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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02610543
First Posted: November 20, 2015
Last Update Posted: November 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
PRA Health Sciences
Information provided by (Responsible Party):
UCB Pharma ( UCB Celltech )
  Purpose

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.


Condition Intervention Phase
Primary Sjögren's Syndrome Drug: UCB5857 Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by UCB Pharma ( UCB Celltech ):

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Change from Baseline to Week 4 in the European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI) [ Time Frame: Week 4 ]
    The ESSDAI is a physician administered questionnaire containing 12 organ-specific domains designed to measure disease activity

  • Change from Baseline to Week 8 in the European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI) [ Time Frame: Week 8 ]
    The ESSDAI is a physician administered questionnaire containing 12 organ-specific domains designed to measure disease activity

  • Change from Baseline to Week 4 in the EULAR Sjögren's Syndrome Patient Response Index (ESSPRI) [ Time Frame: Week 4 ]
    The ESSPRI is a patient completed questionnaire to assess subjective patient symptoms, which includes 3 domains (dryness, limb pain and fatigue)

  • Change from Baseline to Week 8 in the EULAR Sjögren's Syndrome Patient Response Index (ESSPRI) [ Time Frame: Week 8 ]
    The ESSPRI is a patient completed questionnaire to assess subjective patient symptoms, which includes 3 domains (dryness, limb pain and fatigue)

  • Change from Baseline to Week 12 in the EULAR Sjögren's Syndrome Patient Response Index (ESSPRI) [ Time Frame: Week 12 ]
    The ESSPRI is a patient completed questionnaire to assess subjective patient symptoms, which includes 3 domains (dryness, limb pain and fatigue)

  • Change from Baseline to Week 4 in the stimulated salivary flow [ Time Frame: Week 4 ]
    The stimulated salivary flow test evaluates the status of salivary glands and the production of saliva. Saliva is collected into a graduated container after gustatory provocation with a stimulant

  • Change from Baseline to Week 8 in the stimulated salivary flow [ Time Frame: Week 8 ]
    The stimulated salivary flow test evaluates the status of salivary glands and the production of saliva. Saliva is collected into a graduated container after gustatory provocation with a stimulant

  • Change from Baseline to Week 12 in the stimulated salivary flow [ Time Frame: Week 12 ]
    The stimulated salivary flow test evaluates the status of salivary glands and the production of saliva. Saliva is collected into a graduated container after gustatory provocation with a stimulant

  • Change from Baseline to Week 4 in the unstimulated salivary flow [ Time Frame: Week 4 ]
    The unstimulated salivary flow test evaluates the status of salivary glands and the production of saliva. Saliva is collected into a graduated container without gustatory provocation

  • Change from Baseline to Week 8 in the unstimulated salivary flow [ Time Frame: Week 8 ]
    The unstimulated salivary flow test evaluates the status of salivary glands and the production of saliva. Saliva is collected into a graduated container without gustatory provocation.

  • Change from Baseline to Week 12 in the unstimulated salivary flow [ Time Frame: Week 12 ]
    The unstimulated salivary flow test evaluates the status of salivary glands and the production of saliva. Saliva is collected into a graduated container without gustatory provocation

  • Change in sum total tear secretion from Baseline to Week 12 measured by Schirmer´s I test(without anesthesia) [ Time Frame: Week 12 ]
    The Schirmer's test measures basic tear function. A 35 mm x 5mm size paper strip is inserted into each eye for a period of 5 minutes to measure the production of tears.


Enrollment: 27
Actual Study Start Date: October 2015
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: UCB5857
UCB5857 once daily for 12 weeks
Drug: UCB5857
Active Substance: UCB5857 Pharmaceutical form: Capsule Concentration: 5 mg, 10 mg, 30 mg Route of administration: oral
Placebo Comparator: Placebo
Placebo once daily for 12 weeks
Drug: Placebo
Active substance: Placebo Pharmaceutical Form: Capsule Route of administration: oral

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
    • Positive testing for HCV at Screening (Visit 1)
  • A subject with a history of a recent serious or life-threatening infection or any current signs or symptoms that may indicate a significant infection at Screening (Visit 1) to randomization, as per the Investigator's clinical judgment is also excluded Subject must have completed any prior anti-infective therapy prior to the first dose of study drug with the exception of anti-infectives taken specifically for the treatment of acne, rosacea, onychomycosis, or vaginal yeast infections; for the prophylaxis of urinary tract infections; or prophylaxis for pre-surgical or pre-procedural reasons (including dental procedures). Note: minocycline may not be used for these purposes
  • Subject is at a particularly high risk of significant infection due to their lifestyle and/or occupation
  • Subject has received intranasal influenza vaccine within the 8 weeks prior to Screening (Visit 1)
  • Subject has significant hematologic abnormalities of hemoglobin <10.0 g/dL, or white blood cell (WBC) <2000 /mm^3, or absolute neutrophil count <1000 /mm^3, or platelets <100,000 /mm^3 at Screening (Visit 1)
  • Subject has a history of cancer
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02610543


Locations
France
Ss0004 34
Brest, France
Ss0004 30
Le Kremlin-Bicêtre, France
Ss0004 35
Strasbourg, France
Italy
Ss0004 20
L'Aquila, Italy
Ss0004 21
Palermo, Italy
Ss0004 22
Udine, Italy
Spain
Ss0004 42
Cordoba, Spain
Ss0004 40
Villajoyosa, Spain
Sweden
Ss0004 50
Stockholm, Sweden
United Kingdom
Ss0004 01
Birmingham, United Kingdom
Ss0004 05
Essex, United Kingdom
Ss0004 04
Leeds, United Kingdom
Ss0004 03
Newcastle upon Tyne, United Kingdom
Ss0004 02
Swindon, United Kingdom
Sponsors and Collaborators
UCB Celltech
PRA Health Sciences
Investigators
Study Director: UCB Cares +18445992273 (UCB)
  More Information

Responsible Party: UCB Celltech
ClinicalTrials.gov Identifier: NCT02610543     History of Changes
Other Study ID Numbers: SS0004
2014-004523-51 ( EudraCT Number )
First Submitted: November 18, 2015
First Posted: November 20, 2015
Last Update Posted: November 8, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by UCB Pharma ( UCB Celltech ):
Primary Sjögren's Syndrome

Additional relevant MeSH terms:
Syndrome
Sjogren's Syndrome
Disease
Pathologic Processes
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases