Efficacy and Safety of S95011 in Primary Sjögren's Syndrome Patients
A Phase IIa Efficacy and Safety Trial With Intravenous S95011 in Primary Sjögren's Syndrome Patients: An International, Multicentre, Randomised, Double-blind, Placebo-controlled Study
2 other identifiers
interventional
48
7 countries
19
Brief Summary
The purpose of this study is to assess the effect of multiple intravenous infusions of S95011 compared to placebo in reducing disease activity in patients with primary Sjögren's syndrome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2021
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 19, 2020
CompletedFirst Posted
Study publicly available on registry
October 28, 2020
CompletedStudy Start
First participant enrolled
August 3, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 16, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 9, 2023
CompletedResults Posted
Study results publicly available
April 23, 2024
CompletedApril 23, 2024
April 1, 2024
1.5 years
October 19, 2020
January 15, 2024
April 10, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in ESSDAI Total Score
Efficacy criterion Eular Sjögren Syndrome Disease Activity index (ESSDAI) is a physician-administered clinical index which has been validated to objectively assess systemic manifestations in Primary Sjögren's Syndrome patients. Scores range from 0 - 123, with a lower score representing less disease activity.
From baseline to week 13
Secondary Outcomes (7)
ESSDAI Score by Domain and Total Score
At baseline, week 4 and week 13
ESSPRI Score by Symptom and Total Score
At baseline, week 4 and week 13
Quality of Life (SF-36)
At baseline and week 13
Fatigue (MFI)
At baseline and week 13
Physician's Global Assessment (PhGA) of the Disease Activity
At baseline and week 13
- +2 more secondary outcomes
Study Arms (2)
S95011 concentrate for solution for infusion
EXPERIMENTALS95011 is administrated by one IV infusion every 2 weeks for the first month and then every 3 weeks.
S95011 Placebo concentrate for solution for infusion
PLACEBO COMPARATORS95011 placebo is administrated by one IV infusion every 2 weeks for the first month and then every 3 weeks.
Interventions
IV administration every 2 weeks until week 4 and then every 3 weeks until week 10.
IV administration every 2 weeks until week 4 and then every 3 weeks until week 10.
Eligibility Criteria
You may qualify if:
- Diagnosis of primary Sjögren's Syndrome based on 2016 American College of Rheumatology-EULAR criteria
- ESSDAI total score ≥ 6 during screening, with at least 6 points scored within the 7 following domains: constitutional, lymphadenopathy, glandular, articular, cutaneous, hematologic and biologic,
- Positive anti-Sjögren's Syndrome A (Ro) antibodies or anti-nuclear antibodies (ANA) ≥ 1:320 or rheumatoid factor (RF) \>20 IU/ml during screening period, measured in a central laboratory
- Stimulated whole salivary flow rate \> 0 mL/minute
You may not qualify if:
- Prior administration within the timeframe described in the protocol of any of the following:
- Belimumab,
- Rituximab or other B cell depleting agents,
- Abatacept,
- Tumor necrosis factor inhibitors,
- Tocilizumab,
- Cyclophosphamide,
- Cyclosporine (except for eye drops), tacrolimus, sirolimus, mycophenolate mofetil (MMF), azathioprine, or leflunomide
- Janus kinase (JAK) inhibitors
- Meeting any of the following conditions:
- Corticosteroids: \> 10 mg/day oral prednisone (or equivalent) within 4 weeks prior to randomisation (W000); Any change or initiation of new dose of oral prednisone (or equivalent) within 4 weeks prior to randomisation (W000); Intramuscular, IV, or intra-articular corticosteroids within 4 weeks prior to randomisation (W000); Any change or initiation of new dose of topical corticosteroids within 2 weeks prior to randomisation (W000),
- Antimalarials: any change or initiation of new dose of antimalarials (e.g. chloroquine, hydroxychloroquine, quinacrine) within 16 weeks prior to randomisation (W000),
- Methotrexate: \> 25 mg/week of methotrexate; any initiation or change of dose of methotrexate within 12 weeks prior to randomisation (W000); any change in route of administration within 4 weeks prior to randomisation (W000),
- Non-steroidal anti-inflammatory drugs (NSAIDs): Any change or initiation of new dose of regularly scheduled NSAIDs within 2 weeks prior to randomisation (W000),
- Cevimeline or pilocarpine and cyclosporine eye drops (Restasis) and lifitegrast: any increase or initiation of new doses within 2 weeks prior to randomisation (W000).
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Colorado Arthritis Associates
Lakewood, Colorado, 80228, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
The Queen Elizabeth Hospital Rheumatology Unit
Woodville, 5011, Australia
Hôpital Saint-André
Bordeaux, 33000, France
CHU de Bicêtre
Le Kremlin-Bicêtre, 94275, France
Hôpital Laribiosière
Paris, 75010, France
Hôpital Pitié-Salpêtrière
Paris, 75013, France
Hôpital Saint Antoine
Paris, 75571, France
Universitätsklinikum Erlangen Medizinische Klinik 3 Rheumatologie und Immunologie
Erlangen, 91054, Germany
Universitätsklinikum Freiburg Department Innere Medizin Klinik für Rheumatologie und Klinische Immunologie
Freiburg im Breisgau, 79106, Germany
Debreceni Egyetem Orvos és Egészségtudományi Centrum Belgyógyászat C épület - Klinikai Immunológiai Tanszék
Debrecen, 4032, Hungary
Békés Megyei Központi Kórház, Pándy Kálmán Tagkórház, Infektológia-Hepatológia
Gyula, 5700, Hungary
Vita Verum Medical Bt. Berényi u. 72-100. 95. számú épület 16. Rendelő
Székesfehérvár, 8000, Hungary
CLINICA SAGRADA FAMILIA Servicio de Reumatología y Unidad de Ensayos Clínicos
Barcelona, 08022, Spain
CLINICAL GAIAS SANTIAGO Servicio de Reumatología
Santiago de Compostela, 15702, Spain
Hospital Infanta Luisa Quirón Salud Servicio de Reumatología
Seville, 41010, Spain
Queen Elizabeth Hospital, University Hospitals Birmingham NHS Foundation Trust
Birmingham, B15 2TH, United Kingdom
Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, NE7 7DN, United Kingdom
Southampton General Hospital, University Hospital Southampton NHS Trust
Southampton, SO16 6YD, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Studies Department
- Organization
- Institut de Recherches Internationales Servier (I.R.I.S.)
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2020
First Posted
October 28, 2020
Study Start
August 3, 2021
Primary Completion
January 16, 2023
Study Completion
May 9, 2023
Last Updated
April 23, 2024
Results First Posted
April 23, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- After Marketing Authorisation in EEA or US if the study is used for the approval.
- Access Criteria
- Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.
Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data. Access can be requested for all interventional clinical studies: * used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US). * where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope. In addition, access can be requested for all interventional clinical studies in patients: * sponsored by Servier * with a first patient enrolled as of 1 January 2004 onwards * for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.