COMPLETED

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

Conditions

Quick Navigation

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 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

Quick Facts

Study Start:2023-10-06

Study Completion:2026-01-16

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06015308

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:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Principal Investigator

Clinical Sciences & Operations

STUDY_DIRECTOR

Sanofi

Study Locations (Sites)

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

Birmingham, Alabama, 35209

United States

Center for Dermatology and Plastic Surgery- Site Number : 8401119

Scottsdale, Arizona, 85260

United States

Orange County Clinical Trials- Site Number : 8401271

Anaheim, California, 92801

United States

First OC Dermatology- Site Number : 8401025

Fountain Valley, California, 92708

United States

Center for Dermatology Clinical Research- Site Number : 8401018

Fremont, California, 94538

United States

Valley Research- Site Number : 8401097

Fresno, California, 93720

United States

Paradigm Clinical Research Centers- Site Number : 8401273

La Mesa, California, 91942

United States

Sunwise Clinical Research- Site Number : 8401022

Lafayette, California, 94549

United States

Antelope Valley Clinical Trials- Site Number : 8401099

Lancaster, California, 93534

United States

Torrance Clinical Research- Site Number : 8401027

Lomita, California, 90717

United States

Clinical Science Institute- Site Number : 8401028

Santa Monica, California, 90404

United States

Velocity Clinical Research - Denver Site Number : 8401168

Denver, Colorado, 80209

United States

Daxia Trials- Site Number : 8401145

Boca Raton, Florida, 33431

United States

Encore Medical Research of Boynton Beach- Site Number : 8401030

Boynton Beach, Florida, 33436

United States

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

Fort Myers, Florida, 33912

United States

Doral Medical Research- Site Number : 8401094

Hialeah, Florida, 33016

United States

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

Kendall, Florida, 33183

United States

Acevedo Clinical Research Associates- Site Number : 8401088

Miami, Florida, 33142

United States

Future Care Solution - Miami- Site Number : 8401144

Miami, Florida, 33142

United States

Sanchez Clinical Research- Site Number : 8401095

Miami, Florida, 33157

United States

Florida International Research Center- Site Number : 8401091

Miami, Florida, 33173

United States

Wellness Clinical Research - Miami Lakes- Site Number : 8401109

Miami Lakes, Florida, 33016

United States

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

Orlando, Florida, 32806

United States

SEC Clinical Research- Site Number : 8401270

Pensacola, Florida, 32501

United States

Global Clinical Professionals (GCP)- Site Number : 8401045

St. Petersburg, Florida, 33705

United States

Clinical Research Trials of Florida- Site Number : 8401023

Tampa, Florida, 33607

United States

Paradigm Clinical Research - Boise- Site Number : 8401272

Boise, Idaho, 83709

United States

Skin Sciences- Site Number : 8401039

Louisville, Kentucky, 40217

United States

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

Baton Rouge, Louisiana, 70809

United States

BRCR Global Gretna- Site Number : 8401243

Gretna, Louisiana, 70053

United States

Boeson Research - Missoula- Site Number : 8401269

Missoula, Montana, 59804

United States

Henderson Clinical Trials- Site Number : 8401169

Henderson, Nevada, 89052

United States

Skin Search Rochester- Site Number : 8401216

Rochester, New York, 14623

United States

Velocity Clinical Research - Durham- Site Number : 8401175

Durham, North Carolina, 27701

United States

Velocity Clinical Research - Springdale- Site Number : 8401153

Cincinnati, Ohio, 45246

United States

Velocity Clinical Research - Medford- Site Number : 8401170

Medford, Oregon, 97504

United States

Vial Health - DermDox Dermatology- Site Number : 8401031

Camp Hill, Pennsylvania, 17011

United States

Velocity Clinical Research - Providence- Site Number : 8401179

East Greenwich, Rhode Island, 02818

United States

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

Charleston, South Carolina, 29414

United States

Velocity Clinical Research - Columbia- Site Number : 8401176

Columbia, South Carolina, 29204

United States

Velocity Clinical Research - Austin- Site Number : 8401173

Cedar Park, Texas, 78613

United States

Modern Research Associates- Site Number : 8401093

Dallas, Texas, 75231

United States

Heights Dermatology & Aesthetic Center- Site Number : 8401143

Houston, Texas, 77008

United States

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

San Antonio, Texas, 78229

United States

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

San Antonio, Texas, 78258

United States

Stryde Research - Epiphany Dermatology- Site Number : 8401185

Southlake, Texas, 76092

United States

Ogden Clinic Mountain View (Avacare) Site Number : 8401167

Pleasant View, Utah, 84404

United States

Collaborators and Investigators

Sponsor: Sanofi

Clinical Sciences & Operations, STUDY_DIRECTOR, 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 Date2023-10-06

Study Completion Date2026-01-16

Study Record Updates

Study Start Date2023-10-06

Study Completion Date2026-01-16

Terms related to this study

Additional Relevant MeSH Terms

Dermatitis Atopic