      • Houston, Texas, United States, 77065
        • Active, not recruiting
        • Center for Clinical Studies - Houston - Northwest Freeway /ID# 258036
      • San Antonio, Texas, United States, 78229
        • Active, not recruiting
        • Progressive Clinical Research /ID# 259365
      • Sugar Land, Texas, United States, 77479-3794
        • Active, not recruiting
        • Complete Dermatology /ID# 258025

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult individuals must be < 64 years old at Baseline Visit. Where permitted outside United States (US)/European Union (EU), adolescent individuals who are at least 12 years old at Screening may participate in Study 1 and Study 2. Adolescent individuals in the US who are at least 12 years old at Screening may participate in Study 4.
  • Diagnosis of severe alopecia areata (AA) with Severity of Alopecia Tool (SALT) score >= 50 scalp hair loss at Screening and Baseline.
  • Severe AA with no spontaneous scalp hair regrowth over the past 6 months.
  • Current episode of AA of less than 8 years.

Exclusion Criteria:

  • Current diagnosis of primarily diffuse type of AA.
  • Current diagnosis of other types of alopecia that would interfere with evaluation of AA, including but not limited to female pattern hair loss, male pattern hair loss (androgenetic alopecia) Stage III or greater based on Hamilton-Norwood classification, traction alopecia, lichen planopilaris (LPP), discoid lupus, frontal fibrosing alopecia (FFA), central centrifugal cicatricial alopecia (CCCA), folliculitis decalvans, trichotillomania, and telogen effluvium.
  • Diagnosis of other types of inflammatory scalp, eyebrow, or eyelash disorders that would interfere with evaluation of AA as determined by the investigator, including but not limited to seborrheic dermatitis, scalp psoriasis, atopic dermatitis (AD), and tinea capitis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study 1: Group 1 Upadacitinib Dose A
Participants will receive upadacitinib Dose A once daily for 52 weeks in Period A and Period B.
Drug: Upadacitinib
Oral Tablets
Other Names:
  • ABT-494
  • Rinvoq
Experimental: Study 1: Group 2 Upadacitinib Dose B
Participants will receive upadacitinib Dose B once daily for 52 weeks in Period A and Period B.
Drug: Upadacitinib
Oral Tablets
Other Names:
  • ABT-494
  • Rinvoq
Experimental: Study 1: Group 3 Placebo
Participants will receive matching placebo once daily for 24 weeks in Period A.
Drug: Placebo
Oral Tablets
Experimental: Study 1: Group 4 Upadacitinib Dose A
Participants initially randomized to placebo (Period A) with a SALT score > 20 at Week 24 will be re-randomized to receive upadacitinib Dose A once daily for 28 weeks in Period B.
Drug: Upadacitinib
Oral Tablets
Other Names:
  • ABT-494
  • Rinvoq
Drug: Placebo
Oral Tablets
Experimental: Study 1: Group 5 Upadacitinib Dose B
Participants initially randomized to placebo (Period A) with a SALT score > 20 at Week 24 will be re-randomized to receive upadacitinib Dose B once daily for 28 weeks in Period B.
Drug: Upadacitinib
Oral Tablets
Other Names:
  • ABT-494
  • Rinvoq
Drug: Placebo
Oral Tablets
Experimental: Study 2: Group 1 Upadacitinib Dose A
Participants will receive upadacitinib Dose A once daily for 52 weeks in Period A and Period B.
Drug: Upadacitinib
Oral Tablets
Other Names:
  • ABT-494
  • Rinvoq
Experimental: Study 2: Group 2 Upadacitinib Dose B
Participants will receive upadacitinib Dose B once daily for 52 weeks in Period A and Period B.
Drug: Upadacitinib
Oral Tablets
Other Names:
  • ABT-494
  • Rinvoq
Experimental: Study 2: Group 3 Placebo
Participants will receive matching placebo once daily for 24 weeks in Period A.
Drug: Placebo
Oral Tablets
Experimental: Study 2: Group 4 Upadacitinib Dose A
Participants initially randomized to placebo (Period A) with a SALT score > 20 at Week 24 will be re-randomized to receive upadacitinib Dose A once daily for 28 weeks in Period B.
