A Study To Assess The Efficacy And Safety Of PF-04236921 In Subjects With Crohn's Disease Who Failed Anti-TNF Therapy (ANDANTE)

Pfizer

Status and phase: Completed; Phase 2

Conditions: Crohn's Disease

Treatments: Drug: PF-04236921 SC injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT01287897

B0151003

2010-023034-23 (EudraCT Number)

ANDANTE (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 250 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects must have failed or are intolerant to anti TNFs
• hsCRP greater or equal to 5.0 mg/L
• Ulcerations demonstrated by colonoscopy as defined by SES CD assessment performed within 8 weeks of study entry (screening) and able to retrospectively complete the SES-CD or colonoscopy performed during screening

Exclusion criteria

• Pregnant or breastfeeding women
• Crohn's Disease with active fistulae or abscess
• History of diverticulitis or symptomatic diverticulosis
• Abnormality in hematology or chemistry profiles at screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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250 participants in 3 patient groups, including a placebo group

Placebo- SC injection

Placebo Comparator group

Treatment:

Drug: PF-04236921 SC injection

Drug: PF-04236921 SC injection

Drug: PF-04236921 SC injection

Drug Dose level 1 - SC injection

Experimental group

Treatment:

Drug: PF-04236921 SC injection

Drug: PF-04236921 SC injection

Drug: PF-04236921 SC injection

Drug Dose level 2 - SC injection

Experimental group

Treatment:

Drug: PF-04236921 SC injection

Drug: PF-04236921 SC injection

Drug: PF-04236921 SC injection