EUCTR2020-001526-59-DE
Active, not recruiting
Phase 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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Institut de Recherches Internationales Servier
- Enrollment
- 45
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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 24 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\)
- •\- Janus kinase (JAK) inhibitors in the past 1 week prior to randomisation (W000\)
- •2\. Meeting any of the following conditions:
Outcomes
Primary Outcomes
Not specified
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