Drug: Upadacitinib
Oral Tablets
Other Names:
  • ABT-494
  • Rinvoq
Drug: Placebo
Oral Tablets
Experimental: Study 2: Group 5 Upadacitinib Dose B
Participants initially randomized to placebo (Period A) with a SALT score > 20 at Week 24 will be re-randomized to receive upadacitinib Dose B once daily for 28 weeks in Period B.
Drug: Upadacitinib
Oral Tablets
Other Names:
  • ABT-494
  • Rinvoq
Drug: Placebo
Oral Tablets
Experimental: Study 3: Group 1 Upadacitinib Dose B (SALT > 20)
Participants receiving upadacitinib Dose A with a SALT score > 20 at Week 52 (end of Period B) of Study 1 or Study 2 will dose escalate to upadacitinib Dose B once daily for 108 weeks.
Drug: Upadacitinib
Oral Tablets
Other Names:
  • ABT-494
  • Rinvoq
Experimental: Study 3: Group 2 Upadacitinib Dose A (SALT ≤ 20)
Participants receiving upadacitinib Dose A with a SALT score ≤ 20 at Week 52 (end of Period B) of Study 1 or Study 2 will remain on upadacitinib Dose A once daily for 108 weeks.
Drug: Upadacitinib
Oral Tablets
Other Names:
  • ABT-494
  • Rinvoq
Experimental: Study 3: Group 3 Upadacitinib Dose B (Non-Sustained)
Participants who end Period B on upadacitinib Dose B with a with a SALT score > 20 at Week 40 or Week 52 of Study 1 or Study 2 will remain on upadacitinib Dose B once daily for 108 weeks.
Drug: Upadacitinib
Oral Tablets
Other Names:
  • ABT-494
  • Rinvoq
Experimental: Study 3: Group 4 Upadacitinib Dose B (Sustained)
Participants who end Period B on upadacitinib Dose B with a with a SALT score ≤ 20 at Week 40 and Week 52 of Study 1 or Study 2 will be re-randomized to receive upadacitinib Dose B once daily for 108 weeks.
Drug: Upadacitinib
Oral Tablets
Other Names:
  • ABT-494
  • Rinvoq
Experimental: Study 3: Group 5 Upadacitinib Dose A (Sustained)
Participants who end Period B on upadacitinib Dose B with a with a SALT score ≤ 20 at Week 40 and Week 52 of Study 1 or Study 2 will be re-randomized to receive upadacitinib Dose A once daily for 108 weeks.
Drug: Upadacitinib
Oral Tablets
Other Names:
  • ABT-494
  • Rinvoq
Experimental: Study 1: Group 6 Placebo
Participants initially randomized to placebo with a SALT score ≤ 20 at Week 24 will continue on placebo through Week 160.
Drug: Placebo
Oral Tablets
Experimental: Study 2: Group 6 Placebo
Participants initially randomized to placebo with a SALT score ≤ 20 at Week 24 will continue on placebo through Week 160.
Drug: Placebo
Oral Tablets
Experimental: Study 4: Group 1 Upadacitinib Dose A
US only adolescent participants will receive upadacitinib Dose A once daily for 52 weeks in Period A and Period B.
Drug: Upadacitinib
Oral Tablets
Other Names:
  • ABT-494
  • Rinvoq
Experimental: Study 4: Group 2 Upadacitinib Dose B
US only adolescent participants will receive upadacitinib Dose B once daily for 52 weeks in Period A and Period B.
Drug: Upadacitinib
Oral Tablets
Other Names:
  • ABT-494
  • Rinvoq
Experimental: Study 4: Group 3 Placebo
US only adolescent participants will receive matching placebo once daily for 24 weeks in Period A.
Drug: Placebo
Oral Tablets
Experimental: Study 4: Group 4 Upadacitinib Dose A
Participants initially randomized to placebo (Period A) with a SALT score > 20 at Week 24 will be re-randomized to receive upadacitinib Dose A once daily for 28 weeks in Period B.
Drug: Upadacitinib
Oral Tablets
Other Names:
  • ABT-494
  • Rinvoq
Experimental: Study 4: Group 5 Upadacitinib Dose B
Participants initially randomized to placebo (Period A) with a SALT score > 20 at Week 24 will be re-randomized to receive upadacitinib Dose B once daily for 28 weeks in Period B.
Drug: Upadacitinib
Oral Tablets
Other Names:
  • ABT-494
  • Rinvoq
Experimental: Study 4: Group 6 Placebo
Participants initially randomized to placebo with a SALT score ≤ 20 at Week 24 will continue on placebo through Week 160.
Drug: Placebo
Oral Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants with the Achievement of Severity of Alopecia Tool (SALT) Score <= 20
