Dose Ranging Study of Amlitelimab in Adult Participants With Moderate-to-severe Asthma

Completed · Phase 2 · Has a placebo group

Conditions studied: Asthma

In brief

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.

Key facts

Study ID: NCT05421598
Run by: Sanofi
People needed: 437
Starts: 2022-06-30
Expected to finish: 2025-03-20
Last updated by the study team: 2026-03-30

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

The participant must be between the ages of 18 and 75 inclusive at the time of signing the informed consent.
Moderate to severe asthma diagnosed by a physician for ≥ 12 months according to stages 4 and 5 of the Global Initiative for Asthma (GINA ).
Participants on existing therapy with medium to high doses of ICS (≥500 μg fluticasone propionate daily or comparable ICS dose in combination with at least one additional controller (e.g., long-acting beta agonist [LABA], leukotriene receptor antagonist [LTRA], long-acting muscarinic antagonist [LAMA], methylxanthines) for at least 3 months.
≥ 1 severe asthma exacerbation in the past year, with at least one exacerbation during treatment with medium to high doses of ICS (≥ 500 μg fluticasone propionate daily or one dose of ICS comparable).
Participants with pre-BD forced expiratory volume in 1 second (FEV1) > 40% and < 80% of predicted normal at the screening visit.
5-item ACQ-5 score >1.5 at randomization.
Participants with at least 12% reversibility and 200 mL post-BD FEV after administration of albuterol/salbutamol or levalbuterol/levosalbutamol at screening or documented history of a reversibility test.
Weight ≥40 kg and ≤150 kg at the randomization visit.

You may not qualify if…

Participants were excluded from the study if any of the following criteria apply:
Chronic lung disease other than asthma.
Current or former smoker including active vaping of any products and/or marijuana with cessation within 6 months of screening or history of >10 pack-years.
Participants who experienced a deterioration of asthma that results in emergency treatment or hospitalization, or treatment with systemic steroids at any time from 1 month prior to screening.
Suspicion of, or confirmed, coronavirus disease 2019 (COVID-19) infection during the screening period including known history of COVID-19 infection within 4 weeks prior to Screening; mechanical ventilation or extracorporeal membrane oxygenation (ECMO) secondary to COVID-19 within 3 months prior to Screening; COVID-19 infection who have not yet sufficiently recovered to participate in the procedures of a clinical trial.
Active infection or history of clinically significant infection
Known history of, or suspected, significant current immunosuppression, including history of invasive opportunistic or helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration.
Active or latent tuberculosis (TB)
A history of malignancy of any type (excluding basal and squamous cell skin cancer and in situ cervical carcinoma that has been excised and cured >3 years prior to baseline).
History of solid organ transplant.
Hepatitis B, C or HIV.
Pregnant or breastfeeding.
History (within last 2 years prior to Baseline) of prescription drug or substance abuse, including alcohol, considered significant by the Investigator.
Any prior use of anti-OX40 or anti-OX40L mAb, including amlitelimab.
Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Where it is running

California Allergy and Asthma Medical Group, Inc. Site Number : 8400002 — Los Angeles, California, United States
Allergy Asthma Associates of Santa Clara Valley Site Number : 8400019 — San Jose, California, United States
Bensch Clinical Research LLC Site Number : 8400004 — Stockton, California, United States
Allianz Research Institute Site Number : 8400023 — Westminster, California, United States
Helix Biomedics, LLC Site Number : 8400029 — Boynton Beach, Florida, United States
Renaissance Research and Medical Group, Inc Site Number : 8400030 — Cape Coral, Florida, United States
Beautiful Minds Clinical Research Center Site Number : 8400027 — Cutler Bay, Florida, United States
Reliable Clinical Research, LLC Site Number : 8400020 — Hialeah, Florida, United States
Savin Medical Group, LLC Site Number : 8400015 — Miami, Florida, United States
Pines Care Research Center LLC Site Number : 8400028 — Pembroke Pines, Florida, United States
Treasure Valley Medical Research Site Number : 8400031 — Boise, Idaho, United States
The South Bend Clinic, LLC Site Number : 8400033 — South Bend, Indiana, United States
University of Kansas Medical Center Site Number : 8400016 — Kansas City, Kansas, United States
Johns Hopkins University School of Medicine Site Number : 8400012 — Baltimore, Maryland, United States
Headlands Research Detroit Site Number : 8400032 — Southfield, Michigan, United States
Henderson Clinical Trials Site Number : 8400037 — Henderson, Nevada, United States
Asthma and Allergy Center Site Number : 8400005 — Toledo, Ohio, United States
OK Clinical Research, LLC Site Number : 8400001 — Edmond, Oklahoma, United States
Allergy, Asthma and Clinical Research Center Site Number : 8400035 — Oklahoma City, Oklahoma, United States
TTS Research Site Number : 8400011 — Boerne, Texas, United States
Investigational Site Number : 0320001 — CABA, Buenos Aires, Argentina
Investigational Site Number : 0320002 — CABA, Buenos Aires, Argentina
Investigational Site Number : 0320008 — La Plata, Buenos Aires, Argentina
Investigational Site Number : 0320009 — Buenos Aires, Buenos Aires F.D., Argentina
University of California San Diego Health Site Number : 8400026 — La Jolla, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.