MedTrace Logo

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

NCT02610543 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2020-12-01

No results posted yet for this study

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

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

Sponsors & Collaborators

  • PRA Health Sciences

    collaborator INDUSTRY

  • UCB Celltech

    lead INDUSTRY

Principal Investigators

  • UCB Cares · +18445992273 (UCB)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2017-09-07
Completion
2017-12-05

Countries

  • France
  • Italy
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02610543 on ClinicalTrials.gov