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A Study to Assess Efficacy, Safety and Tolerability of the Anti-IL-13 Monoclonal Antibody QAX576 in the Treatment of Perinanal Fistulas in Patients Suffering From Crohn's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01316601
Recruitment Status : Completed
First Posted : March 16, 2011
Last Update Posted : May 28, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:

Test safety and efficacy and of a novel IL-13 AB in the treatment of perianal fistulas

  • Trial with medicinal product

Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: QAX567 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : January 2011
Primary Completion Date : November 2012
Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. complete closure of fistula

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria: - diagnosis of Crohn's disease > 6 month with fistula - at least 1 ineffective fistula treatment in the past

Exclusion criteria: - TNF a antibody treatment failed in the past

- planned surgery

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01316601

Zurich, Switzerland
Sponsors and Collaborators
Gerhard Rogler
Novartis Pharmaceuticals
Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich
More Information

Responsible Party: Gerhard Rogler, Prof.Dr.Dr. Gerhard Rogler, University of Zurich
ClinicalTrials.gov Identifier: NCT01316601     History of Changes
Other Study ID Numbers: Novartis CQAX576
First Posted: March 16, 2011    Key Record Dates
Last Update Posted: May 28, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases