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.
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.
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There are 104 Locations for this study
Birmingham Alabama, 35205, United States
Glendale Arizona, 85308, United States
Phoenix Arizona, 85018, United States
Phoenix Arizona, 85032, United States
Fort Smith Arkansas, 72916, United States
Fountain Valley California, 92708, United States
Los Angeles California, 90045, United States
Sacramento California, 95815, United States More Info
Thousand Oaks California, 91320, United States
Coral Gables Florida, 33134, United States
Margate Florida, 33063, United States
Margate Florida, 33063, United States
Miami Florida, 33172, United States
Sanford Florida, 32771, United States
Marietta Georgia, 30060, United States
Bay City Michigan, 48706, United States
Canton Michigan, 48187, United States
Clarkston Michigan, 48346, United States
Detroit Michigan, 48202, United States
New Brighton Minnesota, 55112, United States
Lee's Summit Missouri, 64064, United States More Info
Lincoln Nebraska, 68516, United States
Reno Nevada, 89509, United States More Info
East Windsor New Jersey, 08520, United States
Verona New Jersey, 07044, United States
New York New York, 10029, United States
Portland Oregon, 97210, United States
Portland Oregon, 97223, United States
Charleston South Carolina, 29425, United States
Murfreesboro Tennessee, 37130, United States
Arlington Texas, 76011, United States
Bellaire Texas, 77401, United States
Dallas Texas, 75230, United States
Dallas Texas, 75235, United States
Houston Texas, 77065, United States
San Antonio Texas, 78229, United States
Darlinghurst New South Wales, 2010, Australia More Info
Kogarah New South Wales, 2217, Australia
Coorparoo Queensland, 4151, Australia
Woolloongabba Queensland, 4102, Australia
East Melbourne Victoria, 3002, Australia
Parkville Victoria, 3050, Australia
Fremantle Western Australia, 6160, Australia
Rio de Janeiro , 20241, Brazil
Surrey British Columbia, V3R 6, Canada
Winnipeg Manitoba, R3M 3, Canada
Barrie Ontario, L4M 7, Canada More Info
Markham Ontario, L3P 1, Canada
Ottawa Ontario, K1H 7, Canada
Waterloo Ontario, N2J 1, Canada
Québec Quebec, G1V 4, Canada More Info
Guangzhou Guangdong, 51008, China
Guangzhou Guangdong, 51009, China
Guangzhou Guangdong, 51016, China
Shenzhen Guangdong, 51802, China
Shenzhen Guangdong, 51803, China
Nanchang Jiangxi, 33003, China
Changchun Jilin, 13002, China
Shanghai Shanghai, 20004, China
Chengdu Sichuan, 61001, China
Chengdu Sichuan, 61004, China
Tianjin Tianjin, 30005, China
Chongqing , 40001, China
Kurume-shi Fukuoka, 830-0, Japan
Sagamihara-shi Kanagawa, 252-0, Japan
Niigata-shi Niigata, 951-8, Japan
Osaka-shi Osaka, 545-8, Japan
Hamamatsu-shi Shizuoka, 431-3, Japan
Shinjuku-ku Tokyo, 160-0, Japan
Ube-shi Yamaguchi, 755-8, Japan
Mitaka , 181-8, Japan
Epsom Auckland, 1051, New Zealand
Otahuhu Auckland, 2025, New Zealand
Hamilton , 3204, New Zealand
Wellington , 6021, New Zealand
Bayamon , 00961, Puerto Rico
San Juan , 00917, Puerto Rico
San Juan , 00918, Puerto Rico
High Wycombe Buckinghamshire, HP11 , United Kingdom More Info
Worthing West Sussex, BN11 , United Kingdom
Harrow , HA1 3, United Kingdom
London , SW10 , United Kingdom More Info
Salford , M6 8H, United Kingdom
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