Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01284062 · ClinicalTrials.gov registry record · Phase 2
Pharmacokinetics/Pharmacodynamics Biomarker Study in Active Ulcerative Colitis Patients
A Phase 2 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 2
- Development phase
- 84
- Enrollment target
NCT01284062: Completed Phase 2 study, sponsored by Pfizer.
NCT01284062 is a Phase 2 study that has completed, run by Pfizer. The registered enrollment target is 84 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (37% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01284062, a Phase 2 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 84 participants
- Enrollment target
Study 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.
Primary Outcome
The fold change from baseline in fecal calprotectin at Week 14, is the ratio of the measurement of fecal calprotectin at Week 14 to baseline measurement; this was calculated as the change from baseline in natural log transformed fecal calprotectin at Week 14.
Interventions
- OTHER placebo
- BIOLOGICAL Anrukinzumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2011-03 |
| Est. Completion | 2013-04 |
| Phase | Phase 2 |
What the finished NCT01284062 record still lists
NCT01284062 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (37% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT01284062 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01284062 about?
NCT01284062 is a clinical study titled "Pharmacokinetics/Pharmacodynamics Biomarker Study in Active Ulcerative Colitis Patients". 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...
What is the current status of trial NCT01284062?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 84 participants. The study started on 2011-03. Estimated completion is 2013-04.
What interventions are being tested in trial NCT01284062?
The interventions under investigation include: placebo (OTHER), Anrukinzumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT01284062?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01284062's enrollment target sits among peer trials
84 822nd of 2000 higher than 1,173 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02391519 · 84 participants
Effects of High Altitude on AMPK Activation
- NCT03838536 · 84 participants · NA
Synergistic Activity of Human Milk Nutrients and Infant Cognition
- NCT03884075 · 84 participants · Phase 2
Non-Alcoholic Fatty Liver Disease, the HEpatic Response to Oral Glucose, and the Effect of Semaglutide (NAFLD HEROES)
- NCT03894917 · 84 participants
Characterizing Disease Biology, Treatment and Toxicity in Older Adults With Hepatocellular Carcinoma
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia