A Study To Assess Adverse Events and Effectiveness of Upadacitinib Oral Tablets in Adult and Adolescent Participants With Vitiligo (Viti-Up)

A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy, Safety, and Tolerability of Upadacitinib in Adult and Adolescent Subjects With Non-Segmental Vitiligo Who Are Eligible for Systemic Therapy

Vitiligo is a common chronic autoimmune disease that causes the body's immune system to attack its own pigment producing skin cells. This study is to evaluate how safe and effective upadacitinib is in participants with non-segmental vitiligo (NSV). Adverse effects and change in disease activity will be assessed.

Upadacitinib is an approved drug for various immune-mediated inflammatory diseases and is currently being investigated for the treatment of NSV. There will be 2 replicate studies running at the same time (Study 1 and Study 2 with periods A and B) and an optional exploratory Narrow-Band Ultraviolet B (NB-UVB) phototherapy study (Study 3). In Period A, participants are placed in 1 of 2 groups called treatment arms. Each group receives a different treatment. There is a 1 in 3 chance that participants will receive placebo and 2 in 3 chance participants will receive upadacitinib. In Period B, all participants will receive upadacitinib. Approximately 270 adult and adolescent participants with NSV will be enrolled in each main study ((Study 1 and Study 2, 540 subjects total) at approximately 90 sites worldwide with an option for adult participants who completed Period A of either study and did not achieve T-VASI 90 at week 48 while on study drug, to enter Study 3.

In Studies 1 and 2: Period A, participants will receive oral tablets of upadacitinib or placebo once a day for 48 weeks. In Period B, participants will receive oral tablets of upadacitinib 15 mg once a day for 112 weeks. Participants will be followed up for 30 days. Study 3 participants will receive upadacitinib monotherapy or upadacitinib with NB-UBV phototherapy for at least 24 weeks followed by upadacitinib alone.

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: Active, not recruiting
• Conditions: Vitiligo
• Intervention / Treatment: Drug: Upadacitinib; Drug: Placebo; Other: NB-UVB (narrow-band ultraviolet B) Phototherapy

