A multicentre, randomised, double-blind (sponsor-unblinded), placebo-controlled study with open label extension to investigate the safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of GSK2982772 in subjects with active ulcerative colitis (study 202152)
- Conditions
- ulcerative colitis10017969
- Registration Number
- NL-OMON45582
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 3
• 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.
• Indeterminate colitis, Crohn*s Disease, infectious colitis, or ischemic colitis.
• Fulminant UC, or UC limited to the rectum (disease extent <15 cm from the anal verge).
• Previous small bowel or colonic surgery, histological evidence of colonic dysplasia or bowel stricture.
• Colostomy, fistulae or known symptomatic stenosis of the intestine.
• Clostridium difficile toxin test or active/previous colonic CMV infection.
• Suicidal ideation behaviour as measures using the Columbia Suicide Severity Rating Scale or history of attempted suicide.
• Active infection, or a history of infections. See protocol page 30-31 for details.
• Treatment with the therapies listed in Section 6.11.2, or changes to those treatments, within the prescribed timeframe.
• Received a live or attenuated vaccine within 30 days of randomization or plan to receive a vaccination during the study until 5 half-lives (or 2 days) plus 30 days after receiving GSK2982772.
• Presence of HBsAg, positive hepatitis C antibody test result. Positive serology for HIV.
• Exposure to more than 4 investigational medicinal products within 12 months prior to the first dose.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Adverse effects.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Mayo score, UCEIS, change from baseline of markers (incl. CRP and FCP),<br /><br>Modified Riley Score and Geboes Index, plasma concentrations.</p><br>