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

NCT06444451 | Active Not Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: DRI181802024-511225-64U1111-1295-6359
• Study Type: interventional
• Target: 166
• Locations: 16 countries
• Sites: 74

Brief 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).

Conditions

Alopecia Areata

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Severity of Alopecia Tool (SALT) score at 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).

  Baseline to Week 36

Secondary Outcomes (19)

• Change from the baseline in SALT score at Week 24 (key secondary)

  Baseline to Week 24

• Proportion of participants achieving a SALT score ≤20 at Weeks 24 and 36

  Week 24 and 36

• Time to SALT score ≤20

  Up to Week 36

• Proportion of participants achieving a SALT score ≤10 at Weeks 24 and 36

  Week 24 and 36

• Time to SALT score ≤10

  Up to Week 36

Study Arms (3)

Amlitelimab dose group 1

EXPERIMENTAL

Subcutaneous injection as per protocol

Drug: Amlitelimab

Amlitelimab dose group 2

EXPERIMENTAL

Subcutaneous injection as per protocol

Drug: Amlitelimab

Placebo

PLACEBO COMPARATOR

Subcutaneous injection as per protocol

Drug: Placebo

Interventions

Amlitelimab DRUG

Pharmaceutical form: Injection solution Route of administration: SC injection

Also known as: SAR445229

Amlitelimab dose group 1; Amlitelimab dose group 2

Placebo DRUG

Pharmaceutical form: Injection solution Route of administration: SC injection

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Definitive diagnosis of AA of more than 6 months.
• Diagnosis of severe AA, as determined by all of the following:
• Hair loss affecting ≥50% of the scalp, as measured by Severity of Alopecia Tool (SALT) at both screening and baseline visits.
• 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.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanofi: lead

Study Sites (74)

