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

Sanofi

Status and phase: Enrolling; Phase 2

Conditions: Alopecia Areata

Treatments: Drug: Placebo; Drug: Amlitelimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06444451

DRI18180

U1111-1295-6359 (Registry Identifier)

2024-511225-64 (Registry Identifier)

Details and patient eligibility

About

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 treatment period, all participants will have the option to enter a separate study, the open-label extension (OLE) study, once eligibility is confirmed.

The study duration will be up to 56 weeks for participants not entering the OLE including a 2-to-4-week screening, a 36-week randomized double-blind period, and a 16-week safety follow-up. For participants entering the OLE, the DRI18180 study duration will be up to 40 weeks, including a 2-to-4-week screening, a 36-week randomized double-blind period The total number of visits will be up to 12 visits (or 11 visits for those entering the OLE study).

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 hair loss of less than 8 years.

  3. No evidence of terminal hair regrowth within 6 months (ie, equivalent to less than 10 points spontaneous reduction in SALT over the past 6 months).

     Note: participants with severe AA for ≥8 years may be enrolled if episodes of regrowth are observed in the affected areas over the past 8 years, spontaneously and/or under treatment.

• 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, 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 (IMP) effect on AA due to scalp inflammation.
• 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 12 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 3 patient groups, including a placebo group

Amlitelimab dose group 1

Experimental group

Description:

Subcutaneous injection as per protocol

Treatment:

Drug: Amlitelimab

Amlitelimab dose group 2

Experimental group

Description:

Subcutaneous injection as per protocol

Treatment:

Drug: Amlitelimab

Placebo

Placebo Comparator group

Description:

Subcutaneous injection as per protocol

Treatment:

Drug: Placebo