A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants With Severe Alopecia Areata
Study Purpose
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.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 12 Years - 63 Years |
Gender | All |
Inclusion Criteria:
- - Adult individuals must be < 64 years old at Baseline Visit.
- - 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.
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT06012240 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
AbbVie |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
ABBVIE INC. |
Principal Investigator Affiliation | AbbVie |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Recruiting |
Countries | Australia, Brazil, Canada, China, Japan, New Zealand, Puerto Rico, United Kingdom, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Alopecia Areata |
Study Website: | View Trial Website |
Arms
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.
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.
Experimental: Study 1: Group 3 Placebo
Participants will receive matching placebo once daily for 24 weeks in Period A.
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.
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.
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.
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.
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.
Experimental: Study 2: Group 3 Placebo
Participants will receive matching placebo once daily for 24 weeks in Period A.
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.
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.
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.
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.
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.
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.
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.
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.
Interventions
Drug: - Upadacitinib
Oral Tablets
Drug: - Placebo
Oral Tablets
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Recruiting
Address
Total Skin and Beauty Dermatology Center /ID# 259539
Birmingham, Alabama, 35205
Status
Recruiting
Address
Advanced Research Associates - Glendale /ID# 259108
Glendale, Arizona, 85308
Status
Recruiting
Address
Southwest Skin Specialists /ID# 258234
Phoenix, Arizona, 85018-3953
Status
Recruiting
Address
Alliance Dermatology and MOHs Center, PC /ID# 258111
Phoenix, Arizona, 85032
Status
Recruiting
Address
Johnson Dermatology Clinic /ID# 259103
Fort Smith, Arkansas, 72916-6103
Status
Recruiting
Address
Private Practice - Dr. Joseph Raoof /ID# 258031
Encino, California, 91436
Status
Recruiting
Address
First OC Dermatology Research /ID# 259220
Fountain Valley, California, 92708-3701
Status
Recruiting
Address
Dermatology Research Associates /ID# 258033
Los Angeles, California, 90045
Status
Recruiting
Address
Integrative Skin Science and Research /ID# 258114
Sacramento, California, 95815
Status
Recruiting
Address
UC Davis Health /ID# 258112
Sacramento, California, 95816-3300
Status
Recruiting
Address
Clinical Trials Research Institute /ID# 258021
Thousand Oaks, California, 91320-2130
Status
Recruiting
Address
Skin Care Research Boca Raton /ID# 258012
Boca Raton, Florida, 33486-2269
Status
Recruiting
Address
Apex Clinical Trials /ID# 259205
Brandon, Florida, 33511
Status
Recruiting
Address
Florida Academic Dermatology Center /ID# 259353
Coral Gables, Florida, 33134-5755
Status
Recruiting
Address
Revival Research /ID# 259213
Doral, Florida, 33122-1902
Status
Recruiting
Address
Skin Care Research - Hollywood /ID# 259210
Hollywood, Florida, 33021-6748
Status
Recruiting
Address
GSI Clinical Research, LLC /ID# 259352
Margate, Florida, 33063
Status
Recruiting
Address
Life Clinical Trials - Margate - FL-7 /ID# 259358
Margate, Florida, 33063
Status
Recruiting
Address
Lenus Research and Medical Group /ID# 259356
Miami, Florida, 33172
Status
Recruiting
Address
International Clinical Research - Sanford /ID# 259547
Sanford, Florida, 32771
Status
Recruiting
Address
Advanced Clinical Research Institute /ID# 259204
Tampa, Florida, 33607
Status
Recruiting
