Long-Term Safety Of PF-00547659 In Ulcerative Colitis
(TURANDOT II Trial)

Recruiting in Palo Alto (17 mi)

+98 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Shire

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

Subjects with Ulcerative Colitis who have completed an induction study with PF-00547659 will receive an additional 144 weeks of open-label treatment to evaluate the long-term safety of the drug.

Eligibility Criteria

Inclusion Criteria

Subjects between 18 and 66 years of age.

Subjects previously enrolled in study A7281009 (NCT01620255) who have completed the 84 day (12 week) induction period.

Treatment Details

Interventions

PF-00547659 (Monoclonal Antibodies)

Participant Groups

2Treatment groups

Experimental Treatment

Group I: SHP647 75 mgExperimental Treatment1 Intervention

Participants will receive 75 milligrams (mg) of SHP647 subcutaneous (SC) injection every 4 weeks for 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen. During the first 72 weeks, a one time dose escalation to 225 mg of SHP647 SC injection every 4 weeks is allowed after 8 weeks of the study for participants who experience clinical deterioration or unacceptably low level of response to the investigational product. The decision to escalate will be guided by the response and relapse criteria tempered by clinical judgment. Following the first 72 weeks, participants will receive 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen.

Group II: SHP647 225 mgExperimental Treatment1 Intervention

Participants will receive 225 mg of SHP647 SC injection every 4 weeks for 72 weeks followed by 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen.