NCT02966834|CompletedPhase 2ResultsFDA Drug

Dose Response Study of GSK2330672 for the Treatment of Pruritus in Participants With Primary Biliary Cholangitis

A Randomized, Double-blind, Multi-dose, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of GSK2330672 Administration for the Treatment of Pruritus in Patients With Primary Biliary Cholangitis (GLIMMER: GSK2330672 triaL of IBAT Inhibition With Multidose Measurement for Evaluation of Response)

GlaxoSmithKline ClinicalTrials.gov

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2 other identifiers

2010002016-002416-41

Study Type

interventional

Target

147

Locations

10 countries

Sites

Timeline

RegisteredNov 2016

StartedJan 2017

CompletionApr 2020

Brief Summary

This study is being conducted to evaluate the efficacy, safety and tolerability of GSK2330672 administration for the treatment of pruritus (itch) in participants with primary biliary cholangitis (PBC). Participants will receive either placebo or one of the 4 dose regimens of GSK2330672 (20 milligram \[mg\], 90 mg or 180 mg taken once daily or 90 mg twice daily). Participants on GSK2330672 will also receive placebo tablets to maintain blinding. The study has a prospectively defined adaptive design that will utilize interim data to further inform and potentially optimize the doses under investigation. Hence, additional dose regimen may be added during study. The total duration of a participant in the study will be up to 45 days of screening and 24 weeks of study including follow-up.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

147

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Jan 2017

Typical duration for phase_2

Geographic Reach

10 countries

66 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.3 years study duration

First Submitted

Initial submission to the registry

November 15, 2016

Completed

2 days until next milestone

First Posted

Study publicly available on registry

November 17, 2016

Completed

2 months until next milestone

Study Start

First participant enrolled

January 11, 2017

Completed

3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2020

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2020

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

May 4, 2021

Completed

Last Updated

May 4, 2021

Status Verified

April 1, 2021

Enrollment Period

3.3 years

First QC Date

November 15, 2016

Results QC Date

April 8, 2021

Last Update Submit

April 8, 2021

Conditions

Cholestasis

Keywords

linerixibatPBCitchGSK2330672GLIMMERprimary biliary cholangitispruritus

Outcome Measures

Primary Outcomes (1)

Mean Change From Baseline at Week 16 in the Mean Worst Daily Itch Score
Participants were required to score the severity of their itching using a 0-10 numerical rating scale (NRS) where 0 represents no itching and 10 indicates the worst imaginable itching. The Worst Daily Itch Score is the most severe (highest) NRS recorded on a given day. Mean Worst Daily Itch score was calculated as the average of the worst daily itch scores provided in the 7 days prior to the Week 16 visit. Baseline is the average of the scores in the 7 days prior to the Week 4 (Visit 3 \[V3\]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was done using Analysis of covariance (ANCOVA) including treatment group and centered Mean Worst Daily Itch score at Baseline.
Baseline and Week 16

Secondary Outcomes (31)

Mean Change From Baseline at Week 16 in Primary Biliary Cholangitis-40 (PBC-40) Scale
Baseline and at Week 16
Mean Change From Baseline at Week 16 in Serum Alkaline Phosphatase (ALP) Concentrations, in Participants With High Risk of PBC Progression
Baseline and at Week 16
Number of Participants With Serum ALP Concentrations Less Than (<)1.67 Times ULN and Total Bilirubin Concentrations Less Than or Equal to (<=) ULN at Week 16
At Week 16
Mean Change From Baseline at Week 16 in Serum Alanine Aminotransferase (ALT) Among Those With a High Risk of PBC Progression
Baseline and at Week 16
Mean Change From Baseline at Week 16 in Serum Aspartate Aminotransferase (AST) Among Those With a High Risk of PBC Progression
Baseline and at Week 16
+26 more secondary outcomes

Study Arms (6)

Placebo

PLACEBO COMPARATOR

Participants will receive matching placebo

Drug: Placebo