Clinical trial NCT04605978: Efficacy and Safety of S95011 in Primary Sjögren's Syndrome Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Primary Sjögren's Syndrome
Keywords: Sjögren
Sjögren's Syndrome
Autoimmune disease
Systemic
Xerostomia
xerophthalmia
Salivary gland disease
Arthritis
Joint disease
Monoclonal antibody
Lead sponsor: Servier
Sponsor class: INDUSTRY
Collaborators: name: ADIR, a Servier Group company
First posted: 2020-10-28
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change in ESSDAI Total Score
timeFrame: From baseline to week 13
Secondary outcomes:
measure: ESSDAI Score by Domain and Total Score
timeFrame: At baseline, week 4 and week 13
measure: ESSPRI Score by Symptom and Total Score
timeFrame: At baseline, week 4 and week 13
measure: Quality of Life (SF-36)
timeFrame: At baseline and week 13
measure: Fatigue (MFI)
timeFrame: At baseline and week 13
measure: Physician's Global Assessment (PhGA) of the Disease Activity
timeFrame: At baseline and week 13
measure: Patient's Global Assessment (PGA) of the Disease Activity
timeFrame: At baseline and week 13
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Through study completion, up to Week 28
Other outcomes:
Locations:
city: Lakewood
country: United States
facility: Colorado Arthritis Associates
state: Colorado
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Woodville
country: Australia
facility: The Queen Elizabeth Hospital Rheumatology Unit
city: Bordeaux
country: France
facility: Hôpital Saint-André
city: Le Kremlin-Bicêtre
country: France
facility: CHU de Bicêtre
city: Paris
country: France
facility: Hôpital Laribiosière
city: Paris
country: France
facility: Hôpital Pitié-Salpêtrière
city: Paris
country: France
facility: Hôpital Saint Antoine
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen Medizinische Klinik 3 Rheumatologie und Immunologie
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg Department Innere Medizin Klinik für Rheumatologie und Klinische Immunologie
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Orvos és Egészségtudományi Centrum Belgyógyászat C épület - Klinikai Immunológiai Tanszék
city: Gyula
country: Hungary
facility: Békés Megyei Központi Kórház, Pándy Kálmán Tagkórház, Infektológia-Hepatológia
city: Székesfehérvár
country: Hungary
facility: Vita Verum Medical Bt. Berényi u. 72-100. 95. számú épület 16. Rendelő
city: Barcelona
country: Spain
facility: CLINICA SAGRADA FAMILIA Servicio de Reumatología y Unidad de Ensayos Clínicos
city: Santiago De Compostela
country: Spain
facility: CLINICAL GAIAS SANTIAGO Servicio de Reumatología
city: Sevilla
country: Spain
facility: Hospital Infanta Luisa Quirón Salud Servicio de Reumatología
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital, University Hospitals Birmingham NHS Foundation Trust
city: Newcastle Upon Tyne
country: United Kingdom
facility: Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust
city: Southampton
country: United Kingdom
facility: Southampton General Hospital, University Hospital Southampton NHS Trust
Study officials:
References: