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

Conditions

• Dermatitis Atopic

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Amlitelimab — DRUG
  Subcutaneous injection in abdomen, outer thigh, or upper arm
• Placebo — DRUG
  Subcutaneous injection in abdomen, outer thigh, or upper arm
• Tdap vaccine — BIOLOGICAL
  Intramuscular (IM) injection into the deltoid muscle of the upper arm
• PPS vaccine — BIOLOGICAL
  Intramuscular or subcutaneous injection into the deltoid muscle of the upper arm

Study Details

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 \[RIVER-AD\]).

Key Dates

Start date

Oct 6, 2023

Status verified

Apr 2026

Primary completion

Oct 1, 2025

Completion

Jan 16, 2026

Study Design

Enrollment

224 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Amlitelimab
  Participants will receive amlitelimab and vaccines as per protocol.
• Placebo Comparator: Placebo
  Participants will receive placebo matching amlitelimab and vaccines as per protocol.

Primary Outcome Measure

Percentage of participants with a positive tetanus response at Week 16 [ Time Frame: Week 16 ]

Locations (47)

Find similar trials in Birmingham, AL

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