Address
Avita Clinical Research /ID# 258011
Tampa, Florida, 33613-1825
Status
Recruiting
Address
Cleaver Medical Group Dermatology /ID# 259801
Dawsonville, Georgia, 30534
Status
Recruiting
Address
Marietta Dermatology /ID# 259818
Marietta, Georgia, 30060
Status
Recruiting
Address
U.S. Dermatology Partners Leawood /ID# 259203
Leawood, Kansas, 66211-1453
Status
Recruiting
Address
MetroBoston Clinical Partners /ID# 259559
Boston, Massachusetts, 02135-3511
Status
Recruiting
Address
Great Lakes Research Group - Bay City /ID# 259100
Bay City, Michigan, 48706
Status
Recruiting
Address
Hamzavi Dermatology - Canton /ID# 260115
Canton, Michigan, 48187
Status
Recruiting
Address
Clin Res Inst of Michigan, LLC /ID# 259802
Chesterfield, Michigan, 48047
Status
Recruiting
Address
Clarkston Dermatology /ID# 258018
Clarkston, Michigan, 48346
Status
Recruiting
Address
Henry Ford Medical Center /ID# 258067
Detroit, Michigan, 48202-3046
Status
Recruiting
Address
Minnesota Clinical Study Center /ID# 259218
New Brighton, Minnesota, 55112
Status
Recruiting
Address
Dermatology and Skin Center of Lees Summit /ID# 259206
Lee's Summit, Missouri, 64064-2301
Status
Recruiting
Address
Physician Research Collaboration, LLC /ID# 259354
Lincoln, Nebraska, 68516
Status
Recruiting
Address
Skin Specialists, PC /ID# 259237
Omaha, Nebraska, 68144
Status
Recruiting
Address
Skin Cancer and Dermatology Institute - Reno /ID# 259208
Reno, Nevada, 89509
Status
Recruiting
Address
Psoriasis Treatment Center of Central New Jersey /ID# 258007
East Windsor, New Jersey, 08520
Status
Recruiting
Address
Schweiger Dermatology, P.C. /ID# 259531
Verona, New Jersey, 07044-2946
Status
Recruiting
Address
Icahn School of Medicine at Mount Sinai /ID# 259808
New York, New York, 10029
Status
Recruiting
Address
Remington-Davis Clinical Research /ID# 258106
Columbus, Ohio, 43215
Status
Recruiting
Address
Dermatologists of Southwest Ohio, Inc /ID# 260116
Mason, Ohio, 45040-4520
Status
Recruiting
Address
Oregon Dermatology and Research Center /ID# 258243
Portland, Oregon, 97210
Status
Recruiting
Address
Oregon Medical Research Center /ID# 258107
Portland, Oregon, 97223
Status
Recruiting
Address
MUSC - Rutledge Tower /ID# 259828
Charleston, South Carolina, 29425-8903
Status
Recruiting
Address
International Clinical Research - Tennessee LLC /ID# 259552
Murfreesboro, Tennessee, 37130-2450
Status
Recruiting
Address
Arlington Research Center, Inc /ID# 258028
Arlington, Texas, 76011
Status
Recruiting
Address
Bellaire Dermatology Associates /ID# 259360
Bellaire, Texas, 77401
Status
Recruiting
Address
U.S. Dermatology Partners - Cedar Park /ID# 259367
Cedar Park, Texas, 78613
Status
Recruiting
Address
Dermatology Treatment and Research Center /ID# 259357
Dallas, Texas, 75230
Status
Recruiting
Address
Modern Research Associates, PLLC /ID# 259349
Dallas, Texas, 75231
Status
Recruiting
Address
Reveal Research Institute, Dallas /ID# 259361
Dallas, Texas, 75235-2519
Status
Recruiting
Address
Center for Clinical Studies /ID# 258036
Houston, Texas, 77065
Status
Recruiting
Address
Progressive Clinical Research /ID# 259365
San Antonio, Texas, 78229
Status
Recruiting
Address
Complete Dermatology /ID# 258025
Sugar Land, Texas, 77479-3794
International Sites
Status
Recruiting
Address
Holdsworth House Medical Practice /ID# 258571
Darlinghurst, New South Wales, 2010
Status
Recruiting
Address
St George Dermatology & Skin Cancer Centre /ID# 258567
Kogarah, New South Wales, 2217
Status
Recruiting
Address
Cornerstone Dermatology /ID# 258769
Coorparoo, Queensland, 4151
Status
Recruiting
Address
Veracity Clinical Research /ID# 258566
Woolloongabba, Queensland, 4102
Status
Recruiting
Address
Skin Health Institute Inc /ID# 258570
Carlton, Victoria, 3053
Status
Recruiting
Address
Sinclair Dermatology - Melbourne /ID# 258565
East Melbourne, Victoria, 3002
Status
Recruiting
Address
The Royal Melbourne Hospital /ID# 258770
Parkville, Victoria, 3050
Status
Recruiting
Address
Fremantle Dermatology /ID# 260207
Fremantle, Western Australia, 6160
Status
Recruiting
Address
Instituto Brasil de Pesquisa Clinica S.A - IBPClin /ID# 258750
Rio de Janeiro, , 20241-180
Status
Recruiting
Address
