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 States, Argentina, Brazil437 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 range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This was a Phase 2 trial testing different doses of amlitelimab — since Phase 2 is mainly about finding the right dose and early safety signals rather than proving the treatment works, what do the results so far actually tell us about whether this drug might be effective for someone with my level of asthma severity?
2The trial measured how often severe asthma attacks happened over 48 weeks — based on what was found, did any of the doses tested show a meaningful reduction in those exacerbations compared to placebo, and how does that compare to biologics I might already be eligible for?
3Since this trial is completed but the drug isn't approved yet, what would the realistic next steps be for amlitelimab, and is there any way I could still access it through a follow-on study or expanded access program?
4Amlitelimab works on a different part of the immune system than some other asthma biologics — given my specific triggers and test results, is there a reason my doctor might think this approach could be a better or worse fit for me compared to treatments that are already approved?
5Given that this was a dose-ranging study, were there any safety concerns flagged at higher doses that my doctor thinks I should be aware of when weighing this kind of treatment against my current asthma management plan?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Annualized Rate of Severe Asthma Exacerbation Events Over 48 Weeks