Basiliximab Maintenance in Ulcerative Colitis

This study has been terminated.
(lack of efficacy)
Information provided by:
Cerimon Pharmaceuticals Identifier:
First received: February 2, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted

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

Condition Intervention Phase
Ulcerative Colitis
Drug: Basiliximab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Evaluation of the Safety and Efficacy of Basiliximab Maintenance in Ulcerative Colitis

Resource links provided by NLM:

Further study details as provided by Cerimon Pharmaceuticals:

Primary Outcome Measures:
  • Assess the safety of basiliximab in subjects with ulcerative colitis [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluate the efficacy and assess the immunogenicity of t his multiple-dose maintenance regimen in this population [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 88
Study Start Date: July 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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.
Other Name: Simulect


Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01061996

United Kingdom
Bristol, United Kingdom
Sponsors and Collaborators
Cerimon Pharmaceuticals
Study Director: Shaily J. Reichert Cerimon Pharmaceuticals
  More Information

Responsible Party: Shaily J. Reichert, Cerimon Pharmaceuticals, Inc. Identifier: NCT01061996     History of Changes
Other Study ID Numbers: BSX-002 
Study First Received: February 2, 2010
Last Updated: February 2, 2010
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Czech Republic: State Institute for Drug Control
India: Drugs Controller General of India
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Ministry of Health of the Russian Federation
Slovakia: State Institute for Drug Control
Ukraine: State Pharmacological Center - Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Cerimon Pharmaceuticals:
Ulcerative Colitis

Additional relevant MeSH terms:
Colitis, Ulcerative
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases
Pathologic Processes
Immunologic Factors
Immunosuppressive Agents
Physiological Effects of Drugs processed this record on May 26, 2016