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

Conditions

• Chronic Obstructive Pulmonary Disease

Eligibility Criteria

Sex

ALL

Age

40 Years - 85 Years

Healthy Volunteers

Not accepted

Interventions

• Itepekimab (SAR440340) — DRUG
  Pharmaceutical form:solution for injection in pre-filled syringe Route of administration:subcutaneous
• Placebo — DRUG
  Pharmaceutical form:solution for injection in pre-filled syringe Route of administration:subcutaneous

Study Details

This is a parallel, double blind, Phase 3, 2-arm study that is designed to provide additional safety information, assess the durability of treatment response, and provide additional PK and immunogenicity assessments. The primary purpose of this study is to evaluate safety and tolerability of both itepekimab SC Q2W or itepekimab SC Q4W in participants with COPD having completed the treatment period of the clinical studies EFC16750 or EFC16819. A secondary purpose of this study is to provide efficacy outcomes beyond the treatment period of the parent trials EFC16750 and EFC16819. Study details include: * The study duration will be up to 72 weeks * The treatment duration will be up to 52 weeks * A follow-up period of 20 weeks will be conducted * The number of on-site visits will be 7 and the number of phone contacts will be 5

Key Dates

Start date

Jan 11, 2024

Status verified

May 2026

Primary completion

Dec 1, 2026

Completion

Dec 1, 2026

Study Design

Enrollment

700 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Itepekimab Q2W
  Subcutaneous (SC) administration of Itepekimab every 2 weeks (Q2W) for up to 52 weeks
• Experimental: Itepekimab Q4W
  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

Primary Outcome Measure

Incidence of treatment-emergent AEs, AESIs, SAEs, and AEs leading to permanent treatment discontinuation [ Time Frame: Baseline up to Week 72 ]

Locations (64)

Find similar trials in Chandler, AZ

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