drugset / Trial / NCT03239600
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Proof of Mechanism of GSK2618960 in Primary Sjögren's Syndrome (pSS)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GSK2618960 | Monoclonal antibody | 2 mg/kg | Intravenous |
| Background | Methotrexate | Small molecule | 7.5 mg | — |
| Background | Methotrexate | Small molecule | 15 mg | — |