Participant Flow Module
The Participant Flow Module provides information about the flow of participants through each stage of the clinical trial. This includes pre-assignment details, recruitment information, and the types of units analyzed, helping researchers understand how participants move through the study.
Participant Flow Module path is as follows:
Study -> Results Section -> Participant Flow Module
Participant Flow Module
Ignite Creation Date:
2025-12-24 @ 5:04 PM
Ignite Modification Date:
2025-12-25 @ 2:44 PM
NCT ID:
NCT03956550
Pre Assignment Details:
A total of 259 participants were randomized in 1:1:1 ratio to receive REGN5069 at 100 mg IV Q4W, REGN5069 at 1000 mg IV Q4W, or matching placebo Q4W. Participants were to receive 3 fixed-dose IV infusions at baseline, week 4, and week 8. 171 participants were randomized to receive REGN5069 (86 participants in the 100 mg Q4W group and 85 in the 1000 mg Q4W group) and 88 were randomized to receive placebo.
Recruitment Details:
The study was conducted in 5 countries and 12 sites participated in enrollment. It consisted of screening period up to 30 days, followed by a 12-week randomized, double-blind, placebo-controlled treatment period, a 24-week follow-up period, and end-of-study phone call approximately 52 weeks after first dose. Study was terminated after all participants completed the week 36 visits.
Study:
NCT03956550
Study Brief:
Results Section:
NCT03956550