Psoriasis Clinical Trial

A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants With Severe Alopecia Areata

Summary

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.

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

1500

Study ID:

NCT06012240

Recruitment Status:

Recruiting

Sponsor:

AbbVie

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There are 113 Locations for this study

See Locations Near You

Total Skin and Beauty Dermatology Center /ID# 259539
Birmingham Alabama, 35205, United States
Advanced Research Associates - Glendale /ID# 259108
Glendale Arizona, 85308, United States
Southwest Skin Specialists /ID# 258234
Phoenix Arizona, 85018, United States
Alliance Dermatology and MOHs Center, PC /ID# 258111
Phoenix Arizona, 85032, United States
Johnson Dermatology Clinic /ID# 259103
Fort Smith Arkansas, 72916, United States
Joseph Raoof Md,Inc /Id# 258031
Encino California, 91436, United States More Info
Site Coordinator
Contact
818-788-5060 opt 2
First OC Dermatology /ID# 259220
Fountain Valley California, 92708, United States
University of California Irvine /ID# 259096
Irvine California, 92697, United States
Dermatology Research Associates /ID# 258033
Los Angeles California, 90045, United States
Integrative Skin Science and Research /ID# 258114
Sacramento California, 95815, United States More Info
Site Coordinator
Contact
(916) 524-1216
University of California Davis Health /ID# 258112
Sacramento California, 95817, United States More Info
Site Coordinator
Contact
916-551-2635
Clinical Trials Research Institute /ID# 258021
Thousand Oaks California, 91320, United States
Skin Care Research Boca Raton /ID# 258012
Boca Raton Florida, 33486, United States More Info
Site Coordinator
Contact
+1-561-948-3116
Apex Clinical Trials /ID# 259205
Brandon Florida, 33511, United States More Info
Site Coordinator
Contact
+1-813-321-1786
Florida Academic Dermatology Center /ID# 259353
Coral Gables Florida, 33134, United States
Revival Research /ID# 259213
Doral Florida, 33122, United States More Info
Site Coordinator
Contact
786-518-5129
Skin Care Research - Hollywood /ID# 259210
Hollywood Florida, 33021, United States More Info
Site Coordinator
Contact
+1-561-948-3116
GSI Clinical Research, LLC /ID# 259352
Margate Florida, 33063, United States
Life Clinical Trials - Margate - FL-7 /ID# 259358
Margate Florida, 33063, United States
Lenus Research and Medical Group /ID# 259356
Miami Florida, 33172, United States
International Clinical Research - Sanford /ID# 259547
Sanford Florida, 32771, United States
Advanced Clinical Research Institute /ID# 259204
Tampa Florida, 33607, United States More Info
Site Coordinator
Contact
1-813-362-1037
Avita Clinical Research /ID# 258011
Tampa Florida, 33613, United States More Info
Site Coordinator
Contact
+1-813-603-1800
Cleaver Medical Group Dermatology /ID# 259801
Dawsonville Georgia, 30534, United States More Info
Site Coordinator
Contact
770-746-6369
Marietta Dermatology /ID# 259818
Marietta Georgia, 30060, United States
U.S. Dermatology Partners Leawood /ID# 259203
Leawood Kansas, 66211, United States More Info
Site Coordinator
Contact
913-451-7546
MetroBoston Clinical Partners /ID# 259559
Boston Massachusetts, 02135, United States More Info
Site Coordinator
Contact
617-789-5300
Lahey Hospital & Medical Center /ID# 260484
Burlington Massachusetts, 01805, United States More Info
Site Coordinator
Contact
781-744-1375
Great Lakes Research Group - Bay City /ID# 259100
Bay City Michigan, 48706, United States
Hamzavi Dermatology - Canton /ID# 260115
Canton Michigan, 48187, United States
Clin Res Inst of Michigan, LLC /ID# 259802
Chesterfield Michigan, 48047, United States More Info
Site Coordinator
Contact
586.598.3329
Clarkston Dermatology /ID# 258018
Clarkston Michigan, 48346, United States
Henry Ford Medical Center - New Center One /ID# 258067
Detroit Michigan, 48202, United States
Minnesota Clinical Study Center /ID# 259218
