Basiliximab Maintenance in Ulcerative Colitis

NCT01061996 | Terminated Phase 2

• 1 other identifier: BSX-002
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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

Conditions

Ulcerative Colitis

Keywords

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Assess the safety of basiliximab in subjects with ulcerative colitis

  1 year

Secondary Outcomes (1)

• Evaluate the efficacy and assess the immunogenicity of t his multiple-dose maintenance regimen in this population

  1 year

Study Arms (1)

1

EXPERIMENTAL

Drug: Basiliximab

Interventions

Basiliximab DRUG

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.

Also known as: Simulect

1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cerimon Pharmaceuticals: lead

Study Sites (1)

Unknown Facility

Bristol, United Kingdom

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Basiliximab

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Shaily J. Reichert

  Cerimon Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 2, 2010
• First Posted: February 4, 2010
• Study Start: July 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: February 4, 2010

Record last verified: 2010-02

Locations

GB (1)