Back to resultsBasiliximab Maintenance in Ulcerative Colitis
Primary Purpose
Ulcerative Colitis
Status
Terminated
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Basiliximab
Sponsored by
About this trial
This is an interventional treatment trial for Ulcerative Colitis focused on measuring Ulcerative Colitis
Eligibility Criteria
Inclusion Criteria:
- Previously met eligibility criteria in the previous basiliximab UC study
- Must have a total Mayo score at entry consistent with clinical response or clinical remission.
- Signed a current IRB/IEC-approved informed consent form
- Females of childbearing potential must use an effective birth control method, and be willing to continue birth control during the study, and for 4 months after the last dose of study drug.
- Females of non-childbearing potential should be surgically sterile (bilateral tubal ligation with surgery at least 6 months before study entry, hysterectomy, or bilateral oophorectomy at least 2 months before study entry) or post-menopausal for at least 2 years.
Exclusion Criteria:
Subject is severely ill, as evidenced by more than 6 episodes of loose stools, all of them bloody, during a 24-hour period within the prior 7 days, concurrent with any of the following systemic features:
- Heart rate > 90 beats/min at rest
- Temperature > 37.8 degrees C
- Hemoglobin < 10.5 g/dL
- Subject is currently receiving a restricted/prohibited concomitant medication
- Subject has undergone colectomy (total, or subtotal)
- Subject is pregnant or breast-feeding
- Prior noncompliance with previous study visit schedule and requirements
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Assess the safety of basiliximab in subjects with ulcerative colitis
Secondary Outcome Measures
Evaluate the efficacy and assess the immunogenicity of t his multiple-dose maintenance regimen in this population
Full Information
NCT ID
NCT01061996
First Posted
February 2, 2010
Last Updated
February 2, 2010
Sponsor
Cerimon Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01061996
Brief Title
Basiliximab Maintenance in Ulcerative Colitis
Official Title
An Open Label Evaluation of the Safety and Efficacy of Basiliximab Maintenance in Ulcerative Colitis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Terminated
Why Stopped
lack of efficacy
Study Start Date
July 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Cerimon Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Primary Objective Safety: assess the safety of basiliximab 40 mg, given every 4 weeks, in subjects with ulcerative colitis who completed previous basiliximab studies.
Secondary Objectives: evaluate the efficacy and assess the immunogenicity of this multiple-dose maintenance regimen in this population
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
Ulcerative Colitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Basiliximab
Other Intervention Name(s)
Simulect
Intervention Description
Study Drug: basiliximab 40 mg, given as a short intravenous infusion Dosing Schedule: once every 4 weeks Concomitant Therapy: Oral corticosteroids (prednisone or equivalent) will be tapered during the first few months of the study participation Duration of Study Participation: The duration of individual study participation will vary.
Primary Outcome Measure Information:
Title
Assess the safety of basiliximab in subjects with ulcerative colitis
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Evaluate the efficacy and assess the immunogenicity of t his multiple-dose maintenance regimen in this population
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Previously met eligibility criteria in the previous basiliximab UC study
Must have a total Mayo score at entry consistent with clinical response or clinical remission.
Signed a current IRB/IEC-approved informed consent form
Females of childbearing potential must use an effective birth control method, and be willing to continue birth control during the study, and for 4 months after the last dose of study drug.
Females of non-childbearing potential should be surgically sterile (bilateral tubal ligation with surgery at least 6 months before study entry, hysterectomy, or bilateral oophorectomy at least 2 months before study entry) or post-menopausal for at least 2 years.
Exclusion Criteria:
Subject is severely ill, as evidenced by more than 6 episodes of loose stools, all of them bloody, during a 24-hour period within the prior 7 days, concurrent with any of the following systemic features:
Heart rate > 90 beats/min at rest
Temperature > 37.8 degrees C
Hemoglobin < 10.5 g/dL
Subject is currently receiving a restricted/prohibited concomitant medication
Subject has undergone colectomy (total, or subtotal)
Subject is pregnant or breast-feeding
Prior noncompliance with previous study visit schedule and requirements
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shaily J. Reichert
Organizational Affiliation
Cerimon Pharmaceuticals
Official's Role
Study Director
Facility Information:
City
Bristol
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Basiliximab Maintenance in Ulcerative Colitis
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