A Phase 2 Open-label, Long-term Extension Safety Study of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis (EXPEDITION OLE)
Brazikumab Maintenance Dose, Brazikumab Induction Dose
18 Years - 80 Years
Endpoint Classification: -
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Verified 01 Jun 2023 by AstraZeneca
No locations available
|Experimental: Brazikumab Maintenance Dose|
Administer at 4-week intervals through Week 52 Participants who receive IV induction dosing will be administered brazikumab SC at 4-week intervals starting Week 12 through Week 52
Drug: Brazikumab Maintenance Dose
Completers in the lead-in study D5272C00001 (Legacy #3151-201-008) will receive a maintenance dose of brazikumab administered subcutaneously every 4 weeks up to Week 52 (Group A). The SC dose of brazikumab will be administered to all responders/completers in the lead-in study regardless of the prior treatment administered.
|Experimental: Brazikumab Induction Dose|
Administer at Week 0, Week 4, and Week 8
Drug: Brazikumab Induction Dose
Participants in the lead-in study D5272C00001 (Legacy #3151-201-008) who have not responded to treatment and have met criteria for rescue treatment are considered inadequate/non-responders (Group B). In these eligible participants, IV induction dosing of brazikumab at Week 0, Week 4, and Week 8 will be administered, followed by brazikumab administered subcutaneously every 4 weeks thereafter (up to Week 52).