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Itepekimab Q2W for Chronic Obstructive Pulmonary Disease (AERIFY-4 Trial)

Phase 3

Recruiting

Research Sponsored by Sanofi

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

- Patients with COPD who completed the treatment period in a previous itepekimab COPD Phase 3 clinical study (ie, EFC16750 or EFC16819) and for which an end-of-treatment (EOT) visit occurred no later than 3 days before the enrolment visit of this study.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline of the parent studies (efc16750,efc16819) up to week 52

Awards & highlights

AERIFY-4 Trial Summary

This trial is a research study that will help gather more information about the safety and effectiveness of a medication called itepekimab in people with chronic obstructive pulmonary disease (COPD). The

Who is the study for?

This trial is for patients with COPD who finished a previous Phase 3 itepekimab study and had their end-of-treatment visit within 3 days before enrolling in this study. It's not specified who can't join, but typically those with certain health issues or conflicting treatments are excluded.Check my eligibility

What is being tested?

The trial tests the long-term safety of Itepekimab given every two or four weeks to people with COPD. Participants will either continue receiving Itepekimab or a placebo without knowing which one they're getting, to compare outcomes over up to 72 weeks.See study design

What are the potential side effects?

While specific side effects aren't listed here, common ones for new respiratory drugs may include irritation at the injection site, headache, coughing, and potential allergic reactions.

AERIFY-4 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

AERIFY-4 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline of the parent studies (efc16750,efc16819) up to week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline of the parent studies (efc16750,efc16819) up to week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline of the parent studies (efc16750,efc16819) up to week 52 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Incidence of treatment-emergent AEs, AESIs, SAEs, and AEs leading to permanent treatment discontinuation

Secondary outcome measures

Annualized rate of moderatetosevere acute exacerbation of COPD (AECOPD)

Annualized rate of severe AECOPD

Change from Week 0 for CASA-Q

+8 more

AERIFY-4 Trial Design

2Treatment groups

Experimental Treatment

Group I: Itepekimab Q4WExperimental Treatment2 Interventions

SC administration of Itepekimab every 4 weeks (Q4W) for up to 52 weeks, with alternating SC administration of matching placebo at the 2-week interval between active IMP

Group II: Itepekimab Q2WExperimental Treatment1 Intervention

Subcutaneous (SC) administration of Itepekimab every 2 weeks (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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor

2,164 Previous Clinical Trials

3,514,280 Total Patients Enrolled

Regeneron PharmaceuticalsIndustry Sponsor

621 Previous Clinical Trials

379,905 Total Patients Enrolled

Clinical Sciences & OperationsStudy DirectorSanofi

862 Previous Clinical Trials

2,019,138 Total Patients Enrolled

Frequently Asked Questions

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

Is the enrollment phase for this investigation currently ongoing?

"Indeed, the data available on clinicaltrials.gov confirms that this particular clinical trial is currently in the process of recruiting eligible participants. The study was initially posted on January 11th, 2024 and received its most recent update on January 23rd, 2024. In order to complete the research successfully, a total of 700 patients will be sought from two designated sites."

Answered by AI

What is the current number of individuals receiving treatment within this specific clinical trial?

"Indeed, the details on clinicaltrials.gov indicate that this research study is actively seeking eligible participants. The trial was initially listed on January 11th, 2024 and underwent its most recent update on January 23rd, 2024. A total of 700 individuals are being sought for enrollment at two designated sites."

Answered by AI

Are participants above the age of 35 eligible for inclusion in this clinical trial?

"Applicants eligible for this clinical trial must fall within the age range of 40 to 85. It's worth noting that there are a total of 36 trials specifically targeting patients under 18 years old and another set of 470 trials designed for individuals over the age of 65."

Answered by AI

What is the level of safety demonstrated by Itepekimab Q2W in patients?

"Based on our team's assessment at Power, the safety of Itepekimab Q2W is rated as 3. This rating reflects that this trial is in Phase 3, indicating there is evidence supporting its efficacy and multiple rounds of data confirming its safety."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Investigate Long-term Safety and Tolerability of Itepekimab in Participants With COPD

2024. "A Study to Investigate Long-term Safety and Tolerability of Itepekimab in Participants With COPD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06208306.

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