Status:
COMPLETED
Dose Ranging Study of Amlitelimab in Adult Participants With Moderate-to-severe Asthma
Lead Sponsor:
Sanofi
Conditions:
Asthma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This is a parallel, Phase 2, global, multicenter, randomized, double-blind, placebo-controlled, dose-ranging, four-arms study for treatment. The purpose of this study is to assess the efficacy, safet...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Participants are 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 experience 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.
Key Trial Info
Start Date :
June 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 20 2025
Estimated Enrollment :
446 Patients enrolled
Trial Details
Trial ID
NCT05421598
Start Date
June 30 2022
End Date
March 20 2025
Last Update
October 9 2025
Active Locations (113)
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1
University of California San Diego Health Site Number : 8400026
La Jolla, California, United States, 92093-0990
2
California Allergy and Asthma Medical Group, Inc. Site Number : 8400002
Los Angeles, California, United States, 90025
3
Allergy Asthma Associates of Santa Clara Valley Site Number : 8400019
San Jose, California, United States, 95117
4
Bensch Clinical Research LLC Site Number : 8400004
Stockton, California, United States, 95207