NCT03961815

Open-label Extension Study of Brazikumab in Crohn's Disease

An Open-label, Long-term Extension Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease (INTREPID OLE)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of Study D5271C00002 (Legacy #3150-303-008) is to permit participants in D5271C00001 (Legacy #3150-301-008) to receive open-label brazikumab in Study D5271C00002 (Legacy #3150-303-008). This will permit long-term observation of safety in these participants with brazikumab.

Conditions

• Crohn's Disease
• IBD

Interventions

Type	Name	Description
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.
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

Timeline

• Start date: 2020-01-06
• Primary completion: 2023-09-19
• Completion: 2023-09-19
• First posted: 2019-05-23
• Last updated: 2026-04-01
• Results posted: 2026-04-01

Locations

15 sites across 5 countries: United States, Germany, Poland, South Africa, Taiwan

Regulatory

• FDA-regulated drug study