A Study to Assess the Efficacy of RO5459072 in Participants With Primary Sjogren's Syndrome
NCT ID: NCT02701985
Last Updated: 2018-08-01
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
75 participants
INTERVENTIONAL
2016-07-05
2017-07-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-severe Systemic Disease Activity
NCT06104124
A Safety and Efficacy Study of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-Severe Symptom State
NCT06245408
Proof of Concept Study to Evaluate the Efficacy and Safety of BMS-931699 (Lulizumab) or BMS-986142 in Primary Sjögren's Syndrome
NCT02843659
A Study of RSLV-132 in Subjects With Primary Sjogren's Syndrome
NCT03247686
A Study of RSLV-132 in Females With Sjögren's Disease
NCT06440525
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo
Matching-placebo capsules will be administered orally, 2 times a day, for up to 12 weeks.
Placebo
Matching-placebo capsules will be administered orally, 2 times a day with food.
RO5459072
RO5459072 at a dose of 100 milligrams (as capsules) will be administered orally, 2 times a day, for up to 12 weeks.
RO5459072
RO5459072 at a dose of 100 milligrams (as capsules) will be administered orally, 2 times a day with food.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Placebo
Matching-placebo capsules will be administered orally, 2 times a day with food.
RO5459072
RO5459072 at a dose of 100 milligrams (as capsules) will be administered orally, 2 times a day with food.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* ESSDAI score greater than or equal to (\>/=) 5
* ESSPRI score \>/=5
* Elevated serum titers of anti-Sjogren's-syndrome-related antigen A (anti-SSA) and/or anti-Sjogren's-syndrome-related antigen B (anti-SSB) antibodies at screening
* Negative pregnancy test at screening and baseline (for women only)
* Willing to comply with the study procedures and restrictions, including measures to prevent pregnancy and restrictions on sperm donation
Exclusion Criteria
* Severe complications of Sjogren's syndrome
* Systemic immunosuppressant therapy, cyclophosphamide, or B-cell depleting therapy within 6 months prior to the screening visit
* Corticosteroid therapy exceeding 7.5 mg prednisone equivalents per day
* A positive test result for hepatitis B (HBV), hepatitis C (HCV), or human immunodeficiency virus (HIV), or tuberculosis, or any other active viral, fungal, yeast or bacterial infection at screening
* A history suggesting reduced immune function or any other conditions predisposing participants to serious infection
* A history of lymphoma, myeloma or monoclonal gammopathy of unknown significance (MGUS), or any other malignancies within the past 5 years
* A diagnosis of fibromyalgia or significant depression
* Having any concomitant disease or condition that could interfere with the conduct of the study, or that would pose an unacceptable risk to the individual
* Participation in an investigational drug or device study within 3 months prior to screening
* Inability to comply with the study protocol for any other reason
* Women who are lactating, breastfeeding or planning to nurse
* Using other prohibited medication (moderate or potent inhibitors of CYP3A4; strong inducers of CYP3A4; strong inhibitors of the transporter P-glycoprotein \[P-gp\]; sensitive substrates of CYP3A4 with a narrow therapeutic index)
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hoffmann-La Roche
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Wallace Rheumatic Study Center
Beverly Hills, California, United States
Denver Arthritis Clinic
Denver, Colorado, United States
Ochsner Clinic Foundation
Baton Rouge, Louisiana, United States
John Hopkins Bayview Medical Center
Baltimore, Maryland, United States
University Of Michigan
Ann Arbor, Michigan, United States
Winthrop University Hospital
Mineola, New York, United States
Shanahan Rheumatology & Immunology, PLLC
Raleigh, North Carolina, United States
MetroHealth System
Cleveland, Ohio, United States
Altoona Center For Clinical Research
Duncansville, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Clinical Research Center of Reading
Wyomissing, Pennsylvania, United States
Ramesh Gupta - PP
Memphis, Tennessee, United States
Hopital Avicenne, Paris
Bobigny, , France
C.H.U. Ambroise Pare (AP-HP)
Boulogne-Billancourt, , France
Hopital La Cavale Blanche; Rhumatologie
Brest, , France
Hopital Lapeyronie; Immunologie Rhumatologie
Montpellier, , France
Charité Research Organisation GmbH
Berlin, , Germany
Szpital Uniwersytecki; nr 2 im. Dr J. Biziela; Klinika Reumatologii i Ukladowych Chorob
Bydgoszcz, , Poland
MedPolonia
Poznan, , Poland
Niepubliczny Opieki Zdrowotnej; Reumatika - Ctr Reum.
Warsaw, , Poland
Centrum Medyczne AMED
Warsaw, , Poland
Instituto Portugues de Reumatologia
Lisbon, , Portugal
Centro Hospitalar de Lisboa Norte, EPE - Hospital Santa Maria
Lisbon, , Portugal
Centro Hospitalar do Porto - Hospital de Santo António
Porto, , Portugal
Centro Hospitalar de Sao Joao,E.P.E.
Porto, , Portugal
University Hospitals Birmingham NHS Foundation Trust
Birmingham, , United Kingdom
Barts and the London NHS Trust
London, , United Kingdom
University College London Hospitals NHS Foundation Trust - University College Hospital
London, , United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, , United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust; Royal Hallamshire Hospital
Sheffield, , United Kingdom
Great Western Hospitals NHS Foundation Trust.
Wiltshire, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Bentley D, Fisher BA, Barone F, Kolb FA, Attley G. A randomized, double-blind, placebo-controlled, parallel group study on the effects of a cathepsin S inhibitor in primary Sjogren's syndrome. Rheumatology (Oxford). 2023 Nov 2;62(11):3644-3653. doi: 10.1093/rheumatology/kead092.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2015-004476-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
BP30037
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.