Trials / Completed
CompletedNCT01284062
Pharmacokinetics/Pharmacodynamics Biomarker Study in Active Ulcerative Colitis Patients
A Phase 2a, Randomized, Double-blind, Sponsor Unblinded, Placebo-controlled, Multiple Dose Study To Evaluate The Pharmacodynamics, Pharmacokinetics And Safety Of Anrukinzumab In Subjects With Active Ulcerative Colitis
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 84 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This study represents the first investigation of anrukinzumab in patients with active ulcerative colitis (UC) and will evaluate proof of mechanism by changes in the mechanism based biomarker (YKL 40) and pharmacodynamic biomarkers (fecal calprotectin, lactoferrin and hs-CRP). It will provide further assessment of the safety, tolerability, and pharmacokinetics (PK) by administration of multiple intravenous (IV) doses of anrukinzumab.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Anrukinzumab | 200 mg sterile liquid vial, administered intravenously, one-hour infusion on Day 1, Week 2, 4, 8, and 12 |
| BIOLOGICAL | Anrukinzumab | 200 mg sterile liquid vial, dose level 400 mg administered intravenously, one-hour infusion on Day 1, Week 2, 4, 8, and 12 |
| BIOLOGICAL | Anrukinzumab | 200 mg sterile liquid vial, dose level 600 mg administered intravenously, one-hour infusion on Day 1, Week 2, 4, 8, and 12 Note: dosing in the 600 mg arm will be delayed until the safety of the 200 mg and 400 mg arms has been reviewed. |
| OTHER | placebo | 200 mg liquid sterile vial, administered at matching dose level 200 mg, 400 mg or 600 mg intravenously, one-hour infusion on Day 1, Week 2, 4, 8, and 12 |
Timeline
- Start date
- 2011-03-01
- Primary completion
- 2013-04-01
- Completion
- 2013-04-01
- First posted
- 2011-01-26
- Last updated
- 2014-11-18
- Results posted
- 2014-11-18
Locations
76 sites across 11 countries: United States, Austria, Bulgaria, Canada, France, Germany, Hungary, Netherlands, Poland, Romania, Spain
Source: ClinicalTrials.gov record NCT01284062. Inclusion in this directory is not an endorsement.