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) - study 202152

GlaxoSmithKline0 sites3 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sponsor

•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.

Not specified