drugset / Trial / NCT03239600

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

NCT03239600 ↗

Phase 2 Withdrawn GlaxoSmithKline
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2017-09-19
Primary completion
2017-10-12
Completion
2017-10-12

Outcome

Outcome not reported

Stopped (Business): “The study is stopped for Portfolio prioritization.”

Drugs

EvaluationDrugModalityDoseRoute
Subject GSK2618960 Monoclonal antibody 2 mg/kg Intravenous
Background Methotrexate Small molecule 7.5 mg —
Background Methotrexate Small molecule 15 mg —

Indications