An open label, experimental medicine investigation of the safety and tolerability of 400 mg b.i.d. GSK2586184 in patients with moderate to severely active ulcerative colitis (200208)
- Conditions
- 10017969ulcerative colitis
- Registration Number
- NL-OMON38611
- Lead Sponsor
- GlaxoSmithKline BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
* 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.
* 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Adverse events.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Mayo-score, rectal bleeding, UCEIS (ulcerative colitis endoscopic index of<br /><br>severity), IBDQ, CRP, faecal calprotectin, PK parameters.</p><br>
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