A study to assess the long-term safety and tolerability of itepekimab in patients with chronic obstructive pulmonary disease (COPD)
- Conditions
- Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecified
- Registration Number
- CTRI/2024/06/069046
- Lead Sponsor
- Sanofi Healthcare India Pvt Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
- 02- signed ICF
- 03- 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, not breastfeeding, and at least one of the following conditions applies.
--- Not a WOCBP as defined in appendix 4 of protocol or
--- A WOCBP who agrees to follow the contraceptive guidance in Appendix 4 during the intervention period and for at least 20 weeks after the last dose of study intervention.
- 04
-01- Pregnancy during parent study.
-02- Diagnosis of a malignancy during parent study, except a squamous or basal cell carcinoma of the skin.
-03- Any opportunistic infection during the parent study, such as TB or other infections whose nature or course may suggest an immunocompromised status.
-04- Anaphylactic reactions or systemic allergic reactions that are related to IMP and require treatment during the parent study.
-05- Serum ALT more than 3 x upper limit of normal (ULN) and total bilirubin more than 2 x ULN during the parent study.
-06- Serum ALT more than 5 x ULN if baseline ALT less than equal to 2 x ULN or ALT more than 8 x ULN if baseline ALT more than 2 x ULN during the parent study.
-07- Any other situation that led to a permanent premature IMP discontinuation in parent trials
-08- Individuals accommodated in an institution because of regulatory or legal order, prisoners or participants who are legally institutionalized.
-09- Participants not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures. Any other clinically significant change in the participants medical condition that may affect the participants safety as a result of participation in this extension study in the judgment of the Investigator. In case of doubt, please liaise with the sponsor
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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)Timepoint: Week 0, and Week 72
- Secondary Outcome Measures
Name Time Method Evaluate immunogenicity to itepekimab in participants with moderate-to-severe COPD who participated in previous itepekimab COPD clinical studies (EFC16750, EFC16819)Timepoint: Week 0, week 24, week 52 and Week 72;Evaluate the long-term efficacy of itepekimab through various endpoints in participants with moderate-to-severe COPD who participated in previous itepekimab COPD clinical studies (EFC16750, EFC16819)Timepoint: Week 0 to Week 52;Evaluate the PK profile of itepekimab in participants with moderate-to-severe COPD who participated in previous itepekimab COPD clinical studies (EFC16750, EFC16819)Timepoint: Week 0, week 24, week 52 and Week 72