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Monoclonal Antibodies

Itepekimab for Bronchiectasis

Phase 2
Recruiting
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to end of treatment (eot) (24-52 weeks)

Summary

This trial is testing a new drug called itepekimab in people with NCFB to see if it is effective and safe. The study will last up to 77 weeks and involve monthly

Who is the study for?
This trial is for adults aged 18-85 with non-cystic fibrosis bronchiectasis (NCFB), who've had at least 2 moderate or 1 severe lung flare-up in the past year. They should have symptoms like cough, mucus, or frequent infections and a certain level of lung function.
What is being tested?
The study compares two doses of Itepekimab (an experimental drug) against a placebo to see which is better for NCFB. Participants are randomly assigned to one of three groups and will be monitored through visits or calls each month for up to about a year and a half.
What are the potential side effects?
While specific side effects aren't listed here, Itepekimab could potentially cause reactions related to the immune system since it targets IL-33, an inflammatory protein. This might include allergic reactions, fatigue, or respiratory issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to end of treatment (eot) (24-52 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to end of treatment (eot) (24-52 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Annualized rate of moderate or severe Pulmonary exacerbations (PEs) over the treatment period
Secondary study objectives
Change From Baseline in FEV1 at Week 8 and Week 24
Change from Baseline in QOL-B Respiratory Symptoms Domain Score in Adult Participants at Week 24
Change from baseline in SGRQ total score at Week 24
+1 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Itepekimab Q4WExperimental Treatment2 Interventions
SC administration of Itepekimab every 4 weeks (Q4W) with alternating placebo administration at the 2week interval between active IMP as SC injection for up to 52 weeks
Group II: Itepekimab Q2WExperimental Treatment1 Intervention
Subcutaneous (SC) administration of Itepekimab every 2 weeks (Q2W) for up to 52 weeks
Group III: PlaceboPlacebo Group1 Intervention
SC administration of matching placebo Q2W for up to 52 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor
2,195 Previous Clinical Trials
4,034,833 Total Patients Enrolled
Regeneron PharmaceuticalsIndustry Sponsor
659 Previous Clinical Trials
385,369 Total Patients Enrolled
~192 spots leftby Mar 2026
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