A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Adult Participants With Severe Alopecia Areata

Study on the Effects of Investigational Medication for Severe Alopecia Areata (a condition causing hair loss)

Not Recruiting
18 years or above
All
Phase 2
166 participants needed

Study Overview

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).

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Alopecia Areata
  • Age: 18 years or above
  • Gender: All

Inclusion Criteria:

  • Definitive diagnosis of AA of more than 6 months.
  • Diagnosis of severe AA, as determined by all of the following:
    1. Hair loss affecting ≥50% of the scalp, as measured by Severity of Alopecia Tool (SALT) at both screening and baseline visits.
    2. Current episode of severe hair loss of less than 8 years. Participants with a history of AA of more than 8 years who have observed episodes of terminal hair regrowth over their scalp ("moving patches" spontaneously or following treatment) in the past 8 years can be included.
    3. Stable disease: no evidence of terminal hair regrowth within 6 months (less than 10% improvement over the past 6 months). (guidance: if participant reports to have quite a bit more hair than 6 months prior, then patient cannot be included).
  • Willingness in maintaining a consistent hair style and hair care, including hair

    products, and to refrain from weaves, extensions, adhesive wigs, other than banded perimeter devices, refrain from shaving of scalp hair for 2 weeks prior to each study visit from baseline to the end of study.

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

  • Participants that are currently experiencing other forms of alopecia, including but not limited to: androgenetic alopecia, trichotillomania, telogen effluvium, traction alopecia, scarring alopecia.
  • Participants currently with any local or systemic active medical conditions, which in the opinion of the Investigator would interfere with evaluations of the IMP effect on AA due to scalp inflammation, including but not limited to seborrheic dermatitis requiring topical treatment to the scalp, lupus erythematosus, lichen planus, psoriasis, secondary syphilis, tinea capitis, thyroiditis, systemic sclerosis, hair transplants, micropigmentation/tattoo of the scalp.
  • Received the specified treatment regimens within the timeframe outlined in the protocol.
  • Prior use of any oral JAKi or the topical JAKi ruxolitinib for more than 24 months, regardless if washout period is respected.
  • Participants with shaved heads must not enter the study until hair has grown back and SALT score can be reliably administered.

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial

Updated on 13 Feb 2025. Study ID: NCT06444451

This study investigates the effects of an investigational medication given as a subcutaneous injection for people with severe alopecia areata, a condition causing hair loss. The study involves participants aged 18 and older who have had alopecia areata for more than six months, with significant hair loss affecting more than half of their scalp.

Participants will be randomly assigned to one of three study arms. Some will receive the investigational medication, while others will receive a placebo, which is an inactive substance that looks like the investigational medication but does not contain any medicine. The study is double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo during the study.

  • Who can participate: Adults aged 18 and older with a confirmed diagnosis of severe alopecia areata for more than six months can participate. Participants must have hair loss affecting at least 50% of their scalp and no significant hair regrowth in the past six months.
  • Study details: Participants will receive injections and must maintain a consistent hairstyle throughout the study. They should avoid certain hair treatments and styles, such as weaves or extensions, during the study period.
  • Study Timelines and Visits: The study will last 56 weeks. The study requires 12 visits.