A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Adult Participants With Severe Alopecia Areata
Public ClinicalTrials.gov record NCT06444451. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2, Randomized, Double-blind, Placebo--controlled, Parallel Group, 3-arm, Multinational, Multicenter, Proof-of-concept Study to Evaluate the Efficacy and Safety of Amlitelimab Monotherapy by Subcutaneous Injection in Adult Participants With Severe Alopecia Areata
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a parallel, Phase 2 multinational, multicenter, randomized, double-blind, placebo-controlled, 3-arm study to investigate the efficacy and safety of subcutaneous (SC) injections of amlitelimab treatment as monotherapy in participants aged 18 years and older with severe alopecia areata (AA). At the end of the double-blind treatment period, all participants will have the option to enter the open-label extension (OLE) period. The study duration will be up to 160 weeks for participants entering the OLE period including a 2-to-4-week screening, a 36-week randomized double-blind period, an optional OLE period (104 weeks) and a 16-week safety follow-up. The open-label extension period is optional and open to all participants who have completed the double-blind treatment period. The total number of visits will be up to 38 visits (or 12 visits for those not entering the OLE study).
Study identification
- NCT ID
- NCT06444451
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 166 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 6, 2024 (Actual)
- Primary completion
- Sep 24, 2025 (Actual)
- Completion
- May 21, 2026 (Actual)
- Last update posted
- Aug 10, 2026
2024 – 2026
United States locations
- U.S. sites
- 17
- U.S. states
- 13
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Total Skin and Beauty Dermatology Center- Site Number : 8400018 | Birmingham | Alabama | 35205 | — |
| First OC Dermatology- Site Number : 8400014 | Fountain Valley | California | 92708 | — |
| Center for Dermatology Clinical Research- Site Number : 8400008 | Fremont | California | 94538 | — |
| UC Irvine Healthcare - Gottschalk Medical Plaza- Site Number : 8400007 | Irvine | California | 92697 | — |
| Dermatology Research Associates - Los Angeles- Site Number : 8400015 | Los Angeles | California | 90045 | — |
| New Horizon Research Center- Site Number : 8400017 | Miami | Florida | 33165 | — |
| Dawes Fretzin Clinical Research- Site Number : 8400010 | Indianapolis | Indiana | 46256 | — |
| Michigan Center for Research Company- Site Number : 8400016 | Clarkston | Michigan | 48346 | — |
| Joel Schlessinger, PC- Site Number : 8400021 | Omaha | Nebraska | 68144 | — |
| Icahn School of Medicine at Mount Sinai- Site Number : 8400003 | New York | New York | 10029 | — |
| DJL Clinical Research - Charlotte - Park Road- Site Number : 8400013 | Charlotte | North Carolina | 28210 | — |
| Cleveland Clinic- Site Number : 8400028 | Cleveland | Ohio | 44195 | — |
| Apex Clinical Research Center- Site Number : 8400027 | Mayfield Heights | Ohio | 44124 | — |
| Vital Prospects Clinical Research Institute - Tulsa- Site Number : 8400004 | Tulsa | Oklahoma | 74136 | — |
| Oregon Medical Research Center- Site Number : 8400002 | Portland | Oregon | 97201 | — |
| Health Concepts- Site Number : 8400001 | Rapid City | South Dakota | 57702 | — |
| Progressive Clinical Research - San Antonio- Site Number : 8400019 | San Antonio | Texas | 78229 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 57 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06444451, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 10, 2026 · Synced Oct 1, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06444451 live on ClinicalTrials.gov.