A study to investigate long-term safety and tolerability of itepekimab in participants with COPD

JRCT ID: jRCT2071230130

Registered date:28/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Chronic Obstructive Pulmonary Disease
• Date of first enrollment: 10/04/2024
• Target sample size: 700
• Countries of recruitment: United States,Japan,Chile,Japan
• Study type: Interventional

Intervention(s)

Drug: Itepekimab (SAR440340, REGN3500)
Pharmaceutical form: solution for injection in pre-filled syringe, Route of administration: subcutaneous
Drug: Placebo
Pharmaceutical form: solution for injection in pre-filled syringe, Route of administration: subcutaneous

Study Arms:
- Experimental: Itepekimab every 2 weeks (Q2W)
Subcutaneous (SC) administration of Itepekimab Q2W for up to 52 weeks
- Experimental: Itepekimab every 4 weeks (Q4W)
SC administration of Itepekimab Q4W for up to 52 weeks, with alternating SC administration of matching placebo at the 2-week interval between active IMP

Outcome(s)

Primary Outcome

1. Incidence of treatment-emergent adverse events (AEs), AEs of special interest, serious AEs, 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 until the end of study visit

Secondary Outcome

1. Functional itepekimab concentrations in serum
[Time Frame: Baseline up to Week 52]
2. Incidence of treatment-emergent 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-bronchodilatory and post-bronchodilatory forced expiratory volume in 1 second (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): St. George's Respiratory Questionnaire (SGRQ) total score and domain scores
[Time Frame: Baseline of the parent studies (EFC16750, EFC16819) up to Week 52]
The 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): European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) single index score
[Time Frame: Baseline of the parent studies (EFC16750, EFC16819) up to Week 52]
The EQ-5D-5L is a standardized health-related quality-of-life 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 EQ-VAS records the participant's self-rated health on a vertical VAS.
11. Change from Week 0 for cough and sputum assessment questionnaire (CASA-Q)
[Time Frame: Baseline up to Week 52]
The CASA-Q was developed for use in COPD and chronic (non-obstructive) bronchitis patients.

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: <= 85age old
• Gender: Both
• Include 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 visit occurred no later than 3 days before the enrolment visit of this study.

Exclude 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 or other infections whose nature or course may suggest an immunocompromised status
- Anaphylactic reactions or systemic allergic reactions that are related to investigational medicinal product (IMP) and require treatment during the parent study
- Any situation that led to a permanent premature IMP discontinuation in parent trials

Related Information

• Primary Sponsor: Tanaka Tomoyuki
• Secondary ID(s): NCT06208306,2023-508085-15