• Study Type: Interventional
• Enrollment (Actual): 614
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1061
    • Centro de Investigacion y Prevencion Cardiovascular (CIPREC) /ID# 259889
  • Buenos Aires F.D.
    • Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina, 1055
      • Buenos Aires Skin /ID# 259885
    • Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina, 1425
      • Instituto de Neumonologia y Dermatologia /ID# 259888
    • Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina, 1425
      • Psoriahue Med Interdisciplinar /ID# 259890
  • Córdoba Province
    • Córdoba, Córdoba Province, Argentina, 5000
      • Instituto De Investigaciones Clínicas Córdoba /ID# 260371
  • Tucumán Province
    • San Miguel de Tucumán, Tucumán Province, Argentina, 4000
      • Sanatorio 9 de Julio /ID# 260245
• Belgium
  • Liège, Belgium, 4000
    • CHU de Liege /ID# 259427
  • Brussels Capital
    • Brussels, Brussels Capital, Belgium, 1200
      • Cliniques Universitaires UCL Saint-Luc /ID# 259429
  • Hainaut
    • Charleroi, Hainaut, Belgium, 6280
      • Grand Hôpital de Charleroi - Les Viviers /ID# 259437
  • Oost-Vlaanderen
    • Ghent, Oost-Vlaanderen, Belgium, 9000
      • UZ Gent /ID# 259430
• Bulgaria
  • Pleven, Bulgaria, 5800
    • Medical Center Cordis /ID# 259954
  • Sofia
    • Sofiya, Sofia, Bulgaria, 1407
      • Ambulatory for Specialized Medical Care-IPSMC-skin and venereal diseases /ID# 259955
    • Sofiya, Sofia, Bulgaria, 1463
      • Diagnostic Consultative Centre (Dcc) - Foкus 5 /ID# 259956
    • Sofiya, Sofia, Bulgaria, 1618
      • Diagnosis - Consult Centre 20 - Sofia /ID# 259953
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2J 7E1
      • Dermatology Research Institute - Blackfoot Trail /ID# 261175
  • British Columbia
    • Surrey, British Columbia, Canada, V3R 6A7
      • Dr. Chih-ho Hong Medical Inc. /ID# 260239
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3M 3Z4
      • Wiseman Dermatology Research /ID# 260236
  • New Brunswick
    • Fredericton, New Brunswick, Canada, R3M 3Z4
      • Brunswick Dermatology Center /ID# 260237
  • Ontario
    • Hamilton, Ontario, Canada, L8L 3C3
      • LEADER Research /ID# 260407
    • Waterloo, Ontario, Canada, N2J 1C4
      • Private Practice - Dr. Kim Papp Clinical Research /ID# 260406
  • Quebec
    • Québec, Quebec, Canada, G1V 4X7
      • Centre de Recherche dermatologique du Quebec Metropolitain /ID# 260241
    • Saint-Jérôme, Quebec, Canada, J7Z 7E2
      • Dre Angelique Gagne-Henley M.D. inc. /ID# 260238
• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100730
      • Beijing Tongren Hospital Affiliated To Capital Medical University /ID# 260919
  • Guangdong
    • Guangzhou, Guangdong, China, 510091
      • Dermatology Hospital of Southern Medical University /ID# 260136
    • Guangzhou, Guangdong, China, 510260
      • The Second Affiliated Hospital of Guangzhou Medical University /ID# 259929
  • Hubei
    • Wuhan, Hubei, China, 430060
      • Renmin Hospital of Wuhan University /ID# 260477
  • Shaanxi
    • Xi'an, Shaanxi, China, 710004
      • Second Affiliated Hospital of Xian Jiaotong University /ID# 260011
    • Xi'an, Shaanxi, China, 710061
      • The First Affiliated Hospital of Xi'an Jiaotong University /ID# 260340
  • Shandong
    • Jinan, Shandong, China, 250022
      • Shandong Dermatological Hospital /ID# 260338
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200040
      • Huashan Hospital, Fudan University /ID# 259823
  • Sichuan
    • Chengdu, Sichuan, China, 610017
      • Chengdu Second Municipal People's Hospital /ID# 260423
    • Chengdu, Sichuan, China, 610041
      • West China Hospital, Sichuan University /ID# 260624
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300052
      • Tianjin Medical University General Hospital /ID# 259812
  • Yunnan
    • Kunming, Yunnan, China, 650032
      • First Affiliated Hospital of Kunming Medical University /ID# 260017
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Hangzhou Third People'S Hospital /ID# 261005
