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

PHASE3TerminatedINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

January 6, 2020

Primary Completion Date

September 19, 2023

Study Completion Date

September 19, 2023

Conditions
Crohn's DiseaseIBD
Interventions
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

Trial Locations (15)

7500

Research Site, Cape Town

7800

Research Site, Plumstead

20251

Research Site, Hamburg

33016

Research Site, Miami Lakes

33157

Research Site, Miami

33165

Research Site, Miami

33626

Research Site, Tampa

33756

Research Site, Clearwater

33813

Research Site, Lakeland

34741

Research Site, Kissimmee

40443

Research Site, Taichung

44122

Research Site, Beachwood

77058

Research Site, Houston

95648

Research Site, Lincoln

35-302

Research Site, Rzeszów

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY