| 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 |
| 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. |
| Not Provided |
| Interventional |
| Phase 2 |
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment |
| Colitis, Ulcerative |
- Biological: Anrukinzumab
200 mg sterile liquid vial, administered intravenously, one-hour infusion on Day 1, Week 2, 4, 8, and 12
Other Name: PF-05230917
- 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
Other Name: PF-05230917
- 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 Name: PF-05230917
- 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
|
- Experimental: Arm 1
200 mg PF-05230917, Anrukinzumab active dose level
Intervention: Biological: Anrukinzumab
- Experimental: Arm 2
400 mg PF-05230917, Anrukinzumab active dose level
Intervention: Biological: Anrukinzumab
- Experimental: Arm 3
600 mg PF-05230917, Anrukinzumab active dose level
Intervention: Biological: Anrukinzumab
- Placebo Comparator: Arm 4
Matching placebo - administered at matching dose level 200 mg, 400 mg or 600 mg.
Intervention: Other: placebo
|
| Reinisch W, Panés J, Khurana S, Toth G, Hua F, Comer GM, Hinz M, Page K, O'Toole M, Moorehead TM, Zhu H, Sun Y, Cataldi F. Anrukinzumab, an anti-interleukin 13 monoclonal antibody, in active UC: efficacy and safety from a phase IIa randomised multicentre study. Gut. 2015 Jun;64(6):894-900. doi: 10.1136/gutjnl-2014-308337. Epub 2015 Jan 7. |
| |
| Completed |
| 84 |
| April 2013 |
| April 2013 (Final data collection date for primary outcome measure) |
|
Inclusion Criteria:
- Male or Female, Age >=18 and <=65 years
- Active ulcerative colitis (UC) beyond the rectum based upon Mayo Score
- women of childbearing potential with highly effective method of contraception
Exclusion Criteria:
- Indeterminate disease status, Crohn's disease, ischemic colitis, positive HIV, positive or history of tuberculosis infection, active enteric infections, transplant organ recipient, concomitant steroids, immunosuppressives or anti-TNFs.
|
| Sexes Eligible for Study: |
All |
|
| 18 Years to 65 Years (Adult) |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Austria, Bulgaria, Canada, France, Germany, Hungary, Netherlands, Poland, Romania, Spain, United States |
| Belgium |
| |
| NCT01284062 |
B2421003
IMA-638 Anti-IL13 mAb
2010-023762-49 ( EudraCT Number ) |
| No |
| Not Provided |
| Not Provided |
| Pfizer |
| Pfizer |
| Not Provided |
| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
|
| Pfizer |
| November 2014 |
