NCT02610543

UCB Proof of Concept Study in Patients With Primary Sjögren's Syndrome

A Randomized, Double-blind, Placebo-controlled, Proof-of-concept Study to Evaluate the Efficacy of UCB5857 Over 12 Weeks in Subjects With Primary Sjögren's Syndrome

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: UCB Celltech · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2, multicenter, double-blind, placebo-controlled, 12-week proof-of-concept study to assess the efficacy, safety, and tolerability of UCB5857 in subjects with primary Sjögren's Syndrome (pSS). The primary objective of this study is to evaluate the efficacy on overall disease activity and safety of UCB5857 added to current treatment relative to placebo in subjects with pSS.

Conditions

• Primary Sjögren's Syndrome

Interventions

Type	Name	Description
DRUG	UCB5857	Active Substance: UCB5857 Pharmaceutical form: Capsule Concentration: 5 mg, 10 mg, 30 mg Route of administration: oral
DRUG	Placebo	Active substance: Placebo Pharmaceutical Form: Capsule Route of administration: oral

Timeline

• Start date: 2015-10-01
• Primary completion: 2017-09-07
• Completion: 2017-12-05
• First posted: 2015-11-20
• Last updated: 2020-12-01

Locations

14 sites across 5 countries: France, Italy, Spain, Sweden, United Kingdom