Time Frame: Week 24
The SALT is a global AA severity score based on the combination of extent and density of scalp hair loss. The score is determined by visually defining the amount of terminal hair loss in each of the 4 views of the scalp (left and right side each accounting for 18% of scalp area, the top for 40%, and the back for 24%) and adding these together with a maximum score of 100%.
Week 24
Number of Participants with Adverse Events (AEs)
Time Frame: Up to approximately 164 weeks
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Up to approximately 164 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants with the Achievement of SALT Score <= 20
Time Frame: Up to Week 12
The SALT is a global AA severity score based on the combination of extent and density of scalp hair loss. The score is determined by visually defining the amount of terminal hair loss in each of the 4 views of the scalp (left and right side each accounting for 18% of scalp area, the top for 40%, and the back for 24%) and adding these together with a maximum score of 100%.
Up to Week 12
Percentage of Participants with the Achievement of Clinician-Reported Outcome (ClinRO) Measure for Eyebrow Hair Loss of 0 or 1
Time Frame: Baseline to Week 24
The ClinRO for Eyebrow Hair Loss is a 4-point response scale where 0 = The eyebrows have full coverage and no areas of hair loss and 3 = No notable eyebrows. Responses should have a ≥ 2-point improvement from Baseline among participants with Baseline score ≥ 2.
Baseline to Week 24
Percentage of Participants with the Achievement of SALT 75
Time Frame: Baseline to Week 24
SALT 75 is defined as at least a 75% improvement [decrease] from Baseline in SALT score.
Baseline to Week 24
Percentage of Participants with the Achievement of SALT 90
Time Frame: Baseline to Week 24
SALT 90 is defined as at least a 90% improvement [decrease] from Baseline in SALT score.
Baseline to Week 24
Percent Change from Baseline in SALT Score
Time Frame: Baseline to Week 24
The SALT is a global AA severity score based on the combination of extent and density of scalp hair loss. The score is determined by visually defining the amount of terminal hair loss in each of the 4 views of the scalp (left and right side each accounting for 18% of scalp area, the top for 40%, and the back for 24%) and adding these together with a maximum score of 100%.
Baseline to Week 24
Percentage of Participants with the Achievement of Patients' Global Impression of Change of Alopecia Areata (PaGIC-AA) Score of 1 "Much Better" or 2 "Moderately Better"
Time Frame: Up to Week 24
The PaGIC-AA is a single-item measure that asks participants to rate how their alopecia condition has changed overall since the start of the study using a 7-point scale. Responses range from "much better" to "much worse."
Up to Week 24
Percentage of Participants with the Achievement of Patient-Reported Outcome (PRO) for Scalp Hair Assessment 0/1 with ≥ 2-Point Improvement (Reduction)
Time Frame: Baseline to Week 24
The PRO for Scalp Hair Assessment is single item, five-point, categorical response scale that asks respondents to look in the mirror and assess the total area of the scalp with missing hair. Response items range from "No missing hair" to "Nearly all or all" and includes percentage ranges for each category (0%, 1 to 20%, 21 to 49%, 50 to 94%, and 95 to 100%). Responses among participants with baseline score >=3.
Baseline to Week 24
Percentage of Participants with the Achievement of SALT Score 0
Time Frame: Week 24
The SALT is a global AA severity score based on the combination of extent and density of scalp hair loss. The score is determined by visually defining the amount of terminal hair loss in each of the 4 views of the scalp (left and right side each accounting for 18% of scalp area, the top for 40%, and the back for 24%) and adding these together with a maximum score of 100%.
Week 24
