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

UCB Celltech14 sites in 5 countries27 target enrollmentOctober 2015

ConditionsPrimary Sjögren's Syndrome

InterventionsUCB5857 Placebo

DrugsUCB5857 Placebo

Overview

Phase: Phase 2
Intervention: UCB5857
Conditions: Primary Sjögren's Syndrome
Sponsor: UCB Celltech
Enrollment: 27
Locations: 14
Primary Endpoint: Change from Baseline to Week 12 in the European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI)
Status: Terminated
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

October 2015

End Date

December 5, 2017

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

UCB Celltech

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject must be between 18 years and 75 years of age
•Women of childbearing potential must agree to use a highly effective method of birth control during the study and for a period of 3 months after their final dose of study drug. Women not agreeing to use birth control must be of non-childbearing potential defined as; permanently sterile, congenitally sterile or postmenopausal for at least 2 years prior to Screening (Visit 1). Women of childbearing potential are required to have a serum pregnancy test taken at Screening (Visit 1), which is confirmed to be negative by urine testing prior to the first dose of study drug at Week 1 (Visit 2) Male subjects with a partner of childbearing potential must be willing to use a condom when sexually active during the study and for 3 months after the last dose of study drug In addition female partner of childbearing potential of male subject must be willing to use a highly effective method of contraception for duration of study and for 3 months after last dose of study drug
•Subject must meet the 2002 AECG (American-European Consensus Group) criteria for Primary Sjӧgren's Syndrome
•Subject must have a serum test positive for anti-SSA/Ro (Ro-52 or Ro-60) and/or anti SSB/La autoantibodies

Exclusion Criteria

•Subject has a diagnosis of any other autoimmune disease, ie, secondary Sjögren's syndrome (eg, rheumatoid arthritis, systemic lupus erythematosus
•Subject has a diagnosis of any other sicca syndrome (eg, history of head and neck radiation treatment, sarcoidosis chronic graft-versus-host disease)
•Subject has significant fibromyalgia syndrome as defined by the American College of Rheumatology 2010 classification criteria
•Subject has significant depression as defined by the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders
•Subject has oral candidiasis
•Subject is female and is breast-feeding, pregnant, or plans to become pregnant or to start breastfeeding during the study or within 3 months after the final dose of the investigational medicinal product (IMP)
•Subject has evidence of an immunosuppressive state, including human immunodeficiency virus (HIV) infection, hypogammaglobulinemias, T-cell deficiencies, or human T-cell leukemia virus type 1 (HTLV-1)
•o Positive testing for HIV-1/2 at Screening (Visit 1)
•Subject has a history of chronic infections, including but not limited to concurrent acute or chronic viral hepatitis B (HBV) or hepatitis C (HCV)
•Positive testing for HBV at Screening (Visit 1)

Arms & Interventions

UCB5857

UCB5857 once daily for 12 weeks

Intervention: UCB5857

Placebo

Placebo once daily for 12 weeks

Intervention: Placebo

Outcomes

Primary Outcomes

Change from Baseline to Week 12 in the European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI)

Time Frame: Week 12

The ESSDAI is a physician administered questionnaire containing 12 organ-specific domains designed to measure disease activity

Secondary Outcomes

Change from Baseline to Week 4 in the European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI)(Week 4)
Change from Baseline to Week 8 in the European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI)(Week 8)
Change from Baseline to Week 4 in the EULAR Sjögren's Syndrome Patient Response Index (ESSPRI)(Week 4)
Change from Baseline to Week 8 in the EULAR Sjögren's Syndrome Patient Response Index (ESSPRI)(Week 8)
Change from Baseline to Week 4 in the stimulated salivary flow(Week 4)
Change from Baseline to Week 12 in the EULAR Sjögren's Syndrome Patient Response Index (ESSPRI)(Week 12)
Change from Baseline to Week 8 in the stimulated salivary flow(Week 8)
Change from Baseline to Week 12 in the stimulated salivary flow(Week 12)
Change from Baseline to Week 4 in the unstimulated salivary flow(Week 4)
Change from Baseline to Week 8 in the unstimulated salivary flow(Week 8)
Change from Baseline to Week 12 in the unstimulated salivary flow(Week 12)
Change in sum total tear secretion from Baseline to Week 12 measured by Schirmer´s I test(without anesthesia)(Week 12)