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

April 22, 2024 updated by: Sanofi

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

700

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Trial Transparency email recommended (Toll free for US & Canada)
  • Phone Number: option 6 800-633-1610
  • Email: Contact-US@sanofi.com

Study Locations

  • Canada
      • Windsor, Canada, N8X 5A6
        • Recruiting
        • Investigational Site Number : 1240018
    • Alberta
      • Sherwood Park, Alberta, Canada, T8H 0N2
        • Recruiting
        • Investigational Site Number : 1240006
    • Ontario
      • Toronto, Ontario, Canada, M5T 3A9
        • Recruiting
        • Investigational Site Number : 1240009
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Recruiting
        • Investigational Site Number : 1240004
      • Trois-Rivieres, Quebec, Canada, G8T 7A1
        • Recruiting
        • Investigational Site Number : 1240001
  • Chile
    • Reg Metropolitana De Santiago
      • Santiago, Reg Metropolitana De Santiago, Chile, 7500010
        • Recruiting
        • Investigational Site Number : 1520007
      • Santiago, Reg Metropolitana De Santiago, Chile, 7500698
        • Recruiting
        • Investigational Site Number : 1520003
      • Santiago, Reg Metropolitana De Santiago, Chile, 7750000
        • Recruiting
        • Investigational Site Number : 1520002
  • Israel
      • Jerusalem, Israel, 91120
        • Recruiting
        • Investigational Site Number : 3760002
      • Rehovot, Israel, 76100
        • Recruiting
        • Investigational Site Number : 3760004
  • Japan
    • Fukuoka
      • Kurume-shi, Fukuoka, Japan, 830-0011
        • Recruiting
        • Investigational Site Number : 3920002
    • Hyogo
      • Himeji-shi, Hyogo, Japan, 670-0849
        • Recruiting
        • Investigational Site Number : 3920006
    • Tokyo
      • Kiyose-City, Tokyo, Japan, 204-8522
        • Recruiting
        • Investigational Site Number : 3920005
      • Shinagawa-ku, Tokyo, Japan, 140-8522
        • Recruiting
        • Investigational Site Number : 3920004
  • Korea, Republic of
    • Seoul-teukbyeolsi
      • Seoul, Seoul-teukbyeolsi, Korea, Republic of, 05030
        • Recruiting
        • Investigational Site Number : 4100001
  • Taiwan
      • Taichung, Taiwan, 40447
        • Recruiting
        • Investigational Site Number : 1580006
  • United States
    • Colorado
      • Boulder, Colorado, United States, 80301
        • Recruiting
        • Alpine Clinical Research Center Site Number : 8401180
    • Florida
      • Boynton Beach, Florida, United States, 33435
        • Recruiting
        • Helix Biomedics, LLC Site Number : 8402049
      • DeBary, Florida, United States, 32713
        • Recruiting
        • Omega Research Site Number : 8402031
      • Miami, Florida, United States, 33165
        • Recruiting
        • Phoenix Medical Research Site Number : 8402019
      • Miami, Florida, United States, 33126
        • Recruiting
        • Finlay Medical Research Corp. Site Number : 8402007
      • Miami, Florida, United States, 33176
        • Recruiting
        • Reed Medical Research Site Number : 8401032
      • Miami Lakes, Florida, United States, 33014
        • Recruiting
        • Deluxe Health Center Site Number : 8401188
      • Ocala, Florida, United States, 34471
        • Recruiting
        • Renstar Medical Research Site Number : 8402015
      • Orlando, Florida, United States, 32819
        • Recruiting
        • HMD Research LLC Site Number : 8402016
      • Orlando, Florida, United States, 32825-4454
        • Recruiting
        • Florida Institute for Clinical Research Site Number : 8401013
      • Tampa, Florida, United States, 33606
        • Recruiting
        • Clinical Research of West Florida, Inc Site Number : 8402008
    • Georgia
      • Adairsville, Georgia, United States, 30103
        • Recruiting
        • Appalachian Clinical Research Site Number : 8400024
      • Cordele, Georgia, United States, 31015
        • Recruiting
        • David Kavtaradze MD, Inc. Site Number : 8401029
    • Louisiana
      • Covington, Louisiana, United States, 70433
        • Recruiting
        • Benchmark Research Site Number : 8401193
      • Shreveport, Louisiana, United States, 71105
        • Recruiting
        • Care Access Shreveport Site Number : 8402047
    • Maine
      • Bangor, Maine, United States, 04401
        • Recruiting
        • Paul A Shapero, MD, PA Site Number : 8401016
    • Michigan
      • Lathrup Village, Michigan, United States, 48076
        • Recruiting
        • Revive Research Institute Site Number : 8402186
    • Missouri
      • Saint Charles, Missouri, United States, 63301
        • Recruiting
        • Midwest Chest Consultants, P.C. Site Number : 8401002
    • North Carolina
      • Huntersville, North Carolina, United States, 28078
        • Recruiting
        • Advanced Respiratory and Sleep Medicine Site Number : 8400022
    • Texas
      • McKinney, Texas, United States, 75069
        • Recruiting
        • Metroplex Pulmonary and Sleep Center Site Number : 8401015
      • Webster, Texas, United States, 77598
        • Recruiting
        • Clear Lake Specialties Research Center, PLLC Site Number : 8401025

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline up to Week 72

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional itepekimab concentrations in serum
Time Frame: Baseline up to Week 52
Baseline up to Week 52
Incidence of treatmentemergent (TE) anti-drug antibody responses
Time Frame: Baseline up to Week 72
Baseline up to Week 72
Annualized rate of moderatetosevere acute exacerbation of COPD (AECOPD)
Time Frame: Baseline up to Week 52
Baseline up to Week 52
Annualized rate of severe AECOPD
Time Frame: Baseline up to Week 52
Baseline up to Week 52
Time to first moderate-to-severe AECOPD
Time Frame: Baseline up to Week 52
Baseline up to Week 52
Time to first severe AECOPD
Time Frame: Baseline up to Week 52
Baseline up to Week 52
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
Baseline of the parent studies (EFC16750,EFC16819) up to Week 52
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.
Baseline of the parent studies (EFC16750,EFC16819) up to Week 52
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.
Baseline up to Week 52
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.
Baseline of the parent studies (EFC16750,EFC16819) up to Week 52
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).
Baseline of the parent studies (EFC16750,EFC16819) up to Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Collaborators

Regeneron Pharmaceuticals

Investigators

  • Study Director: Clinical Sciences & Operations, Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 11, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

January 5, 2024

First Submitted That Met QC Criteria

January 5, 2024

First Posted (Actual)

January 17, 2024

Study Record Updates

Last Update Posted (Actual)

April 23, 2024

Last Update Submitted That Met QC Criteria

April 22, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LTS18133
  • U1111-1295-3333 (Registry Identifier: ICTRP)
  • 2023-508085-15 (Registry Identifier: CTIS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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