Nine-Weeks Treatment With 683699 In Subjects With Moderately-To-Severely Active Crohn's Disease



Status:Completed
Conditions:Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 65
Updated:10/14/2017
Start Date:October 2004
End Date:July 2006

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A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Investigate the Efficacy and Safety of Nine-weeks Administration of Three Doses of SB-683699 in Subjects With Moderately to Severely Active Crohn's Disease

This study will evaluate the effectiveness and safety of the investigational drug 683699 in
treating subjects with moderately to severely active CD (Crohn's Disease).


Inclusion criteria:

- Diagnosed with CD and reconfirmed in previous 2 years by a radiologic or endoscopic
assessment including histology.

- CDAI (Crohn's Disease Activity Index) score of 220-450 after 1 week of screening.

- CRP (C-Reactive Protein) level of >4mg at screening.

Exclusion criteria:

- Significantly abnormal laboratory tests or ECG (electrocardiogram) results.

- Current use of an elemental diet or parenteral nutrition.

- Clinically significant positive stool culture.

- Ongoing neoplastic disease of the bowel.

- Bowel perforation other than fistulae.

- Has an ileostomy or colostomy.

- Fixed symptomatic gastrointestinal (GI) stricture within 6 months or obstructive
symptoms within 3 months of screening.

- Any bowel resection within 12 months of screening or bowel resection without
subsequent demonstration of recurrence of active CD.

- More than 100cm of bowel resected.

- Non-curative bowel surgery with 2 months of screening.

- Symptoms attributed to short bowel syndrome.

- Uncontrolled bacterial, viral, or fungal infection or congenital or acquired
immunodeficiency.

- Women who are pregnant, breast feeding, or planning to become pregnant during the
study.

Permitted medications:

- Less than or equal to 20mg/day oral corticosteroids for at least 4 weeks prior to
screening and on stable doses for 2 weeks prior to screening.

- Azathioprine and 6-MP (6-Mercaptopurine) stable dose for 3 months prior to screening.

- 5-ASA (5-Aminosalicylic acid) stable dose for 1 month prior to screening.

Prohibited medications:

- Greater than 20mg/day oral corticosteroids, or systemic intravenous corticosteroids,
or antibiotics as a treatment for CD within 4 weeks prior to screening.

- Cyclosporine or methotrexate during the 2 months prior to screening.

- Infliximab or other biological treatments within 3 months prior to screening.
We found this trial at
14
sites
West Yarmouth, Massachusetts 02673
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Calgary, Alberta
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Calgary,
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Charlotte, North Carolina 28203
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Charlotte, NC
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Cincinnati, Ohio 45229
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Cincinnati, OH
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Garden Grove, California 92844
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Garden Grove, CA
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Great Neck, New York 11023
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Great Neck, NY
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Houston, Texas 77030
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Houston, TX
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Medford, Oregon 97504
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Medford, OR
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Memphis, Tennessee 38120
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Memphis, TN
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Miami, Florida 33136
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Miami, FL
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Raleigh, North Carolina 27614
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Raleigh, NC
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Roseville, California 95678
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Roseville, CA
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Simpsonville, South Carolina 29681
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Simpsonville, SC
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Topeka, Kansas 66604
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Topeka, KS
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