Ulcerative Colitis Clinical Trial
Official title:
A Phase 2, Randomized, Double-blind, Multicenter, Dose-exploration Study of Visilizumab in Subjects With Intravenous Steroid-refractory Ulcerative Colitis
Verified date | April 2012 |
Source | Abbott |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The purpose of this study is to assess the efficacy, immunogenicity, and safety of various doses of visilizumab in subjects with intravenous steroid-refractory ulcerative colitis (IVSR-UC) and to evaluate optimal dosing.
Status | Terminated |
Enrollment | 38 |
Est. completion date | November 2007 |
Est. primary completion date | November 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria Eligible subjects will be considered for inclusion in this study if they meet all of the following criteria: - Males and females, 18 years of age or older. - Diagnosis of ulcerative colitis (UC), as verified by endoscopy performed within 60 months prior to consent. - Severe active disease, as defined by modified Truelove Witts severity index (MTWSI) >= 11 at consent, with a confirmatory MTWSI >= 10 on or after the fifth consecutive day of intravenous (IV) steroids and within 1 day prior to randomization. - Mayo score >= 10 and Mayo mucosal subscore >= 2 after a minimum of 3 consecutive days (ie, on or after the fourth consecutive day) of IV steroids. - Adequate contraception from the day of consent through 3 months after the last dose of study drug. - Negative serum pregnancy test at screening. - Negative Clostridium difficile test within 10 days prior to randomization. - Signed and dated informed consent and Health Insurance Portability and Accountability Act (HIPAA) if applicable. Exclusion Criteria Subjects will be ineligible for this study if they meet any one of the following criteria: - UC requiring immediate intervention. - History of total proctocolectomy, or subtotal colectomy with ileorectal anastomosis - Presence of ileostomy. - White blood cell count less than 2.5 x 10^3/mcL; platelet count less than 150 x 10^3/mcL; or hemoglobin level less than 8 g/dL. - Active medically significant infections, particularly those of viral etiology, eg, known cytomegalovirus (CMV) colitis. This includes any incidence of medically significant opportunistic infections within the past 12 months. - Live vaccination within 6 weeks prior to randomization. - Significant organ dysfunction, including cardiac, renal, liver, central nervous system (CNS), pulmonary, vascular, gastrointestinal, endocrine, or laboratory abnormality. - History or treatment of lymphoproliferative disorder (LPD) or malignancy within the past 5 years (excluding nonmelanoma skin cancer or carcinoma in situ of the cervix). - Seropositivity for infection with human immunodeficiency virus (HIV-1), hepatitis B virus (HBV) surface antigen, or hepatitis C virus (HCV). - Pregnancy or nursing. - Treatment with a first dose of infliximab or another anti-TNF-a drug within 4 weeks of randomization, or treatment with a subsequent dose of an anti-TNF-a drug within 2 weeks of randomization. - Treatment with cyclosporine or tacrolimus (FK506) within 2 weeks prior to randomization. - Treatment with any other investigational drugs or therapies within 60 days prior to randomization, except those mentioned in the two exclusion criteria above. - Unwilling or unable to discontinue all UC drugs, except glucocorticoids and oral 5-ASA, immediately prior to randomization. - Nontherapeutic levels of chronic antiseizure medications in subjects with a prior history of seizures. - Any condition that, in the investigator's opinion, makes the subject unsuitable for study participation. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Site Reference ID/Investigator# 71875 | Hamilton | |
Canada | Site Reference ID/Investigator# 71873 | Winnipeg | |
Croatia | Site Reference ID/Investigator# 72338 | Osijek | |
Croatia | Site Reference ID/Investigator# 72334 | Zagreb | |
Italy | Site Reference ID/Investigator# 72345 | Bologna | |
Russian Federation | Site Reference ID/Investigator# 72314 | Moscow | |
Russian Federation | Site Reference ID/Investigator# 71953 | Nizhny-Novgorod | |
Russian Federation | Site Reference ID/Investigator# 72315 | St. Petersburg | |
Russian Federation | Site Reference ID/Investigator# 72342 | St. Petersburg | |
Spain | Site Reference ID/Investigator# 72368 | Badalona - Barcelona | |
Spain | Site Reference ID/Investigator# 72366 | Majadahonda (Madrid) | |
United States | Site Reference ID/Investigator# 71895 | Chapel Hill | North Carolina |
United States | Site Reference ID/Investigator# 71896 | Cleveland | Ohio |
United States | Site Reference ID/Investigator# 71913 | Manhasset | New York |
United States | Site Reference ID/Investigator# 71894 | Savannah | Georgia |
United States | Site Reference ID/Investigator# 71897 | Worcester | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Abbott |
United States, Canada, Croatia, Italy, Russian Federation, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of subjects in each of the three visilizumab dose groups who respond to treatment in the dose-exploration portion of this study (Stage 1). | Day 45 | No | |
Secondary | Comparison of subjects in the three visilizumab dose groups | During the course of the study | No |
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 |