A multicentre, randomised, double-blind (sponsor-unblinded),placebo-controlled study with open label extension to investigatethe safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of GSK2982772 in subjects with active ulcerative colitis.

GlaxoSmithKline Research & Development Ltd0 sites36 target enrollmentJuly 19, 2016

ConditionsActive ulcerative colitis MedDRA version: 20.0Level: HLGTClassification code 10017969Term: Gastrointestinal inflammatory conditionsSystem Organ Class: 10017947 - Gastrointestinal disorders Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Active ulcerative colitis
Sponsor: GlaxoSmithKline Research & Development Ltd
Enrollment: 36
Status: Active, not recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

July 19, 2016

End Date

June 17, 2019

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

GlaxoSmithKline Research & Development Ltd

Eligibility Criteria

Inclusion Criteria

•1\. Between 18 and 75 years of age inclusive, at the time of signing the informed consent.
•TYPE OF SUBJECT AND DIAGNOSIS INCLUDING DISEASE SEVERITY
•2\. Subjects that do not have any medical conditions, other than active UC, that in the opinion of the Investigator put the subject at unacceptable risk or interfere with study assessments or integrity of the data. These medical conditions should be stable at the time of screening and are expected to remain stable for the duration of the study.
•3\. Subject has had a confirmed diagnosis of active UC, as documented by complete diagnostic colonoscopy to the terminal ileum (TI) with biopsy performed \= 3 months prior to screening. If diagnostic colonoscopy was not performed to the TI, it must be documented by the PI that the subject has diffuse inflammation from the rectum extending proximally to the colon in a continuous and uniform way.
•4\. A Complete Mayo Score of \=3 points and endoscopy sub score of 2 to 3 at screening, despite concurrent treatment with at least 1 of the following (oral corticosteroids or any oral 5\-aminosalicylates (5\-ASA) or purine analogues or all as defined below):
•a. Oral 5\-ASA at a stable dose (equivalent to \= 2\.4 g/day of Asacol) for at least 4 weeks prior to first dose. Must remain on a stable dose until end of treatment.
•b. Purine analogues (azathioprine, mercaptopurine, thiopurines) or methotrexate for at least12 weeks prior to first dose. Must remain on a stable dose until end of treatment.
•c. Stable low dose oral corticosteroid (up to 20 mg prednisolone or equivalent) for 2 weeks prior to sigmoidoscopy. Must remain on a stable dose until end of treatment.
•5\. If on rectal 5\-ASA or corticosteroids, must remain on a stable dose for at least 4 weeks prior to first dose. Must remain on stable dose until the end of treatment.
•6\. Subject is naive to any biological therapies for UC.

Exclusion Criteria

•CONCURRENT CONDITIONS/MEDICAL HISTORY
•1\.Subject with diagnosis of indeterminate colitis, Crohn’s Disease, infectious colitis, or ischemic colitis
•2\.Subject with fulminant UC, or UC limited to the rectum
•3\.Subject with previous small bowel or colonic surgery (with exception of
•appendectomy), histological evidence of colonic dysplasia or bowel stricture.
•4\.Subject with colostomy, fistulae or known symptomatic stenosis of the intestine
•5\.Subject with toxic megacolon
•6\.Subject with positive Clostridium difficile toxin test or active/previous colonic CMV infection
•7\.Subject with current history of suicidal ideation behaviour as measures using the Columbia Suicide Severity Rating Scale or history of attempted suicide
•8\.An active infection, or a history of infections as follows: