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

Launched by SANOFI · May 31, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called amlitelimab, which is given as an injection under the skin, for adults with severe alopecia areata (a condition that causes significant hair loss). The study aims to see if this treatment is effective and safe compared to a placebo, which is an inactive treatment. Participants in this trial must be at least 18 years old and have been diagnosed with severe alopecia areata for more than six months, meaning they have lost a significant amount of hair on their scalp.

If you decide to participate, you can expect to be involved for up to 56 weeks, which includes some initial screening and follow-up visits. During the first part of the study, neither you nor the researchers will know if you are receiving the actual treatment or the placebo. After the treatment period, there is an option to join another study to continue receiving the treatment. It's important to note that participants cannot have other types of hair loss or active medical conditions that could interfere with the study. If you have questions about your eligibility or what to expect, the study team will provide guidance.

Gender

ALL

Eligibility criteria

• 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