WithdrawnPhase 2

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

Stopped: The study is stopped for Portfolio prioritization.

United Kingdom0Started 2017-09-19

Plain-language summary

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.

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Number of subjects with Adverse Events (AEs): Part 1

Timeframe: Up to Week 29

Number of subjects with abnormal clinical chemistry values: Part 1

Timeframe: Up to Week 29

Number of subjects with abnormal hematology values: Part 1

Timeframe: Up to Week 29

Number of subjects with abnormal urine analysis values: Part 1

Timeframe: Up to Week 29

Number of subjects with abnormal findings of body temperature: Part 1

Timeframe: Up to Week 29

Number of subjects with abnormal findings of blood pressure: Part 1

Timeframe: Up to Week 29

Number of subjects with abnormal findings of pulse rate: Part 1

Timeframe: Up to Week 29

Number of subjects with abnormal findings of respiratory rate: Part 1

Timeframe: Up to Week 29

Trial details

NCT IDNCT03239600

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-10-12

View on ClinicalTrials.gov More Autoimmune Diseases trials

Plain-language summary

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of subjects with Adverse Events (AEs): Part 1

Timeframe: Up to Week 29

Number of subjects with abnormal clinical chemistry values: Part 1

Timeframe: Up to Week 29

Number of subjects with abnormal hematology values: Part 1

Timeframe: Up to Week 29

Number of subjects with abnormal urine analysis values: Part 1

Timeframe: Up to Week 29

Number of subjects with abnormal findings of body temperature: Part 1

Timeframe: Up to Week 29

Number of subjects with abnormal findings of blood pressure: Part 1

Timeframe: Up to Week 29

Number of subjects with abnormal findings of pulse rate: Part 1

Timeframe: Up to Week 29

Number of subjects with abnormal findings of respiratory rate: Part 1

Timeframe: Up to Week 29