Purpose

This is a parallel group, Phase 3, multinational, multicenter, randomized, double-blind, placebo-controlled, 3-arm monotherapy study for treatment of participants diagnosed with moderate to severe atopic dermatitis (AD), whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. The purpose of this study is to measure the efficacy and safety of treatment with amlitelimab solution for SC injection compared with placebo in participants with moderate to severe AD aged 12 years and older. Study details include: At the end of the treatment period, participants will have an option to enter a separate study: the blinded extension study EFC17600 (ESTUARY). For participants not entering the blinded extension Study EFC17600 (ESTUARY), the study duration will be up to 44 weeks including a 2 to 4-week screening, a 24-week randomized double-blind period, and a 16-week safety follow-up. For participants entering the blinded extension Study EFC17600 (ESTUARY), the study duration will be up to 28 weeks including a 2 to 4-week screening and a 24-week randomized double-blind period. The total treatment duration will be up to 24 weeks. The total number of visits will be up to 10 visits (or 9 visits for those entering the blinded extension study EFC17600 (ESTUARY).

Condition

Eligibility

Eligible Ages
Over 12 Years
Eligible Genders
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 (within 6 months before screening) of either inadequate response or inadvisability to topical treatments, and/or inadequate response to systemic therapies (within 12 months before screening) - 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 patient's 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: SC injection
    Other names:
    • SAR445229
Experimental
Amlitelimab dose 2
Subcutaneous injection as per protocol
  • Drug: Amlitelimab
    Pharmaceutical form: Injection solution Route of administration: SC injection
    Other names:
    • SAR445229
Placebo Comparator
Placebo
Subcutaneous injection as per protocol
  • Drug: Placebo
    Pharmaceutical form: Injection solution Route of administration: SC injection

Recruiting Locations

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

Eclipse Clinical Research- Site Number : 8401158
Tucson, Arizona 85745

Torrance Clinical Research- Site Number : 8401027
Lomita, California 90717

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

Allergy & Asthma Associates of Southern California - Mission Viejo- Site Number : 8401079
Mission Viejo, California 92691

Cura Clinical Research - Oxnard- Site Number : 8401142
Oxnard, California 93030

Clinical Science Institute- Site Number : 8401028
Santa Monica, California 90404

University of Connecticut Health Center- Site Number : 8401115
Farmington, Connecticut 06032

Pediatric Skin Research- Site Number : 8401198
Coral Gables, Florida 33146

Anchor Medical Research- Site Number : 8401300
Miami, Florida 33176

Clinical Research Trials of Florida- Site Number : 8401023
Tampa, Florida 33607

AllerVie Clinical Research - Columbus- Site Number : 8401104
Columbus, Georgia 31904

First Georgia Physician Group- Site Number : 8401190
Fayetteville, Georgia 30214

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

MedPharmics - Covington- Site Number : 8401137
Covington, Louisiana 70433

Care Access Research - Marriottsville- Site Number : 8401126
Marriottsville, Maryland 21104

Tufts Medical Center Site Number : 8401201
Boston, Massachusetts 02111

University Of Mississippi Medical Center- Site Number : 8401184
Jackson, Mississippi 39216

Care Access - Hoboken- Site Number : 8401132
Hoboken, New Jersey 07030

The University of New Mexico- Site Number : 8401263
Albuquerque, New Mexico 87106

Montefiore Medical Center - Moses Campus- Site Number : 8401150
Bronx, New York 10467

OmeraNY- Site Number : 8401156
Brooklyn, New York 11220

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

Red River Research Partners- Site Number : 8401196
Fargo, North Dakota 58103

Bexley Dermatology Research- Site Number : 8401051
Bexley, Ohio 43209

Velocity Clinical Research - Springdale- Site Number : 8401153
Cincinnati, Ohio 45246

Dermatology Associates of Plymouth Meeting- Site Number : 8401147
Plymouth Meeting, Pennsylvania 19462

PEAK Research- Site Number : 8401083
Upper Saint Clair, Pennsylvania 15241

Health Concepts- Site Number : 8401059
Rapid City, South Dakota 57702

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

Derm Texas- Site Number : 8401217
Dallas, Texas 75235

Center for Clinical Studies - Houston - Binz Street- Site Number : 8401063
Houston, Texas 77004

Prolato Clinical Research Center- Site Number : 8401209
Houston, Texas 77054

Sienna Dermatology- Site Number : 8401148
Missouri City, Texas 77459

Progressive Clinical Research - San Antonio- Site Number : 8401016
San Antonio, Texas 78229

Care Access - Arlington- Site Number : 8401134
Arlington, Virginia 22206

Velocity Clinical Research - Hampton- Site Number : 8401154
Hampton, Virginia 23666

More Details

NCT ID
NCT06181435
Status
Recruiting
Sponsor
Sanofi

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.