A Study Evaluating the Effects of GLPG3970 Given as an Oral Treatment for 12 Weeks in Adults With Active Primary Sjögren's Syndrome (pSS)

Summary

This is a first exploration of GLPG3970 in participants with active primary Sjogren's Syndrome (pSS) to evaluate the efficacy, safety and tolerability and to determine its pharmacokinetics (PK) profile compared to placebo.

Timeline

Start

2021-01-28

Primary completion

2021-10-28

Completion

2021-12-27

Outcome

Missed primary endpoint

Stopped (Business): “Study was terminated based on Sponsor decision”

registry analysis (superiority test); GLPG3970 vs Placebo; p = 0.617; LS Mean Difference -1.4 (90% CI -6.2 to 3.4); Mixed Models Analysis NCT04700280 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	GLPG3970	Unknown	400 mg	Oral

Indications