Basiliximab Maintenance in Ulcerative Colitis

Ulcerative Colitis Clinical Trial

Official title:

An Open Label Evaluation of the Safety and Efficacy of Basiliximab Maintenance in Ulcerative Colitis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01061996
• Other study ID #: BSX-002
• Status: Terminated
• Phase: Phase 2
• First received: February 2, 2010
• Last updated: February 2, 2010
• Start date: July 2007
• Est. completion date: December 2008

Study information

• Verified date: February 2010
• Source: Cerimon Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHPBelgium: The Federal Public Service (FPS) Health, Food Chain Safety and EnvironmentCzech Republic: State Institute for Drug ControlIndia: Drugs Controller General of IndiaPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRussia: Ministry of Health of the Russian FederationSlovakia: State Institute for Drug ControlUkraine: State Pharmacological Center - Ministry of HealthUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 88
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Previously met eligibility criteria in the previous basiliximab UC study

2. Must have a total Mayo score at entry consistent with clinical response or clinical remission.

3. Signed a current IRB/IEC-approved informed consent form

4. 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.

5. 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:

1. 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

2. Subject is currently receiving a restricted/prohibited concomitant medication

3. Subject has undergone colectomy (total, or subtotal)

4. Subject is pregnant or breast-feeding

5. Prior noncompliance with previous study visit schedule and requirements

Study Design

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• Basiliximab
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cerimon Pharmaceuticals

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the safety of basiliximab in subjects with ulcerative colitis		1 year	Yes
Secondary	Evaluate the efficacy and assess the immunogenicity of t his multiple-dose maintenance regimen in this population		1 year	Yes