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

April 24, 2024 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 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 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 or Study 2, 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 240 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

  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • Recruiting
        • Holdsworth House Medical Practice /ID# 258571
        • Contact:
          • Site Coordinator
          • Phone Number: (02) 9331 7228
      • Kogarah, New South Wales, Australia, 2217
        • Recruiting
        • St George Dermatology & Skin Cancer Centre /ID# 258567
    • Queensland
      • Coorparoo, Queensland, Australia, 4151
        • Recruiting
        • Cornerstone Dermatology /ID# 258769
      • Woolloongabba, Queensland, Australia, 4102
        • Recruiting
        • Veracity Clinical Research /ID# 258566
    • Victoria
      • Carlton, Victoria, Australia, 3053
        • Recruiting
        • Skin Health Institute Inc /ID# 258570
        • Contact:
          • Site Coordinator
          • Phone Number: 9623 9465
      • East Melbourne, Victoria, Australia, 3002
        • Recruiting
        • Sinclair Dermatology - Melbourne /ID# 258565
      • Parkville, Victoria, Australia, 3050
        • Recruiting
        • The Royal Melbourne Hospital /ID# 258770
    • Western Australia
      • Fremantle, Western Australia, Australia, 6160
        • Recruiting
        • Fremantle Dermatology /ID# 260207
  • Brazil
      • Rio de Janeiro, Brazil, 20241-180
        • Recruiting
        • Instituto Brasil de Pesquisa Clinica S.A - IBPClin /ID# 258750
  • Canada
    • British Columbia
      • Surrey, British Columbia, Canada, V3R 6A7
        • Recruiting
        • Dr. Chih-ho Hong Medical Inc. /ID# 258814
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3M 3Z4
        • Recruiting
        • Wiseman Dermatology Research /ID# 258819
    • Ontario
      • Barrie, Ontario, Canada, L4M 7G1
        • Recruiting
        • SimcoDerm Medical and Surgical Dermatology Center /ID# 258820
        • Contact:
          • Site Coordinator
          • Phone Number: 647-202-6393
      • Markham, Ontario, Canada, L3P 1X2
        • Recruiting
        • Lynde Institute for Dermatology /ID# 258815
      • Ottawa, Ontario, Canada, K1H 7X3
        • Recruiting
        • JRB Research /ID# 259248
      • Peterborough, Ontario, Canada, K9J 5K2
        • Recruiting
        • SKiN Centre for Dermatology /ID# 258813
        • Contact:
          • Site Coordinator
          • Phone Number: (705) 874-1533
      • Waterloo, Ontario, Canada, N2J 1C4
        • Recruiting
        • Private Practice - Dr. Kim Papp Clinical Research /ID# 259249
    • Quebec
      • Québec, Quebec, Canada, G1V 4X7
        • Recruiting
        • Centre de Recherche dermatologique du Quebec Metropolitain /ID# 258811
        • Contact:
          • Site Coordinator
          • Phone Number: 418-650-5161
  • China
      • Chongqing, China, 400010
        • Recruiting
        • The Second Affiliated Hospital of Chongqing Medical University /ID# 260254
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Recruiting
        • The First Affiliated Hospital, Sun Yat-sen University /ID# 257367
      • Guangzhou, Guangdong, China, 510163
        • Recruiting
        • The First Affiliated Hospital of Guangzhou Medical University /ID# 258663
      • Guangzhou, Guangdong, China, 510091
        • Recruiting
        • Dermatology Hospital of Southern Medical University /ID# 257118
      • Shenzhen, Guangdong, China, 518020
        • Recruiting
        • Shenzhen People's Hospital /ID# 258208
      • Shenzhen, Guangdong, China, 518039
        • Recruiting
        • Shenzhen Second People's Hospital /ID# 258060
    • Jiangxi
      • Nanchang, Jiangxi, China, 330030
        • Recruiting
        • Dermatology Hospital of Jiangxi Provincial /ID# 259488
    • Jilin
      • Changchun, Jilin, China, 130021
        • Recruiting
        • The First Hospital of Jilin University /ID# 257496
    • Shanghai
      • Shanghai, Shanghai, China, 200040
