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

Primary Sjögren's Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04605978
• Other study ID #: CL2-95011-001
• Secondary ID: 2020-001526-59
• Status: Completed
• Phase: Phase 2
• Start date: August 3, 2021
• Est. completion date: May 9, 2023

Study information

• Verified date: April 2024
• Source: Servier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: May 9, 2023
• Est. primary completion date: January 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Primary Sjögren's Syndrome
• Sjogren's Syndrome
• Syndrome

Intervention

Drug:
• S95011 concentrate for solution for infusion
IV administration every 2 weeks until week 4 and then every 3 weeks until week 10.
• Placebo concentrate for solution for infusion
IV administration every 2 weeks until week 4 and then every 3 weeks until week 10.

Locations

Country	Name	City	State
Australia	The Queen Elizabeth Hospital Rheumatology Unit	Woodville
France	Hôpital Saint-André	Bordeaux
France	CHU de Bicêtre	Le Kremlin-Bicêtre
France	Hôpital Laribiosière	Paris
France	Hôpital Pitié-Salpêtrière	Paris
France	Hôpital Saint Antoine	Paris
Germany	Universitätsklinikum Erlangen Medizinische Klinik 3 Rheumatologie und Immunologie	Erlangen
Germany	Universitätsklinikum Freiburg Department Innere Medizin Klinik für Rheumatologie und Klinische Immunologie	Freiburg
Hungary	Debreceni Egyetem Orvos és Egészségtudományi Centrum Belgyógyászat C épület - Klinikai Immunológiai Tanszék	Debrecen
Hungary	Békés Megyei Központi Kórház, Pándy Kálmán Tagkórház, Infektológia-Hepatológia	Gyula
Hungary	Vita Verum Medical Bt. Berényi u. 72-100. 95. számú épület 16. Rendelo	Székesfehérvár
Spain	CLINICA SAGRADA FAMILIA Servicio de Reumatología y Unidad de Ensayos Clínicos	Barcelona
Spain	CLINICAL GAIAS SANTIAGO Servicio de Reumatología	Santiago De Compostela
Spain	Hospital Infanta Luisa Quirón Salud Servicio de Reumatología	Sevilla
United Kingdom	Queen Elizabeth Hospital, University Hospitals Birmingham NHS Foundation Trust	Birmingham
United Kingdom	Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust	Newcastle Upon Tyne
United Kingdom	Southampton General Hospital, University Hospital Southampton NHS Trust	Southampton
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	Colorado Arthritis Associates	Lakewood	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
Institut de Recherches Internationales Servier	ADIR, a Servier Group company

Countries where clinical trial is conducted

United States,  Australia,  France,  Germany,  Hungary,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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. Scores range from 0 - 123, with a lower score representing less disease activity.	From baseline to week 13
Secondary	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. 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.	At baseline, week 4 and week 13
Secondary	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. 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.	At baseline, week 4 and week 13
Secondary	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. Scores for each subscale range from 0 - 100, with a lower number representing a worse quality of life.	At baseline and week 13
Secondary	Fatigue (MFI)	Efficacy criterion Modified Fatigue Impact Scale (MFI) is a 20-item survey to evaluate ?ve dimensions of fatigue. Scores range from 4 to 20 for each sub-score, with a lower score representing less fatigue.	At baseline and week 13
Secondary	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), with a lower score representing less disease activity.	At baseline and week 13
Secondary	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), with a lower score representing less disease activity.	At baseline and week 13
Secondary	Number of Participants With Adverse Events (AEs)	Safety criterion	Through study completion, up to Week 28

External Links

•   Find Results on Servier Clinical Trial Data website