A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Proof of Mechanism of GSK2618960 in Primary Sjögren's Syndrome (pSS)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-19

Study Completion Date

2017-10-12

Brief Summary

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This study aims to evaluate the safety, tolerability and PK of repeat dose administration of GSK2618960 in the treatment of pSS. The study will contain two parts, Part I will be open label and Part II will be randomized, double-blind. The minimum duration of Part I \& Part II of the study will be 26 and 32 weeks respectively.

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Detailed Description

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Conditions

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Autoimmune Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a parallel assignment where in Part II of the study, randomized subject will receive GSK2618960 and placebo drug simultaneously.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

This is a randomized, double blind (sponsor unblind) study and masking will be performed.

Study Groups

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Part I & II: GSK2618960 2 milligram per kilogram (mg/kg)

GSK2618960 2mg/kg will be administered intravenously (IV) with Methotrexate (MTX)

Group Type EXPERIMENTAL

GSK2618960 2 mg/kg

Intervention Type DRUG

GSK2618960 solution for injection, 100mg/mL is clear to opalescent, colorless to yellow or pale brown liquid.

Methotrexate

Intervention Type DRUG

MTX dose between 7.5 to 15 mg will be administered in tablet form once in a week till last dose of GSK2618960 to all subjects in Part I and Part II.

Part II: Placebo

Placebo will be administered IV with MTX

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo solution will be administered by IV infusion.

Methotrexate

Intervention Type DRUG

MTX dose between 7.5 to 15 mg will be administered in tablet form once in a week till last dose of GSK2618960 to all subjects in Part I and Part II.

Interventions

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GSK2618960 2 mg/kg

GSK2618960 solution for injection, 100mg/mL is clear to opalescent, colorless to yellow or pale brown liquid.

Intervention Type DRUG

Placebo

Placebo solution will be administered by IV infusion.

Intervention Type DRUG

Methotrexate

MTX dose between 7.5 to 15 mg will be administered in tablet form once in a week till last dose of GSK2618960 to all subjects in Part I and Part II.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Part I and Part II: Male and females aged 18-70
* Part I and Part II: pSS diagnosis according to the American-European Consensus Group Criteria
* Part I and Part II: Documented previous biopsy evidence of salivary gland inflammation consistent with pSS and/or documented history of anti-Ro and/or anti-La antibodies
* Part II: Has any of the following abnormalities at screening: hypergammaglobulinaemia \[serum Immunoglobulin G (IgG) greater than or equal to 16 gram per liter (g/L); Presence of Rheumatoid factor (RF); Anti Nuclear Antibodies (ANA) titer greater than or equal to 320:1.
* Stimulated whole salivary flow greater than 0.1 milliliter per minute (mL/min) at screening.
* Symptomatic oral dryness greater than or equal to 5 out of 10 on Visual Analogue Scale (VAS) scale and/or Schirmer test less than 10 millimeter (mm) at screening.

Exclusion Criteria

* Part I and II: Secondary Sjögren's Syndrome
* Part I and II: Receiving cyclophosphamide, other biologic, immunosuppressive or immunomodulatory treatments
* Part I and II: Active infections, or history of recurrent infections
* Part I and II: History of significant medical illness
* Part I and II: History of lymphoma

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No