        • Recruiting
        • Huashan Hospital, Fudan University /ID# 257758
    • Sichuan
      • Chengdu, Sichuan, China, 610017
        • Recruiting
        • Chengdu Second Municipal People's Hospital /ID# 259492
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • West China Hospital, Sichuan University /ID# 259560
    • Tianjin
      • Tianjin, Tianjin, China, 300052
        • Recruiting
        • Tianjin Medical University General Hospital /ID# 259525
  • Japan
      • Mitaka, Japan, 181-8611
        • Recruiting
        • Kyorin University - Mitaka Campus /ID# 257283
    • Fukuoka
      • Kurume-shi, Fukuoka, Japan, 830-0011
        • Recruiting
        • Kurume University Hospital /ID# 257255
    • Kanagawa
      • Sagamihara-shi, Kanagawa, Japan, 252-0375
        • Recruiting
        • Kitasato University Hospital /ID# 257285
    • Niigata
      • Niigata-shi, Niigata, Japan, 951-8520
        • Recruiting
        • Niigata University Medical & Dental Hospital /ID# 259425
    • Osaka
      • Osaka-shi, Osaka, Japan, 545-8586
        • Recruiting
        • Osaka Metropolitan University Hospital /ID# 257256
    • Shizuoka
      • Hamamatsu-shi, Shizuoka, Japan, 431-3192
        • Recruiting
        • Hamamatsu University Hospital /ID# 257253
    • Tokyo
      • Shinjuku-ku, Tokyo, Japan, 160-0023
        • Recruiting
        • Tokyo Medical University Hospital /ID# 258132
    • Yamaguchi
      • Ube-shi, Yamaguchi, Japan, 755-8505
        • Recruiting
        • Yamaguchi University Hospital /ID# 257252
  • New Zealand
      • Hamilton, New Zealand, 3204
        • Recruiting
        • Clinical Trials New Zealand /ID# 258564
      • Wellington, New Zealand, 6021
        • Recruiting
        • P3 Research Ltd /ID# 259846
    • Auckland
      • Epsom, Auckland, New Zealand, 1051
        • Recruiting
        • Greenlane Clinical Centre /ID# 258563
      • Otahuhu, Auckland, New Zealand, 2025
        • Recruiting
        • Middlemore Hospital /ID# 258562
  • Puerto Rico
      • Bayamon, Puerto Rico, 00961-6910
        • Recruiting
        • Santa Cruz Behavioral (SCB) Research Center /ID# 259350
      • Caguas, Puerto Rico, 00727
        • Recruiting
        • Dr. Samuel Sanchez PSC /ID# 259359
        • Contact:
          • Site Coordinator
          • Phone Number: 787-429-6644
      • San Juan, Puerto Rico, 00909
        • Recruiting
        • Clinical Research Puerto Rico /ID# 259355
        • Contact:
          • Site Coordinator
          • Phone Number: 787-723-5945
      • San Juan, Puerto Rico, 00917-3104
        • Recruiting
        • GCM Medical Group PSC /ID# 258013
      • San Juan, Puerto Rico, 00918-3756
        • Recruiting
        • Mindful Medical Research /ID# 260113
  • United Kingdom
      • Harrow, United Kingdom, HA1 3UJ
        • Recruiting
        • London North West University Healthcare NHS Trust /ID# 257914
      • London, United Kingdom, SW10 9NH
        • Recruiting
        • Chelsea and Westminster Hospital NHS Foundation Trust /ID# 259128
        • Contact:
          • Site Coordinator
          • Phone Number: 44 20 335 8000
      • Salford, United Kingdom, M6 8HD
        • Recruiting
        • Northern Care Alliance NHS Group /ID# 257952
    • Buckinghamshire
      • High Wycombe, Buckinghamshire, United Kingdom, HP11 2QW
        • Recruiting
        • Velocity Clinical Research Ltd /ID# 257925
        • Contact:
          • Site Coordinator
          • Phone Number: +44 7748 505888
    • West Sussex
      • Worthing, West Sussex, United Kingdom, BN11 2DH
        • Recruiting
        • University Hospitals Sussex NHS Foundation Trust /ID# 257912
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Recruiting
        • Total Skin and Beauty Dermatology Center /ID# 259539
    • Arizona
      • Glendale, Arizona, United States, 85308
        • Recruiting
        • Advanced Research Associates - Glendale /ID# 259108
      • Phoenix, Arizona, United States, 85032
        • Recruiting
        • Alliance Dermatology and MOHs Center, PC /ID# 258111
      • Phoenix, Arizona, United States, 85018-3953
        • Recruiting
        • Southwest Skin Specialists /ID# 258234
