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

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.

Timeline

Start

2015-10

Primary completion

2017-09-07

Completion

2017-12-05

Outcome

Outcome not reported

Stopped: “Study stopped prematurely due to enrolment challenges.”

Publications

• Results Juarez M, Diaz N, Johnston GI, Nayar S, Payne A, Helmer E, Cain D, Williams P, Devauchelle-Pensec V, Fisher BA, Giacomelli R, Gottenberg JE, Guggino G, Kvarnstrom M, Mariette X, Ng WF, Rosas J, Sanchez Burson J, Triolo G, Barone F, Bowman SJ. A phase 2 randomized, double-blind, placebo-controlled, proof-of-concept study of oral seletalisib in primary Sjogren's syndrome. Rheumatology (Oxford). 2021 Mar 2;60(3):1364-1375. doi: 10.1093/rheumatology/keaa410.

Drugs

Indications