Achievement of SALT score <= 20 for the Comparison of Upadacitinib Dose A QD Versus Placebo
Time Frame: Week 24
The SALT is a global AA severity score based on the combination of extent and density of scalp hair loss. The score is determined by visually defining the amount of terminal hair loss in each of the 4 views of the scalp (left and right side each accounting for 18% of scalp area, the top for 40%, and the back for 24%) and adding these together with a maximum score of 100%.
Week 24
Change from Baseline in Skindex-16 AA Emotions Domain Scores
Time Frame: Week 24
The Skindex-16 AA Emotions Domain is a 7-item assessment ranging from 0 = never bothered to 6 = always bothered that measures the effects of AA on a subject's health-related quality of life. Higher scores indicate greater impact on health-related quality of life.
Week 24
Change from Baseline in Skindex-16 AA Functioning Domain Scores
Time Frame: Week 24
The Skindex-16 AA Emotions Domain is a 5-item assessment ranging from 0 = never bothered to 6 = always bothered, that measures the effects of AA on a subject's health-related quality of life. Higher scores indicate greater impact on health-related quality of life.
Week 24
Change from Baseline in Alopecia Areata Symptom Impact Scale (AASIS) Interference Subscale Score
Time Frame: Week 24
The AASIS Interference Subscale is a 6-item assessment with scores ranging from 0 = 'did not interfere' to 10 = 'interfered completely' with higher scores indicating greater symptom interference.
Week 24
Change from Baseline in AASIS Symptoms Subscale Score
Time Frame: Week 24
The AASIS Symptom Subscale is a 7-item assessment with scores ranging from 0 = 'not present' to 10 = 'as bad as you can imagine' with higher scores indicating greater symptom severity.
Week 24
Achievement of Hospital Anxiety and Depression Scale (HADS)-Anxiety < 8 and HADS-Depression < 8 at Week 24 Among Participants with HADS-A >= 8 or HADS-D >= 8 at Baseline
Time Frame: Baseline to Week 24
The HADS is a self-administered scale which measures anxiety and depression. It contains 14 items and is comprised of anxiety (7 items) and depression (7 items) subscales, which are scored separately and summed to give a total score. Item scores range from 0 (best) to 3 (worst), and total scores are categorized as normal (0 to 7), borderline abnormal (8 to 10), and abnormal (11 to 21).
Baseline to Week 24
Percentage of Participants with the Achievement of SALT Score <= 10
Time Frame: Up to Week 24
The SALT is a global AA severity score based on the combination of extent and density of scalp hair loss. The score is determined by visually defining the amount of terminal hair loss in each of the 4 views of the scalp (left and right side each accounting for 18% of scalp area, the top for 40%, and the back for 24%) and adding these together with a maximum score of 100%.
Up to Week 24
Percentage of Participants with the Achievement of ClinRO Measure for Eyelash Hair Loss of 0 or 1
Time Frame: Baseline to Week 24
The ClinRO for Eyelash Hair Loss is a 4-point response scale where 0 = The eyelashes form a continuous line along the eyelids on both eyes and 3 = No notable eyelashes. Responses should have a ≥ 2-point improvement from Baseline among participants with Baseline score ≥ 2.
Baseline to Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2023

Primary Completion (Estimated)

April 1, 2030

Study Completion (Estimated)

April 1, 2030

Study Registration Dates

First Submitted

August 22, 2023

First Submitted That Met QC Criteria

August 22, 2023

First Posted (Actual)

August 25, 2023

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M23-716
  • 2023-505061-82-01 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

IPD Sharing Time Frame

For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

IPD Sharing Access Criteria

To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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