Phase
Condition
Inflammatory Bowel Disease
Ulcerative Colitis
Ulcers
Treatment
N/AClinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Established diagnosis of ulcerative colitis
Active ulcerative colitis disease extent ≥ 15 cm
Active disease despite treatment with mesalamine
Exclusion
Exclusion Criteria:
Crohn's disease, indeterminate colitis, ischemic colitis, radiation colitis,microscopic colitis, diverticular disease associated colitis,
Toxic megacolon or fulminant colitis
Colon resection
Evidence of infectious colitis
Celiac disease
Bleeding hemorrhoids
History or presence of ischemic heart disease, myocardial infarction, peripheralarterial disease, ischemic stroke, or transient ischemic attack
Any severe concomitant renal, endocrine, or psychiatric disorder
Any relevant known systemic disease
History of cancer in the last five years
Abnormal hepatic function or liver cirrhosis
Abnormal HbA1c at screening visit
Patients with known hypersensitivity to soy
Known intolerance/hypersensitivity to Investigational Medicinal Product (IMP)
Treatment with steroids/methotrexate/Tumor necrosisfactor-alpha-antagonists/azathioprine/ 6-mercaptopurine/anti-integrin/coumarins
Treatment with other investigational drug
Existing or intended pregnancy or breast-feeding
Study Design
Connect with a study center
Agaplesion Markus-Krankenhaus, 1st Dept. of Medicine
Frankfurt a.M., 60431
GermanySite Not Available
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