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Purpose

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

Condition

Eligibility

Eligible Ages
Between 40 Years and 85 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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.

Exclusion Criteria

  • Diagnosis of a malignancy during parent study, except a squamous or basal cell carcinoma of the skin - Any opportunistic infection during the parent study, such as tuberculosis (TB) or other infections whose nature or course may suggest an immunocompromised status - Anaphylactic reactions or systemic allergic reactions that are related to IMP and require treatment during the parent study - Any situation that led to a permanent premature IMP discontinuation in parent trials The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Itepekimab Q2W 		Subcutaneous (SC) administration of Itepekimab every 2 weeks (Q2W) for up to 52 weeks
  • Drug: Itepekimab (SAR440340)
    Pharmaceutical form:solution for injection in pre-filled syringe Route of administration:subcutaneous
    Other names:
    • REGN3500
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
  • Drug: Itepekimab (SAR440340)
    Pharmaceutical form:solution for injection in pre-filled syringe Route of administration:subcutaneous
    Other names:
    • REGN3500
  • Drug: Placebo
    Pharmaceutical form:solution for injection in pre-filled syringe Route of administration:subcutaneous

Recruiting Locations

Clinical Research of West Florida - Tampa - North Howard Avenue- Site Number : 8402008
Tampa, Florida 33606

More Details

Status
Recruiting
Sponsor
Sanofi

Study Contact

Trial Transparency email recommended (Toll free for US & Canada)
800-633-1610
contact-us@sanofi.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.