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

Gerhard Rogler

Status and phase: Completed; Phase 2

Conditions: Crohn's Disease

Treatments: Drug: QAX567

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01316601

Novartis CQAX576

Details and patient eligibility

About

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

• Trial with medicinal product

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind