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Monoclonal Antibodies

Itepekimab Q4W 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 study (eos) (44 to 72 weeks)

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 study (eos) (44 to 72 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to end of study (eos) (44 to 72 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to end of study (eos) (44 to 72 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Annualized rate of moderate or severe Pulmonary exacerbations (PEs) over the treatment period

Secondary outcome measures

Annualized rate of severe PEs over the treatment period

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

+10 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor

2,164 Previous Clinical Trials

3,514,680 Total Patients Enrolled

Regeneron PharmaceuticalsIndustry Sponsor

622 Previous Clinical Trials

380,431 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper limit for the total number of individuals involved in this medical study?

"Affirmative. Information on clinicaltrials.gov indicates that this research study is currently seeking participants. It was originally listed on February 20, 2024, and last modified on April 11, 2024. The trial aims to enroll 300 individuals across six designated sites."

Answered by AI

Are there any ongoing opportunities for individuals to participate in this trial at the moment?

"Indeed, the information available on clinicaltrials.gov indicates that this specific trial is actively in search of suitable participants. The trial was initially made public on February 20th, 2024 and received its latest update on April 11th, 2024. To fulfill its requirements, the study aims to recruit a total of 300 individuals from six distinct sites."

Answered by AI

Does this research include individuals who are older than 65 years of age?

"To be considered eligible for participation in this research, individuals must range from 18 to 85 years of age."

Answered by AI

Has Itepekimab been granted approval by the FDA for administration every four weeks?

"Based on our evaluation at Power, the safety rating for Itepekimab Q4W is a 2. This assessment stems from it being in Phase 2 of testing, where there is existing safety data but no evidence yet regarding efficacy."

Answered by AI

Do I meet the necessary criteria to participate in this research trial?

"The trial aims to recruit 300 individuals aged between 18 and 85 who have bronchiectasis. Noteworthy requirements include a history of at least two moderate or one severe pulmonary exacerbations in the prior year, manifestation of chronic cough, persistent sputum production, and/or recurrent respiratory infections consistent with non-cystic fibrosis bronchiectasis (NCFB), as well as having a forced expiratory volume in one second (FEV1) equal to or greater than 30% predicted value."

Answered by AI

At present, how many locations are hosting this particular clinical trial?

"Among the 6 available sites for this trial are Allianz Research Institute Site Number: 8400013 in Westminster, Investigational Site Number: 8260008 in Norwich, and Investigational Site Number: 8260003 in Tyne And Wear."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Proof-of-Concept Study to Assess the Efficacy, Safety and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Non-cystic Fibrosis Bronchiectasis

2024. "A Proof-of-Concept Study to Assess the Efficacy, Safety and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Non-cystic Fibrosis Bronchiectasis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06280391.

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