    • Hangzhou, Zhejiang, China, 310020
      • Sir Run Run Shaw Hospital Zhejiang University School of Medicine /ID# 260626
    • Wenzhou, Zhejiang, China, 325000
      • The First Affiliated Hospital of Wenzhou Medical University /ID# 259822
• France
  • Alpes-Maritimes
    • Nice, Alpes-Maritimes, France, 06202
      • Chu de Nice-Hopital L'Archet Ii /Id# 259442
  • Gironde
    • Bordeaux, Gironde, France, 33000
      • Centre Hospitalier Universitaire de Bordeaux - Groupe Hospitalier Saint-Andre /ID# 259443
  • Haute-Garonne
    • Toulouse, Haute-Garonne, France, 31400
      • CHU Toulouse - Hopital Larrey /ID# 259445
  • Paris
    • Créteil, Paris, France, 94010
      • Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 259446
  • Rhone
    • Lyon, Rhone, France, 69003
      • HCL - Hopital Edouard Herriot /ID# 259444
• Germany
  • Berlin, Germany, 10117
    • Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 260294
  • Bavaria
    • Erlangen, Bavaria, Germany, 91054
      • Universitaetsklinikum Erlangen /ID# 260153
    • Munich, Bavaria, Germany, 81675
      • Klinikum rechts der Isar /ID# 260291
  • Brandenburg
    • Blankenfelde-Mahlow, Brandenburg, Germany, 15831
      • Dermatologie Mahlow /ID# 260148
  • Hesse
    • Bonn, Hesse, Germany, 53111
      • MVZ Dermatologisches Zentrum Bonn GmbH /ID# 260287
    • Frankfurt am Main, Hesse, Germany, 60590
      • Universitaetsklinikum Frankfurt /ID# 260288
  • Lower Saxony
    • Bad Bentheim, Lower Saxony, Germany, 48455
      • Fachklinik Bad Bentheim /ID# 260293
  • North Rhine-Westphalia
    • Münster, North Rhine-Westphalia, Germany, 48149
      • Universitaetsklinikum Muenster /ID# 260147
  • Rhineland-Palatinate
    • Mainz, Rhineland-Palatinate, Germany, 55131
      • Universitaetsmedizin Mainz /ID# 260151
  • Saxony
    • Dresden, Saxony, Germany, 01307
      • Universitaetsklinikum Carl Gustav Carus Dresden /ID# 260289
  • Saxony-Anhalt
    • Halle, Saxony-Anhalt, Germany, 06108
      • Private Practice - Dr. Abdou Zarzour /ID# 260290
• Hungary
  • Debrecen, Hungary, 4031
    • DERMA-B Egeszsegugyi es Szolgaltato - Debrecen - Gyepusor Utca /ID# 260072
• Israel
  • Haifa, Israel, 3109601
    • Rambam Health Care Campus /ID# 259852
  • Petah Tikva, Israel, 4941492
    • Rabin Medical Center /ID# 260420
  • Jerusalem
    • Jerusalem, Jerusalem, Israel, 91120
      • Hadassah Medical Center-Hebrew University /ID# 259849
  • Tel Aviv
    • Ramat Gan, Tel Aviv, Israel, 5265601
      • The Chaim Sheba Medical Center /ID# 259851
    • Tel Aviv, Tel Aviv, Israel, 6423906
      • Tel Aviv Sourasky Medical Center /ID# 259850
• Italy
  • Brescia, Italy, 25123
    • ASST degli Spedali Civili di Brescia /ID# 259772
  • Roma
    • Rome, Roma, Italy, 00144
      • IRCCS Istituti Fisioterapici Ospitalieri-Istituto Dermatologico San Gallicano /ID# 259771
• Japan
  • Aichi-ken
    • Nagoya, Aichi-ken, Japan, 467-8602
      • Nagoya City University Hospital /ID# 260551
  • Osaka
    • Sakai-shi, Osaka, Japan, 593-8324
      • Dermatology and Ophthalmology Kume Clinic /ID# 260555
    • Suita-shi, Osaka, Japan, 565-0871
      • The University of Osaka Hospital /ID# 261285
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan, 113-8603
      • Nippon Medical School Hospital /ID# 260550
    • Shinjuku-ku, Tokyo, Japan, 160-0023
      • Tokyo Medical University Hospital /ID# 260552
  • Yamagata
    • Yamagata, Yamagata, Japan, 990-9585
      • Yamagata University Hospital /ID# 260553
  • Yamanashi
    • Kofu, Yamanashi, Japan, 400-8506
      • Yamanashi Prefectural Central Hospital /ID# 260554
• Netherlands
  • North Brabant
    • Bergen op Zoom, North Brabant, Netherlands, 4624 VT
      • Bravis Ziekenhuis /ID# 259501
    • Breda, North Brabant, Netherlands, 4818 CK
      • Amphia Ziekenhuis /ID# 259696
  • North Holland
    • Amsterdam, North Holland, Netherlands, 1105 AZ
      • Amsterdam UMC, locatie AMC /ID# 259676
• Poland
  • Kuyavian-Pomeranian Voivodeship
    • Osielsko, Kuyavian-Pomeranian Voivodeship, Poland, 86-031
      • Dermodent Centrum Medyczne Aldona Czajkowska Rafał Czajkowski /ID# 259690
  • Lesser Poland Voivodeship
    • Krakow, Lesser Poland Voivodeship, Poland, 30-002
      • Specjalistyczny Gabinet Dermatologiczny Aplikacyjno Badawczy /ID# 260016
    • Krakow, Lesser Poland Voivodeship, Poland, 30-149
      • Malopolskie Centrum Kliniczne /ID# 259686
    • Krakow, Lesser Poland Voivodeship, Poland, 31-501
      • Krakowskie Centrum Medyczne /ID# 261424
  • Masovian Voivodeship
    • Warsaw, Masovian Voivodeship, Poland, 00-716
      • Klinika Osipowicz & Turkowski sp.z.o.o /ID# 259761
    • Warsaw, Masovian Voivodeship, Poland, 02-953
      • Klinika Ambroziak Dermatologia /ID# 260018
    • Warsaw, Masovian Voivodeship, Poland, 02-962
      • Royalderm Agnieszka Nawrocka /ID# 259691
  • Podlaskie Voivodeship
    • Bialystok, Podlaskie Voivodeship, Poland, 15-351
      • Osteo Medic s.c. Artur Racewicz Jerzy Supronik /ID# 259753
  • Silesian Voivodeship
    • Katowice, Silesian Voivodeship, Poland, 40-615
      • Centrum Medyczne Angelius Provita /ID# 259752
  • West Pomeranian Voivodeship
    • Szczecin, West Pomeranian Voivodeship, Poland, 71-434
      • Twoja Przychodnia SCM /ID# 259757
• Portugal
  • Coimbra, Portugal, 3000-075
    • Unidade Local de Saude de Coimbra, EPE /ID# 259793
  • Leiria, Portugal, 2410-197
    • Unidade Local de Saude da Regiao de Leiria, EPE /ID# 259789
  • Lisbon, Portugal, 1998-018
    • Hospital CUF Descobertas /ID# 259788
  • Porto, Portugal, 4099-003
    • Unidade Local de Saude de Santo Antonio, E.P.E. /ID# 259791
• Puerto Rico
  • Bayamón, Puerto Rico, 00961-6910
    • Santa Cruz Behavioral (SCB) Research Center /ID# 260100
  • Caguas, Puerto Rico, 00727
    • Dr. Samuel Sanchez PSC /ID# 260090
  • San Juan, Puerto Rico, 00918-3756
    • Mindful Medical Research /ID# 260092
• Slovakia
  • Trnava, Slovakia, 917 02
    • Fakultna nemocnica Trnava /ID# 260164
  • Bratislava Region
    • Bratislava, Bratislava Region, Slovakia, 851 01
      • Derma therapy spol /ID# 260838
• South Korea
  • Daejeon Gwang Yeogsi
    • Daejeon, Daejeon Gwang Yeogsi, South Korea, 35015
      • Chungnam National University Hospital /ID# 260917
  • Gyeonggido
    • Bucheon-si, Gyeonggido, South Korea, 14584
      • Soon Chun Hyang University Hospital Bucheon /ID# 260836
    • Suwon, Gyeonggido, South Korea, 16247
      • The Catholic University Of Korea St. Vincent's Hospital /ID# 260880
    • Suwon, Gyeonggido, South Korea, 16499
      • Ajou University Hospital /ID# 260916
  • Seoul Teugbyeolsi
    • Seoul, Seoul Teugbyeolsi, South Korea, 05278
      • Kyung Hee University Hospital at Gangdong /ID# 260879
• Spain
  • Granada, Spain, 18016
    • Hospital Universitario Clinico San Cecilio /ID# 259374
  • Madrid, Spain, 28006
    • Grupo Pedro Jaen /ID# 259375
  • Valencia, Spain, 46014
    • Consorci Hospital General Universitario de Valencia /ID# 259372
  • Zaragoza, Spain, 50009
    • Hospital Clinico Universitario Lozano Blesa /ID# 259373
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Hospital Universitario Germans Trias i Pujol /ID# 259371
  • Madrid
    • Getafe, Madrid, Spain, 28905
      • Hospital Universitario de Getafe /ID# 259376
    • Pozuelo de Alarcón, Madrid, Spain, 28223
      • Hospital Universitario Quironsalud Madrid /ID# 259377
• United States
  • Arizona
    • Glendale, Arizona, United States, 85308
      • Advanced Research Associates - Glendale /ID# 259915
    • Phoenix, Arizona, United States, 85032
      • Alliance Dermatology and Mohs Center /ID# 259926
  • California
    • Encino, California, United States, 91436
      • Private Practice - Dr. Tooraj Raoof /ID# 260055
    • Irvine, California, United States, 92697-1385
      • University of California Irvine /ID# 260080
    • Los Angeles, California, United States, 90036-5679
      • Vitiligo & Pigmentation Institute of Southern California /ID# 259970
    • Los Angeles, California, United States, 90045
      • Dermatology Research Associates /ID# 260056
