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

Completed · Phase 2 · NCT06015308

Conditions: Dermatitis Atopic

Research payments reported, 2025: $1.9M
U.S. investigators named: 45
Sites paid: 36
Planned or actual enrollment: 224

About the trial

Sponsor: Sanofi
Tested: Amlitelimab (drug), Placebo (drug), Tdap vaccine (biological), PPS vaccine (biological)
Dates: Started 2023-10-06; completion 2026-01-16
Results posted: Not yet

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 (p…

From ClinicalTrials.gov, last updated 2026-08-10. Full record, eligibility and contacts (opens in a new tab)

Industry funding

Sanofi US Services Inc. reported $1.9M in research payments for this study in 2025 (274 payments).

Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.

U.S. investigators named on this study

Clinicians the company named as principal investigators in its Open Payments reports.

Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.

At a glance

About the trial

Industry funding

U.S. investigators named on this study

Sites paid to run it