Dose Ranging Study of Amlitelimab in Adult Participants With Moderate-to-severe Asthma
Completed · Phase 2 · NCT05421598
Conditions: Asthma
At a glance
- Research payments reported, 2025
- $418,244
- U.S. investigators named
- 21
- Sites paid
- 21
- Planned or actual enrollment
- 437
About the trial
- Sponsor
- Sanofi
- Tested
- Amlitelimab (drug), Placebo (drug)
- Dates
- Started 2022-06-30; completion 2025-03-20
- Results posted
- Yes
This was a parallel, Phase 2, global, multicenter, randomized, double-blind, placebo-controlled, dose-ranging, four-arms study for treatment. The purpose of this study was to assess the efficacy, safety, and tolerability of add-on therapy with amlitelimab in adult participants with moderate-to-severe asthma. Study details include: * The study duration (per participant) was up to approximately 76 weeks for participants not going into LTS study and will be up to approximately 64 weeks for participants going into LTS study. * The randomized treatment duration was up to approximately 60 weeks. * The scheduled number of visits was 13.
From ClinicalTrials.gov, last updated 2026-03-30. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Sanofi US Services Inc. reported $418,244 in research payments for this study in 2025 (92 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
- Vikas Sayal, M.D. Pulmonology · Bullhead City, AZ
- George W. Bensch, M.D. Specialist · Stockton, CA
- Alan B. Goldsobel, MD Allergy & Immunology · San Jose, CA
- David N. Pham, MD Pulmonology · Westminster, CA
- Yamil A. Canaan, M.D. Internal Medicine · Miami, FL
- Nestor O. Cancio Morales, M.D. Pulmonology · Miami, FL
- Joel Gonzalez, M.D. Internal Medicine · Homestead, FL
- Juan M. Hernandez-trujillo, MD Pediatrics · Miami Lakes, FL
- Jaynier Moya, MD Internal Medicine · Pembroke Pines, FL
- Alexis R. Renta, M.D. Pain Medicine · Boynton Beach, FL
- Mohammad T. Sheikh General Practice · Lauderhill, FL
- Mario Castro, MD Pulmonology · Kansas City, KS
- Mark Liu, M.D. Pulmonology · Baltimore, MD
- Njira L. Lugogo, M.D. Pulmonology · Ann Arbor, MI
- David W. Strong, M.D., PH.D. Emergency Medicine · Detroit, MI
- Carl E. Thornblade, MD Allergy & Immunology · Missoula, MT
- Jeremy Cole, MD Sleep Medicine · Edmond, OK
- Martha M. Tarpay, MD Allergy & Immunology · Oklahoma City, OK
- David Fuentes, MD Allergy & Immunology · Boerne, TX
- James M. Harris, M.D. Urology · Houston, TX
- Andrew Smith, MD Allergy & Immunology · Sandy, UT
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Elligo Health Research Inc $101,118
- Pines Care Research Center Llc $98,127
- Johns Hopkins University $31,636
- Beautiful Minds Medical Center Llc $25,540
- Henderson Clinical Trials Llc $20,298
- Allergy and Asthma Associates of Sa Clara Valley Research Center $17,388
- Helix Biomedics Llc $15,993
- University of Kansas Hospital $15,160
- Headlands Horizons Llc $14,016
- Martha Tarpay MD Allergy Asthma and Clinical Researc Center $14,000
- Allianz Research Institute Inc $13,503
- University of Michigan Health System, MI $10,535
- Ok Clinical Research LLC $6,825
- Elias Research Associates LLC $6,750
- Qcare Site Services Inc $6,750
- Renaissance Research and Medical Group, Inc $4,980
- University of Kansas Medical Center Research Institute Inc Kumc Research Institute $4,550
- Interspond LLC $4,250
- George Bensch M D Bensch Clinical Research Llc $2,625
- Reliable Clinical Research Llc $2,600
- Allergy Associates of Utah $1,600
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.