EUCTR2020-001526-59-HUActive, not recruitingPhase 1
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
Institut de Recherches Internationales Servier0 sites45 target enrollmentStarted: July 28, 2020Last updated:
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 45
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1.Diagnosis of primary Sjögren’s Syndrome based on 2016 ACR-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-SSA (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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 35
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
Exclusion Criteria
- •1.Prior administration of any of the following:
- •- Belimumab in the past 6 months prior to randomisation (W000)
- •- Rituximab or other B cell depleting agents e.g. VAY736 in the past 12 months prior to randomisation (W000).
- •- Abatacept in the past 3 months prior to randomisation (W000),
- •- Tumor necrosis factor inhibitors (adalimumab, certolizumab, etanercept, golimumab, infliximab, and biosimilars) in the past 3 months prior to randomisation (W000)
- •- Tocilizumab in the past 3 months prior to randomisation (W000)
- •- Cyclophosphamide (or any other alkylating agent) in the past 6 months prior to randomisation (W000);
- •- Cyclosporine (except for eye drops), tacrolimus, sirolimus, mycophenolate mofetil (MMF), azathioprine, or leflunomide in the past 3 months prior to randomisation (W000)
- •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 within 12 weeks prior
- •to randomisation (W000); 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 oral pilocarpine and cyclosporine eye drops (Restasis) and lifitegrast: any increase or initiation of new doses within 2 weeks prior to randomisation (W000)
- •- Ocular topics (excluding artificial tears, gels, lubricants,
- •antibiotherapy): any dose modification or initiation of new doses within
- •90 days prior to randomisation (W000).
- •- Required regular use of medications known to cause dry mouth/eyes
- •as a regular and major side effect, and which have not been on a stable
- •dose for at least 30 days prior to randomization (W000), or any
- •anticipated change in the treatment regimen during the course of the
Investigators
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