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

NCT06015308 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2026-04-13

No results posted yet for this study

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 \[RIVER-AD\]).

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-06
Primary Completion
2025-10-01
Completion
2026-01-16
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06015308 on ClinicalTrials.gov