Long-term Safety and Efficacy Evaluation of Subcutaneous Amlitelimab in Adult Participants With Moderate-to-severe Asthma Who Completed Treatment Period of Previous Amlitelimab Asthma Clinical Study

Investigating the Safety and Efficacy of an Investigational Medication for Moderate-to-Severe Asthma in Participants Who Completed a Previous Study

Recruiting
18 years - 75 years
All
Phase 2
380 participants needed
3 Locations

Study Overview

This is a study of amlitelimab for the treatment of participants with moderate-to-severe asthma. The study will have a double-blind treatment period until Week 24 for each participant and an open-label treatment period where each participant will receive open-label amlitelimab from Week 24 onwards. The purpose of this study is to evaluate long-term safety, tolerability, and efficacy of amlitelimab for the treatment of adult participants with moderate-to-severe asthma who have previously been enrolled and completed the treatment period of the parent study. The study duration will be up to 156 weeks. The treatment duration will be up to 144 weeks. The number of visits will be 18.

Study Details

The duration of the study for each participant will be up to 156 weeks.

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Asthma
  • Age: 18 years - 75 years
  • Gender: All

Inclusion Criteria:

  • Participants with moderate-to-severe asthma who completed the treatment period of the parent study per protocol
  • Participants on background dose with medium-to-high doses of ICS therapy (≥500 µg of fluticasone propionate daily or comparable ICS dosage up to a maximum of 2000 µg/day of fluticasone propionate or clinically comparable) in combination with a second or third controller (eg, LABA, LTRA, LAMA, methylxanthines), with or without OCS (up to a maximum of 15 mg prednisone or equivalent daily or 30 mg every other day) as maintained during the parent study in which they participated Note for Japan: participants must be on ≥400 μg of fluticasone propionate daily or equivalent.
  • Contraception for male and female participants;

For female participants:

  • incapable of becoming pregnant
  • not pregnant or breast feeding
  • not to donate or cryopreserve eggs for female participants For male participants
  • No sperm donation or cryopreserving sperms

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

  • Chronic lung disease other than asthma
  • Participants who developed a new medical condition or a change in status of an established medical condition or require a new treatment or medication prior to enrollment, which (per Investigator's medical judgment) would adversely affect the participation in this study or would require permanent IMP discontinuation
  • Current smoker or active vaping of any products and/or marijuana smoking
  • Prescription drug or substance abuse, including alcohol, considered significant by the Investigator
  • Any new development with the participant's disease or condition or any significant laboratory test abnormality during the parent study that, in the opinion of the Investigator, may present an unreasonable risk for the participant
  • 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
  • Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized
  • Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures
  • Participants are employees of the investigative site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals
        The above information is not intended to contain all considerations relevant to a potential
        participation in a clinical trial.

Updated on 30 May 2024. Study ID: NCT06033833

This study investigates the use of an investigational medication for adults with moderate-to-severe asthma. Asthma is a condition where the airways in the lungs become narrow and inflamed, making it hard to breathe. The purpose of this study is to look at the long-term safety, tolerability, and effectiveness of the investigational medication in participants who have already completed a previous study related to this treatment.

Participants in the study will first receive either the investigational medication or a placebo without knowing which one they are getting, in a process called 'double-blind'. After 24 weeks, all participants will receive the investigational medication openly, meaning they will know what they are receiving. A placebo is an inactive substance that looks like the investigational medication but does not contain any medicine.

  • Who can participate: Adults with moderate-to-severe asthma who completed a previous study and are on specific asthma treatments can participate. Key exclusions include those with other chronic lung diseases or significant medical changes.
  • Study details: Participants will receive the investigational medication and may initially receive a placebo. They must follow the study procedures and maintain their current asthma treatments.
  • Study Timelines and Visits: The study will last up to 156 weeks. The study requires 18 visits.

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