A study to evaluate the efficacy and safety of subcutaneous amlitelimab monotherapy compared with placebo in adult participants with severe alopecia areata

Active, not recruiting

• Conditions: Alopecia areata

• Registration Number: jRCT2061240031
• Lead Sponsor: Sanofi K.K.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-07
• Study Start: 2024-07-24
• Last Update Posted: 2025-02-21

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Definitive diagnosis of alopecia areata (AA) of more than 6 months.
• Diagnosis of severe AA, as determined by all of the following: a) Hair loss affecting >=50% of the scalp, as measured by Severity of Alopecia Tool (SALT) at both screening and baseline visits.
  b) 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. c) 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 that in opinion of the Investigator would interfere with evaluations of the investigational medicinal product effect on AA due to scalp inflammation.
• Received the specified treatment regimens within the timeframe outlined in the protocol.
• Prior use of any oral Janus kinase inhibitor (JAKi) or the topical JAKi ruxolitinib for more than 24 months, regardless if washout period is respected.
• Subjects with shaved heads must not enter the study until hair has grown back and SALT score can be reliably administered.

Study & Design

• Study Type: Interventional
• Study Design: parallel assignment

Primary Outcome Measures

Name	Time	Method
Change from baseline in Severity of Alopecia Tool (SALT) score at Week 36	Baseline to Week 36	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).