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

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ClinicalTrials.gov Identifier: NCT04605978

Recruitment Status : Completed

First Posted : October 28, 2020

Results First Posted : April 23, 2024

Last Update Posted : April 23, 2024

View this study on the modernized ClinicalTrials.gov

Sponsor:

Collaborator:

ADIR, a Servier Group company

Information provided by (Responsible Party):

Servier ( Institut de Recherches Internationales Servier )

Tracking Information

First Submitted Date ^ICMJE

October 19, 2020

First Posted Date ^ICMJE

October 28, 2020

Results First Submitted Date ^ICMJE

January 15, 2024

Results First Posted Date ^ICMJE

April 23, 2024

Last Update Posted Date

April 23, 2024

Actual Study Start Date ^ICMJE

August 3, 2021

Actual Primary Completion Date

January 16, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in ESSDAI Total Score [ Time Frame: From baseline to week 13 ]

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.

Original Primary Outcome Measures ^ICMJE

Change in ESSDAI total score [ Time Frame: From baseline to week 13 ]

Change History

Current Secondary Outcome Measures ^ICMJE

ESSDAI Score by Domain and Total Score [ Time Frame: At baseline, week 4 and week 13 ]
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.
ESSPRI Score by Symptom and Total Score [ Time Frame: At baseline, week 4 and week 13 ]
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.
Quality of Life (SF-36) [ Time Frame: At baseline and week 13 ]
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.
Fatigue (MFI) [ Time Frame: At baseline and week 13 ]
Efficacy criterion Modified Fatigue Impact Scale (MFI) is a 20-item survey to evaluate ﬁve dimensions of fatigue. Scores range from 4 to 20 for each sub-score, with a lower score representing less fatigue.
Physician's Global Assessment (PhGA) of the Disease Activity [ Time Frame: At baseline and week 13 ]
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.
Patient's Global Assessment (PGA) of the Disease Activity [ Time Frame: At baseline and week 13 ]
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.
Number of Participants With Adverse Events (AEs) [ Time Frame: Through study completion, up to Week 28 ]
Safety criterion

Original Secondary Outcome Measures ^ICMJE

ESSDAI score by domain and total score [ Time Frame: At baseline, week 4 and week 13 ]
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
ESSPRI score by symptom and total score [ Time Frame: At baseline, week 4 and week 13 ]
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) [ Time Frame: At baseline and week 13 ]
Efficacy criterion The Short Form (SF-36) Health Survey is a 36-item, patient-reported survey of patient health to asses QoL
Fatigue (MFI) [ Time Frame: At baseline and week 13 ]
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 [ Time Frame: At baseline and week 13 ]
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 [ Time Frame: At baseline and week 13 ]
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) [ Time Frame: Through study completion, up to Week 28 ]
Safety criterion

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Primary Sjögren's Syndrome

Intervention ^ICMJE

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

Study Arms ^ICMJE

Experimental: 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.

Intervention: Drug: S95011 concentrate for solution for infusion
Placebo Comparator: 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.

Intervention: Drug: Placebo concentrate for solution for infusion

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Actual Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Actual Study Completion Date ^ICMJE

May 9, 2023

Actual Primary Completion Date

January 16, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years to 75 Years (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

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

Removed Location Countries

Canada

Administrative Information

NCT Number ^ICMJE

NCT04605978

Other Study ID Numbers ^ICMJE

CL2-95011-001
2020-001526-59 ( EudraCT Number )

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No

IPD Sharing Statement ^ICMJE

Plan to Share IPD:	Yes
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.
Supporting Materials:	Study Protocol
Supporting Materials:	Statistical Analysis Plan (SAP)
Supporting Materials:	Informed Consent Form (ICF)
Supporting Materials:	Clinical Study Report (CSR)
Time Frame:	After Marketing Authorisation in EEA or US if the study is used for the approval.
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.
URL:	https://clinicaltrials.servier.com/