18
Participants
Start Date
January 6, 2020
Primary Completion Date
September 19, 2023
Study Completion Date
September 19, 2023
Brazikumab Induction Dose
Participants who met criteria for early termination due to lack of efficacy (rescue treatment criteria) or who did not meet CDAI response at Week 52 in the lead-in study D5121C00001 are considered inadequate/non responders, and will receive IV induction dosing brazikumab at Week 0, Week 4, and Week 8 followed by maintenance dosing of brazikumab subcutaneously every 4 weeks thereafter up to Week 52.
Brazikumab Maintenance Dose
Responders from Lead-In study D5271C00001 who completed requirements through Week 52 and met CDAI response (CDAI score of \< 150 points or CDAI reduction from Baseline of ≥ 100 points) without ongoing rescue treatment at Week 52 in the lead-in study. will receive maintenance dose of brazikumab administered subcutaneously every 4 weeks through Week 52, starting at Week 0. The subcutaneous dose of brazikumab will be administered to all responders/completers in the lead-in study regardless of the prior treatment administered
Research Site, Cape Town
Research Site, Plumstead
Research Site, Hamburg
Research Site, Miami Lakes
Research Site, Miami
Research Site, Miami
Research Site, Tampa
Research Site, Clearwater
Research Site, Lakeland
Research Site, Kissimmee
Research Site, Taichung
Research Site, Beachwood
Research Site, Houston
Research Site, Lincoln
Research Site, Rzeszów
Lead Sponsor
AstraZeneca
INDUSTRY