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Open-label Extension Study of Brazikumab in Ulcerative Colitis

NCT04277546 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2023-11-09

No results posted yet for this study

Summary

The purpose of this OLE Study D5272C00002 (Legacy #3151-202-008) is to permit participants who previously enrolled in the double-blind Study D5272C00001 (Legacy #3151-201-008) to receive brazikumab, allowing for long-term observation of safety and efficacy in these participants treated with brazikumab. There are no formal hypotheses to be tested. Safety and efficacy data obtained in this study will be included in regulatory product submissions as appropriate.

Conditions

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).

Sponsors & Collaborators

Principal Investigators

  • Kathy Bohannon · AstraZeneca

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-03
Primary Completion
2023-10-10
Completion
2023-10-10
FDA Drug
Yes

Countries

  • United States
  • Czechia
  • Germany
  • Israel
  • Italy
  • Japan
  • Poland
  • Puerto Rico
  • South Africa
  • South Korea
  • Taiwan

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04277546 on ClinicalTrials.gov