Overview

Basiliximab Maintenance in Ulcerative Colitis

Status:
Terminated

Trial end date:
2008-12-01

Target enrollment:
0

Participant gender:
All

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

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Cerimon Pharmaceuticals

Treatments:

Antibodies, Monoclonal
Basiliximab

Criteria

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