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A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis

Completed · Phase 3 · NCT06130566

Conditions: Dermatitis Atopic

At a glance

Research payments reported, 2025
$2.8M
U.S. investigators named
45
Sites paid
42
Planned or actual enrollment
601

About the trial

Sponsor
Sanofi
Tested
Amlitelimab (drug), Placebo (drug)
Dates
Started 2023-11-08; completion 2025-11-13
Results posted
Not yet

This is a parallel group, Phase 3, multinational, multicenter, randomized, double blind, placebo-controlled, 3-arm monotherapy study for treatment of participants diagnosed with moderate to severe atopic dermatitis (AD), whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. The purpose of this study is to measure the efficacy and safety of treatment with amlitelimab solution for SC injection compared with placebo in participants with moderate to severe AD aged 12 years and older. Study details include: At the end of the treatment period, participants will have an option to enter a separate study: the blinded extension stu…

From ClinicalTrials.gov, last updated 2026-07-22. Full record, eligibility and contacts (opens in a new tab)

Industry funding

Sanofi US Services Inc. reported $2.8M in research payments for this study in 2025 (327 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.

Sites paid to run it

  • St Jude Clinical Research Llc $342,289
  • Sky Clinical Research Network Group Integrative Skin Care of Ms Skycrng $311,417
  • First Oc Dermatology Research Inc $174,914
  • Direct Helpers Medical Center Inc Direct Helpers Research Center $168,302
  • Velocity Clinical Research Inc $117,006
  • Skin Care Physicians of Georgia $112,584
  • Leon Kircik MD Skin Sciences PLLC $109,278
  • Stryde Consulting Llc $104,469
  • Encore Medical Research Llc $102,810
  • Phoenix Clinical Trials Scottsdale Clinical Trials $102,018
  • Javara Inc $100,806
  • Miami Dermatology and Laser Research Miami Southwest 87th Avenue $97,884
  • Oregon Medical Research Center $80,816
  • Revival Research Institute, Inc $78,943
  • Vaishali PAtel Summit Clinical Research Llc $76,282
  • Henry Ford Health Hospital, MI $73,688
  • Dermatology Treatment and Research Center $66,680
  • Tribe Clinical Research Llc Mountain View Clinical Research $64,531
  • Sunwise Clinical Research Llc $55,422
  • Metroplex Pulmonary and Sleep Center $54,437
  • Clinical Research Philadelphia Llc $52,151
  • Texas Dermatology and Laser Special $51,353
  • Best Skin Research Llc $47,169
  • Northridge Clinical Trials Llc $39,195
  • Cleaver Medical Group Dermatology I Cleaver Medical Group Dermatology $32,762
  • Sadick Research Group LLC $28,871
  • Qcare Site Services Inc $22,074
  • Massachusetts General Hospital Attn Research Finance Attn 2021a $18,057
  • Beth Israel Deaconess Medical Center $16,660
  • Physicians Research Group II Llc $15,595
  • Florida International Research Center Inc $14,931
  • Carbon Health Technolgies Inc $12,966
  • Clinical Neuroscience Solutions Inc $11,460
  • Medisearch Llc $10,723
  • Chear Center LLC $8,650
  • Vast Clinical Research Llc $8,584
  • Universal Dermatology PLLC $6,622
  • Gsr Enterprises Inc $6,470
  • Elias Research Associates LLC $5,936
  • Paddington Testing Company $5,212
  • University of California Davis Medical Center, CA $3,343
  • Cognitive Clinical Trials LLC $2,245

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