A Study To Investigate The Safety And Efficacy Of CP- 690,550 In Patients With Moderate And Severe Ulcerative Colitis.

Pfizer

Status and phase: Completed; Phase 2

Conditions: Ulcerative Colitis

Treatments: Drug: CP- 690 550; Other: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00787202

A3921063

Details and patient eligibility

About

The hypothesis of the study is that at least one dose of CP 690 550 is superior to placebo (inactive drug) in inducing remission in patients with moderate to severe ulcerative colitis.

Enrollment: 195 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients must be at least 18 years of age at screening
• Males and female patients with clinical diagnosis of ulcerative colitis ≥3 months prior to entry into the study.
• Male and female patients with active currently moderate to severe ulcerative colitis defined by Mayo score of ≥6
• Patients with endoscopic sub-score of ≥2 on the Mayo score determined within 7 days of baseline.

Exclusion criteria

• Diagnosis of Crohn's disease or diagnosis of indeterminate colitis
• Treatment naive subjects who have not had previous exposure to treatment for ulcerative colitis
• Patients that are currently receiving immunosuppressants, anti-TNFα therapy or interferon

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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195 participants in 5 patient groups, including a placebo group

15 mg BID

Experimental group

Treatment:

Drug: CP- 690 550

Drug: CP- 690 550

Drug: CP- 690 550

Drug: CP- 690 550

10 mg BID

Experimental group

Treatment:

Drug: CP- 690 550

Drug: CP- 690 550

Drug: CP- 690 550

Drug: CP- 690 550

3 mg BID

Experimental group

Treatment:

Drug: CP- 690 550

Drug: CP- 690 550

Drug: CP- 690 550

Drug: CP- 690 550

0.5 mg BID

Experimental group

Treatment:

Drug: CP- 690 550

Drug: CP- 690 550

Drug: CP- 690 550

Drug: CP- 690 550

Placebo

Placebo Comparator group

Treatment:

Other: placebo