Pharmacokinetics/Pharmacodynamics Biomarker Study in Active Ulcerative Colitis Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01284062
First received: January 25, 2011
Last updated: May 23, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Colitis, Ulcerative
Biological: Anrukinzumab
Other: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2A, Randomized, Double-Blind, Sponsor Unblinded, Placebo-Controlled, Multiple Dose Study To Evaluate The Pharmacodynamics, Pharmacokinetics And Safety Of Anrukinzumab In Patients With Active Ulcerative Colitis

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Fold change from baseline in fecal calprotectin at Week 14. [ Time Frame: Week 14 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The PK of anrukinzumab will be characterized from data obtained at pre specified time points up to 32 weeks. The pharmacokinetic parameters AUC, and half life will be estimated using noncompartmental analysis [ Time Frame: Up to Week 32 ] [ Designated as safety issue: No ]
  • Fold change from baseline in fecal calprotectin at Weeks 2, 4, 8, and 12. [ Time Frame: Weeks 2,4,8, and 12 ] [ Designated as safety issue: No ]
  • Total IL-13 (free IL-13 and IL-13 complexed with anrukinzumab) measured at pre-specified time points up to 32 weeks. [ Time Frame: Up to Week 32 ] [ Designated as safety issue: No ]
  • The frequency of on treatment adverse events, serious adverse events and withdrawals due to adverse events will be summarized. [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]
  • Frequency of ADAs and NAbs, if observed, at pre-specified timepoints timepoints up to 32 weeks. [ Time Frame: Up to Week 32 ] [ Designated as safety issue: Yes ]
  • Clinical response rate at Week 14 [ Time Frame: Week 14 ] [ Designated as safety issue: No ]
  • Clinical remission rate at Week 14 [ Time Frame: Week 14 ] [ Designated as safety issue: No ]
  • Other exploratory efficacy endpoints including change from baseline in total Mayo score, change from baseline in stool frequency, rectal bleeding, and endoscopic subscores. [ Time Frame: Week 32 ] [ Designated as safety issue: No ]

Enrollment: 84
Study Start Date: March 2011
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
200 mg PF-05230917, Anrukinzumab active dose level
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
Experimental: Arm 2
400 mg PF-05230917, Anrukinzumab active dose level
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
Experimental: Arm 3
600 mg PF-05230917, Anrukinzumab active dose level
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
Placebo Comparator: Arm 4
Matching placebo - administered at matching dose level 200 mg, 400 mg or 600 mg.
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
Other Name: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01284062

  Show 57 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01284062     History of Changes
Other Study ID Numbers: B2421003, IMA-638 Anti-IL13 mAb
Study First Received: January 25, 2011
Last Updated: May 23, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Active Ulcerative Colitis
Phase 2A
Double-blind
Randomized
PK/PD Biomarker Study

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases

ClinicalTrials.gov processed this record on September 16, 2014