Clinical Trials List
Protocol NumberLTS18133
Active
2024-04-01 - 2027-12-31
Phase III
Recruiting2
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
-
Trial Applicant
-
Sponsor
Sanofi-Aventis Recherche & Développement
-
Trial scale
Multi-Regional Multi-Center
-
Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Bing-Ru Wu Division of Thoracic Medicine
- 廖偉志 Division of Thoracic Medicine
- Wen-Chien Cheng Division of Thoracic Medicine
Co-Principal Investigator
- 鄭孟軒 Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Pai-Chien Chou
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
chronic obstructive pulmonary disease (COPD)
Objectives
Evaluate the long-term safety and tolerability of
itepekimab in participants with moderate-to-severe
COPD who participated in previous itepekimab
COPD clinical studies (EFC16750, EFC16819)
Test Drug
injection
Active Ingredient
SAR440340/REGN3500/Itepekimab
Dosage Form
230
Dosage
300mg/2ml
Endpoints
Incidence of treatment‑emergent AEs, AESIs,
SAEs, and AEs leading to permanent treatment
discontinuation.
SAEs, and AEs leading to permanent treatment
discontinuation.
Inclution Criteria
Participants are eligible to be included in the study only if all of the following criteria apply:
I 01. 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 EoT visit occurred
no later than 3 days before the enrolment visit of this study.
I 02. Signed written informed consent.
Sex, contraceptive/barrier method and pregnancy testing requirements/breastfeeding
I 03. All
Contraceptive use by men and women should be consistent with local regulations
regarding the methods of contraception for those participating in clinical studies.
a) Male participants: No contraceptive measures required for this study
b) Female participants: Contraceptive use by WOCBP should be consistent with local
regulations regarding the methods of contraception for those participating in clinical
studies.
A female participant is eligible to participate if she is not pregnant (see Appendix 4
[Section 10.4]), not breastfeeding, and at least one of the following conditions applies:
• Not a WOCBP as defined in Appendix 4 (Section 10.4)
OR
• A WOCBP who agrees to follow the contraceptive guidance in Appendix 4
(Section 10.4) during the intervention period and for at least 20 weeks after the last
dose of study intervention.
I 01. 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 EoT visit occurred
no later than 3 days before the enrolment visit of this study.
I 02. Signed written informed consent.
Sex, contraceptive/barrier method and pregnancy testing requirements/breastfeeding
I 03. All
Contraceptive use by men and women should be consistent with local regulations
regarding the methods of contraception for those participating in clinical studies.
a) Male participants: No contraceptive measures required for this study
b) Female participants: Contraceptive use by WOCBP should be consistent with local
regulations regarding the methods of contraception for those participating in clinical
studies.
A female participant is eligible to participate if she is not pregnant (see Appendix 4
[Section 10.4]), not breastfeeding, and at least one of the following conditions applies:
• Not a WOCBP as defined in Appendix 4 (Section 10.4)
OR
• A WOCBP who agrees to follow the contraceptive guidance in Appendix 4
(Section 10.4) during the intervention period and for at least 20 weeks after the last
dose of study intervention.
Exclusion Criteria
Participants are excluded from the study if any of the following criteria apply:
Medical conditions
E 01. Pregnancy during parent study
E 02. Diagnosis of a malignancy during parent study, except a squamous or basal cell carcinoma
of the skin
E 03. Any opportunistic infection during the parent study, such as TB or other infections whose
nature or course may suggest an immunocompromised status (see Appendix 9 [Section 10.9]).
Prior/concomitant therapy
E 04. Anaphylactic reactions or systemic allergic reactions that are related to IMP and require
treatment during the parent study (see Appendix 10 [Section 10.10])
Diagnostic assessments
E 05. Serum ALT >3 × upper limit of normal (ULN) and total bilirubin >2 × ULN during the
parent study
E 06. Serum ALT >5 × ULN if baseline ALT ≤2 × ULN or ALT >8 × ULN if baseline ALT >2
× ULN during the parent study
E 07. Any other situation that led to a permanent premature IMP discontinuation in parent trials
Medical conditions
E 01. Pregnancy during parent study
E 02. Diagnosis of a malignancy during parent study, except a squamous or basal cell carcinoma
of the skin
E 03. Any opportunistic infection during the parent study, such as TB or other infections whose
nature or course may suggest an immunocompromised status (see Appendix 9 [Section 10.9]).
Prior/concomitant therapy
E 04. Anaphylactic reactions or systemic allergic reactions that are related to IMP and require
treatment during the parent study (see Appendix 10 [Section 10.10])
Diagnostic assessments
E 05. Serum ALT >3 × upper limit of normal (ULN) and total bilirubin >2 × ULN during the
parent study
E 06. Serum ALT >5 × ULN if baseline ALT ≤2 × ULN or ALT >8 × ULN if baseline ALT >2
× ULN during the parent study
E 07. Any other situation that led to a permanent premature IMP discontinuation in parent trials
The Estimated Number of Participants
-
Taiwan
8 participants
-
Global
700 participants
