Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00267306 · ClinicalTrials.gov registry record · Phase 1
Ulcerative Colitis Study: Study of Visilizumab in Patients With Severe Ulcerative Colitis
A Phase 1 study, sponsored by Facet Biotech.
- Completed
- Registry status
- Phase 1
- Development phase
- 144
- Enrollment target
NCT00267306: Completed Phase 1 study, sponsored by Facet Biotech.
NCT00267306 is a Phase 1 study that has completed, run by Facet Biotech. The registered enrollment target is 144 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (140% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00267306, a Phase 1 study, has completed, sponsored by Facet Biotech.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 144 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and tolerability of visilizumab in patients with severe ulcerative colitis that has failed to respond to steroid therapy. What is visilizumab? Visilizumab is an antibody designed to reduce inflammation. Antibodies are proteins that are normally made by the immune system to help defend the body from infections and other foreign substances. Visilizumab is thought to selectively affect the immune system to decrease inflammation and, in doing so, it may prevent damage to the intestine caused by ulcerative colitis. Who can participate in this study? The target population for this study is adults with severe ulcerative colitis that has resisted intravenous (IV) steroids. This study is open to patients with the following characteristics: * 16-70 year olds * A diagnosis of ulcerative colitis verified by colonoscopy or barium enema performed within 36 months prior to study entry * Active disease despite ongoing treatment with steroids How is this study conducted? Eligible participants will be administered visilizumab as one daily injection on two consecutive days. All medication and study-related care, except for the costs of in-patient hospitalization, are provided to qualified participants at no cost. This includes all visits, examinations and laboratory work. How does one get more information? This study is currently enrolling patients at hospitals and clinics in North America and Europe. For more information on the study or how to participate in it, please call 1-800-772-0482, email InfoCenter@pdl.com or visit www.IBDtrials.com.
Interventions
- DRUG Visilizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 144 participants |
| Start Date | 2004-01 |
| Est. Completion | 2006-12 |
| Phase | Phase 1 |
What the finished NCT00267306 record still lists
NCT00267306 is an interventional study that assigns participants to a tested intervention. The registered 144 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (140% higher).
The record links to 0 conditions, and to 1 intervention - of which Visilizumab is the first listed.
NCT00267306 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00267306 about?
NCT00267306 is a clinical study titled "Ulcerative Colitis Study: Study of Visilizumab in Patients With Severe Ulcerative Colitis". The purpose of this study is to evaluate the safety and tolerability of visilizumab in patients with severe ulcerative colitis that has failed to respond to steroid therapy. What is visilizumab? Visilizumab is an antibody designed to reduce inflammation. Antibodies are proteins that are normally m...
What is the current status of trial NCT00267306?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 144 participants. The study started on 2004-01. Estimated completion is 2006-12.
What interventions are being tested in trial NCT00267306?
The interventions under investigation include: Visilizumab (DRUG).
Who is sponsoring clinical trial NCT00267306?
This trial is sponsored by Facet Biotech, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00267306's enrollment target sits among peer trials
144 394th of 2000 higher than 1,600 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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
- NCT01861106 · 144 participants · Phase 2
Allogeneic Hematopoietic Stem Cell Transplant for GATA2 Mutations
- NCT03482245 · 144 participants · NA
The Role of Circadian Clock Proteins in Innate and Adaptive Immunity
- NCT03504683 · 144 participants · NA
MEAL TIMING Study: Effect of Time-Restricted Feeding on 24-hour Glycemic Control, Blood Pressure, and Cardiovascular Disease Risk Factors in Adults With Prediabetes
- NCT03905603 · 144 participants · Early Phase 1
Relative Contributions of Predictors of Hyperandrogenism in Older vs. Young Women With PCOS
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