ulcerative colitis
Conditions
Interventions
Treatment with GSK2982772 (treatment phase part A and B) or placebo (part A
only) on top of standard therapy.
colitis ulcerosa
Sponsors
GlaxoSmithKline
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: • Between 18 and 75 years of age inclusive. • Confirmed diagnosis of active UC, as documented by complete diagnostic colonoscopy to the terminal ileum with biopsy at least 3 months prior to screening. • Complete Mayo Score of >=3 points and endoscopy sub score of 2 to 3 at screening, despite concurrent treatment with at least oral corticosteroids or 5-ASA or purine analogues or all. See protocol page 28 for details. • Naive to any biological therapies for UC or previous exposure to a single anti-TNF biologic agent which was discontinued for reasons other than primary non-response more than 8 weeks (or 5 half lives whichever is longer) prior to first dose or previous exposure to a single anti-TNF biologic agent in the context of a clinical trial which was discontinued more than 8 weeks (or 5 half lives whichever is longer) prior to first dose. • BMI 18.5 - 35 kg/m2 (inclusive). • Females must not be pregnant of lactating. • Females of childbearing potential and males must comply with the contraception requirements outlined on page 29 of the protocol.
Exclusion criteria
Exclusion criteria: • Indeterminate colitis, Crohn*s Disease, infectious colitis, or ischemic colitis. • Fulminant UC, or UC limited to the rectum (disease extent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse effects. | — |
Secondary
| Measure | Time frame |
|---|---|
| Mayo score, UCEIS, change from baseline of markers (incl. CRP and FCP), Modified Riley Score and Geboes Index, plasma concentrations. | — |
Countries
The Netherlands
Outcome results
None listed