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

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