ISIS 2302-CS22, A 6-Week, Active-Controlled Clinical Study to Evaluate the Effectiveness of Alicaforsen (ISIS 2302) in Patients With Mild to Moderate Active Ulcerative Colitis
Ionis Pharmaceuticals, Inc.
This is a multi-center trial to test the safety, efficacy and tolerability of alicaforsen
(ISIS 2302), a new type of drug called an antisense drug, in patients with mild to moderate
active Ulcerative Colitis (UC). Alicaforsen is designed to reduce the production of a
specific protein, called ICAM-1, a substance that plays a significant role in the increase of
inflammation and is likely to be involved in inflammatory bowel diseases such as ulcerative
colitis. The ISIS 2302-CS22 study will examine the effects of one of two dosages of
alicaforsen delivered by enema over a six-week period as compared to an active control,
mesalamine enema (The probability of receiving the alicaforsen formulation is 2:1). The
primary objective of this study is to evaluate the percentage reduction in DAI at Week 6.
Imuran (Azathioprine) Dose-Ranging Study in Crohn's Disease
Massachusetts General Hospital
The purpose of this study is to identify an optimal weight based dose of azathioprine that is
safe and effective in the treatment of subjects with active Crohn's disease requiring
treatment with corticosteroids, and for maintaining remission in those subjects.
Trial of Growth Hormone Therapy in Pediatric Crohn's Disease
The purpose of this study is to determine whether taking a growth hormone (GH) drug called
somatropin causes the intestine of a person with Crohn's Disease (CD) to heal faster when
compared to a person with Crohn's Disease that does not receive growth hormone drug.
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