Basiliximab in Moderate to Severe Ulcerative Colitis

December 17, 2008 updated by: Cerimon Pharmaceuticals

A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, With Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis

The purpose of this study is to assess the safety, effectiveness and pharmacokinetics of two levels of intravenous basiliximab in ulcerative colitis, compared to placebo.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

181

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
  • Czech Republic
      • Mlada Boleslav, Czech Republic, 293 50
      • Praha 10, Czech Republic, 100 34
      • Praha 4, Czech Republic
      • Praha 7, Czech Republic, 170 00
      • Tabor, Czech Republic, 390 03
      • Usti nad Orlici, Czech Republic, 562 18
  • India
      • Bangalore, India, 560 054
      • Cochin, India, 682017
      • Hyderabaad, India, 500012
      • Kolkata, India, 700020
      • Lucknow, India, 226014
      • Ludhiana, India, 141001
      • Mumbai, India, 400016
      • New Delhi, India, 110076
      • Visakhapatnam, India, 530 002
  • Poland
      • Gdansk, Poland
      • Krakow, Poland
      • Krakow, Poland, 31-826
      • Poznan, Poland, 60-353
      • Sopot, Poland, 81-756
      • Sopot, Poland, 81-820
      • Warszawa, Poland, 02-098
      • Wroclaw, Poland, 54-144
  • Russian Federation
      • Moscow, Russian Federation, 115446
      • Moscow, Russian Federation, 121309
      • Samara, Russian Federation, 443011
      • Smolensk, Russian Federation, 214001
  • Slovakia
      • Bratislava, Slovakia, 851 01
      • Bratislava, Slovakia, 811 07
      • Nitra, Slovakia, 949 01
      • Nove Mesto nad Vahom, Slovakia, 915 01
      • Presov, Slovakia, 080 01
  • Ukraine
      • Dnepropetrovsk, Ukraine, 49074
      • Ivano-Frankivsk, Ukraine, 76000
      • Kharkiv, Ukraine, 61037
      • Kyiv, Ukraine, 01021
      • Kyiv, Ukraine, 04210
  • United Kingdom
      • Bristol, United Kingdom, BS2 8HW
      • Derbyshire, United Kingdom, DE22 3NE
      • London, United Kingdom, WC1E 6DB
      • Stoke on Trent, United Kingdom, ST4 6QB
      • Wigan, United Kingdom, WN1 2NN
  • United States
    • California
      • Anaheim, California, United States
      • Roseville, California, United States, 95661
    • Colorado
      • Golden, Colorado, United States
      • Littleton, Colorado, United States
    • Florida
      • Hollywood, Florida, United States
      • Jacksonville, Florida, United States
      • Winter Park, Florida, United States, 32789
    • Georgia
      • Atlanta, Georgia, United States
    • Illinois
      • Chicago, Illinois, United States, 60637
      • Urbana, Illinois, United States, 61801
    • Indiana
      • Indianapolis, Indiana, United States, 46202
    • Kansas
      • Topeka, Kansas, United States, 66606
    • Kentucky
      • Lexington, Kentucky, United States, 40536
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
    • Michigan
      • Troy, Michigan, United States
    • New Jersey
      • Egg Harbor Twp, New Jersey, United States, 08234
    • New York
      • Great Neck, New York, United States
      • New York, New York, United States
    • North Dakota
      • Fargo, North Dakota, United States, 58104
    • Ohio
      • Cleveland, Ohio, United States, 44195
    • Pennsylvania
      • Sewickley, Pennsylvania, United States, 15143
    • Tennessee
      • Germantown, Tennessee, United States
    • Texas
      • Fort Worth, Texas, United States, 76104
      • Galveston, Texas, United States
      • Houston, Texas, United States, 77090

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

In addition to others,

  • Men or women age 18-75
  • Diagnosis of ulcerative colitis confirmed through screening endoscopy.
  • Extent of disease must involve at least the left colon
  • Moderate to severe disease (Mayo Score 6-12). Systemic features of tachycardia, fever, and/or significant anemia should not be present.
  • Inadequate response despite treatment with prednisone 40 - 50 mg/day (or other oral steroid at equivalent dose) orally for a minimum of 14 days immediately preceding study entry

Exclusion Criteria:

In addition to other protocol-defined conditions,

  • Pregnancy
  • Stool study that shows presence of ova and parasites, significant bacterial pathogens, or C. difficile toxin
  • Colitis that is indeterminate, suggestive of Crohn's disease, or isolated to the rectum, based on endoscopic and/or biopsy findings
  • Severely ill patients as evidenced by protocol-defined systemic criteria
  • Chest radiograph abnormalities consistent with an infectious process
  • History of colonic dysplasia
  • HIV infection
  • Known viral Hepatitis B or C infection
  • History of or exposure to tuberculosis within 6 months before study entry

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: 1. Placebo
Placebo to mimic 40 mg of Simulect
Drug: Basiliximab
3 doses of 40mg, IV at baseline, week 2, and week 4
Other Names:
  • Simulect
EXPERIMENTAL: 2. 40 mg Simulect
40 mg of Simulect
Drug: Basiliximab
3 doses of 40mg, IV at baseline, week 2, and week 4
Other Names:
  • Simulect

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Mayo Score, Safety
Time Frame: At week 8
At week 8

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical remission at week 4; clinical response at weeks 4 and 8; use of rescue medication; hospitalization or colectomy; and concomitant steroid use
Time Frame: at week 4 and 8
at week 4 and 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cerimon Pharmaceuticals

Investigators

  • Study Director: Daniel Levitt, MD, PhD, Cerimon Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (ACTUAL)

September 1, 2008

Study Completion (ACTUAL)

September 1, 2008

Study Registration Dates

First Submitted

January 31, 2007

First Submitted That Met QC Criteria

January 31, 2007

First Posted (ESTIMATE)

February 2, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

December 18, 2008

Last Update Submitted That Met QC Criteria

December 17, 2008

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BSX-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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