Study identifier:D5271C00002
ClinicalTrials.gov identifier:NCT03961815
EudraCT identifier:2019-001866-14
CTIS identifier:N/A
An Open-label, Long-term Extension Study of Brazikumab in Participants With Moderately to Severely Active Crohn’s Disease (INTREPID OLE)
Crohn’s disease, IBD
Phase 3
No
Brazikumab Induction Dose, Brazikumab Maintenance Dose
All
18
Interventional
18 Years - 80 Years
Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Sept 2024 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Brazikumab Induction Dose Administer at Week 0, Week 4, and Week 8 | Drug: 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. |
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 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 |