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

NCT ID: NCT04605978

Last Updated: 2024-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-03
• Study Completion Date: 2023-05-09

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.

Conditions

Primary Sjögren's Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

S95011 concentrate for solution for infusion

S95011 is administrated by one IV infusion every 2 weeks for the first month and then every 3 weeks.

Group Type: EXPERIMENTAL

S95011 concentrate for solution for infusion

Intervention Type: DRUG

IV administration every 2 weeks until week 4 and then every 3 weeks until week 10.

S95011 Placebo concentrate for solution for infusion

S95011 placebo is administrated by one IV infusion every 2 weeks for the first month and then every 3 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo concentrate for solution for infusion

Intervention Type: DRUG

IV administration every 2 weeks until week 4 and then every 3 weeks until week 10.

Interventions

S95011 concentrate for solution for infusion

IV administration every 2 weeks until week 4 and then every 3 weeks until week 10.

Intervention Type: DRUG

Placebo concentrate for solution for infusion

IV administration every 2 weeks until week 4 and then every 3 weeks until week 10.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ADIR, a Servier Group company

INDUSTRY

Sponsor Role: collaborator

Institut de Recherches Internationales Servier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Colorado Arthritis Associates

Lakewood, Colorado, United States

Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States

The Queen Elizabeth Hospital Rheumatology Unit

Woodville, , Australia

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, , France

Universitätsklinikum Erlangen Medizinische Klinik 3 Rheumatologie und Immunologie

Erlangen, , Germany

Universitätsklinikum Freiburg Department Innere Medizin Klinik für Rheumatologie und Klinische Immunologie

Freiburg im Breisgau, , Germany

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. Rendelő

Székesfehérvár, , Hungary

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

Seville, , Spain

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 Kingdom

Countries

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

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Study Documents

Document Type: Individual Participant Data Set

View Document

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Document Type: Clinical Study Report

View Document

Document Type: study-level clinical trial data

View Document

Related Links

https://clinicaltrials.servier.com/

Find Results on Servier Clinical Trial Data website

Other Identifiers

2020-001526-59

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CL2-95011-001

Identifier Type: -

Identifier Source: org_study_id