Conditions: Crohn's Disease
Keywords: Crohn's Disease safety efficacy pharmacokinetics pharmacodynamics Crohn's Disease Activity Index (CDAI)
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 250
Healthy volunteers: no

Brief summary:
This is a proof of concept study to determine the efficacy and safety of a monoclonal antibody with three doses versus placebo. Subjects will be randomized to a treatment and the dose will be delivered subcutaneously twice, 4 weeks apart. All subjects will have moderate to severe refractory Crohn's Disease.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: PF-04236921 SC injection intervention 2: PF-04236921 SC injection intervention 3: PF-04236921 SC injection
Intervention descriptions: intervention 1: Placebo delivered SC, 2 doses separated by 4 weeks intervention 2: Drug dose level 1 delivered SC, 2 doses separated by 4 weeks intervention 3: Drug dose level 2 delivered SC, 2 doses separated by 4 weeks

Protocol document: