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NCT Number: NCT06208306

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigational Site Number : 0320012, Berazategui, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Itepekimab (SAR440340)

Drug

Pharmaceutical form:solution for injection in pre-filled syringe Route of administration:subcutaneous

Other names: REGN3500

Placebo

Drug

Pharmaceutical form:solution for injection in pre-filled syringe Route of administration:subcutaneous

Primary outcomes

  1. Incidence of treatment-emergent AEs, AESIs, SAEs, and AEs leading to permanent treatment discontinuation

    Time frame: 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 outcomes

  1. Functional itepekimab concentrations in serum

    Time frame: Baseline up to Week 52

  2. Incidence of treatment-emergent (TE) anti-drug antibody responses

    Time frame: Baseline up to Week 72

  3. Annualized rate of moderate-to-severe acute exacerbation of COPD (AECOPD)

    Time frame: Baseline up to Week 52

  4. Annualized rate of severe AECOPD

    Time frame: Baseline up to Week 52

  5. Time to first moderate-to-severe AECOPD

    Time frame: Baseline up to Week 52

  6. Time to first severe AECOPD

    Time frame: Baseline up to Week 52

  7. Change from baseline of the parent studies (EFC16750, EFC16819): Pre-BD and post-BD FEV1

    Time frame: Baseline of the parent studies (EFC16750,EFC16819) up to Week 52

    FEV1 is force expiratory volume in 1 second

  8. Change from baseline of the parent studies (EFC16750, EFC16819): SGRQ total score and domain scores

    Time frame: 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.

  9. Change from baseline of the parent studies (EFC16750, EFC16819): EQ-5D-5L single index score

    Time frame: 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).

  10. Change from baseline of the parent studies (EFC16750, EFC16819): EQ-VAS

    Time frame: 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.

  11. Change from Week 0 for CASA-Q

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Collaborators

  • Regeneron Pharmaceuticals

Registry information

Official study title

A Double-blinded Extension Study to Evaluate the Long-term Safety and Tolerability of Itepekimab in Patients With Chronic Obstructive Pulmonary Disease (COPD) Who Participated in Either EFC16750 or EFC16819 Clinical Studies

Acronym: AERIFY-4

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 17, 2024
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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