A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants With Severe Alopecia Areata (NCT06012240)
A Phase 3 Randomized, Placebo-controlled, Double-blind Program to Evaluate Efficacy and Safety of Upadacitinib in Adult and Adolescent Subjects With Severe Alopecia Areata
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Total Skin and Beauty Dermatology Center /ID# 259539 — Birmingham, Alabama
Age range: 12 Years to 63 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (283 Sites)
Showing the first 25 of 283 sites.
- Total Skin and Beauty Dermatology Center /ID# 259539 — Birmingham, Alabama
- Duplicate_Advanced Research Associates - Glendale /ID# 259108 — Glendale, Arizona
- Southwest Skin Specialists /ID# 258234 — Phoenix, Arizona
- Alliance Dermatology and Mohs Center /ID# 258111 — Phoenix, Arizona
- Johnson Dermatology Clinic /ID# 259103 — Fort Smith, Arkansas
- Exalt Clinical Research /ID# 283814 — Chula Vista, California
- Duplicate_JOSEPH RAOOF MD,INC /ID# 258031 — Encino, California
- First Oc Dermatology /ID# 259220 — Fountain Valley, California
- University of California Irvine /ID# 259096 — Irvine, California
- Dermatology Research Associates /ID# 258033 — Los Angeles, California
- Stanford University School of Medicine - Redwood City /ID# 259542 — Redwood City, California
- Integrative Skin Science and Research /ID# 258114 — Sacramento, California
- University of California Davis Health /ID# 258112 — Sacramento, California
- Clinical Trials Research Institute /ID# 258021 — Thousand Oaks, California
- Skin Care Research Boca Raton /ID# 258012 — Boca Raton, Florida
- Apex Clinical Trials /ID# 259205 — Brandon, Florida
- Florida Academic Dermatology Center /ID# 259353 — Coral Gables, Florida
- Skin Research Institute LLC /ID# 259207 — Coral Gables, Florida
- Revival Research /ID# 259213 — Doral, Florida
- Skin Care Research - Hollywood /ID# 259210 — Hollywood, Florida
- GSI Clinical Research, LLC /ID# 259352 — Margate, Florida
- Life Clinical Trials - N State Rd - Margate /ID# 259358 — Margate, Florida
- Lenus Research and Medical Group /ID# 259356 — Miami, Florida
- International Clinical Research - Sanford /ID# 259547 — Sanford, Florida
- FWD Clinical Research /ID# 266687 — Tamarac, Florida
📞 Contact the Study Coordinator
Phone: (844) 663-3742
Email: abbvieclinicaltrials@abbvie.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Alopecia Areata
- Extension Study to Evaluate Safety and Efficacy of CTP-543 in Adults With Alopecia Areata — Birmingham, Alabama
- A Study of DR-01 in Subjects With Alopecia Areata and Vitiligo — Northridge, California
- A Phase 2b Study to Evaluate Rezpegaldesleukin (Rezpeg) in the Treatment of Severe to Very Severe Alopecia Areata in Adult Patients (Rezolve AA) — Northridge, California
- Alopecia Areata Registry — San Francisco, California
- Intralesional Cyclosporine for Alopecia Areata — Sacramento, California
- A Phase 2a Proof-of-Concept Trial of Bempikibart (ADX-914) for the Treatment of Severe Alopecia Areata (SIGNAL-AA) — Scottsdale, Arizona
Explore by condition: All Alopecia Areata clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.