New Brighton Minnesota, 55112, United States
Dermatology and Skin Center of Lees Summit /ID# 259206
Lee's Summit Missouri, 64064, United States More Info
Site Coordinator
Contact
913-451-7546
Physician Research Collaboration, LLC /ID# 259354
Lincoln Nebraska, 68516, United States
Skin Specialists, PC /ID# 259237
Omaha Nebraska, 68144, United States More Info
Site Coordinator
Contact
402-697-6599
Skin Cancer and Dermatology Institute - Reno /ID# 259208
Reno Nevada, 89509, United States More Info
Site Coordinator
Contact
775-336-3665
Psoriasis Treatment Center of Central New Jersey /ID# 258007
East Windsor New Jersey, 08520, United States
Schweiger Dermatology, P.C. /ID# 259531
Verona New Jersey, 07044, United States
Icahn School of Medicine at Mount Sinai /ID# 259808
New York New York, 10029, United States
Remington-Davis Clinical Research /ID# 258106
Columbus Ohio, 43215, United States More Info
Site Coordinator
Contact
614-487-2560
Dermatologists of Southwest Ohio, Inc /ID# 260116
Mason Ohio, 45040, United States More Info
Site Coordinator
Contact
513-701-5526
Oregon Dermatology and Research Center /ID# 258243
Portland Oregon, 97210, United States
Oregon Medical Research Center /ID# 258107
Portland Oregon, 97223, United States
MUSC - Rutledge Tower /ID# 259828
Charleston South Carolina, 29425, United States
International Clinical Research - Tennessee LLC /ID# 259552
Murfreesboro Tennessee, 37130, United States
Arlington Research Center, Inc /ID# 258028
Arlington Texas, 76011, United States
Bellaire Dermatology Associates /ID# 259360
Bellaire Texas, 77401, United States
U.S. Dermatology Partners - Cedar Park /ID# 259367
Cedar Park Texas, 78613, United States More Info
Site Coordinator
Contact
512-260-5860
Dermatology Treatment and Research Center /ID# 259357
Dallas Texas, 75230, United States
Modern Research Associates, PLLC /ID# 259349
Dallas Texas, 75231, United States More Info
Site Coordinator
Contact
214-361-2008
Reveal Research Institute, Dallas /ID# 259361
Dallas Texas, 75235, United States
Center for Clinical Studies - Houston - Northwest Freeway /ID# 258036
Houston Texas, 77065, United States
Progressive Clinical Research /ID# 259365
San Antonio Texas, 78229, United States
Complete Dermatology /ID# 258025
Sugar Land Texas, 77479, United States More Info
Site Coordinator
Contact
281-240-4313
Holdsworth House Medical Practice /ID# 258571
Darlinghurst New South Wales, 2010, Australia More Info
Site Coordinator
Contact
(02) 9331 7228
St George Dermatology & Skin Cancer Centre /ID# 258567
Kogarah New South Wales, 2217, Australia
Cornerstone Dermatology /ID# 258769
Coorparoo Queensland, 4151, Australia
Veracity Clinical Research /ID# 258566
Woolloongabba Queensland, 4102, Australia
Skin Health Institute Inc /ID# 258570
Carlton Victoria, 3053, Australia More Info
Site Coordinator
Contact
9623 9465
Sinclair Dermatology - Melbourne /ID# 258565
East Melbourne Victoria, 3002, Australia
The Royal Melbourne Hospital /ID# 258770
Parkville Victoria, 3050, Australia
Fremantle Dermatology /ID# 260207
Fremantle Western Australia, 6160, Australia
Irmandade da Santa Casa de Misericordia de Porto Alegre /ID# 258045
Porto Alegre Rio Grande Do Sul, 90020, Brazil
Instituto Brasil de Pesquisa Clinica S.A - IBPClin /ID# 258750
Rio de Janeiro , 20241, Brazil
Hospital Alemao Oswaldo Cruz /ID# 258104
Sao Paulo , 01323, Brazil
Dr. Chih-ho Hong Medical Inc. /ID# 258814
Surrey British Columbia, V3R 6, Canada
Wiseman Dermatology Research /ID# 258819
Winnipeg Manitoba, R3M 3, Canada
SimcoDerm Medical and Surgical Dermatology Center /ID# 258820
Barrie Ontario, L4M 7, Canada More Info
Site Coordinator
Contact
647-202-6393
Lynde Institute for Dermatology /ID# 258815
Markham Ontario, L3P 1, Canada
JRB Research /ID# 259248
Ottawa Ontario, K1H 7, Canada
SKiN Centre for Dermatology /ID# 258813
Peterborough Ontario, K9J 5, Canada More Info
Site Coordinator
Contact
(705) 874-1533
Private Practice - Dr. Kim Papp Clinical Research /ID# 259249
Waterloo Ontario, N2J 1, Canada
Innovaderm Research Inc. /ID# 258812
Montréal Quebec, H2X 2, Canada More Info
Site Coordinator
Contact
514-521-3111
Centre de Recherche dermatologique du Quebec Metropolitain /ID# 258811
Québec Quebec, G1V 4, Canada More Info
Site Coordinator
Contact
418-650-5161
China-Japan Friendship Hospital /ID# 258941
Beijing Beijing, 10002, China More Info
Site Coordinator
Contact
+86 010-84205566
The First Affiliated Hospital, Sun Yat-sen University /ID# 257367
Guangzhou Guangdong, 51008, China
Dermatology Hospital of Southern Medical University /ID# 257118
Guangzhou Guangdong, 51009, China
The First Affiliated Hospital of Guangzhou Medical University /ID# 258663
Guangzhou Guangdong, 51016, China
Shenzhen People's Hospital /ID# 258208
Shenzhen Guangdong, 51802, China
Shenzhen Second People's Hospital /ID# 258060
Shenzhen Guangdong, 51803, China
Dermatology Hospital of Jiangxi Provincial /ID# 259488
Nanchang Jiangxi, 33003, China
The First Hospital of Jilin University /ID# 257496
Changchun Jilin, 13002, China
Huashan Hospital, Fudan University /ID# 257758
Shanghai Shanghai, 20004, China
Chengdu Second Municipal People's Hospital /ID# 259492
Chengdu Sichuan, 61001, China
West China Hospital, Sichuan University /ID# 259560
Chengdu Sichuan, 61004, China
Tianjin Medical University General Hospital /ID# 259525
Tianjin Tianjin, 30005, China
The First Affiliated Hospital of Wenzhou Medical University /ID# 257739
Wenzhou Zhejiang, 32500, China
The Second Affiliated Hospital of Chongqing Medical University /ID# 260254
Chongqing , 40001, China
Kurume University Hospital /ID# 257255
Kurume-shi Fukuoka, 830-0, Japan
Kitasato University Hospital /ID# 257285
Sagamihara-shi Kanagawa, 252-0, Japan
Niigata University Medical & Dental Hospital /ID# 259425
Niigata-shi Niigata, 951-8, Japan
Osaka Metropolitan University Hospital /ID# 257256
Osaka-shi Osaka, 545-8, Japan
Hamamatsu University Hospital /ID# 257253
Hamamatsu-shi Shizuoka, 431-3, Japan
Tokyo Medical University Hospital /ID# 258132
Shinjuku-ku Tokyo, 160-0, Japan
Yamaguchi University Hospital /ID# 257252
Ube-shi Yamaguchi, 755-8, Japan
Kyorin University - Mitaka Campus /ID# 257283
Mitaka , 181-8, Japan
Greenlane Clinical Centre /ID# 258563
Epsom Auckland, 1051, New Zealand
Middlemore Hospital /ID# 258562
Otahuhu Auckland, 2025, New Zealand
Clinical Trials New Zealand /ID# 258564
Hamilton , 3204, New Zealand
P3 Research Ltd /ID# 259846
Wellington , 6021, New Zealand
Santa Cruz Behavioral (SCB) Research Center /ID# 259350
Bayamon , 00961, Puerto Rico
Dr. Samuel Sanchez PSC /ID# 259359
Caguas , 00727, Puerto Rico More Info
Site Coordinator
Contact
787-429-6644
Clinical Research Puerto Rico /ID# 259355
San Juan , 00909, Puerto Rico More Info
Site Coordinator
Contact
787-723-5945
GCM Medical Group PSC /ID# 258013
San Juan , 00917, Puerto Rico
Mindful Medical Research /ID# 260113
San Juan , 00918, Puerto Rico
Velocity Clinical Research Ltd /ID# 257925
High Wycombe Buckinghamshire, HP11 , United Kingdom More Info
Site Coordinator
Contact
+44 7748 505888
Oxford University Hospitals NHS Foundation Trust /ID# 257948
Oxford Oxfordshire, OX3 9, United Kingdom
University Hospitals Sussex NHS Foundation Trust /ID# 257912
Worthing West Sussex, BN11 , United Kingdom
Gloucestershire Royal Hospital /ID# 257953
Gloucester , GL1 3, United Kingdom
London North West University Healthcare NHS Trust /ID# 257914
Harrow , HA1 3, United Kingdom
Chelsea and Westminster Hospital NHS Foundation Trust /ID# 259128
London , SW10 , United Kingdom More Info
Site Coordinator
Contact
44 20 335 8000
Northern Care Alliance NHS Group /ID# 257952
Salford , M6 8H, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

1500

Study ID:

NCT06012240

Recruitment Status:

Recruiting

Sponsor:


AbbVie

How clear is this clinincal trial information?

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