ACTIVE_NOT_RECRUITING

A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis (COAST 2)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallelgroup, 3-arm, Multinational, Multicenter Study to Evaluate the Efficacy and Safety of Amlitelimab Monotherapy by Subcutaneous Injection in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis

Quick Facts

Study Start:2023-12-21
Study Completion:2026-03-17
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06181435

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants must be 12 years of age (when signing informed consent form)
  2. * Diagnosis of AD for at least 1 year (defined by the American Academy of Dermatology Consensus Criteria)
  3. * 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)
  4. * v-IGA-AD of 3 or 4 at baseline visit
  5. * EASI score of 16 or higher at baseline
  6. * AD involvement of 10% or more of BSA at baseline
  7. * Weekly average of daily PP-NRS of ≥ 4 at baseline visit.
  8. * Able and willing to comply with requested study visits and procedures
  9. * Body weight ≥ 25 kg
  1. * Skin co-morbidity that would adversely affect the ability to undertake AD assessments
  2. * Known history of or suspected significant current immunosuppression
  3. * 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)
  4. * History of solid organ or stem cell transplant
  5. * Any active or chronic infection including helminthic infection requiring systemic treatment within 4 weeks prior to baseline
  6. * Positive for human immunodeficiency virus (HIV), Hepatitis B or hepatitis C at screening visit
  7. * 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
  8. * Having received any of the specified therapy within the specified timeframe(s) prior to the baseline visit
  9. * In the Investigator's opinion, any clinically significant laboratory results or protocol specified laboratory abnormalities at screening
  10. * History of hypersensitivity or allergy to any of the excipients or investigational medicinal product (IMP)

Contacts and Locations

Study Locations (Sites)

Center for Dermatology and Plastic Surgery- Site Number : 8401119
Scottsdale, Arizona, 85260
United States
Eclipse Clinical Research- Site Number : 8401158
Tucson, Arizona, 85745
United States
Torrance Clinical Research- Site Number : 8401027
Lomita, California, 90717
United States
Dermatology Research Associates - Los Angeles- Site Number : 8401092
Los Angeles, California, 90045
United States
Allergy & Asthma Associates of Southern California - Mission Viejo- Site Number : 8401079
Mission Viejo, California, 92691
United States
Cura Clinical Research - Oxnard- Site Number : 8401142
Oxnard, California, 93030
United States
Clinical Science Institute- Site Number : 8401028
Santa Monica, California, 90404
United States
University of Connecticut Health Center- Site Number : 8401115
Farmington, Connecticut, 06032
United States
Pediatric Skin Research- Site Number : 8401198
Coral Gables, Florida, 33146
United States
Skin Care Research - Hollywood- Site Number : 8401071
Hollywood, Florida, 33021
United States
Savin Medical Group - Miami- Site Number : 8401085
Miami, Florida, 33126
United States
Anchor Medical Research- Site Number : 8401300
Miami, Florida, 33176
United States
Accel Research - Nona Pediatric Center- Site Number : 8401081
Orlando, Florida, 32829
United States
Nuline Clinical Trial Center- Site Number : 8401161
Pompano Beach, Florida, 33060
United States
Clinical Research Trials of Florida- Site Number : 8401023
Tampa, Florida, 33607
United States
AllerVie Clinical Research - Columbus- Site Number : 8401104
Columbus, Georgia, 31904
United States
First Georgia Physician Group- Site Number : 8401190
Fayetteville, Georgia, 30214
United States
Access Dermatology- Site Number : 8401296
Bowling Green, Kentucky, 42104
United States
MedPharmics - Covington- Site Number : 8401137
Covington, Louisiana, 70433
United States
Care Access Research - Marriottsville- Site Number : 8401126
Marriottsville, Maryland, 21104
United States
Tufts Medical Center Site Number : 8401201
Boston, Massachusetts, 02111
United States
University Of Mississippi Medical Center- Site Number : 8401184
Jackson, Mississippi, 39216
United States
Care Access - Hoboken- Site Number : 8401132
Hoboken, New Jersey, 07030
United States
University of New Mexico Comprehensive Cancer Center- Site Number : 8401263
Albuquerque, New Mexico, 87102
United States
Montefiore Medical Center - Moses Campus- Site Number : 8401150
Bronx, New York, 10467
United States
OmeraNY- Site Number : 8401156
Brooklyn, New York, 11220
United States
Equity Medical- Site Number : 8401239
New York, New York, 10023
United States
Red River Research Partners- Site Number : 8401196
Fargo, North Dakota, 58103
United States
Bexley Dermatology Research- Site Number : 8401051
Bexley, Ohio, 43209
United States
Velocity Clinical Research - Springdale- Site Number : 8401153
Cincinnati, Ohio, 45246
United States
Dermatology Associates of Plymouth Meeting- Site Number : 8401147
Plymouth Meeting, Pennsylvania, 19462
United States
PEAK Research- Site Number : 8401083
Upper Saint Clair, Pennsylvania, 15241
United States
Columbia Dermatology & Aesthetics- Site Number : 8401166
Columbia, South Carolina, 29212
United States
Health Concepts- Site Number : 8401059
Rapid City, South Dakota, 57702
United States
Arlington Research Center- Site Number : 8401248
Arlington, Texas, 76011
United States
Derm Texas- Site Number : 8401217
Dallas, Texas, 75235
United States
Center for Clinical Studies - Houston - Binz Street- Site Number : 8401063
Houston, Texas, 77004
United States
Prolato Clinical Research Center- Site Number : 8401209
Houston, Texas, 77054
United States
Sienna Dermatology- Site Number : 8401148
Missouri City, Texas, 77459
United States
Progressive Clinical Research - San Antonio- Site Number : 8401016
San Antonio, Texas, 78229
United States
Advanced Research Institute - Odgen- Site Number : 8401057
Ogden, Utah, 84405
United States
Care Access - Arlington- Site Number : 8401134
Arlington, Virginia, 22206
United States
Velocity Clinical Research - Hampton- Site Number : 8401154
Hampton, Virginia, 23666
United States

Collaborators and Investigators

Sponsor: Sanofi

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-21
Study Completion Date2026-03-17

Study Record Updates

Study Start Date2023-12-21
Study Completion Date2026-03-17

Terms related to this study

Additional Relevant MeSH Terms

  • Dermatitis Atopic