ulcerative colitis
Conditions
Interventions
Treatment with GSK2586184.
Sponsors
GlaxoSmithKline BV
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Male or female, between 18 and 75 years of age inclusive. * Moderate to severely active UC at least 6 months prior to Screening confirmed by colonoscopy or sigmoidoscopy with video recording, and biopsy. * Mayo score of 6 to 12 points and endoscopy sub score of 2 to 3 at screening, despite concurrent treatment (see protocol page 20 for details). * Females of non-childbearing potential. See protocol page 21 for details. * Female partners of child-bearing potential of male participants must agree to use acceptable contraception methods.
Exclusion criteria
Exclusion criteria: * Fulminant UC, or UC limited to rectum. * Previous colonic surgery, histological evidence of colonic dysplasia, or bowel stricture. * Live vaccination within 4 weeks before the first dose of study medication, or a live vaccination planned during the course of the study. * Acute or chronic infections (see protocol page 22 for details). * Females of child-bearing potential.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events. | — |
Secondary
| Measure | Time frame |
|---|---|
| Mayo-score, rectal bleeding, UCEIS (ulcerative colitis endoscopic index of severity), IBDQ, CRP, faecal calprotectin, PK parameters. | — |
Countries
Netherlands
Outcome results
None listed