Alopecia areata
Conditions
Interventions
Drug: Amlitelimab (SAR445229)
Pharmaceutical form: Injection solution
Route of administration: Subcutaneous (SC) injection
Drug: Placebo
Pharmaceutical form: Injection solution
Route of administra
Sponsors
Obara Kentaro
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change from baseline in Severity of Alopecia Tool (SALT) score at Week 36 [Time frame: 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). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change from the baseline in SALT score at Week 24 (key secondary) [Time frame: Baseline to Week 24] 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). 2. Proportion of participants achieving a SALT score ==2-point improvement from baseline at Weeks 24 and 36 (among participants with ClinRO Measure for EB Hair Loss >=2 at Baseline) [Time frame: Week 24 and 36] ClinRO Measure for EB Hair Loss is a single item, clinician-reported numeric rating scale (NRS) measuring EB hair loss. Scores range from "0 = normal appearance/no EB hair loss" to "3 = severe appearance/severe EB hair loss". 10. Proportion of participants achieving ClinRO Measure for Eyelash (EL) Hair Loss 0 or 1 with >=2-point improvement from baseline at Weeks 24 and 36 (among participants with ClinRO Measure for EL Hair Loss >=2 at Baseline) [Time frame: Week 24 and 36] ClinRO Measure for EL Hair Loss is a single item, clinician-reported NRS measuring EL hair loss. Scores range from "0 = normal appearance/no EL hair loss" to "3 = severe appearance/severe EL hair loss". 11. Proportion of participants achieving a Patient Global Impression of Change (PGI-C) response defined as a score of "moderately improved" or "greatly improved" at Weeks 24 and 36 [Time frame: Week 24 and 36] The PGI-C is a questionnaire that asks participants to provide the overall self-assessment of change in their AA overall on a 5-point scale. The PGI-C will be scored from "1 = Much better" to "5 = Much worse". 12. Proportion of participants achieving a Patient Global Impression of Severity (PGI-S) response defined as a score of "mild" or "none" at Weeks 24 and 36 [Time frame: Week 24 and 36] The PGI-S is a single item 5-point scale (1 = no symptoms to 5 = very severe symptoms) which asks a participant to assess current severity of AA symptoms. 13. Mean changes from baseline in Skindex-16 for AA (SKINDEX-16AA) at Weeks 24 and 36 [Time | — |
Countries
Argentina, Australia, Bulgaria, Canada, Chile, China, Czechia, France, Germany, Italy, Japan, Netherlands, Romania, Spain, United Kingdom, United States
Contacts
Public ContactUnit Clinical
Sanofi K.K.
Outcome results
None listed