Dose Ranging Study of Amlitelimab in Adult Participants With Moderate-to-severe Asthma (NCT05421598) | Clinical Trial Compass
CompletedPhase 2
Dose Ranging Study of Amlitelimab in Adult Participants With Moderate-to-severe Asthma
United States437 participantsStarted 2022-06-30
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* 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 Criteria:
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 …
What they're measuring
1
Annualized Rate of Severe Asthma Exacerbation Events Over 48 Weeks