A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab on Background Topical Corticosteroids Therapy in Participants Aged 12 Years and Older With Moderate-to-severe AD Who Have Had an Inadequate Response to Prior Biologic Therapy or an Oral JAK Inhibitor

Purpose

This is a parallel group, Phase 3, multinational, multicenter, randomized, double-blind, placebo-controlled, 3-arm study for treatment of participants diagnosed with moderate-to-severe AD on background TCS who have had inadequate response to prior biologic or oral JAKi therapy. The purpose of this study is to measure the efficacy and safety of treatment with amlitelimab solution for subcutaneous (SC) injection compared with placebo in participants with moderate-to-severe AD aged 12 years and older on background TCS and have had an inadequate response to prior biologic or an oral JAKi therapy. Study details include: At the end of the treatment period, participants will have the option to enter the Long-Term Safety Study LTS17367 (RIVER-AD). The study duration will be up to 56 weeks for participants not entering the long-term safety study (LTS17367 [RIVER-AD]) including a 2 to 4-week screening, a 36-week randomized double-blind period, and a 16-week safety follow-up. The study duration will be up to 40 weeks for participants entering the long-term safety study (LTS17367 [RIVER-AD]) including a 2 to 4-week screening and a 36-week randomized double-blind period. The total treatment duration will be up to 36 weeks. The total number of visits will be up to 13 visits (or 12 visits for those entering the long-term safety study LTS17367 [RIVER-AD] study).

Condition

  • Dermatitis Atopic

Eligibility

Eligible Ages
Over 12 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Participants must be 12 years of age (when signing informed consent form) - Diagnosis of AD for at least 1 year (defined by the American Academy of Dermatology Consensus Criteria) - Documented history prior to screening visit of inadequate response to a biologic AD medication or an oral JAKi therapy. - v-IGA-AD of 3 or 4 at baseline visit - EASI score of 16 or higher at baseline - AD involvement of 10% or more of BSA at baseline - Weekly average of daily PP-NRS of ≥ 4 at baseline visit. - Able and willing to comply with requested study visits and procedures - Body weight ≥25 kg

Exclusion Criteria

Participants are excluded from the study if any of the following criteria apply: - Skin co-morbidity that would adversely affect the ability to undertake AD assessments - Known history of or suspected significant current immunosuppression - Any malignancies or history of malignancies prior to baseline (with the exception of non-melanoma skin cancer excised and cured >5 years prior to baseline) - History of solid organ or stem cell transplant - Any active or chronic infection including helminthic infection requiring systemic treatment within 4 weeks prior to baseline - Positive for human immunodeficiency virus (HIV), Hepatitis B or hepatitis C at screening visit - Having active tuberculosis (TB), latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection, or who are at high risk of contracting TB - Having received any of the specified therapy within the specified timeframe(s) prior to the baseline visit - In the Investigator's opinion, any clinically significant laboratory results or protocol specified laboratory abnormalities at screening - History of hypersensitivity or allergy to any of the excipients or investigational medicinal product (IMP) The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Amlitelimab dose 1
Subcutaneous injection as per protocol
  • Drug: Amlitelimab
    Pharmaceutical form: Injection solution Route of administration: Subcutaneous
    Other names:
    • SAR445229
  • Drug: Topical corticosteroids
    Pharmaceutical form: Various Topical formulation Route of administration: Topical
  • Drug: Topical tacrolimus or pimecrolimus
    Pharmaceutical form: Various Topical formulation Route of administration: Topical
Experimental
Amlitelimab dose 2
Subcutaneous injection as per protocol
  • Drug: Amlitelimab
    Pharmaceutical form: Injection solution Route of administration: Subcutaneous
    Other names:
    • SAR445229
  • Drug: Topical corticosteroids
    Pharmaceutical form: Various Topical formulation Route of administration: Topical
  • Drug: Topical tacrolimus or pimecrolimus
    Pharmaceutical form: Various Topical formulation Route of administration: Topical
Placebo Comparator
Placebo
Subcutaneous injection as per protocol
  • Drug: Placebo
    Pharmaceutical form: Injection solution Route of administration: Subcutaneous
  • Drug: Topical corticosteroids
    Pharmaceutical form: Various Topical formulation Route of administration: Topical
  • Drug: Topical tacrolimus or pimecrolimus
    Pharmaceutical form: Various Topical formulation Route of administration: Topical

