NCT03759288

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

A 52-Week, Multicenter, Randomized, Double-blind, Placebo and Active-Controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease (INTREPID Lead-In)

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

• Crohn's Disease
• IBD

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-12-07
• Primary completion: 2023-10-18
• Completion: 2023-10-18
• First posted: 2018-11-29
• Last updated: 2023-11-21

Locations

101 sites across 17 countries: United States, Canada, Czechia, Germany, Hungary, India, Israel, Italy, Poland, Russia, Slovakia, South Africa, South Korea, Spain, Taiwan, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study