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Trial record 1 of 1 for:    S95011
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Efficacy and Safety of S95011 in Primary Sjögren's Syndrome Patients

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ClinicalTrials.gov Identifier: NCT04605978
Recruitment Status : Completed
First Posted : October 28, 2020
Results First Posted : April 23, 2024
Last Update Posted : April 23, 2024
Sponsor:
Collaborator:
ADIR, a Servier Group company
Information provided by (Responsible Party):
Servier ( Institut de Recherches Internationales Servier )

Study Description
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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.

Condition or disease Intervention/treatment Phase
Primary Sjögren's Syndrome Drug: S95011 concentrate for solution for infusion Drug: Placebo concentrate for solution for infusion Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 3, 2021
Actual Primary Completion Date : January 16, 2023
Actual Study Completion Date : May 9, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: S95011 concentrate for solution for infusion
S95011 is administrated by one IV infusion every 2 weeks for the first month and then every 3 weeks.
 Drug: S95011 concentrate for solution for infusion
IV administration every 2 weeks until week 4 and then every 3 weeks until week 10.
Placebo Comparator: S95011 Placebo concentrate for solution for infusion
S95011 placebo is administrated by one IV infusion every 2 weeks for the first month and then every 3 weeks.
 Drug: Placebo concentrate for solution for infusion
IV administration every 2 weeks until week 4 and then every 3 weeks until week 10.


Outcome Measures
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Primary Outcome Measures :
  1. Change in ESSDAI Total Score [ Time Frame: From baseline to week 13 ]
    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.


Secondary Outcome Measures :
  1. ESSDAI Score by Domain and Total Score [ Time Frame: At baseline, week 4 and week 13 ]
    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. There are 12 organ-specific domains and for each domain, features of disease activity are scored according to their severity. These scores are then summed across the 12 domains in a weighted manner to provide the total score. The total score ranges from 0 to 123. A higher score always represents a more severe disease activity. The domain [weight] and score range are as follows: Constitutional [3] 0-2; Lymphadenopathy and lymphoma [4] 0-3; Glandular [2] 0-2; Articular [2] 0-3; Cutaneous [3] 0-3; Pulmonary [5] 0-3; Renal [5] 0-3; Muscular [6] 0-3; PNS [5] 0-3; CNS [5] 0-3; Hematological [2] 0-3; Biological [1] 0-2.

  2. ESSPRI Score by Symptom and Total Score [ Time Frame: At baseline, week 4 and week 13 ]
    Efficacy criterion EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) is an index designed to measure patients' symptoms in primary Sjögren's Syndrome. The three domains included in this scale are dryness, fatigue, and pain, each of which are scored on a scale of 0-10. The total score is calculated as the average of the three domain scores and therefore the maximum total score is 10. The higher score represents more severe symptoms.

  3. Quality of Life (SF-36) [ Time Frame: At baseline and week 13 ]
    Efficacy criterion The Short Form (SF-36) Health Survey is a 36-item, patient-reported survey of patient health to asses QoL. Scores for each subscale range from 0 - 100, with a lower number representing a worse quality of life.

  4. Fatigue (MFI) [ Time Frame: At baseline and week 13 ]
    Efficacy criterion Modified Fatigue Impact Scale (MFI) is a 20-item survey to evaluate five dimensions of fatigue. Scores range from 4 to 20 for each sub-score, with a lower score representing less fatigue.

  5. Physician's Global Assessment (PhGA) of the Disease Activity [ Time Frame: At baseline and week 13 ]
    Efficacy criterion Physician's global assessment (PhGA) of the disease activity is a 0 to 10 numerical rating scale (NRS), with a lower score representing less disease activity.

  6. Patient's Global Assessment (PGA) of the Disease Activity [ Time Frame: At baseline and week 13 ]
    Efficacy criterion Patient's global assessment (PGA) of the disease activity is a 0 to 10 numerical rating scale (NRS), with a lower score representing less disease activity.

  7. Number of Participants With Adverse Events (AEs) [ Time Frame: Through study completion, up to Week 28 ]
    Safety criterion


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of primary Sjögren's Syndrome based on 2016 American College of Rheumatology-EULAR criteria
  2. 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,
  3. 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
  4. Stimulated whole salivary flow rate > 0 mL/minute

Exclusion Criteria:

  1. 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

  2. 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).
  3. Secondary Sjögren's Syndrome
Contacts and Locations
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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): NCT04605978


Locations
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Sponsors and Collaborators
Institut de Recherches Internationales Servier
ADIR, a Servier Group company
  Study Documents (Full-Text)

Documents provided by Servier ( Institut de Recherches Internationales Servier ):
Study Protocol  [PDF] March 24, 2022
Statistical Analysis Plan  [PDF] March 2, 2023

More Information
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Additional Information:

Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Study Protocol  This link exits the ClinicalTrials.gov site
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Informed Consent Form  This link exits the ClinicalTrials.gov site
Clinical Study Report  This link exits the ClinicalTrials.gov site
study-level clinical trial data  This link exits the ClinicalTrials.gov site

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Responsible Party: Institut de Recherches Internationales Servier
ClinicalTrials.gov Identifier: NCT04605978    
Other Study ID Numbers: CL2-95011-001
2020-001526-59 ( EudraCT Number )
First Posted: October 28, 2020    Key Record Dates
Results First Posted: April 23, 2024
Last Update Posted: April 23, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.
URL: https://clinicaltrials.servier.com/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Servier ( Institut de Recherches Internationales Servier ):
Sjögren
Sjögren's Syndrome
Autoimmune disease
Systemic
Xerostomia
 xerophthalmia
Salivary gland disease
Arthritis
Joint disease
Monoclonal antibody
Additional relevant MeSH terms:
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Sjogren's Syndrome
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
Pharmaceutical Solutions