    • Arkansas
      • Fort Smith, Arkansas, United States, 72916-6103
        • Recruiting
        • Johnson Dermatology Clinic /ID# 259103
    • California
      • Encino, California, United States, 91436
        • Recruiting
        • Private Practice - Dr. Joseph Raoof /ID# 258031
        • Contact:
          • Site Coordinator
          • Phone Number: 818-788-5060 opt 2
      • Fountain Valley, California, United States, 92708-3701
        • Recruiting
        • First OC Dermatology Research /ID# 259220
      • Los Angeles, California, United States, 90045
        • Recruiting
        • Dermatology Research Associates /ID# 258033
      • 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, 95816-3300
        • Recruiting
        • UC 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
        • Recruiting
        • Apex Clinical Trials /ID# 259205
        • Contact:
          • Site Coordinator
          • Phone Number: +1-813-321-1786
      • Coral Gables, Florida, United States, 33134-5755
        • Recruiting
        • Florida Academic Dermatology Center /ID# 259353
      • Doral, Florida, United States, 33122-1902
        • Recruiting
        • Revival Research /ID# 259213
        • Contact:
          • Site Coordinator
          • Phone Number: 786-518-5129
      • 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
        • Recruiting
        • Life Clinical Trials - Margate - FL-7 /ID# 259358
      • Miami, Florida, United States, 33172
        • Recruiting
        • Lenus Research and Medical Group /ID# 259356
      • Sanford, Florida, United States, 32771
        • Recruiting
        • International Clinical Research - Sanford /ID# 259547
      • Tampa, Florida, United States, 33613-1825
        • Recruiting
        • Avita Clinical Research /ID# 258011
        • Contact:
          • Site Coordinator
          • Phone Number: +1-813-603-1800
      • Tampa, Florida, United States, 33607
        • Recruiting
        • Advanced Clinical Research Institute /ID# 259204
        • Contact:
          • Site Coordinator
          • Phone Number: 1-813-362-1037
    • Georgia
      • Dawsonville, Georgia, United States, 30534
        • Recruiting
        • Cleaver Medical Group Dermatology /ID# 259801
        • Contact:
          • Site Coordinator
          • Phone Number: 770-746-6369
      • Marietta, Georgia, United States, 30060
        • Recruiting
        • Marietta Dermatology /ID# 259818
    • Kansas
      • Leawood, Kansas, United States, 66211-1453
        • Recruiting
        • U.S. Dermatology Partners Leawood /ID# 259203
        • Contact:
          • Site Coordinator
          • Phone Number: 913-451-7546
    • Massachusetts
      • Boston, Massachusetts, United States, 02135-3511
        • Recruiting
        • MetroBoston Clinical Partners /ID# 259559
        • Contact:
          • Site Coordinator
          • Phone Number: 617-789-5300
    • Michigan
      • Bay City, Michigan, United States, 48706
        • Recruiting
        • Great Lakes Research Group - Bay City /ID# 259100
      • Canton, Michigan, United States, 48187
        • Recruiting
        • Hamzavi Dermatology - Canton /ID# 260115
      • Chesterfield, Michigan, United States, 48047
        • Recruiting
        • Clin Res Inst of Michigan, LLC /ID# 259802
        • Contact:
          • Site Coordinator
          • Phone Number: 586.598.3329
      • Clarkston, Michigan, United States, 48346
        • Recruiting
        • Clarkston Dermatology /ID# 258018
      • Detroit, Michigan, United States, 48202-3046
        • Recruiting
        • Henry Ford Medical Center /ID# 258067
    • Minnesota
      • New Brighton, Minnesota, United States, 55112
        • Recruiting
        • Minnesota Clinical Study Center /ID# 259218
    • Missouri
      • Lee's Summit, Missouri, United States, 64064-2301
        • Recruiting
        • Dermatology and Skin Center of Lees Summit /ID# 259206
        • Contact:
          • Site Coordinator
          • Phone Number: 913-451-7546
    • Nebraska
      • Lincoln, Nebraska, United States, 68516
        • Recruiting
        • Physician Research Collaboration, LLC /ID# 259354
