MedTrace Logo

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

NCT01671956 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2025-11-25

Study results available
· View outcomes & findings →

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

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

Sponsors & Collaborators

  • Immune Pharmaceuticals

    collaborator INDUSTRY

  • Alexion Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2018-08-31
Completion
2018-11-14

Countries

  • Israel

Study Locations

More Related Trials

Entities

Drugs

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 NCT01671956 on ClinicalTrials.gov