Dr. Chih-ho Hong Medical Inc. /ID# 258814
Surrey, British Columbia, V3R 6A7
Status
Recruiting
Address
Wiseman Dermatology Research /ID# 258819
Winnipeg, Manitoba, R3M 3Z4
Status
Recruiting
Address
SimcoDerm Medical and Surgical Dermatology Center /ID# 258820
Barrie, Ontario, L4M 7G1
Status
Recruiting
Address
Lynde Institute for Dermatology /ID# 258815
Markham, Ontario, L3P 1X2
Status
Recruiting
Address
JRB Research /ID# 259248
Ottawa, Ontario, K1H 7X3
Status
Recruiting
Address
SKiN Centre for Dermatology /ID# 258813
Peterborough, Ontario, K9J 5K2
Status
Recruiting
Address
Private Practice - Dr. Kim Papp Clinical Research /ID# 259249
Waterloo, Ontario, N2J 1C4
Status
Recruiting
Address
Centre de Recherche dermatologique du Quebec Metropolitain /ID# 258811
Québec, Quebec, G1V 4X7
Status
Recruiting
Address
The First Affiliated Hospital, Sun Yat-sen University /ID# 257367
Guangzhou, Guangdong, 510080
Status
Recruiting
Address
Dermatology Hospital of Southern Medical University /ID# 257118
Guangzhou, Guangdong, 510091
Status
Recruiting
Address
The First Affiliated Hospital of Guangzhou Medical University /ID# 258663
Guangzhou, Guangdong, 510163
Status
Recruiting
Address
Shenzhen People's Hospital /ID# 258208
Shenzhen, Guangdong, 518020
Status
Recruiting
Address
Shenzhen Second People's Hospital /ID# 258060
Shenzhen, Guangdong, 518039
Status
Recruiting
Address
Dermatology Hospital of Jiangxi Provincial /ID# 259488
Nanchang, Jiangxi, 330030
Status
Recruiting
Address
The First Hospital of Jilin University /ID# 257496
Changchun, Jilin, 130021
Status
Recruiting
Address
Huashan Hospital, Fudan University /ID# 257758
Shanghai, Shanghai, 200040
Status
Recruiting
Address
Chengdu Second Municipal People's Hospital /ID# 259492
Chengdu, Sichuan, 610017
Status
Recruiting
Address
West China Hospital, Sichuan University /ID# 259560
Chengdu, Sichuan, 610041
Status
Recruiting
Address
Tianjin Medical University General Hospital /ID# 259525
Tianjin, Tianjin, 300052
Status
Recruiting
Address
The Second Affiliated Hospital of Chongqing Medical University /ID# 260254
Chongqing, , 400010
Status
Recruiting
Address
Kurume University Hospital /ID# 257255
Kurume-shi, Fukuoka, 830-0011
Status
Recruiting
Address
Kitasato University Hospital /ID# 257285
Sagamihara-shi, Kanagawa, 252-0375
Status
Recruiting
Address
Niigata University Medical & Dental Hospital /ID# 259425
Niigata-shi, Niigata, 951-8520
Status
Recruiting
Address
Osaka Metropolitan University Hospital /ID# 257256
Osaka-shi, Osaka, 545-8586
Status
Recruiting
Address
Hamamatsu University Hospital /ID# 257253
Hamamatsu-shi, Shizuoka, 431-3192
Status
Recruiting
Address
Tokyo Medical University Hospital /ID# 258132
Shinjuku-ku, Tokyo, 160-0023
Status
Recruiting
Address
Yamaguchi University Hospital /ID# 257252
Ube-shi, Yamaguchi, 755-8505
Status
Recruiting
Address
Kyorin University - Mitaka Campus /ID# 257283
Mitaka, , 181-8611
Status
Recruiting
Address
Greenlane Clinical Centre /ID# 258563
Epsom, Auckland, 1051
Status
Recruiting
Address
Middlemore Hospital /ID# 258562
Otahuhu, Auckland, 2025
Status
Recruiting
Address
Clinical Trials New Zealand /ID# 258564
Hamilton, , 3204
Status
Recruiting
Address
P3 Research Ltd /ID# 259846
Wellington, , 6021
Status
Recruiting
Address
Santa Cruz Behavioral (SCB) Research Center /ID# 259350
Bayamon, , 00961-6910
Status
Recruiting
Address
Dr. Samuel Sanchez PSC /ID# 259359
Caguas, , 00727
Status
Recruiting
Address
Clinical Research Puerto Rico /ID# 259355
San Juan, , 00909
Status
Recruiting
Address
GCM Medical Group PSC /ID# 258013
San Juan, , 00917-3104
Status
Recruiting
Address
Mindful Medical Research /ID# 260113
San Juan, , 00918-3756
Status
Recruiting
Address
Velocity Clinical Research Ltd /ID# 257925
High Wycombe, Buckinghamshire, HP11 2QW
Status
Recruiting
Address
University Hospitals Sussex NHS Foundation Trust /ID# 257912
Worthing, West Sussex, BN11 2DH
Status
Recruiting
Address
London North West University Healthcare NHS Trust /ID# 257914
Harrow, , HA1 3UJ
Status
Recruiting
Address
Chelsea and Westminster Hospital NHS Foundation Trust /ID# 259128
London, , SW10 9NH
Status
Recruiting
Address
Northern Care Alliance NHS Group /ID# 257952
Salford, , M6 8HD