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

Primary Purpose

Primary Sjögren's Syndrome

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

S95011 concentrate for solution for infusion

Placebo concentrate for solution for infusion

About this trial

This is an interventional treatment trial for Primary Sjögren's Syndrome focused on measuring Sjögren, Sjögren's Syndrome, Autoimmune disease, Systemic, Xerostomia, xerophthalmia, Salivary gland disease, Arthritis, Joint disease, Monoclonal antibody

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Colorado Arthritis Associates
Altoona Center for Clinical Research
The Queen Elizabeth Hospital Rheumatology Unit
Hôpital Saint-André
CHU de Bicêtre
Hôpital Laribiosière
Hôpital Pitié-Salpêtrière
Hôpital Saint Antoine
Universitätsklinikum Erlangen Medizinische Klinik 3 Rheumatologie und Immunologie
Universitätsklinikum Freiburg Department Innere Medizin Klinik für Rheumatologie und Klinische Immunologie
Debreceni Egyetem Orvos és Egészségtudományi Centrum Belgyógyászat C épület - Klinikai Immunológiai Tanszék
Békés Megyei Központi Kórház, Pándy Kálmán Tagkórház, Infektológia-Hepatológia
Vita Verum Medical Bt. Berényi u. 72-100. 95. számú épület 16. Rendelő
CLINICA SAGRADA FAMILIA Servicio de Reumatología y Unidad de Ensayos Clínicos
CLINICAL GAIAS SANTIAGO Servicio de Reumatología
Hospital Infanta Luisa Quirón Salud Servicio de Reumatología
Queen Elizabeth Hospital, University Hospitals Birmingham NHS Foundation Trust
Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust
Southampton General Hospital, University Hospital Southampton NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

S95011 concentrate for solution for infusion

S95011 Placebo concentrate for solution for infusion

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

ESSDAI score by domain and total score

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

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

Fatigue (MFI)

Efficacy criterion Modified Fatigue Impact Scale (MFI) is a 20-item survey to evaluate ﬁve dimensions of fatigue

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)

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)

Incidence of adverse events (AEs)

Safety criterion

Full Information

NCT ID

NCT04605978

First Posted

October 19, 2020

Last Updated

June 2, 2023

Sponsor

Institut de Recherches Internationales Servier

Collaborators

ADIR, a Servier Group company

1. Study Identification

Unique Protocol Identification Number

NCT04605978

Brief Title

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

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Completed

Study Start Date

August 3, 2021 (Actual)

Primary Completion Date

January 16, 2023 (Actual)

Study Completion Date

May 2, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institut de Recherches Internationales Servier

Collaborators

ADIR, a Servier Group company

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Sjögren's Syndrome

Keywords

Sjögren, Sjögren's Syndrome, Autoimmune disease, Systemic, Xerostomia, xerophthalmia, Salivary gland disease, Arthritis, Joint disease, Monoclonal antibody

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

S95011 concentrate for solution for infusion

Arm Type

Experimental

Arm Description

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

Arm Title

S95011 Placebo concentrate for solution for infusion

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

S95011 concentrate for solution for infusion

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo concentrate for solution for infusion

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in ESSDAI total score

Description

Time Frame

From baseline to week 13

Secondary Outcome Measure Information:

Title

ESSDAI score by domain and total score

Description

Time Frame

At baseline, week 4 and week 13

Title

ESSPRI score by symptom and total score

Description

Efficacy criterion EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) is an index designed to measure patients' symptoms in primary Sjögren's Syndrome

Time Frame

At baseline, week 4 and week 13

Title

Quality of life (SF-36)

Description

Efficacy criterion The Short Form (SF-36) Health Survey is a 36-item, patient-reported survey of patient health to asses QoL

Time Frame

At baseline and week 13

Title

Fatigue (MFI)

Description

Efficacy criterion Modified Fatigue Impact Scale (MFI) is a 20-item survey to evaluate ﬁve dimensions of fatigue

Time Frame

At baseline and week 13

Title

Physician's global assessment (PhGA) of the disease activity

Description

Efficacy criterion Physician's global assessment (PhGA) of the disease activity is a 0 to 10 numerical rating scale (NRS)

Time Frame

At baseline and week 13

Title

Patient's global assessment (PGA) of the disease activity

Description

Efficacy criterion Patient's global assessment (PGA) of the disease activity is a 0 to 10 numerical rating scale (NRS)

