Long-Term Safety Of PF-00547659 In Ulcerative Colitis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01771809
• Date of registration: 08/01/2013
• Prospective Registration: Yes
• Primary sponsor: Shire
• Public title: Long-Term Safety Of PF-00547659 In Ulcerative Colitis TURANDOT II
• Scientific title: A Multicenter Open-Label Extension Study To Assess Long-Term Safety Of PF-00547659 In Subjects With Ulcerative Colitis (TURANDOT II)
• Date of first enrolment: March 18, 2013
• Target sample size: 330
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01771809
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Australia, Austria, Belgium, Bulgaria, Canada, Czech Republic, Czechia, France, Germany, Hungary, Israel, Italy, Korea, Republic of, Netherlands, New Zealand, Poland, Russian Federation, Serbia, Slovakia, South Africa, Spain, Switzerland, United States

Contacts

• Name: Shire Physician
• Affiliation: Shire

Key inclusion & exclusion 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.

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).



Age minimum: 18 Years
Age maximum: 66 Years
Gender: All

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Intervention(s)

Drug: 225mg SHP647 (PF-00547659)

Drug: 75mg SHP647 (PF-00547659)

Primary Outcome(s)

Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), and Who Withdrew From Treatment Due to Treatment-Emergent Adverse Events (TEAEs) [Time Frame: From start of study drug administration up to 168 weeks]

Secondary Outcome(s)

Percentage of Participants With Mucosal Healing at Week 16 [Time Frame: Week 16]

Number of Participants With Positive Anti-drug (SHP647) Antibodies (ADA) [Time Frame: Baseline, Week 8, 16, 24, 40, 48, 64 and 156]

Serum Trough Concentrations of SHP647 Versus Time [Time Frame: Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72 and 156]

Number of Participants With Positive Neutralizing Antibodies (NAb) [Time Frame: Baseline, Week 8, 16, 24, 40, 48, 64 and 156]

Secondary ID(s)

A7281010

2012-002031-28

TURANDOT II

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 18/04/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01771809