A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants With Severe Alopecia Areata (NCT06012240) — China Trial Details

Condition(s) studied

Alopecia Areata

Investigational drug(s) / intervention(s)

UpadacitinibPlacebo

Upadacitinib: Oral Tablets

Placebo: Oral Tablets

Study 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 and Study 4 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 and Study 4 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, Study 2 or Study 4, 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 280 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

Sex

ALL

Min age

12 Years

Max age

63 Years

Healthy volunteers

No

Inclusion Criteria: * Adult individuals must be \< 64 years old at Baseline Visit. Where permitted outside United States (US)/European Union (EU), adolescent individuals who are at least 12 years old at Screening may participate in Study 1 and Study 2. Adolescent individuals in the US who are at least 12 years old at Screening may participate in Study 4. * 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. * Current episode of AA of less than 8 years. Exclusion Criteria: * Current diagnosis of primarily diffuse type of AA. * Current 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 as determined by the investigator, including but not limited to seborrheic dermatitis, scalp psoriasis, atopic dermatitis (AD), and tinea capitis.

Primary outcome measure(s)

Percentage of Participants with the Achievement of Severity of Alopecia Tool (SALT) Score <= 20 — 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%.
Number of Participants with Adverse Events (AEs) — Up to approximately 164 weeks
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

Trial sites (283)

Facility	City	Region	Status
Total Skin and Beauty Dermatology Center /ID# 259539	Birmingham	Alabama	Active Not Recruiting
Duplicate_Advanced Research Associates - Glendale /ID# 259108	Glendale	Arizona	Completed
Southwest Skin Specialists /ID# 258234	Phoenix	Arizona	Completed
Alliance Dermatology and Mohs Center /ID# 258111	Phoenix	Arizona	Active Not Recruiting
Johnson Dermatology Clinic /ID# 259103	Fort Smith	Arkansas	Active Not Recruiting
Exalt Clinical Research /ID# 283814	Chula Vista	California	Not Yet Recruiting
Duplicate_JOSEPH RAOOF MD,INC /ID# 258031	Encino	California	Completed
First Oc Dermatology /ID# 259220	Fountain Valley	California	Recruiting
University of California Irvine /ID# 259096	Irvine	California	Active Not Recruiting
Dermatology Research Associates /ID# 258033	Los Angeles	California	Recruiting
Stanford University School of Medicine - Redwood City /ID# 259542	Redwood City	California	Completed
Integrative Skin Science and Research /ID# 258114	Sacramento	California	Recruiting
University of California Davis Health /ID# 258112	Sacramento	California	Recruiting
Clinical Trials Research Institute /ID# 258021	Thousand Oaks	California	Recruiting
Skin Care Research Boca Raton /ID# 258012	Boca Raton	Florida	Recruiting
Apex Clinical Trials /ID# 259205	Brandon	Florida	Active Not Recruiting
Florida Academic Dermatology Center /ID# 259353	Coral Gables	Florida	Active Not Recruiting
Skin Research Institute LLC /ID# 259207	Coral Gables	Florida	Completed
Revival Research /ID# 259213	Doral	Florida	Completed
Skin Care Research - Hollywood /ID# 259210	Hollywood	Florida	Recruiting
GSI Clinical Research, LLC /ID# 259352	Margate	Florida	Recruiting
Life Clinical Trials - N State Rd - Margate /ID# 259358	Margate	Florida	Active Not Recruiting
Lenus Research and Medical Group /ID# 259356	Miami	Florida	Recruiting
International Clinical Research - Sanford /ID# 259547	Sanford	Florida	Completed
FWD Clinical Research /ID# 266687	Tamarac	Florida	Completed
Advanced Clinical Research Institute - Tampa /ID# 259204	Tampa	Florida	Recruiting
Avita Clinical Research /ID# 258011	Tampa	Florida	Completed
Cleaver Medical Group Dermatology /ID# 259801	Dawsonville	Georgia	Active Not Recruiting
Marietta Dermatology /ID# 259818	Marietta	Georgia	Active Not Recruiting
Georgia Skin & Cancer Clinic /ID# 283529	Savannah	Georgia	Not Yet Recruiting
Northwestern University Feinberg School of Medicine /ID# 259555	Chicago	Illinois	Completed
NorthShore University HealthSystem - Skokie /ID# 266684	Skokie	Illinois	Active Not Recruiting
Indiana University Health University Hospital /ID# 259827	Indianapolis	Indiana	Recruiting
U.S. Dermatology Partners Leawood /ID# 259203	Leawood	Kansas	Completed
Tulane University School of Medicine /ID# 259799	New Orleans	Louisiana	Recruiting
Raven Clinical Research /ID# 268453	Marriottsville	Maryland	Completed
MetroBoston Clinical Partners /ID# 259559	Boston	Massachusetts	Active Not Recruiting
Lahey Hospital & Medical Center /ID# 260484	Burlington	Massachusetts	Completed
Great Lakes Research Group - Bay City /ID# 259100	Bay City	Michigan	Completed
Derm Institute of West Michigan /ID# 259546	Caledonia	Michigan	Recruiting

+ 243 more sites — see the full list on the official registry below.

On this site

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