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Safety, Tolerability, Efficacy and Dose-response of GSK2831781 in Ulcerative Colitis

NCT03893565 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2022-04-27

Study results available
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Summary

This is a Phase 2, multicenter, randomized, double-blind, parallel group, placebo-controlled study to investigate the safety, tolerability, efficacy and dose-response of GSK2831781 in participants with moderate to severe active ulcerative colitis. The study consists of a 5-week screening window, 10-week Induction Phase, 30-week double-blind Extended Treatment Phase (ETP) with 42-week Follow-Up Phase. Non-Responders identified following the Week 10 assessment will be allocated to open label treatment, consisting of Induction (Weeks 12 to 22), an Open label ETP (Weeks 22 to 42) and a follow-Up to Week 54.

Conditions

  • Colitis, Ulcerative

Interventions

DRUG

GSK2831781 - Double Blind Phase

GSK2831781 will be administered intravenously in the double blind induction phase and subcutaneously in the double blind ETP (both according to randomization).

DRUG

Placebo

Placebo (commercial saline solution) will be administered intravenously in the double blind induction phase and subcutaneously in the double blind ETP (both according to randomization).

DRUG

GSK2831781 - Open Label phase

GSK2831781 will be administered intravenously in the open label induction phase and subcutaneously in the open label ETP.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-06
Primary Completion
2021-05-17
Completion
2021-05-17
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Czechia
  • Estonia
  • France
  • India
  • Japan
  • Netherlands
  • Poland
  • Russia
  • Serbia
  • Slovakia
  • South Africa
  • Ukraine
  • United Kingdom

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03893565 on ClinicalTrials.gov