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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Sanofi
Study ID
NCT06444451
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Amlitelimab — DRUG
    Pharmaceutical form: Injection solution Route of administration: SC injection
  • Placebo — DRUG
    Pharmaceutical form: Injection solution Route of administration: SC injection

Study Details

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).

Key Dates

Start date
Jun 6, 2024
Status verified
Jun 2026
Primary completion
Sep 24, 2025
Completion
May 21, 2026

Study Design

Enrollment
166 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Amlitelimab dose group 1
    Subcutaneous injection as per protocol
  • Experimental: Amlitelimab dose group 2
    Subcutaneous injection as per protocol
  • Placebo Comparator: Placebo
    Subcutaneous injection as per protocol

Primary Outcome Measure

Change from baseline in Severity of Alopecia Tool (SALT) score at Week 36 [ Time Frame: Baseline to Week 36 ]

Locations (17)

FacilityCityStateZIPSite coordinators
Total Skin and Beauty Dermatology Center- Site Number : 8400018BirminghamAlabama35205-
First OC Dermatology- Site Number : 8400014Fountain ValleyCalifornia92708-
Center for Dermatology Clinical Research- Site Number : 8400008FremontCalifornia94538-
UC Irvine Healthcare - Gottschalk Medical Plaza- Site Number : 8400007IrvineCalifornia92697-
Dermatology Research Associates - Los Angeles- Site Number : 8400015Los AngelesCalifornia90045-
New Horizon Research Center- Site Number : 8400017MiamiFlorida33165-
Dawes Fretzin Clinical Research- Site Number : 8400010IndianapolisIndiana46256-
Michigan Center for Research Company- Site Number : 8400016ClarkstonMichigan48346-
Joel Schlessinger, PC- Site Number : 8400021OmahaNebraska68144-
Icahn School of Medicine at Mount Sinai- Site Number : 8400003New YorkNew York10029-
DJL Clinical Research - Charlotte - Park Road- Site Number : 8400013CharlotteNorth Carolina28210-
Cleveland Clinic- Site Number : 8400028ClevelandOhio44195-
Apex Clinical Research Center- Site Number : 8400027Mayfield HeightsOhio44124-
Vital Prospects Clinical Research Institute - Tulsa- Site Number : 8400004TulsaOklahoma74136-
Oregon Medical Research Center- Site Number : 8400002PortlandOregon97201-
Health Concepts- Site Number : 8400001Rapid CitySouth Dakota57702-
Progressive Clinical Research - San Antonio- Site Number : 8400019San AntonioTexas78229-

Find similar trials in Birmingham, AL

By research site
Total Skin and Beauty Dermatology Center· Birmingham, ALFirst OC Dermatology· Fountain Valley, CACenter for Dermatology Clinical Research· Fremont, CAUC Irvine Healthcare - Gottschalk Medical Plaza· Irvine, CADermatology Research Associates - Los Angeles· Los Angeles, CANew Horizon Research Center· Miami, FL

Related Studies