NCT01671956

Evaluation of Safety, Efficacy, Pharmacokinetic and Pharmacodynamic of Bertilimumab in Patients With Active Moderate to Severe Ulcerative Colitis

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study Designed to Evaluate the Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Profile of Bertilimumab in Patients With Active Moderate to Severe Ulcerative Colitis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Alexion Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double blind, placebo-controlled, parallel group multi-center study in adult participants with active moderate to severe UC.

Conditions

• Ulcerative Colitis, Active Moderate
• Ulcerative Colitis, Active Severe

Interventions

Type	Name	Description
BIOLOGICAL	Bertilimumab	IV infusion over 30 minutes, at Day 0, Day 14 and Day 28
BIOLOGICAL	Placebo	IV infusion over 30 minutes, at Day 0, Day 14 and Day 28

Timeline

• Start date: 2015-07-31
• Primary completion: 2018-08-31
• Completion: 2018-11-14
• First posted: 2012-08-24
• Last updated: 2025-11-25
• Results posted: 2025-11-25

Locations

6 sites across 1 country: Israel