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Study identifier: NCT06012240 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Alopecia Areata  ·  Sponsor: AbbVie

PhasePhase 3
Planned participants1500
Who can joinAll sexes, 12 Years to 63 Years
Healthy volunteersNo

About this study

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 fo…

This description comes directly from the study's public registry record.

Talk to the study team

ABBVIE CALL CENTER  ·  844-663-3742  ·  abbvieclinicaltrials@abbvie.com

Always discuss trial participation with your own doctor first.

Locations (282)

Total Skin and Beauty Dermatology Center /ID# 259539Birmingham, Alabama, United StatesActive Not Recruiting
Duplicate_Advanced Research Associates - Glendale /ID# 259108Glendale, Arizona, United StatesCompleted
Southwest Skin Specialists /ID# 258234Phoenix, Arizona, United StatesCompleted
Alliance Dermatology and Mohs Center /ID# 258111Phoenix, Arizona, United StatesActive Not Recruiting
Johnson Dermatology Clinic /ID# 259103Fort Smith, Arkansas, United StatesActive Not Recruiting
Exalt Clinical Research /ID# 283814Chula Vista, California, United StatesNot Yet Recruiting
Duplicate_JOSEPH RAOOF MD,INC /ID# 258031Encino, California, United StatesCompleted
First OC Dermatology /ID# 259220Fountain Valley, California, United StatesRecruiting
University of California Irvine /ID# 259096Irvine, California, United StatesActive Not Recruiting
Dermatology Research Associates /ID# 258033Los Angeles, California, United StatesRecruiting
Stanford University School of Medicine - Redwood City /ID# 259542Redwood City, California, United StatesCompleted
Integrative Skin Science and Research /ID# 258114Sacramento, California, United StatesRecruiting

+ 270 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06012240