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Monoclonal Antibodies

Amlitelimab for Alopecia Areata

Phase 2
Recruiting
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of severe AA with specific criteria including hair loss affecting ≥50% of the scalp, current episode of hair loss of less than 8 years, and no evidence of terminal hair regrowth within 6 months
Be older than 18 years old
Must not have
Prior use of oral JAKi or the topical JAKi ruxolitinib for more than 12 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 24 and36
Awards & highlights

Summary

This trial is testing the effectiveness and safety of a drug called amlitelimab for treating severe alopecia areata in adults. Participants will receive injections of the drug and may have the option to

Who is the study for?
Adults with severe alopecia areata (AA) for less than 8 years, no recent hair regrowth, and willing to maintain a consistent hairstyle. They must have lost more than half of their scalp hair. Those with AA for over 8 years can join if they've had some regrowth.
What is being tested?
The trial is testing Amlitelimab injections against a placebo in adults with severe AA. It's double-blind, meaning neither the participants nor the researchers know who gets the real treatment or placebo until after the study.
What are the potential side effects?
Specific side effects aren't listed here, but generally, subcutaneous injections like Amlitelimab could cause reactions at the injection site, potential allergic responses, and other immune-related effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have severe alopecia areata with over half my scalp losing hair for less than 8 years without hair regrowth in the last 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have used oral or topical JAK inhibitors for over a year.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 24 and36
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 24 and36 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline in Severity of Alopecia Tool (SALT) score at Week 24
Secondary study objectives
Change from the baseline in SALT score at Week 36 (key secondary)
Mean changes from baseline in SKINDEX-16AA at Weeks 24 and 36
Proportion of participants achieving ClinRO Measure for Eyelash (EL) Hair Loss 0 or 1 with ≥2-point improvement from baseline (among participants with ClinRO Measure for EL Hair Loss ≥2 at Baseline)
+13 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Amlitelimab dose group 2Experimental Treatment1 Intervention
Subcutaneous injection as per protocol
Group II: Amlitelimab dose group 1Experimental Treatment1 Intervention
Subcutaneous injection as per protocol
Group III: PlaceboPlacebo Group1 Intervention
Subcutaneous injection as per protocol

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor
2,187 Previous Clinical Trials
3,979,628 Total Patients Enrolled
2 Trials studying Alopecia Areata
299 Patients Enrolled for Alopecia Areata
~100 spots leftby Aug 2025
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