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Evaluation of Efficacy and Safety of Tralokinumab in Patients With Active, Moderate-to-severe Ulcerative Colitis

NCT01482884 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 147

Last updated 2016-04-05

Study results available
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Summary

The study is designed to evaluate the clinical efficacy and safety of tralokinumab as compared to placebo. Investigational product will be administered as subcutaneous injection. All patients will continue background therapy for ulcerative colitis as per local standards of care in addition to investigational product.

Conditions

Interventions

DRUG

tralokinumab

2 sc injections of every 2 weeks for 12 weeks.

DRUG

placebo

2 sc injections of every 2 weeks for 12 weeks.

Sponsors & Collaborators

  • MedImmune Ltd

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Mark Berner Hansen, MD, PhD · AstraZeneca R&D Mölndal Pepparedsleden 1, S-431 83 Mölndal, Sweden

  • Silvio Danese, MD, PhD · IBD Center, Instituto Clinico Humanitas, Department of Gastroenterology, Via Manzoni 56, 20089 Rozzano, Milan, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2013-03-31
Completion
2013-06-30

Countries

  • Czechia
  • France
  • Germany
  • Italy
  • Poland
  • United Kingdom

Study Locations

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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 NCT01482884 on ClinicalTrials.gov