      • Omaha, Nebraska, United States, 68144
        • Recruiting
        • Skin Specialists, PC /ID# 259237
        • Contact:
          • Site Coordinator
          • Phone Number: 402-697-6599
    • Nevada
      • Reno, Nevada, United States, 89509
        • Recruiting
        • Skin Cancer and Dermatology Institute - Reno /ID# 259208
        • Contact:
          • Site Coordinator
          • Phone Number: 775-336-3665
    • New Jersey
      • East Windsor, New Jersey, United States, 08520
        • Recruiting
        • Psoriasis Treatment Center of Central New Jersey /ID# 258007
      • Verona, New Jersey, United States, 07044-2946
        • Recruiting
        • Schweiger Dermatology, P.C. /ID# 259531
    • New York
      • New York, New York, United States, 10029
        • Recruiting
        • Icahn School of Medicine at Mount Sinai /ID# 259808
    • Ohio
      • Columbus, Ohio, United States, 43215
        • Recruiting
        • Remington-Davis Clinical Research /ID# 258106
        • Contact:
          • Site Coordinator
          • Phone Number: 614-487-2560
      • Mason, Ohio, United States, 45040-4520
        • Recruiting
        • Dermatologists of Southwest Ohio, Inc /ID# 260116
        • Contact:
          • Site Coordinator
          • Phone Number: 513-701-5526
    • Oregon
      • Portland, Oregon, United States, 97210
        • Recruiting
        • Oregon Dermatology and Research Center /ID# 258243
      • Portland, Oregon, United States, 97223
        • Recruiting
        • Oregon Medical Research Center /ID# 258107
    • South Carolina
      • Charleston, South Carolina, United States, 29425-8903
        • Recruiting
        • MUSC - Rutledge Tower /ID# 259828
    • 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, 75235-2519
        • Recruiting
        • Reveal Research Institute, Dallas /ID# 259361
      • Dallas, Texas, United States, 75231
        • Recruiting
        • Modern Research Associates, PLLC /ID# 259349
        • Contact:
          • Site Coordinator
          • Phone Number: 214-361-2008
      • Houston, Texas, United States, 77065
        • Recruiting
        • Center for Clinical Studies /ID# 258036
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Progressive Clinical Research /ID# 259365
      • Sugar Land, Texas, United States, 77479-3794
        • Recruiting
        • Complete Dermatology /ID# 258025
        • Contact:
          • Site Coordinator
          • Phone Number: 281-240-4313

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 (OUS), adolescent individuals who are at least 12 years old at Screening may participate.
  • 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 AND no significant scalp hair loss over the past 3 months.
  • Current episode of AA of less than 8 years.

Exclusion Criteria:

  • Diagnosis of primarily diffuse type of AA.
  • 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, 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

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants with the Achievement of SALT Score <= 10
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
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 ClinRO Measure for Eyelash 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 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
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

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)

May 26, 2025

Study Completion (Estimated)

January 22, 2028

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 (Estimated)

April 26, 2024

Last Update Submitted That Met QC Criteria

April 24, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M23-716
  • 2023-505061-82-00 (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 data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

IPD Sharing Time Frame

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

IPD Sharing Access Criteria

Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on 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
  • CSR

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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