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NCT06444451 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Adult Participants With Severe Alopecia Areata
A Phase 2 study of Alopecia Areata, sponsored by Sanofi.
- Active
- Registry status
- Phase 2
- Development phase
- 166
- Enrollment target
- 20
- Study locations
NCT06444451: Active Phase 2 study of Alopecia Areata, sponsored by Sanofi.
NCT06444451 is a Phase 2 study of Alopecia Areata that is active but no longer recruiting, run by Sanofi. The registered enrollment target is 166 participants, below the 1,949-participant average among 26 other Alopecia Areata trials with a reported enrollment target (91% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06444451, a Phase 2 study of Alopecia Areata, is active but no longer recruiting, sponsored by Sanofi.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 166 participants
- Enrollment target
- 20
- Study locations
Study Summary
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).
Primary Outcome
SALT is a quantitative Investigator assessment of AA severity scores range in severity from 0 (no hair loss) to a maximum of 100 (complete hair loss).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Amlitelimab
Study Locations (20)
California
- First OC Dermatology- Site Number : 8400014 - Fountain Valley
- Center for Dermatology Clinical Research- Site Number : 8400008 - Fremont
- UC Irvine Healthcare - Gottschalk Medical Plaza- Site Number : 8400007 - Irvine
- Dermatology Research Associates - Los Angeles- Site Number : 8400015 - Los Angeles
Ohio
- Cleveland Clinic- Site Number : 8400028 - Cleveland
- Apex Clinical Research Center- Site Number : 8400027 - Mayfield Heights
Other
- Investigational Site Number : 0320004 - Buenos Aires
- Investigational Site Number : 0320001 - Buenos Aires
Alabama
- Total Skin and Beauty Dermatology Center- Site Number : 8400018 - Birmingham
Florida
- New Horizon Research Center- Site Number : 8400017 - Miami
Indiana
- Dawes Fretzin Clinical Research- Site Number : 8400010 - Indianapolis
Michigan
- Michigan Center for Research Company- Site Number : 8400016 - Clarkston
Nebraska
- Joel Schlessinger, PC- Site Number : 8400021 - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 166 participants |
| Start Date | 2024-06-06 |
| Est. Completion | 2028-01-05 |
| Phase | Phase 2 |
What the registry record for NCT06444451 still lists
NCT06444451 is an interventional study that assigns participants to a tested intervention. The registered 166 participants enrollment target is mid-sized for trials with a published cap, below the 1,949-participant average among 26 other Alopecia Areata trials with a reported enrollment target (91% 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.
NCT06444451 names 20 study sites across 15 states, led by California, Ohio, Other.
Frequently Asked Questions
What is clinical trial NCT06444451 about?
NCT06444451 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Adult Participants With Severe Alopecia Areata". 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). A...
What is the current status of trial NCT06444451?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 166 participants. The study started on 2024-06-06. Estimated completion is 2028-01-05.
What conditions does trial NCT06444451 study?
This clinical trial studies the following conditions: Alopecia Areata.
What interventions are being tested in trial NCT06444451?
The interventions under investigation include: Placebo (DRUG), Amlitelimab (DRUG).
Who is sponsoring clinical trial NCT06444451?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06444451 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Indiana, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT06444451's enrollment target sits among peer trials
166 12th of 26 higher than 15 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.
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