Basiliximab in Moderate to Severe Ulcerative Colitis

NCT00430898 | Completed Phase 2 DMC

• 1 other identifier: BSX-001
• Study Type: interventional
• Target: 181
• Locations: 9 countries
• Sites: 68

Brief Summary

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.

Conditions

Ulcerative Colitis

Keywords

ulcerative colitis basiliximab

Outcome Measures

Primary Outcomes (1)

• Change in Mayo Score, Safety

  At week 8

Secondary Outcomes (1)

• Clinical remission at week 4; clinical response at weeks 4 and 8; use of rescue medication; hospitalization or colectomy; and concomitant steroid use

  at week 4 and 8

Study Arms (2)

1. Placebo

PLACEBO COMPARATOR

Placebo to mimic 40 mg of Simulect

Drug: Basiliximab

2. 40 mg Simulect

EXPERIMENTAL

40 mg of Simulect

Drug: Basiliximab

Interventions

Basiliximab DRUG

3 doses of 40mg, IV at baseline, week 2, and week 4

Also known as: Simulect

1. Placebo; 2. 40 mg Simulect

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cerimon Pharmaceuticals: lead

Study Sites (68)

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Anaheim, California, United States

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Roseville, California, 95661, United States

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Golden, Colorado, United States

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Littleton, Colorado, United States

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Hollywood, Florida, United States

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Jacksonville, Florida, United States

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Winter Park, Florida, 32789, United States

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Atlanta, Georgia, United States

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Chicago, Illinois, 60637, United States

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Urbana, Illinois, 61801, United States

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Indianapolis, Indiana, 46202, United States

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Topeka, Kansas, 66606, United States

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Lexington, Kentucky, 40536, United States

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Boston, Massachusetts, 02114, United States

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Troy, Michigan, United States

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Egg Harbor Twp, New Jersey, 08234, United States

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Great Neck, New York, United States

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New York, New York, United States

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Fargo, North Dakota, 58104, United States

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Cleveland, Ohio, 44195, United States

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Sewickley, Pennsylvania, 15143, United States

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Germantown, Tennessee, United States

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Fort Worth, Texas, 76104, United States

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Galveston, Texas, United States

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Houston, Texas, 77090, United States

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Leuven, 3000, Belgium

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Mladá Boleslav, 293 50, Czechia

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Prague, 100 34, Czechia

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Prague, 170 00, Czechia

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Prague, Czechia

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Tábor, 390 03, Czechia

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Ústí nad Orlicí, 562 18, Czechia

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Bangalore, 560 054, India

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Hyderabaad, 500012, India

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Kochi, 682017, India

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Kolkata, 700020, India

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Lucknow, 226014, India

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Ludhiana, 141001, India

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Mumbai, 400016, India

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New Delhi, 110076, India

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Visakhapatnam, 530 002, India

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Gdansk, Poland

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Krakow, 31-826, Poland

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Krakow, Poland

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Poznan, 60-353, Poland

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Sopot, 81-756, Poland

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Sopot, 81-820, Poland

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Warsaw, 02-098, Poland

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Wroclaw, 54-144, Poland

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Moscow, 115446, Russia

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Moscow, 121309, Russia

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Samara, 443011, Russia

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Smolensk, 214001, Russia

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Bratislava, 811 07, Slovakia

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Bratislava, 851 01, Slovakia

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Nitra, 949 01, Slovakia

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Nové Mesto nad Váhom, 915 01, Slovakia

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Prešov, 080 01, Slovakia

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Dnipro, 49074, Ukraine

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Ivano-Frankivsk, 76000, Ukraine

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Kharkiv, 61037, Ukraine

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Kyiv, 01021, Ukraine

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Kyiv, 04210, Ukraine

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Bristol, BS2 8HW, United Kingdom

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Derbyshire, DE22 3NE, United Kingdom

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London, WC1E 6DB, United Kingdom

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Stoke-on-Trent, ST4 6QB, United Kingdom

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Wigan, WN1 2NN, United Kingdom

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Related Publications (1)

• Sands BE, Sandborn WJ, Creed TJ, Dayan CM, Dhanda AD, Van Assche GA, Gregus M, Sood A, Choudhuri G, Stempien MJ, Levitt D, Probert CS. Basiliximab does not increase efficacy of corticosteroids in patients with steroid-refractory ulcerative colitis. Gastroenterology. 2012 Aug;143(2):356-64.e1. doi: 10.1053/j.gastro.2012.04.043. Epub 2012 Apr 28.

  PMID: 22549092 DERIVED

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

• Daniel Levitt, MD, PhD

  Cerimon Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 31, 2007
• First Posted: February 2, 2007
• Study Start: January 1, 2007
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: December 18, 2008

Record last verified: 2008-12

Locations

BE (1); IN (9); UA (5); US (25); RU (4); PL (8); GB (5); SL (5); CZ (6)