Evaluation of SAR440340 and as Combination Therapy With Dupilumab in Moderate-to-Severe Asthma Participants
Summary
Primary Objective: To evaluate the effects of SAR440340 with or without dupilumab, compared to placebo, on reducing the incidence of "loss of asthma control" (LOAC) events. Secondary Objectives: To evaluate the effects of SAR440340/REGN3500 and coadministration of SAR440340 and dupilumab, compared with placebo, on forced expiratory volume in 1 second (FEV1). To evaluate the effects of coadministration of SAR440340 and dupilumab, compared with SAR440340 and compared with dupilumab, on FEV1. To assess safety and tolerability of SAR440340 alone and in coadministration with dupilumab.
Timeline
- Start
- 2018-03-12
- Primary completion
- 2019-03-21
- Completion
- 2019-08-07
Outcome
Mixed primary results
registry analysis (superiority test); Placebo vs SAR440340 300 mg; p =0.0214; Odds ratio 0.423 (95% CI 0.203 to 0.88) NCT03387852 ↗
registry analysis (superiority test); Placebo vs SAR440340 + Dupilumab; p =0.0709; Odds ratio 0.520 (95% CI 0.256 to 1.057) NCT03387852 ↗
Publications
- Yin Z, Zhou Y, Turnquist HR, Liu Q. Neuro-epithelial-ILC2 crosstalk in barrier tissues. Trends Immunol. 2022 Nov;43(11):901-916. doi: 10.1016/j.it.2022.09.006. Epub 2022 Oct 14.
- Wechsler ME, Ruddy MK, Pavord ID, Israel E, Rabe KF, Ford LB, Maspero JF, Abdulai RM, Hu CC, Martincova R, Jessel A, Nivens MC, Amin N, Weinreich DM, Yancopoulos GD, Goulaouic H. Efficacy and Safety of Itepekimab in Patients with Moderate-to-Severe Asthma. N Engl J Med. 2021 Oct 28;385(18):1656-1668. doi: 10.1056/NEJMoa2024257.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dupilumab | Monoclonal antibody | 300 mg | Subcutaneous |
| Subject | Itepekimab | Monoclonal antibody | 300 mg | Subcutaneous |
| Background | Fluticasone | Other / unclassified | — | Inhaled |