Phase 2
Completed N=330
Long-Term Safety Of PF-00547659 In Ulcerative Colitis
Source: ClinicalTrials.gov NCT01771809 ↗Enrolled (actual)
330
Serious AEs
22.4%
Results posted
Apr 2019
Primary outcomePrimary: 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) — 146; 147; 34; 40 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
146; 147; 34; 40; 12; 23 | — |
| SECONDARY Percentage of Participants With Mucosal Healing at Week 16 |
27.4; 29.5 | — |
| SECONDARY Serum Trough Concentrations of SHP647 Versus Time |
6398.62; 8064.41; 5496.56; 16787.31; 6245.79; 20345.29 | — |
| SECONDARY Number of Participants With Positive Anti-drug (SHP647) Antibodies (ADA) |
9; 10; 3; 1; 1; 1 | — |
| SECONDARY Number of Participants With Positive Neutralizing Antibodies (NAb) |
139; 143; 0; 4; 0; 1 | — |
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.
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).
Data sourced from ClinicalTrials.gov (NCT01771809). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.