Total Skin and Beauty Dermatology Center- Site Number : 8400018

Birmingham, Alabama, 35205, United States

Location

First OC Dermatology- Site Number : 8400014

Fountain Valley, California, 92708, United States

Location

Center for Dermatology Clinical Research- Site Number : 8400008

Fremont, California, 94538, United States

Location

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

Irvine, California, 92697, United States

Location

Dermatology Research Associates - Los Angeles- Site Number : 8400015

Los Angeles, California, 90045, United States

Location

New Horizon Research Center- Site Number : 8400017

Miami, Florida, 33165, United States

Location

Dawes Fretzin Clinical Research- Site Number : 8400010

Indianapolis, Indiana, 46256, United States

Location

Michigan Center for Research Company- Site Number : 8400016

Clarkston, Michigan, 48346, United States

Location

Joel Schlessinger, PC- Site Number : 8400021

Omaha, Nebraska, 68144, United States

Location

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

New York, New York, 10029, United States

Location

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

Charlotte, North Carolina, 28210, United States

Location

Cleveland Clinic- Site Number : 8400028

Cleveland, Ohio, 44195, United States

Location

Apex Clinical Research Center- Site Number : 8400027

Mayfield Heights, Ohio, 44124, United States

Location

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

Tulsa, Oklahoma, 74136, United States

Location

Oregon Medical Research Center- Site Number : 8400002

Portland, Oregon, 97201, United States

Location

Health Concepts- Site Number : 8400001

Rapid City, South Dakota, 57702, United States

Location

Progressive Clinical Research - San Antonio- Site Number : 8400019

San Antonio, Texas, 78229, United States

Location

Investigational Site Number : 0320002

Rosario, Santa Fe Province, 2000, Argentina

Location

Investigational Site Number : 0320004

Buenos Aires, 1055, Argentina

Location

Investigational Site Number : 0320001

Buenos Aires, 1061, Argentina

Location

Investigational Site Number : 0360001

Sydney, New South Wales, 2010, Australia

Location

Investigational Site Number : 0360003

Melbourne, Victoria, 3002, Australia

Location

Investigational Site Number : 1000001

Sofia, 1612, Bulgaria

Location

Investigational Site Number : 1240005

Calgary, Alberta, T2J 7E1, Canada

Location

Investigational Site Number : 1240007

Calgary, Alberta, T2W 4X9, Canada

Location

Investigational Site Number : 1240001

Winnipeg, Manitoba, R3M 3Z4, Canada

Location

Investigational Site Number : 1240003

Hamilton, Ontario, L8L 3C3, Canada

Location

Investigational Site Number : 1240006

Markham, Ontario, L3P 1X2, Canada

Location

Investigational Site Number : 1520003

Santiago, Reg Metropolitana de Santiago, 7580206, Chile

Location

Investigational Site Number : 1520001

Santiago, Reg Metropolitana de Santiago, 7640881, Chile

Location

Investigational Site Number : 1520004

Santiago, Reg Metropolitana de Santiago, 8380465, Chile

Location

Investigational Site Number : 1520002

Santiago, Reg Metropolitana de Santiago, 8420383, Chile

Location

Investigational Site Number : 1560022

Chengdu, 610041, China

Location

Investigational Site Number : 1560006

Hangzhou, 310009, China

Location

Investigational Site Number : 1560001

Shanghai, 200040, China

Location

Investigational Site Number : 2032104

Ostrava, 702 00, Czechia

Location

Investigational Site Number : 2030011

Prague, 150 00, Czechia

Location

Investigational Site Number : 2030012

Prague, 158 00, Czechia

Location

Investigational Site Number : 2500001

Brest, 29200, France

Location

Investigational Site Number : 2500002

Nice, 06202, France

Location

Investigational Site Number : 2500003

Paris, 75010, France

Location

Investigational Site Number : 2500004

Rouen, 76031, France

Location

Investigational Site Number : 2760006

Augsburg, 86150, Germany

Location

Investigational Site Number : 2760008

Berlin, 10117, Germany

Location

Investigational Site Number : 2760007

Berlin, 10629, Germany

Location

Investigational Site Number : 2760001

Hamburg, 20095, Germany

Location

Investigational Site Number : 2760003

Münster, 48149, Germany

Location

Investigational Site Number : 2760004

Osnabrück, 49074, Germany

Location

Investigational Site Number : 3800004

Milan, Milano, 20132, Italy

Location

Investigational Site Number : 3800003

Naples, Napoli, 80131, Italy

Location

Investigational Site Number : 3800002

Rome, Roma, 00168, Italy

Location

Investigational Site Number : 3800001

Bologna, 40138, Italy

Location

Investigational Site Number : 3920003

Ebina-shi, Kanagawa, 243-0432, Japan

Location

Investigational Site Number : 3920001

Yokohama, Kanagawa, 221-0825, Japan

Location

Investigational Site Number : 3920002

Kamiamakusa, Kumamoto, 861-3106, Japan

Location

Investigational Site Number : 3920005

Koto-ku, Tokyo, 136-0075, Japan

Location

Investigational Site Number : 3920004

Fukuoka, 814-0171, Japan

Location

Investigational Site Number : 3920006

Tokyo, 160-0023, Japan

Location

Investigational Site Number : 3920001

Yokohama, 221-0825, Japan

Location

Investigational Site Number : 5280004

Rotterdam, 3015 CE, Netherlands

Location

Investigational Site Number : 6420001

Cluj-Napoca, 400006, Romania

Location

Investigational Site Number : 7240005

Barcelona, Barcelona [Barcelona], 08035, Spain

Location

Investigational Site Number : 7240010

Barcelona, Barcelona [Barcelona], 08036, Spain

Location

Investigational Site Number : 7240007

Pozuelo de Alarcón, Madrid, 28223, Spain

Location

Investigational Site Number : 7240004

Alicante, 03010, Spain

Location

Investigational Site Number : 7240002

Córdoba, 14004, Spain

Location

Investigational Site Number : 7240006

Madrid, 28031, Spain

Location

Investigational Site Number : 7240008

Madrid, 28040, Spain

Location

Investigational Site Number : 8260003

London, London, City of, SW10 9NH, United Kingdom

Location

Investigational Site Number : 8260004

Salford, Manchester, M6 8HD, United Kingdom

Location

Investigational Site Number : 8260006

Oxford, Oxfordshire, OX3 7LE, United Kingdom

Location

Investigational Site Number : 8260005

Dundee, DD1 9SY, United Kingdom

Location

Investigational Site Number : 8260007

London, SE1 9RT, United Kingdom

Location

Investigational Site Number : 8260001

London, SE5 9RL, United Kingdom

Location

Related Links

• DRI18180 Plain Language Results Summary

MeSH Terms

Conditions

Alopecia Areata

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2024
• First Posted: June 5, 2024
• Study Start: June 6, 2024
• Primary Completion: September 24, 2025
• Study Completion (Estimated): January 5, 2028
• Last Updated: October 24, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

IT (4); US (17); CZ (3); NL (1); ES (7); CA (5); AR (3); FR (4); GB (6); DE (6); BU (1); CL (4); RO (1); JP (7); CN (3); AU (2)