Conditions: Crohn's Disease
Keywords: Crohn's disease Safety Efficacy Pharmacokinetics Pharmacodynamics Crohn's Disease Activity Index (CDAI)
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 265
Healthy volunteers: no

Brief summary:
Adults with Crohn's disease that is clinically active despite conventional treatment will be eligible for this study. Patients may receive one of three doses of PF-00547659 (experimental drug) or placebo (inactive drug). Disease activity will be measured every two weeks.

Detailed description:

Arms:
arm 1: Placebo delivered SC, 3 doses separated by 4 weeks. arm 2: Drug dose level 1 delivered SC, 3 doses separated by 4 weeks. arm 3: Drug dose level 2 delievered SC, 3 doses separated by 4 weeks. arm 4: Drug dose level 3 delivered SC, 3 doses separated by 4 weeks.

Interventions: intervention 1: PF-00547659 SC injection intervention 2: PF-00547659 SC injection intervention 3: PF-00547659 SC injection intervention 4: PF-00547659 SC injection
Intervention descriptions: intervention 1: Placebo delivered SC, 3 doses separated by 4 weeks intervention 2: Drug dose level 1 delivered SC, 3 doses separated by 4 weeks intervention 3: Drug dose level 2 delivered SC, 3 doses separated by 4 weeks intervention 4: Drug dose level 3 delivered SC, 3 doses separated by 4 weeks

Protocol document: