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A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants With Severe Alopecia Areata
NCT06012240 · View on ClinicalTrials.gov ↗
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Upadacitinib
Study Locations (20)
California
- Duplicate_JOSEPH RAOOF MD,INC /ID# 258031 — Encino
- First OC Dermatology /ID# 259220 — Fountain Valley
- University of California Irvine /ID# 259096 — Irvine
- Dermatology Research Associates /ID# 258033 — Los Angeles
- Stanford University School of Medicine - Redwood City /ID# 259542 — Redwood City
- Integrative Skin Science and Research /ID# 258114 — Sacramento
- University of California Davis Health /ID# 258112 — Sacramento
- Clinical Trials Research Institute /ID# 258021 — Thousand Oaks
Florida
- Skin Care Research Boca Raton /ID# 258012 — Boca Raton
- Apex Clinical Trials /ID# 259205 — Brandon
- Florida Academic Dermatology Center /ID# 259353 — Coral Gables
- Skin Research Institute LLC /ID# 259207 — Coral Gables
- Revival Research /ID# 259213 — Doral
- Skin Care Research - Hollywood /ID# 259210 — Hollywood
- GSI Clinical Research, LLC /ID# 259352 — Margate
Arizona
- Duplicate_Advanced Research Associates - Glendale /ID# 259108 — Glendale
- Southwest Skin Specialists /ID# 258234 — Phoenix
- Alliance Dermatology and Mohs Center /ID# 258111 — Phoenix
Alabama
- Total Skin and Beauty Dermatology Center /ID# 259539 — Birmingham
Arkansas
- Johnson Dermatology Clinic /ID# 259103 — Fort Smith
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,500 participants |
| Start Date | 2023-10-11 |
| Est. Completion | 2028-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06012240
The ClinicalTrials.gov registry entry for NCT06012240 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,500 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 603 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Alopecia Areata appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06012240 reports 20 study locations spanning 5 distinct geographic areas — top geographies include California, Florida, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06012240 about?
NCT06012240 is a clinical study titled "A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants With Severe Alopecia Areata". 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 adol...
What is the current status of trial NCT06012240?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 1,500 participants. The study started on 2023-10-11. Estimated completion is 2028-01.
What conditions does trial NCT06012240 study?
This clinical trial studies the following conditions: Alopecia Areata. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06012240?
The interventions under investigation include: Placebo (DRUG), Upadacitinib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06012240?
This trial is sponsored by AbbVie, which has 603 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06012240 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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