Trials / Completed
CompletedNCT02840721
Safety, Efficacy, and Tolerability Study of PF-06480605 in Subjects With Moderate to Severe Ulcerative Colitis.
A PHASE 2A, MULTICENTER, SINGLE ARM, OPEN- LABEL, TWO-STAGE, STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06480605 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- Telavant, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the safety, tolerability, and efficacy of PF-06480605 in subjects with moderate to severe ulcerative colitis.
Detailed description
This is a Phase 2a, single arm, two-stage study in subjects with moderate to severe ulcerative colitis. Subjects will receive 500 mg of PF-06480605 intravenously every 2 weeks for a total of 7 doses. Blood, stool, and tissue samples will be collected at various time points throughout the study to evaluate safety, tolerability, efficacy, pharmacokinetics, and immunogenicity. Duration of participation for subjects will be approximately 8 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PF-06480605 | PF-06480605 500 mg IV Q2W x 7 Doses |
Timeline
- Start date
- 2016-10-26
- Primary completion
- 2018-05-31
- Completion
- 2018-08-30
- First posted
- 2016-07-21
- Last updated
- 2023-10-23
- Results posted
- 2019-06-19
Locations
28 sites across 6 countries: United States, Belgium, Italy, Netherlands, Poland, South Korea
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02840721. Inclusion in this directory is not an endorsement.