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NCT06015308

PHASE2

A Study to Investigate Vaccine Responses in Subcutaneous Amlitelimab Treated Atopic Dermatitis Participants Aged 18 Years and Older Compared With Placebo

Sponsor: Sanofi

View on ClinicalTrials.gov

Summary

This is a Phase 2, multicenter, randomized, double-blind placebo controlled, 2-arm study to evaluate the effect of amlitelimab on vaccine antibody responses, and the safety of amlitelimab concurrently administered with non-live vaccines in adult participants with moderate-to-severe atopic dermatitis (AD). The purpose of this study is to compare the immune responses to concomitantly administered Boostrix (tetanus, diphtheria, and acellular pertussis \[Tdap\]) and Pneumovax 23 (PPSV) vaccines in adult participants with moderate-to-severe AD treated with amlitelimab versus placebo. The study will evaluate the percentage of participants achieving a positive anti-tetanus response at Week 16 (primary endpoint) and a positive anti-pneumococcal response at Week 16 (key secondary endpoint). Study details include: The study duration will be up to 36 weeks (for participants not entering the LTS17367 \[RIVER-AD\]). The screening period will be 9 days to 4 weeks. The treatment duration will be up to 16 weeks. The post-treatment safety follow-up period will be16 weeks. The number of visits will be up to 7 (or 6 for those entering LTS17367 \[RIVER-AD\]).

Official title: A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Amlitelimab on Vaccine Antibody Responses in Adult Participants With Moderate to Severe Atopic Dermatitis

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

224

Start Date

2023-10-06

Completion Date

2026-01-16

Last Updated

2026-08-10

Healthy Volunteers

Conditions

Dermatitis Atopic

Interventions

DRUG

Amlitelimab

Subcutaneous injection in abdomen, outer thigh, or upper arm

DRUG

Placebo

Subcutaneous injection in abdomen, outer thigh, or upper arm

BIOLOGICAL

Tdap vaccine

Intramuscular (IM) injection into the deltoid muscle of the upper arm

BIOLOGICAL

PPS vaccine

Intramuscular or subcutaneous injection into the deltoid muscle of the upper arm

Inclusion Criteria: * Participants must be 18 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 * Validated Investigator Global Assessment scale for atopic dermatitis (vIGA-AD) of 3 or 4 at baseline visit * Eczema area and severity index (EASI) score of 12 or higher at baseline * AD involvement of 10% or more of body surface area (BSA) at baseline * Able and willing to comply with requested study visits and procedures * Body weight ≥40 kg and ≤150 kg Exclusion Criteria: * Skin co-morbidity that would adversely affect the ability to undertake AD assessments * Receipt of any vaccine (expect influenza and COVID-19 vaccines) within 3 months prior to screening * Receipt of any pneumococcal vaccine within approximate timeframe of 5 years prior to screening * Prior receipt of two or more doses of Pneumovax 23 at any time * Receipt of any tetanus-, diphtheria-, or pertussis-containing vaccine within approximate timeframe of 5 years prior to screening * Participants for whom administration of the pneumococcal vaccine provided in this study is contraindicated or medically inadvisable, according to local label of the vaccine * Participants for whom administration of the tetanus, diphtheria, and pertussis vaccine provided in this study is contraindicated or medically inadvisable, according to local label of the vaccine * Having received any of the specified therapy within the specified timeframe(s) prior to the baseline visit * Known history of or suspected significant current immunosuppression * Any malignancies or history of malignancies prior to baseline (excluding 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 2 weeks prior baseline * Positive for human immunodeficiency virus (HIV), Hepatitis B or hepatitis C at screening visit * Participants with active tuberculosis (TB), latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection, or who are at high risk of contracting TB The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Locations (57)

Clinical Research Center of Alabama - Homewood- Site Number : 8401101

Birmingham, Alabama, United States

Center for Dermatology and Plastic Surgery- Site Number : 8401119

Scottsdale, Arizona, United States

Orange County Clinical Trials- Site Number : 8401271

Anaheim, California, United States

First OC Dermatology- Site Number : 8401025

Fountain Valley, California, United States

Center for Dermatology Clinical Research- Site Number : 8401018

Fremont, California, United States

Valley Research- Site Number : 8401097

Fresno, California, United States

Paradigm Clinical Research Centers- Site Number : 8401273

La Mesa, California, United States

Sunwise Clinical Research- Site Number : 8401022

Lafayette, California, United States

Antelope Valley Clinical Trials- Site Number : 8401099

Lancaster, California, United States

Torrance Clinical Research- Site Number : 8401027

Lomita, California, United States

Clinical Science Institute- Site Number : 8401028

Santa Monica, California, United States

Velocity Clinical Research - Denver Site Number : 8401168

Denver, Colorado, United States

Daxia Trials- Site Number : 8401145

Boca Raton, Florida, United States

Encore Medical Research of Boynton Beach- Site Number : 8401030

Boynton Beach, Florida, United States

Alliance for Multispeciality Research - Fort Myers- Site Number : 8401111

Fort Myers, Florida, United States

Doral Medical Research- Site Number : 8401094

Hialeah, Florida, United States

C&R Research Services - Kendall- Site Number : 8401029

Kendall, Florida, United States

Acevedo Clinical Research Associates- Site Number : 8401088

Miami, Florida, United States

Future Care Solution - Miami- Site Number : 8401144

Miami, Florida, United States

Sanchez Clinical Research- Site Number : 8401095

Miami, Florida, United States

Florida International Research Center- Site Number : 8401091

Miami, Florida, United States

Wellness Clinical Research - Miami Lakes- Site Number : 8401109

Miami Lakes, Florida, United States

K2 South Orlando - South Orange Avenue- Site Number : 8401268

Orlando, Florida, United States

SEC Clinical Research- Site Number : 8401270

Pensacola, Florida, United States

Global Clinical Professionals (GCP)- Site Number : 8401045

St. Petersburg, Florida, United States

Clinical Research Trials of Florida- Site Number : 8401023

Tampa, Florida, United States

Paradigm Clinical Research - Boise- Site Number : 8401272

Boise, Idaho, United States

Skin Sciences- Site Number : 8401039

Louisville, Kentucky, United States

Velocity Clinical Research at The Dermatology Clinic- Site Number : 8401072

Baton Rouge, Louisiana, United States

BRCR Global Gretna- Site Number : 8401243

Gretna, Louisiana, United States

Boeson Research - Missoula- Site Number : 8401269

Missoula, Montana, United States

Henderson Clinical Trials- Site Number : 8401169

Henderson, Nevada, United States

Skin Search Rochester- Site Number : 8401216

Rochester, New York, United States

Velocity Clinical Research - Durham- Site Number : 8401175

Durham, North Carolina, United States

Velocity Clinical Research - Springdale- Site Number : 8401153

Cincinnati, Ohio, United States

Velocity Clinical Research - Medford- Site Number : 8401170

Medford, Oregon, United States

Vial Health - DermDox Dermatology- Site Number : 8401031

Camp Hill, Pennsylvania, United States

Velocity Clinical Research - Providence- Site Number : 8401179

East Greenwich, Rhode Island, United States

Velocity Clinical Research - Charleston - Ashley Town Center Drive- Site Number : 8401174

Charleston, South Carolina, United States

Velocity Clinical Research - Columbia- Site Number : 8401176

Columbia, South Carolina, United States

Velocity Clinical Research - Austin- Site Number : 8401173

Cedar Park, Texas, United States

Modern Research Associates- Site Number : 8401093

Dallas, Texas, United States

Heights Dermatology & Aesthetic Center- Site Number : 8401143

Houston, Texas, United States

Dermatology Clinical Research Center of San Antonio- Site Number : 8401100

San Antonio, Texas, United States

Discovery Clinical Trials - San Antonio - Stone Oak Parkway- Site Number : 8401026

San Antonio, Texas, United States

Stryde Research - Epiphany Dermatology- Site Number : 8401185

Southlake, Texas, United States

Ogden Clinic Mountain View (Avacare) Site Number : 8401167

Pleasant View, Utah, United States

Investigational Site Number : 1240019

Calgary, Alberta, Canada

Investigational Site Number : 1240023

Calgary, Alberta, Canada

Investigational Site Number : 1240016

Edmonton, Alberta, Canada

Investigational Site Number : 1240014

Barrie, Ontario, Canada

Investigational Site Number : 1240020

Hamilton, Ontario, Canada

Investigational Site Number : 1240017

London, Ontario, Canada

Investigational Site Number : 1240018

Newmarket, Ontario, Canada

Investigational Site Number : 1240024

Richmond Hill, Ontario, Canada

Investigational Site Number : 1240021

Toronto, Ontario, Canada

Investigational Site Number : 1240026

Toronto, Ontario, Canada

Clinical Research Directory

A Study to Investigate Vaccine Responses in Subcutaneous Amlitelimab Treated Atopic Dermatitis Participants Aged 18 Years and Older Compared With Placebo

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (57)