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 range

18 Years – 70 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

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 range

18 Years – 70 Years

Sex

ALL

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