Recruiting Locations

University of Alabama at Birmingham- Site Number : 8401267
Birmingham, Alabama 35233

Center for Dermatology and Plastic Surgery- Site Number : 8401119
Scottsdale, Arizona 85260

Arkansas Dermatology - North Little Rock- Site Number : 8401244
North Little Rock, Arkansas 72117

Encino Research Center- Site Number : 8401042
Encino, California 91436

Center for Dermatology Clinical Research- Site Number : 8401018
Fremont, California 94538

Long Beach Clinical Trials- Site Number : 8401188
Long Beach, California 90806

Dermatology Research Associates - Los Angeles- Site Number : 8401092
Los Angeles, California 90045

LA Universal Research Center- Site Number : 8401064
Los Angeles, California 90057

Rady Children's Hospital- Site Number : 8401291
San Diego, California 92123

Therapeutics Clinical Research- Site Number : 8401283
San Diego, California 92123

Paradigm Research - Wheat Ridge- Site Number : 8401245
Wheat Ridge, Colorado 80033

Encore Medical Research of Boynton Beach- Site Number : 8401030
Boynton Beach, Florida 33436

St Jude Clinical Research- Site Number : 8401287
Doral, Florida 33172

Apex Clinical Research- Site Number : 8401332
Jacksonville, Florida 32256

Global Clinical Professionals (GCP)- Site Number : 8401045
Saint Petersburg, Florida 33705

Avita Clinical Research- Site Number : 8401073
Tampa, Florida 33613

Northwestern University- Site Number : 8401285
Chicago, Illinois 60611

NorthShore University HealthSystem - Skokie- Site Number : 8401038
Skokie, Illinois 60077

Dawes Fretzin Clinical Research- Site Number : 8401015
Indianapolis, Indiana 46256

Access Dermatology Clinic- Site Number : 8401296
Franklin, Kentucky 42134

Tandem Clinical Research, LLC- Site Number : 8401187
Metairie, Louisiana 70006

University of Michigan Medical Center- Site Number : 8401290
Ann Arbor, Michigan 48105

MI Skin Center- Site Number : 8401307
Northville, Michigan 48167

Skin Specialists- Site Number : 8401068
Omaha, Nebraska 68144

SDG Dermatology, PC- Site Number : 8401338
East Windsor, New Jersey 08520

University of New Mexico Comprehensive Cancer Center- Site Number : 8401263
Albuquerque, New Mexico 87102

Equity Medical- Site Number : 8401239
New York, New York 10023

Sadick Research Group - New York - Park Avenue- Site Number : 8401050
New York, New York 10075

Oregon Health and Science University- Site Number : 8401247
Portland, Oregon 97239

Paddington Testing Company- Site Number : 8401041
Philadelphia, Pennsylvania 19103

Clinical Research of Philadelphia- Site Number : 8401193
Philadelphia, Pennsylvania 19114

Medical University of South Carolina - Charleston - Jonathan Lucas Street- Site Number : 8401282
Charleston, South Carolina 29425

Arlington Research Center- Site Number : 8401248
Arlington, Texas 76011

Reveal Research Institute - Dallas- Site Number : 8401219
Dallas, Texas 75235

Advanced Research Institute - Odgen- Site Number : 8401057
Ogden, Utah 84405

Virginia Dermatology & Skin Cancer Center- Site Number : 8401047
Norfolk, Virginia 23502

North Sound Dermatology- Site Number : 8401280
Mill Creek, Washington 98012

Children's Wisconsin- Site Number : 8401246
Milwaukee, Wisconsin 53226

Cheyenne Skin Clinic- Site Number : 8401234
Cheyenne, Wyoming 82009

More Details

NCT ID
NCT06241118
Status
Recruiting
Sponsor
Sanofi

Study Contact

Trial Transparency email recommended (Toll free for US & Canada)
800-633-1610
Contact-US@sanofi.com