A Study to Investigate Long-term Safety and Tolerability... | NCT06208306

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

NCT06208306

Sponsor

Sanofi

Status

Active, not recruiting

Last Update Posted

May 18, 2026Actual

Enrollment

700Estimated

Phase

Phase 3

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

Itepekimab (SAR440340)
Placebo

Countries

United States
Argentina
Brazil
Bulgaria
Canada
Chile
China
Czechia
Estonia
France
Georgia
Germany
Greece
Hungary
India
Israel
Italy
Japan
Lithuania
Mexico
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
South Africa
South Korea
Spain
Taiwan
Turkey (Türkiye)
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
U1111-1295-3333	Registry Identifier	ICTRP
2023-508085-15-00	Registry Identifier	CTIS

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 11, 2024Actual

Primary Completion Date

Dec 1, 2026Estimated

Completion Date

Dec 1, 2026Estimated

First Submitted Date

Jan 5, 2024

First Submission Date that Met QC Criteria

Jan 5, 2024

First Posted Date

Jan 17, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 14, 2026

Last Update Posted Date

May 18, 2026Actual

Name	Class
Regeneron Pharmaceuticals	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

700Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Itepekimab Q2W	Experimental	Subcutaneous (SC) administration of Itepekimab every 2 weeks (Q2W) for up to 52 weeks	Drug: Itepekimab (SAR440340)
Itepekimab Q4W	Experimental	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) Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Itepekimab (SAR440340)	Drug	Pharmaceutical form:solution for injection in pre-filled syringe Route of administration:subcutaneous	Itepekimab Q2W Itepekimab Q4W

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of treatment-emergent AEs, AESIs, SAEs, and AEs leading to permanent treatment discontinuation	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 Outcomes

Measure	Description	Time Frame
Functional itepekimab concentrations in serum		Baseline up to Week 52
Incidence of treatment-emergent (TE) anti-drug antibody responses		Baseline up to Week 72

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Clinical Sciences & Operations	Sanofi	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chandler Clinical Research Trials- Site Number : 8401034		Chandler	Arizona	85224	United States
Noble Clinical Research Site Number : 8401182

Label	URL
LTS18133 Plain Language Results Summary	View source

IPD Sharing Statement Module

Plan to Share IPD

Yes

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

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms