Status:
ACTIVE_NOT_RECRUITING
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
Lead Sponsor:
Sanofi
Conditions:
Asthma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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-labe...
Detailed Description
The duration of the study for each participant will be up to 156 weeks.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 5 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 25 2029
Estimated Enrollment :
335 Patients enrolled
Trial Details
Trial ID
NCT06033833
Start Date
September 5 2023
End Date
June 25 2029
Last Update
September 22 2025
Active Locations (68)
Enter a location and click search to find clinical trials sorted by distance.
1
Bensch Clinical Research LLC- Site Number : 8400004
Stockton, California, United States, 95207
2
Helix Biomedics, LLC - Site Number : 8400029
Boynton Beach, Florida, United States, 33435
3
Savin Medical Group - Miami- Site Number : 8400015
Miami, Florida, United States, 33126
4
Pines Care Research Center LLC- Site Number : 8400028
Pembroke Pines, Florida, United States, 33025