Time Frame

At baseline and week 13

Title

Incidence of adverse events (AEs)

Description

Safety criterion

Time Frame

Through study completion, up to Week 28

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Colorado Arthritis Associates

City

Lakewood

State/Province

Colorado

ZIP/Postal Code

80228

Country

United States

Facility Name

Altoona Center for Clinical Research

City

Duncansville

State/Province

Pennsylvania

ZIP/Postal Code

16635

Country

United States

Facility Name

The Queen Elizabeth Hospital Rheumatology Unit

City

Woodville

ZIP/Postal Code

5011

Country

Australia

Facility Name

Hôpital Saint-André

City

Bordeaux

ZIP/Postal Code

33000

Country

France

Facility Name

CHU de Bicêtre

City

Le Kremlin-Bicêtre

ZIP/Postal Code

94275

Country

France

Facility Name

Hôpital Laribiosière

City

Paris

ZIP/Postal Code

75010

Country

France

Facility Name

Hôpital Pitié-Salpêtrière

City

Paris

ZIP/Postal Code

75013

Country

France

Facility Name

Hôpital Saint Antoine

City

Paris

ZIP/Postal Code

75571

Country

France

Facility Name

Universitätsklinikum Erlangen Medizinische Klinik 3 Rheumatologie und Immunologie

City

Erlangen

ZIP/Postal Code

91054

Country

Germany

Facility Name

Universitätsklinikum Freiburg Department Innere Medizin Klinik für Rheumatologie und Klinische Immunologie

City

Freiburg

ZIP/Postal Code

79106

Country

Germany

Facility Name

Debreceni Egyetem Orvos és Egészségtudományi Centrum Belgyógyászat C épület - Klinikai Immunológiai Tanszék

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Facility Name

Békés Megyei Központi Kórház, Pándy Kálmán Tagkórház, Infektológia-Hepatológia

City

Gyula

ZIP/Postal Code

5700

Country

Hungary

Facility Name

Vita Verum Medical Bt. Berényi u. 72-100. 95. számú épület 16. Rendelő

City

Székesfehérvár

ZIP/Postal Code

8000

Country

Hungary

Facility Name

CLINICA SAGRADA FAMILIA Servicio de Reumatología y Unidad de Ensayos Clínicos

City

Barcelona

ZIP/Postal Code

08022

Country

Spain

Facility Name

CLINICAL GAIAS SANTIAGO Servicio de Reumatología

City

Santiago De Compostela

ZIP/Postal Code

15702

Country

Spain

Facility Name

Hospital Infanta Luisa Quirón Salud Servicio de Reumatología

City

Sevilla

ZIP/Postal Code

41010

Country

Spain

Facility Name

Queen Elizabeth Hospital, University Hospitals Birmingham NHS Foundation Trust

City

Birmingham

ZIP/Postal Code

B15 2TH

Country

United Kingdom

Facility Name

Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust

City

Newcastle Upon Tyne

ZIP/Postal Code

NE7 7DN

Country

United Kingdom

Facility Name

Southampton General Hospital, University Hospital Southampton NHS Trust

City

Southampton

ZIP/Postal Code

SO16 6YD

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data. Access can be requested for all interventional clinical studies: used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US). where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope. In addition, access can be requested for all interventional clinical studies in patients: sponsored by Servier with a first patient enrolled as of 1 January 2004 onwards for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.

IPD Sharing Time Frame

After Marketing Authorisation in EEA or US if the study is used for the approval.

IPD Sharing Access Criteria

Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.

IPD Sharing URL

https://clinicaltrials.servier.com/

Links:

URL

https://clinicaltrials.servier.com/

Description

Find Results on Servier Clinical Trial Data website

Available IPD and Supporting Information:

Available IPD/Information Type

Individual Participant Data Set

Available IPD/Information URL

https://clinicaltrials.servier.com/

Available IPD/Information Type

Study Protocol

Available IPD/Information URL

https://clinicaltrials.servier.com/

Available IPD/Information Type

Statistical Analysis Plan

Available IPD/Information URL

https://clinicaltrials.servier.com/

Available IPD/Information Type

Informed Consent Form

Available IPD/Information URL

https://clinicaltrials.servier.com/

Available IPD/Information Type

Clinical Study Report

Available IPD/Information URL

https://clinicaltrials.servier.com/

Available IPD/Information Type

study-level clinical trial data

Available IPD/Information URL

https://clinicaltrials.servier.com/

Learn more about this trial

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

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