Research Study in Patients With Severe Ulcerative Colitis

Status Completed

Clinical Trial Summary

The purpose of the study is to evaluate an intravenous (by injection) investigational medication to treat severe ulcerative colitis refractory to steroid therapy. The research is being conducted at up to 8 clinical research sites in the US and is open to both men and women ages 18 to 70 years old. Participants in the study will have a number of visits to a research site. All study-related care and medication is provided to qualified participants at no cost: this includes all visits, examinations and laboratory work.

Clinical Trial Description

A Phase I, dose-escalation, pilot study designed to obtain safety and tolerability data on visilizumab administered to patients with severe ulcerative colitis that has failed to respond to steroid therapy. Patients who are currently receiving IV corticosteroids, but whose disease has not responded after at least 5 days of this therapy, will be eligible for the study. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00032305
Study type	Interventional
Source	Facet Biotech
Contact
Status	Completed
Phase	Phase 2/Phase 3
Start date	March 2002
Completion date	November 2005

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05702879` - Combined Microbiota and Metabolic Signature in Ulcerative Colitis Predicts Anti-Inflammatory Therapy Success
Not yet recruiting	`NCT05953402` - A Study of Ozanimod in Pregnant Women With Ulcerative Colitis and Their Offspring
Recruiting	`NCT05316584` - A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence With IBD Therapy	N/A
Recruiting	`NCT03950232` - An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis	Phase 3
Completed	`NCT03124121` - Study of the Golimumab Exposure-Response Relationship Using Serum Trough Levels	Phase 4
Not yet recruiting	`NCT06100289` - A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease	Phase 3
Withdrawn	`NCT04209556` - A Study To Evaluate The Safety And Efficacy Of PF-06826647 In Participants With Moderate To Severe Ulcerative Colitis	Phase 2
Terminated	`NCT00061282` - Clotrimazole Enemas for Pouchitis in Children and Adults	Phase 1/Phase 2
Recruiting	`NCT04398550` - SCD vs. Mediterranean Diet Therapy in Ulcerative Colitis	N/A
Recruiting	`NCT04314375` - Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets in Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative Colitis	Phase 4
Active, not recruiting	`NCT04857112` - Study Evaluating Efficacy and Safety of Amiselimod (MT-1303) in Mild to Moderate Ulcerative Colitis	Phase 2
Completed	`NCT05051943` - A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
Active, not recruiting	`NCT04033445` - A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis	Phase 2/Phase 3
Recruiting	`NCT05428345` - A Study of Vedolizumab SC Given to Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease in South Korea
Active, not recruiting	`NCT06221995` - Energy Expenditure in Patients With Ulcerative Colitis Undergoing Surgery
Recruiting	`NCT04767984` - Testing Atorvastatin to Lower Colon Cancer Risk in Longstanding Ulcerative Colitis	Phase 2
Completed	`NCT02508012` - Medico-economic Evaluation of the Therapeutic Drug Monitoring of Anti-TNF-α Agents in Inflammatory Bowel Diseases	N/A
Recruiting	`NCT06071312` - FMT in Patients With Recurrent CDI and Ulcerative Colitis: Single Infusion Versus Sequential Approach	Phase 1/Phase 2
Completed	`NCT03760003` - Dose-Ranging Phase 2b Study of ABX464 in Moderate to Severe Ulcerative Colitis	Phase 2
Not yet recruiting	`NCT05539625` - Mini-MARVEL - Mitochondrial Antioxidant Therapy in Ulcerative Colitis	Phase 2