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

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 \[RIVER-AD\]).

Conditions

Dermatitis Atopic

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Study Overview

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Study Details

Study overview

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 \[RIVER-AD\]).

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

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

Condition
Dermatitis Atopic
Intervention / Treatment

-

Contacts and Locations

Birmingham

Clinical Research Center of Alabama - Homewood- Site Number : 8401101, Birmingham, Alabama, United States, 35209

Scottsdale

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

Anaheim

Orange County Clinical Trials- Site Number : 8401271, Anaheim, California, United States, 92801

Fountain Valley

First OC Dermatology- Site Number : 8401025, Fountain Valley, California, United States, 92708

Fremont

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

Fresno

Valley Research- Site Number : 8401097, Fresno, California, United States, 93720

La Mesa

Paradigm Clinical Research Centers- Site Number : 8401273, La Mesa, California, United States, 91942

Lafayette

Sunwise Clinical Research- Site Number : 8401022, Lafayette, California, United States, 94549

Lancaster

Antelope Valley Clinical Trials- Site Number : 8401099, Lancaster, California, United States, 93534

Lomita

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Sanofi,

Clinical Sciences & Operations, STUDY_DIRECTOR, Sanofi

Study Record Dates

2026-02-27