PHASE III Study to evaluate safety and efficacy OF Oral CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS - NA

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2013/01/003328

Enrollment

545

Registered

2013-01-28

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Ulcerative Colitis

Interventions

Intervention1: Experimental: 10mg BID: Drug: CP-690,550 oral tablets twice daily Duration: 9 weeks Intervention2: Experimental: 15mg BID: Drug: CP-690,550 oral tablets twice daily Duration: 9 weeks

Eligibility

Inclusion criteria

Inclusion criteria: Subject must be at least 18 years of age. • Males and females with a documented diagnosis of UC at least 4 months prior to entry into the study. • Subjects with moderately to severely active UC based on Mayo score criteria. •Subjects must have failed or be intolerant of at least one of the following treatments for UC: • Oral corticosteroids. • Azathioprine or 6 mercaptopurine (6 MP). • Anti TNF therapy. Note: There is no upper age limit mentioned in the protocol

Exclusion criteria

Exclusion criteria: 1. Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohns disease. 2. Subjects with disease limited to distal 15 cm. 3. Subjects without previous treatment for UC (i.e., treatment naÃ¯ve). 4. Subjects displaying clinical signs of fulminant colitis or toxic megacolon.

Design outcomes

Primary

Measure	Time frame
â?¢ The proportion of subjects in remission at Week 8.Timepoint: Time Frame: 8 weeks	—

Secondary

Measure	Time frame
1. The proportion of subjects achieving mucosal healing at Week 8. 2.The proportion of subjects achieving clinical response at Week 8. 3.The proportion of subjects in clinical remission at Week 8. 4.The proportion of subjects in symptomatic remission at Week 8. 5. The proportion of subjects achieving deep remission at Week 8. 6. Partial Mayo scores and change from baseline over time. 7. Change from baseline at Week 8 in total Mayo score.Timepoint: Time Frame: 8 weeks	—

Measure

Time frame

1. The proportion of subjects achieving mucosal healing at Week 8. 2.The proportion of subjects achieving clinical response at Week 8. 3.The proportion of subjects in clinical remission at Week 8. 4.The proportion of subjects in symptomatic remission at Week 8. 5. The proportion of subjects achieving deep remission at Week 8. 6. Partial Mayo scores and change from baseline over time. 7. Change from baseline at Week 8 in total Mayo score.Timepoint: Time Frame: 8 weeks

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Countries

Australia, Austria, Belgium, Brazil, Canada, Colombia, Croatia, Czech Republic, Denmark, Estonia, France, Germany, Hungary, India, Israel, Italy, Latvia, Netherlands, New Zealand, Poland, Republic of Korea, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Taiwan, United Kingdom, United States of America

Contacts

Public ContactSwapnali Raut

Pfizer Limited

Swapnali.raut@pfizer.com91-9821415224

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026