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Completed

NCT Number: NCT04605978

Efficacy and Safety of S95011 in Primary Sjögren's Syndrome Patients

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.

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Key information

Conditions

Primary Sjögren's Syndrome Arthritis Arthritis, Rheumatoid Autoimmune Diseases Conjunctival Diseases Connective Tissue Diseases Dry Eye Syndromes Eye Diseases Immune System Diseases Joint Diseases Lacrimal Apparatus Diseases Mouth Diseases Musculoskeletal Diseases Rheumatic Diseases Salivary Gland Diseases Sjogren's Syndrome Skin and Connective Tissue Diseases Stomatognathic Diseases Xerophthalmia Xerostomia

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Queen Elizabeth Hospital Rheumatology Unit, Woodville, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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).
  • Secondary Sjögren's Syndrome

Treatment and study plan

S95011 concentrate for solution for infusion

Drug

IV administration every 2 weeks until week 4 and then every 3 weeks until week 10.

Placebo concentrate for solution for infusion

Drug

IV administration every 2 weeks until week 4 and then every 3 weeks until week 10.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Institut de Recherches Internationales Servier

Other

Collaborators

  • ADIR, a Servier Group company

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 28, 2020
Registry last updated
Apr 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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