    • Redwood City, California, United States, 94063
      • Duplicate_Stanford University /ID# 260081
    • Sacramento, California, United States, 95815
      • Integrative Skin Science and Research /ID# 260060
    • Sacramento, California, United States, 95817
      • University of California Davis Health /ID# 260062
    • Thousand Oaks, California, United States, 91320-2130
      • Clinical Trials Research Institute /ID# 259910
  • Florida
    • Boca Raton, Florida, United States, 33486-2269
      • Skin Care Research Boca Raton /ID# 260094
    • Brandon, Florida, United States, 33511
      • Apex Clinical Trials /ID# 260096
    • Coral Gables, Florida, United States, 33134-5755
      • Florida Academic Dermatology Center /ID# 259919
    • Hialeah, Florida, United States, 33012
      • Direct Helpers Research Center /ID# 259932
    • Hollywood, Florida, United States, 33021-6748
      • Skin Care Research - Hollywood /ID# 260101
    • Hollywood, Florida, United States, 33021
      • Encore Medical Research /ID# 259963
    • Margate, Florida, United States, 33063
      • GSI Clinical Research, LLC /ID# 259918
    • Margate, Florida, United States, 33063
      • Life Clinical Trials /ID# 260097
    • Miami Lakes, Florida, United States, 33014
      • Savin Medical Group, LLC /ID# 259968
    • Tampa, Florida, United States, 33607
      • Advanced Clinical Research Institute /ID# 260058
    • Weston, Florida, United States, 33331
      • Encore Medical Research - Weston /ID# 260542
  • Georgia
    • Dawsonville, Georgia, United States, 30534
      • Cleaver Medical Group Dermatology /ID# 259925
  • Illinois
    • Chicago, Illinois, United States, 60610
      • DeNova Research /ID# 260611
  • Indiana
    • Indianapolis, Indiana, United States, 46256
      • Dawes Fretzin, LLC /ID# 260068
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Health University Hospital /ID# 259974
  • Massachusetts
    • Boston, Massachusetts, United States, 02111-1552
      • Tufts Medical Center /ID# 260088
    • Worcester, Massachusetts, United States, 01605
      • UMass Memorial Medical Center /ID# 259921
  • Michigan
    • Auburn Hills, Michigan, United States, 48326
      • Oakland Hills Dermatology /ID# 260602
    • Bay City, Michigan, United States, 48706
      • Great Lakes Research Group - Bay City /ID# 260600
    • Canton, Michigan, United States, 48187
      • Hamzavi Dermatology - Canton /ID# 260545
    • Clarkston, Michigan, United States, 48346
      • Clarkston Dermatology /ID# 260069
    • Detroit, Michigan, United States, 48202-3046
      • Henry Ford Medical Center - New Center One /ID# 260059
  • Minnesota
    • New Brighton, Minnesota, United States, 55112
      • Minnesota Clinical Study Center /ID# 260154
  • Nevada
    • Las Vegas, Nevada, United States, 89119-5190
      • Vivida Dermatology- Flamingo /ID# 260609
  • New York
    • New York, New York, United States, 07044-2946
      • Schweiger Dermatology, P.C. /ID# 260152
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai /ID# 259909
    • Stony Brook, New York, United States, 11790
      • DermResearchCenter of New York, Inc. /ID# 259906
  • Ohio
    • Columbus, Ohio, United States, 43213-4440
      • ClinOhio Research Services /ID# 260300
  • Oregon
    • Portland, Oregon, United States, 97210
      • Oregon Dermatology and Research Center /ID# 259917
    • Portland, Oregon, United States, 97201
      • Oregon Medical Research Center /ID# 259911
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina /ID# 259916
  • Texas
    • Bellaire, Texas, United States, 77401
      • Bellaire Dermatology Associates /ID# 260044
    • Dallas, Texas, United States, 75230
      • Dermatology Treatment and Research Center /ID# 260078
    • Plano, Texas, United States, 75024
      • Innovative Dermatology - Plano /ID# 260628
    • San Antonio, Texas, United States, 78229
      • Progressive Clinical Research /ID# 260070
    • San Antonio, Texas, United States, 78229
      • Dermatology Clinical Research Center of San Antonio /ID# 260047

