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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Primary Sjögren's Syndrome

Intervention / Treatment
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* Drug: S95011 concentrate for solution for infusion
* Drug: Placebo concentrate for solution for infusion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: S95011 concentrate for solution for infusion<br>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<br>* IV administration every 2 weeks until week 4 and then every 3 weeks until week 10.<br>|
| Placebo Comparator: S95011 Placebo concentrate for solution for infusion<br>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<br>* IV administration every 2 weeks until week 4 and then every 3 weeks until week 10.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | From baseline to week 13 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ESSDAI score by domain and 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 | At baseline, week 4 and week 13 | 
| ESSPRI score by symptom and total score | Efficacy criterion EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) is an index designed to measure patients' symptoms in primary Sjögren's Syndrome | At baseline, week 4 and week 13 | 
| Quality of life (SF-36) | Efficacy criterion The Short Form (SF-36) Health Survey is a 36-item, patient-reported survey of patient health to asses QoL | At baseline and week 13 | 
| Fatigue (MFI) | Efficacy criterion Modified Fatigue Impact Scale (MFI) is a 20-item survey to evaluate ﬁve dimensions of fatigue | At baseline and week 13 | 
| Physician's global assessment (PhGA) of the disease activity | Efficacy criterion Physician's global assessment (PhGA) of the disease activity is a 0 to 10 numerical rating scale (NRS) | At baseline and week 13 | 
| Patient's global assessment (PGA) of the disease activity | Efficacy criterion Patient's global assessment (PGA) of the disease activity is a 0 to 10 numerical rating scale (NRS) | At baseline and week 13 | 
| Incidence of adverse events (AEs) | Safety criterion | Through study completion, up to Week 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sjögren, Sjögren's Syndrome, Autoimmune disease, Systemic, Xerostomia, xerophthalmia, Salivary gland disease, Arthritis, Joint disease, Monoclonal antibody