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

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

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

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-TNFα (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-TNFα 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-TNFα antibody treatment
• Intercurrent bacterial or viral (intestinal) infection (serologically or microbiologically confirmed)

Other protocol-defined inclusion/exclusion criteria may apply