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Documented clinical diagnosis of non-segmented vitiligo (NSV).

• At Screening and Baseline Visits, participants must satisfy at least 1 of the following criteria:

  • >= 0.5 F-VASI and 5 <= T-VASI < 50 AND have failed at least 1 topical corticosteroid and/or at least 1 topical calcineurin inhibitor for vitiligo; or
  • >= 0.5 F-VASI and 5 <= T-VASI < 50 AND have a sign of actively progressing vitiligo; or
  • >= 0.5 F-VASI and 10 <= T-VASI < 50.

Exclusion Criteria:

• Segmental or localized vitiligo.
• History of active skin disease other than vitiligo that could interfere with the assessment of vitiligo.
• >33% leukotrichia in areas of vitiligo on the face or > 33% leukotrichia in areas of vitiligo on the body (including the face).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

10

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Study 1, Period A: Group 2; Participants will receive placebo once daily for 48 weeks.	Drug: Placebo; Oral Tablets
Experimental: Study 1, Period A: Group 1; Participants will receive upadacitinib 15 mg once daily for 48 weeks.	Drug: Upadacitinib; Oral Tablets; Other Names: ABT-494; Rinvoq
Experimental: Study 2, Period A: Group 1; Participants will receive upadacitinib 15 mg once daily for 48 weeks.	Drug: Upadacitinib; Oral Tablets; Other Names: ABT-494; Rinvoq
Placebo Comparator: Study 2, Period A: Group 2; Participants will receive placebo once daily for 48 weeks.	Drug: Placebo; Oral Tablets
Experimental: Study 1, Period B: Group 1 Open-Label Extension Period; Participants that were randomized to receive upadacitinib in Period A Group 1, will continue to receive upadacitinib 15 mg once daily for 112 weeks in Period B.	Drug: Upadacitinib; Oral Tablets; Other Names: ABT-494; Rinvoq
Experimental: Study 1, Period B: Group 2 Open-Label Extension Period; Participants that were randomized to receive placebo in Period A Group 2, will receive upadacitinib 15 mg once daily for 112 weeks in Period B.	Drug: Upadacitinib; Oral Tablets; Other Names: ABT-494; Rinvoq
Experimental: Study 2, Period B: Group 1 Open-Label Extension Period; Participants that were randomized to receive upadacitinib in Period A Group 1, will continue to receive upadacitinib 15 mg once daily for 112 weeks in Period B.	Drug: Upadacitinib; Oral Tablets; Other Names: ABT-494; Rinvoq
Experimental: Study 2, Period B: Group 2 Open-Label Extension Period; Participants that were randomized to receive placebo in Period A Group 2, will receive upadacitinib 15 mg once daily for 112 weeks in Period B.	Drug: Upadacitinib; Oral Tablets; Other Names: ABT-494; Rinvoq
Experimental: (Optional) Study 3, Period B: Open Label Upadacitinib; Open Label Upadacitinib Participants will receive upadacitinib 15 mg once daily for 112 weeks	Drug: Upadacitinib; Oral Tablets; Other Names: ABT-494; Rinvoq; Other: NB-UVB (narrow-band ultraviolet B) Phototherapy; NB-UVB phototherapy is a commonly used treatment modality in participants with vitiligo and can be administered in an office setting or at home 2 times per week
Experimental: (Optional) Study 3: Participants will receive 15 mg upadacitinib once daily for 112 weeks and NB-UVB for up to 28 weeks	Drug: Upadacitinib; Oral Tablets; Other Names: ABT-494; Rinvoq; Other: NB-UVB (narrow-band ultraviolet B) Phototherapy; NB-UVB phototherapy is a commonly used treatment modality in participants with vitiligo and can be administered in an office setting or at home 2 times per week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving Total Vitiligo Area Scoring Index (T-VASI) 50 (≥ 50% Improvement in T-VASI From Baseline)	The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. It is based on a composite estimate of the overall area of vitiligo patches, measured by the number of hand units (palm plus 5 digits = 1% body surface area [BSA]) multiplied by the degree of depigmentation within each affected area (0%, 10%, 25%, 50%, 75%, 90%, or 100%). The T-VASI is calculated using a formula that includes contributions from all body regions, with a possible range from 0 to 100.	Week 48
Percentage of Participants Achieving Facial-Vitiligo Area Scoring Index (F-VASI) 75 (≥ 75% Improvement in F-VASI From Baseline)	The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. The F-VASI includes contributions from the face, with a possible range from 0 to 3.	Week 48

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving F-VASI 50 (≥ 50% Improvement in F-VASI From Baseline)	The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. The F-VASI includes contributions from the face, with a possible range from 0 to 3.	Week 48
Percentage of Participants Achieving F-VASI 75 (≥ 75% Improvement in F-VASI From Baseline)	The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. The F-VASI includes contributions from the face, with a possible range from 0 to 3.	Week 24
Percent Change from Baseline in F-VASI	The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. The F-VASI includes contributions from the face, with a possible range from 0 to 3.	Week 24
Percent Change From Baseline in T-VASI	The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. It is based on a composite estimate of the overall area of vitiligo patches, measured by the number of hand units (palm plus 5 digits = 1% body surface area [BSA]) multiplied by the degree of depigmentation within each affected area (0%, 10%, 25%, 50%, 75%, 90%, or 100%). The T-VASI is calculated using a formula that includes contributions from all body regions, with a possible range from 0 to 100.	Week 48
Percentage of Participants Achieving F-VASI 90 (≥ 90% Improvement in F-VASI From Baseline)	The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. The F-VASI includes contributions from the face, with a possible range from 0 to 3.	Week 48
Percentage of Participants Achieving T-VASI 75 (≥ 75% Improvement in T-VASI From Baseline)	The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. It is based on a composite estimate of the overall area of vitiligo patches, measured by the number of hand units (palm plus 5 digits = 1% body surface area [BSA]) multiplied by the degree of depigmentation within each affected area (0%, 10%, 25%, 50%, 75%, 90%, or 100%). The T-VASI is calculated using a formula that includes contributions from all body regions, with a possible range from 0 to 100.	Week 48
Percentage of Participants Achieving 3D Imaging Facial Vitiligo 40 (≥ 40% Reduction in Facial Vitiligo Area Measured by 3D Digital Imaging from Baseline) (Study 1 Only)	3D imaging will be used to objectively quantify the facial vitiligo area.	Week 48
EU/EMA Only: Percentage of Participants Achieving a Physician's Global Impression of Change - Vitiligo (PhGIC-V) of "Much better (1)"	The physician rates the overall change in the patients vitiligo by comparing the severity of vitiligo right now with the severity of vitiligo since the subject started the study treatment. Responses range from 1 = "Much better" to 5 = "Much worse."	At Week 48
EU/EMA Only: Percentage of Participants Achieving a Vitiligo Noticeability Scale (VNS) score of "A lot less noticeable (4)" or "No longer noticeable (5)"	The VNS is a single-item, validated questionnaire used in clinical trials to assess the noticeability of vitiligo lesions following therapy. The item is scored on a 5-point scale: 1 = more noticeable; 2 = as noticeable; 3 = slightly less noticeable; 4 = a lot less noticeable; and 5 = no longer noticeable. A score of 4 or 5 represents treatment success	At Week 48
EU/EMA Only: Percentage of Participants Achieving a Patient's Global Impression of Change-Vitiligo (PaGIC-V) of "Much better (1)"	The PaGIC-V asks participants to rate the overall change in their vitiligo by comparing the severity of their vitiligo right now with the severity of their vitiligo since they started the study treatment. Responses range from 1 = "Much better" to 5 = "Much worse."	At Week 48

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2023
• Primary Completion (Actual): September 23, 2025
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: November 1, 2023
• First Submitted That Met QC Criteria: November 1, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Actual): November 10, 2025
• Last Update Submitted That Met QC Criteria: November 7, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Upadacitinib; Vitiligo; Non-Segmented Vitiligo; Viti-Up
• Additional Relevant MeSH Terms: Skin Diseases; Hypopigmentation; Pigmentation Disorders; Skin and Connective Tissue Diseases; Vitiligo; Therapeutics; upadacitinib; Phototherapy
• Other Study ID Numbers: M19-044; 2023-506195-27-00 (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