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NCT01355614 Clinical Trial

A Phase II Efficacy Study in Fistulizing Crohn's Disease Patients

Crohn's Disease Clinical Trial

Official title:
A Multi-center, Randomized, Double-blind, Active Controlled Study to Assess Efficacy, Safety and Tolerability of the Anti-IL13 Monoclonal Antibody QAX576 in the Treatment of Perianal Fistulas in Patients Suffering From Crohn's Disease

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01355614
Other study ID # CQAX576A2209
Secondary ID 2010-019973-13
Status Completed
Phase Phase 2
First received May 16, 2011
Last updated February 20, 2017
Start date June 2011
Est. completion date March 2013

Study information
Verified date February 2017
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will assess the safety and efficacy of QAX576 if patients with fistulizing Crohn's disease.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date March 2013
Est. primary completion date March 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- At least one draining enterocutaneous perianal fistula

- Diagnosis of Crohn's disease (CD) must have been established for at least 6 months

- At least one ineffective fistula treatment (but no previously failed anti-TNFa (tumour necrosis factor) antibody treatment)

- Patients should not suffer from any other health problems that may jeopardize their participation in the study.

Exclusion Criteria:

- Current or recent (within 30 days of enrollment, or 5 half-lives of the compound, whichever is longer) use of anti-TNFa antibody treatment

- Active Crohn's disease

- Recent or pending abdominal or ano-rectal surgery, particularly presence of stricture, or abscess, or retention for which surgery might be indicated

- Previously failed anti-TNFa antibody treatment

- Intercurrent bacterial or viral (intestinal) infection (serologically or microbiologically confirmed)

Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• QAX576

• Infliximab

Locations
Country Name City State
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Jena
Germany Novartis Investigative Site Kiel
Germany Novartis Investigative Site Muenchen
Switzerland Novartis Investigative Site Zuerich

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Germany,  Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Assessment of efficacy of QAX576 to induce complete closure for at least 4 weeks of all perianal fistulas in patients suffering from Crohn's disease by: clinical observation and cutaneous photodocumentation 52 weeks
Secondary Assessment of safety and tolerability of QAX576 in patients suffering from Crohn's disease as measured by lab assessments, ECG, physical exam etc 52 weeks
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