A Study to Investigate Long-term Safety and Tolerability of Itepekimab in Participants With COPD (AERIFY-4)

Sanofi

Status and phase: Enrolling; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Placebo; Drug: Itepekimab (SAR440340)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06208306

U1111-1295-3333 (Registry Identifier)

2023-508085-15 (Registry Identifier)

LTS18133

Details and patient eligibility

About

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

Enrollment: 700 estimated patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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700 participants in 2 patient groups

Itepekimab Q2W

Experimental group

Description:

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

Treatment:

Drug: Itepekimab (SAR440340)

Itepekimab Q4W

Experimental group

Description:

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

Treatment:

Drug: Itepekimab (SAR440340)

Drug: Placebo