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

Phase 3

Active, not recruiting

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Drug: Itepekimab (SAR440340); Drug: Placebo

• Registration Number: NCT06208306
• Lead Sponsor: Sanofi

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-05
• Study First Submitted QC: 2024-01-05
• Study Start: 2024-01-11
• Study First Posted: 2024-01-17
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-09
• Last Update Posted: 2025-06-12
• Primary Completion: 2026-12-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 700

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Itepekimab Q2W	Itepekimab (SAR440340)	Subcutaneous (SC) administration of Itepekimab every 2 weeks (Q2W) for up to 52 weeks
Itepekimab Q4W	Itepekimab (SAR440340)	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
Itepekimab Q4W	Placebo	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 Measures

Name	Time	Method
Incidence of treatment-emergent AEs, AESIs, SAEs, and AEs leading to permanent treatment discontinuation	Baseline up to Week 72	All AEs (serious or nonserious) will be collected from the signing of the informed consent form (ICF) until the end of study visit

Secondary Outcome Measures

Name	Time	Method
Annualized rate of moderate-to-severe acute exacerbation of COPD (AECOPD)	Baseline up to Week 52
Annualized rate of severe AECOPD	Baseline up to Week 52
Time to first moderate-to-severe AECOPD	Baseline up to Week 52
Time to first severe AECOPD	Baseline up to Week 52
Change from baseline of the parent studies (EFC16750, EFC16819): Pre-BD and post-BD FEV1	Baseline of the parent studies (EFC16750,EFC16819) up to Week 52	FEV1 is force expiratory volume in 1 second
Change from baseline of the parent studies (EFC16750, EFC16819): SGRQ total score and domain scores	Baseline of the parent studies (EFC16750,EFC16819) up to Week 52	The St. George's Respiratory Questionnaire (SGRQ) is a 50-item questionnaire designed to measure and quantify health status in adult participants with chronic airflow limitation.
Change from baseline of the parent studies (EFC16750, EFC16819): EQ-5D-5L single index score	Baseline of the parent studies (EFC16750,EFC16819) up to Week 52	The European Quality of Life 5 Dimensions 5 Level Version (EQ 5D 5L) is a standardized health-related quality-of-life (HRQoL) questionnaire which consists of a descriptive system and the EuroQol visual analog scale (EQ-VAS).
Change from baseline of the parent studies (EFC16750, EFC16819): EQ-VAS	Baseline of the parent studies (EFC16750,EFC16819) up to Week 52	The EuroQol visual analog scale (EQ VAS) records the participant's self-rated health on a vertical VAS.
Change from Week 0 for CASA-Q	Baseline up to Week 52	The cough and sputum assessment questionnaire (CASA-Q) was developed for use in COPD and chronic (non-obstructive) bronchitis patients.
Functional itepekimab concentrations in serum	Baseline up to Week 52
Incidence of treatment-emergent (TE) anti-drug antibody responses	Baseline up to Week 72

Trial Locations

Locations (223)

Chandler Clinical Research Trials- Site Number : 8401034; 🇺🇸 Chandler, Arizona, United States

Noble Clinical Research Site Number : 8401182; 🇺🇸 Tucson, Arizona, United States

Tucson Clinical Research Institute- Site Number : 8401431; 🇺🇸 Tucson, Arizona, United States

IMAX Clinical Trials- Site Number : 8401419; 🇺🇸 La Palma, California, United States

Antelope Valley Clinical Trials Site Number : 8401003; 🇺🇸 Lancaster, California, United States

Downtown L.A. Research Center- Site Number : 8401027; 🇺🇸 Los Angeles, California, United States

Allianz Research Institute CO Site Number : 8402061; 🇺🇸 Aurora, Colorado, United States

Alpine Clinical Research Center - Boulder - 47th Street- Site Number : 8401180; 🇺🇸 Boulder, Colorado, United States

Helix Biomedics- Site Number : 8402049; 🇺🇸 Boynton Beach, Florida, United States

Beautiful Minds Clinical Research Center Site Number : 8401201; 🇺🇸 Cutler Bay, Florida, United States

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