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

Shire

Status and phase: Completed; Phase 2

Conditions: Ulcerative Colitis

Treatments: Drug: 225mg SHP647 (PF-00547659); Drug: 75mg SHP647 (PF-00547659)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01771809

2012-002031-28 (EudraCT Number)

TURANDOT II (Other Identifier)

A7281010

Details and patient eligibility

About

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.

Enrollment: 330 patients

Sex: All

Ages: 18 to 66 years old

Volunteers: No Healthy Volunteers

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.

Exclusion criteria

• Subjects that have completed Day 84 (Week 12) of study A7281009 but have experienced serious event(s) related to the investigational product, an unstable medical condition, or any other reason, in the opinion of the investigator, would preclude entry or participation in this study.
• Subjects who are taking any dose of Azathioprine (AZA), 6-mercaptopurine(6 MP) or Methotrexate (MTX).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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330 participants in 2 patient groups

SHP647 75 mg

Experimental group

Description:

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.

Treatment:

Drug: 75mg SHP647 (PF-00547659)

SHP647 225 mg

Experimental group

Description:

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.

Treatment:

Drug: 225mg SHP647 (PF-00547659)