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Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis

NCT03616821 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 242

Last updated 2023-11-09

No results posted yet for this study

Summary

The present study (D5272C00001/Legacy #3151-201-008) aims to evaluate the efficacy and safety of brazikumab in patients with moderately to severely active UC and will include assessments of clinical responses as demonstrated by improvement of symptoms and of colonic mucosal appearance as observed on endoscopy

Conditions

Interventions

DRUG

Brazikumab

Intravenous brazikumab on day 1, day 15, and day 43 followed by Subcutaneous brazikumab every 4 weeks beginning on day 71 through Week 50

DRUG

Placebo

Intravenous placebo on day 1, day 15, and day 43 followed by Subcutaneous placebo every 4 weeks beginning on Day 71 through Week 50.

Sponsors & Collaborators

Principal Investigators

  • Kathy Bohannon · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-08-07
Primary Completion
2023-10-23
Completion
2023-10-23
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Czechia
  • Germany
  • Hungary
  • India
  • Israel
  • Italy
  • Japan
  • Poland
  • Puerto Rico
  • Russia
  • Slovakia
  • South Africa
  • South Korea
  • Spain
  • Taiwan
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
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 NCT03616821 on ClinicalTrials.gov