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A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Adult Participants With Severe Alopecia Areata
NCT06444451 · View on ClinicalTrials.gov ↗
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06444451
The ClinicalTrials.gov registry entry for NCT06444451 describes a study currently listed as active not recruiting. It is categorized as Phase 2, 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 166 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 275 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: NCT06444451 reports 20 study locations spanning 15 distinct geographic areas — top geographies include California, Ohio, Other. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06444451?
The interventions under investigation include: Placebo (DRUG), Amlitelimab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06444451?
This trial is sponsored by Sanofi, which has 275 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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