Study To Test Whether PF-00547659 Is Safe And Improves Disease Symptoms In Patients With Crohn's Disease (OPERA)

Shire

Status and phase: Completed; Phase 2

Conditions: Crohn's Disease

Treatments: Drug: PF-00547659 SC injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT01276509

OPERA (Other Identifier)

A7281006

2010-023437-30 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 265 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 and/or immunosuppressants (AZA, 6-MP, and/or MTX).
• hsCRP greater than 3mg/L
• Ulcerations demonstrated by colonoscopy performed during screening or 8 weeks prior to screening

Exclusion criteria

• Pregnant or breast feeding
• Short bowel syndrome due to multiple small bowel resections
• Presence of a stoma

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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265 participants in 4 patient groups, including a placebo group

Placebo-SC Injection

Placebo Comparator group

Description:

Placebo delivered SC, 3 doses separated by 4 weeks.

Treatment:

Drug: PF-00547659 SC injection

Drug: PF-00547659 SC injection

Drug: PF-00547659 SC injection

Drug: PF-00547659 SC injection

Drug Dose level 1- SC injection

Experimental group

Description:

Drug dose level 1 delivered SC, 3 doses separated by 4 weeks.

Treatment:

Drug: PF-00547659 SC injection

Drug: PF-00547659 SC injection

Drug: PF-00547659 SC injection

Drug: PF-00547659 SC injection

Drug Dose level 2-SC injection

Experimental group

Description:

Drug dose level 2 delievered SC, 3 doses separated by 4 weeks.

Treatment:

Drug: PF-00547659 SC injection

Drug: PF-00547659 SC injection

Drug: PF-00547659 SC injection

Drug: PF-00547659 SC injection

Drug Dose level 3- SC injection

Experimental group

Description:

Drug dose level 3 delivered SC, 3 doses separated by 4 weeks.

Treatment:

Drug: PF-00547659 SC injection

Drug: PF-00547659 SC injection

Drug: PF-00547659 SC injection

Drug: PF-00547659 SC injection