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

• Status: Withdrawn
• Trial end date: 2017-10-12
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Antibodies, Monoclonal; Methotrexate

Criteria

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