Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

ACTIVE NOT RECRUITING

NCT06444451

PHASE2

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

Sponsor: Sanofi

View on ClinicalTrials.gov

Summary

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).

Official title: A Phase 2, Randomized, Double-blind, Placebo--controlled, Parallel Group, 3-arm, Multinational, Multicenter, Proof-of-concept Study to Evaluate the Efficacy and Safety of Amlitelimab Monotherapy by Subcutaneous Injection in Adult Participants With Severe Alopecia Areata

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

166

Start Date

2024-06-06

Completion Date

2028-01-05

Last Updated

2025-10-24

Healthy Volunteers

Conditions

Alopecia Areata

Interventions

DRUG

Amlitelimab

Pharmaceutical form: Injection solution Route of administration: SC injection

DRUG

Placebo

Pharmaceutical form: Injection solution Route of administration: SC injection

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

Locations (74)

Total Skin and Beauty Dermatology Center- Site Number : 8400018

Birmingham, Alabama, United States

First OC Dermatology- Site Number : 8400014

Fountain Valley, California, United States

Center for Dermatology Clinical Research- Site Number : 8400008

Fremont, California, United States

UC Irvine Healthcare - Gottschalk Medical Plaza- Site Number : 8400007

Irvine, California, United States

Dermatology Research Associates - Los Angeles- Site Number : 8400015

Los Angeles, California, United States

New Horizon Research Center- Site Number : 8400017

Miami, Florida, United States

Dawes Fretzin Clinical Research- Site Number : 8400010

Indianapolis, Indiana, United States

Michigan Center for Research Company- Site Number : 8400016

Clarkston, Michigan, United States

Joel Schlessinger, PC- Site Number : 8400021

Omaha, Nebraska, United States

Icahn School of Medicine at Mount Sinai- Site Number : 8400003

New York, New York, United States

DJL Clinical Research - Charlotte - Park Road- Site Number : 8400013

Charlotte, North Carolina, United States

Cleveland Clinic- Site Number : 8400028

Cleveland, Ohio, United States

Apex Clinical Research Center- Site Number : 8400027

Mayfield Heights, Ohio, United States

Vital Prospects Clinical Research Institute - Tulsa- Site Number : 8400004

Tulsa, Oklahoma, United States

Oregon Medical Research Center- Site Number : 8400002

Portland, Oregon, United States

Health Concepts- Site Number : 8400001

Rapid City, South Dakota, United States

Progressive Clinical Research - San Antonio- Site Number : 8400019

San Antonio, Texas, United States

Investigational Site Number : 0320002

Rosario, Santa Fe Province, Argentina

Investigational Site Number : 0320004

Buenos Aires, Argentina

Investigational Site Number : 0320001

Buenos Aires, Argentina

Investigational Site Number : 0360001

Sydney, New South Wales, Australia

Investigational Site Number : 0360003

Melbourne, Victoria, Australia

Investigational Site Number : 1000001

Sofia, Bulgaria

Investigational Site Number : 1240005

Calgary, Alberta, Canada

Investigational Site Number : 1240007

Calgary, Alberta, Canada

Investigational Site Number : 1240001

Winnipeg, Manitoba, Canada

Investigational Site Number : 1240003

Hamilton, Ontario, Canada

Investigational Site Number : 1240006

Markham, Ontario, Canada

Investigational Site Number : 1520003

Santiago, Reg Metropolitana de Santiago, Chile

Investigational Site Number : 1520001

Santiago, Reg Metropolitana de Santiago, Chile

Investigational Site Number : 1520004

Santiago, Reg Metropolitana de Santiago, Chile

Investigational Site Number : 1520002

Santiago, Reg Metropolitana de Santiago, Chile

Investigational Site Number : 1560022

Chengdu, China

Investigational Site Number : 1560006

Hangzhou, China

Investigational Site Number : 1560001

Shanghai, China

Investigational Site Number : 2032104

Ostrava, Czechia

Investigational Site Number : 2030011

Prague, Czechia

Investigational Site Number : 2030012

Prague, Czechia

Investigational Site Number : 2500001

Brest, France

Investigational Site Number : 2500002

Nice, France

Investigational Site Number : 2500003

Paris, France

Investigational Site Number : 2500004

Rouen, France

Investigational Site Number : 2760006

Augsburg, Germany

Investigational Site Number : 2760008

Berlin, Germany

Investigational Site Number : 2760007

Berlin, Germany

Investigational Site Number : 2760001

Hamburg, Germany

Investigational Site Number : 2760003

Münster, Germany

Investigational Site Number : 2760004

Osnabrück, Germany

Investigational Site Number : 3800004

Milan, Milano, Italy

Investigational Site Number : 3800003

Naples, Napoli, Italy

Investigational Site Number : 3800002

Rome, Roma, Italy

Investigational Site Number : 3800001

Bologna, Italy

Investigational Site Number : 3920003

Ebina-shi, Kanagawa, Japan

Investigational Site Number : 3920001

Yokohama, Kanagawa, Japan

Investigational Site Number : 3920002

Kamiamakusa, Kumamoto, Japan

Investigational Site Number : 3920005

Koto-ku, Tokyo, Japan

Investigational Site Number : 3920004

Fukuoka, Japan

Investigational Site Number : 3920006

Tokyo, Japan

Investigational Site Number : 3920001

Yokohama, Japan

Investigational Site Number : 5280004

Rotterdam, Netherlands

Investigational Site Number : 6420001

Cluj-Napoca, Romania

Investigational Site Number : 7240005

Barcelona, Barcelona [Barcelona], Spain

Investigational Site Number : 7240010

Barcelona, Barcelona [Barcelona], Spain

Investigational Site Number : 7240007

Pozuelo de Alarcón, Madrid, Spain

Investigational Site Number : 7240004

Alicante, Spain

Investigational Site Number : 7240002

Córdoba, Spain

Investigational Site Number : 7240006

Madrid, Spain

Investigational Site Number : 7240008

Madrid, Spain

Investigational Site Number : 8260003

London, London, City of, United Kingdom

Investigational Site Number : 8260004

Salford, Manchester, United Kingdom

Investigational Site Number : 8260006

Oxford, Oxfordshire, United Kingdom

Investigational Site Number : 8260005

Dundee, United Kingdom

Investigational Site Number : 8260007

London, United Kingdom

Investigational Site Number : 8260001

London, United Kingdom

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (74)