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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to end of treatment (eot) (24-52 weeks)

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