Itepekimab for COPD
(AERIFY-1 Trial)

Recruiting in Palo Alto (17 mi)

+537 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Sanofi

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

Primary Objective: Evaluate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate-or-severe COPD exacerbations in former smokers with moderate-to-severe COPD Secondary Objectives: * Evaluate the efficacy of itepekimab compared with placebo on pulmonary function in former smokers with moderate-to-severe COPD * Evaluate the efficacy of itepekimab compared with placebo on occurrence of acute exacerbation of COPD (AECOPD) in former smokers with moderate-to-severe COPD * Evaluate the efficacy of itepekimab compared with placebo on severe AECOPD in former smokers with moderate-to-severe COPD * Evaluate the efficacy of itepekimab compared with placebo on corticosteroid-treated AECOPD in former smokers with moderate-to-severe COPD * Evaluate the efficacy of itepekimab compared with placebo on respiratory symptoms in former smokers with moderate-to-severe COPD * Evaluate the efficacy of itepekimab compared with placebo on Forced Expiratory Volume in 1 second (FEV1) slope in former smokers with moderate-to-severe COPD * Evaluate the efficacy of itepekimab compared with placebo on health-related quality of life (HRQoL) as assessed by St. George's Respiratory Questionnaire (SGRQ) in former smokers with moderate-to-severe COPD * Evaluate the safety and tolerability of itepekimab in former smokers with moderate-to-severe COPD * Evaluate the pharmacokinetic (PK) profile of itepekimab in former smokers with moderate-to-severe COPD * Evaluate immunogenicity to itepekimab in former smokers with moderate-to-severe COPD

Research Team

Clinical Sciences & Operations

Principal Investigator

Sanofi

Eligibility Criteria

This trial is for former smokers aged 40-85 with moderate-to-severe COPD who have had at least one exacerbation while on current therapy. They must not be currently smoking, have quit at least 6 months prior, and agree to contraception if applicable. Excluded are those with certain cardiac arrhythmias, active autoimmune diseases or treatments, a current asthma diagnosis, or previous use of itepekimab.

Inclusion Criteria

I have had severe breathing issues that needed steroids or antibiotics.

I've been on a stable asthma treatment for at least 3 months.

I am between 40 and 85 years old.

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Exclusion Criteria

I have asthma or had it before I turned 18.

I have previously used itepekimab.

This information may not include all the factors that need to be considered before deciding whether to participate in a clinical trial.

See 4 more

Treatment Details

Interventions

Itepekimab SAR440340 (Monoclonal Antibodies)
Placebo (Other)

Trial OverviewThe study tests the effectiveness of Itepekimab (SAR440340) against a placebo in reducing the rate of severe COPD flare-ups in participants. It also examines its impact on lung function, symptoms severity, quality of life and collects data on drug safety and how the body processes it.

Participant Groups

3Treatment groups

Experimental Treatment

Placebo Group

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

Group III: PlaceboPlacebo Group1 Intervention

SC administration of matching placebo Q2W for up to 52 weeks