Safety, tolerability, PK & PD effects of REGN3500 in Asthma Patients
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of Subcutaneously Administered REGN3500 in Adult Patients with Moderate Asthma
IRAS ID
215803
Contact name
Dave Singh
Contact email
Sponsor organisation
Regeneron Pharmaceuticals, Inc
Eudract number
2016-002798-36
Duration of Study in the UK
0 years, 11 months, 2 days
Research summary
The study drug REGN3500 is being developed by Regeneron Pharmaceuticals, Inc. for the treatment of moderate to serve asthma.\n\nAirborne pollutants such as cigarette smoke or viruses can cause the body to release a protein called Interleukin-33, also known as IL-33. When IL-33 is released, it can cause asthma, and other lung diseases worse by increasing irritation in the lungs. REGN3500 is a human monoclonal antibody (mAb) drug that prevents the IL-33 that has been released into the body from causing further lung irritation.\n\nThis will be the first time that REGN3500 will have been given to participants with asthma. \n\nApprox 24 patients are planned to be enrolled in 2 dose cohorts (C1: REGN3500 75 mg or placebo. C2: REGN3500 150 mg or placebo). Each cohort consists of a screening period, a baseline visit, a treatment period, and a follow-up period, with an end of study visit at day 141. The total planned duration of a patient’s participation in the study is approximately 24 weeks. \n\nDuring the treatment period, patients will receive weekly study drug injections on days 1/baseline, 8, 15, and 22, for a total of 4 doses. Study drug will be administered subcutaneously in the clinic. Patients will be followed monthly for approximately 4 months after the end-of-treatment visit at day 29.\n\nDuring the study patients will be required to use at-home spirometry with electronic data storage to measure FEV1. Patients will be instructed to perform expiratory flow manoeuvres at least twice daily throughout the last 2 weeks of the screening period and throughout the duration of the study (treatment and follow-up periods).\n\nThe safety and tolerability of REGN3500 will be monitored by clinical assessment including vital signs (temperature, blood pressure, pulse, and respiration), physical examinations, 12-lead electrocardiograms, and laboratory assessment (including haematology, chemistry, urinalysis) and monitoring of Adverse Events.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
16/NW/0812
Date of REC Opinion
5 Dec 2016
REC opinion
Further Information Favourable Opinion