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 @ 10:45 PM
Ignite Modification Date:
2025-12-25 @ 8:15 PM
NCT ID:
NCT02776735
Pre Assignment Details:
After dose-finding portion, 200mg q2w dose was selected for continuation in study. Portion 1 participants from Cohorts 1 and 3 who continued into extension phase switched to this dose after dose was selected. Participants enrolled into Portions 2 and 3 started on selected dose of 200mg q2w capped dose (Group A: 3 mg/kg q2w; Group B: 4 mg/kg q2w) for extension phase (144 weeks for Portion 2 and 84 weeks for Portion 3). A total of 102 participants were enrolled in the study.
Recruitment Details:
Group A: \>=30kg and \<=60kg and Group B: \<30kg and \>=10kg. Portion 1 of study enrolled participants into 3 dosing regimens (Cohort 1, 2 and 3). Cohort 1: dose capped at 150mg q2w (Group A:2mg/kg q2w; Group B:2.5mg/kg q2w). Cohort 2: dose capped at 200mg q2w (Group A:3mg/kg q2w; Group B:4mg/kg q2w). Cohort 3: dose capped at 150mg qw (Group A:2mg/kg qw; Group B:2.5mg/kg qw). All 3 cohorts in Portion 1 received 12-week core treatment phase and eligible participants entered 144-week extension phase.
Study:
NCT02776735
Study Brief:
Results Section:
NCT02776735