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An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease

NCT03759288 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2023-11-21

No results posted yet for this study

Summary

This study seeks to evaluate the safety and efficacy of brazikumab versus placebo (Stage I) and versus an active comparator (Stage 2) in participants with moderately to severely active CD and will include assessments of clinical response as demonstrated by improvement of symptoms and colonic mucosal appearance as observed on endoscopy

Conditions

Interventions

DRUG

Brazikumab low dose

Intravenous Brazikumab on Days 1, 29, and 57, followed by subcutaneous Brazikumab on Day 85 and every 4 weeks through Week 48

DRUG

Brazikumab high dose

Intravenous Brazikumab on Days 1, 29, and 57, followed by subcutaneous Brazikumab on Day 85 and every 4 weeks through Week 48

DRUG

Humira®

Administered subcutaneously on Day 1, Day 15, and Day 29 and every 2 weeks through Week 50.

DRUG

Placebo

Intravenous placebo on Days 1, 29, 57 followed by subcutaneous placebo on Day 85 and every 4 weeks through Week 48

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
2018-12-07
Primary Completion
2023-10-18
Completion
2023-10-18
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Czechia
  • Germany
  • Hungary
  • India
  • Israel
  • Italy
  • Poland
  • 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 NCT03759288 on ClinicalTrials.gov