Open-label Extension Study of Brazikumab in Ulcerative Colitis

PHASE2TerminatedINTERVENTIONAL
Enrollment

57

Participants

Timeline

Start Date

March 3, 2020

Primary Completion Date

October 10, 2023

Study Completion Date

October 10, 2023

Conditions
Ulcerative Colitis
Interventions
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.

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).

Trial Locations (36)

7500

Research Site, Cape Town

7708

Research Site, Cape Town

7800

Research Site, Plumstead

10002

Research Site, Taipei

20017

Research Site, Rho

20132

Research Site, Milan

20251

Research Site, Hamburg

24105

Research Site, Kiel

26426

Research Site, Wŏnju

33016

Research Site, Miami Lakes

33165

Research Site, Miami

33813

Research Site, Lakeland

40447

Research Site, Taichung

44122

Research Site, Beachwood

47715

Research Site, Evansville

73112

Research Site, Oklahoma City

77346

Research Site, Humble

80907

Research Site, Colorado Springs

89081

Research Site, Ulm

91911

Research Site, Chula Vista

93534

Research Site, Lancaster

3109601

Research Site, Haifa

9103102

Research Site, Jerusalem

370 01

Research Site, České Budějovice

702 00

Research Site, Ostrava

00168

Research Site, Roma

309-1793

Research Site, Kasama-shi

277-0871

Research Site, Kashiwa-shi

108-8642

Research Site, Minatoku

31-513

Research Site, Krakow

35-302

Research Site, Rzeszów

81-756

Research Site, Sopot

87-100

Research Site, Torun

00-635

Research Site, Warsaw

03-580

Research Site, Warsaw

00927

Research Site, San Juan

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY