Itepekimab for COPD
(AERIFY-2 Trial)

Recruiting in Palo Alto (17 mi)

+650 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: Primary population (former smokers cohort): * 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: Primary population (former smokers cohort): * 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 Secondary population (current smokers cohort) * Estimate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate or severe COPD exacerbations in current smokers with moderate-to-severe COPD * Estimate the efficacy of itepekimab compared with placebo on pulmonary function in current smokers with moderate-to-severe COPD * Estimate the safety and tolerability of itepekimab in current smokers with moderate-to-severe COPD * Estimate the PK profile of itepekimab in current smokers with moderate to severe COPD * Estimate immunogenicity to itepekimab in current smokers with moderate-to-severe COPD

Research Team

Clinical Sciences & Operations

Principal Investigator

Sanofi

Eligibility Criteria

This trial is for adults aged 40-85 with moderate-to-severe COPD who are either current or former smokers. They must have had at least one severe exacerbation requiring hospitalization or two moderate ones treated with steroids in the past year, and be on a stable dose of standard COPD therapy.

Inclusion Criteria

I am a current smoker and not planning to quit soon.

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

I have had severe lung flare-ups needing more than a day's hospital stay.

See 13 more

Exclusion Criteria

I have asthma or had it before I turned 18.

I have not vaped any products in the last 6 months.

I do not have active or latent TB, nor have I been in close contact with TB patients recently.

See 6 more

Treatment Details

Interventions

Itepekimab SAR440340 (Monoclonal Antibodies)
Placebo (Other)

Trial OverviewThe study tests Itepekimab's effectiveness compared to a placebo in reducing the rate of severe COPD flare-ups, improving lung function, and enhancing quality of life among both current and former smokers with COPD.

Participant Groups

5Treatment groups

Experimental Treatment

Placebo Group

Group I: Itepekimab Q4W in former smokersExperimental 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 Q2W in former smokersExperimental Treatment1 Intervention

Subcutaneous (SC) administration of Itepekimab every 2 weeks (Q2W) for up to 52 weeks

Group III: Itepekimab Q2W in current smokersExperimental Treatment1 Intervention

SC administration of Itepekimab every 2 weeks (Q2W) for 52 weeks

Group IV: Placebo in current smokersPlacebo Group1 Intervention

SC administration of matching placebo Q2W for 52 weeks

Group V: Placebo in former smokersPlacebo Group1 Intervention

SC administration of matching placebo Q2W for up to 52 weeks