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NCT06012240 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Alopecia Areata, sponsored by AbbVie.

Recruiting
Registry status
Phase 3
Development phase
1,500
Enrollment target
20
Study locations

NCT06012240: Recruiting Phase 3 study of Alopecia Areata, sponsored by AbbVie.

NCT06012240 is a Phase 3 study of Alopecia Areata that is actively recruiting participants, run by AbbVie. The registered enrollment target is 1,500 participants, below the 1,898-participant average among 26 other Alopecia Areata trials with a reported enrollment target (21% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06012240, a Phase 3 study of Alopecia Areata, is actively recruiting participants, sponsored by AbbVie.

RECRUITING
Registry status
Phase 3
Development phase
1,500 participants
Enrollment target
20
Study locations

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.

Primary Outcome

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%.

Conditions Studied

Alopecia Areata

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

FieldValue
Enrollment Target 1,500 participants
Start Date 2023-10-11
Est. Completion 2028-01
Phase Phase 3
AbbVie

526 total trials

What NCT06012240 shows while recruiting

NCT06012240 is an interventional study that assigns participants to a tested intervention. Its 1,500 participants enrollment target places it among the larger protocols in the corpus, below the 1,898-participant average among 26 other Alopecia Areata trials with a reported enrollment target (21% lower).

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.

NCT06012240 names 20 study sites across 5 states, led by California, Florida, Arizona.

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.

What interventions are being tested in trial NCT06012240?

The interventions under investigation include: Placebo (DRUG), Upadacitinib (DRUG).

Who is sponsoring clinical trial NCT06012240?

This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.

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.

Learn More About Clinical Trials

Similar trials for Alopecia Areata

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06012240's enrollment target sits among peer trials

1,500 5th of 26 higher than 21 of 26 other Alopecia Areata trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Alopecia Areata trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT06012240

Source: ClinicalTrials.gov NCT06012240, the US trial registry maintained by the National Library of Medicine. NCT06012240 (large enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.