臨床研究等提出・公開システム

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

A study to investigate long-term safety and tolerability of itepekimab in participants with COPD (AERIFY-4)

Tanaka Tomoyuki

Sanofi K.K.

Tokyo Opera City Tower, 3-20-2, Nishi Shinjuku, Shinjuku-ku, Tokyo 163-1488, Japan

clinical-trials-jp@sanofi.com

Clinical Study Unit

Sanofi K.K.

Tokyo Opera City Tower, 3-20-2, Nishi Shinjuku, Shinjuku-ku, Tokyo 163-1488, Japan

+81-3-6301-3670

clinical-trials-jp@sanofi.com

Recruiting

April. 10, 2024

Interventional

randomized controlled trial

double blind

active control

parallel assignment

treatment purpose

- 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.

- 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

Both

Chronic Obstructive Pulmonary Disease

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

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

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.

+81-942-31-7200

Feb. 19, 2024

Yes

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

United States/Chile