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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04605978




Registration number
NCT04605978
Ethics application status
Date submitted
19/10/2020
Date registered
28/10/2020

Titles & IDs
Public title
Efficacy and Safety of S95011 in Primary Sjögren's Syndrome Patients
Scientific 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
Secondary ID [1] 0 0
2020-001526-59
Secondary ID [2] 0 0
CL2-95011-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary Sjögren's Syndrome 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - S95011 concentrate for solution for infusion
Treatment: Drugs - Placebo concentrate for solution for infusion

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.

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.


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

Treatment: Drugs: Placebo concentrate for solution for infusion
IV administration every 2 weeks until week 4 and then every 3 weeks until week 10.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in ESSDAI Total Score
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
From baseline to week 13
Secondary outcome [1] 0 0
ESSDAI Score by Domain and Total Score
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
At baseline, week 4 and week 13
Secondary outcome [2] 0 0
ESSPRI Score by Symptom and Total Score
Assessment method [2] 0 0
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.
Timepoint [2] 0 0
At baseline, week 4 and week 13
Secondary outcome [3] 0 0
Quality of Life (SF-36)
Assessment method [3] 0 0
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.
Timepoint [3] 0 0
At baseline and week 13
Secondary outcome [4] 0 0
Fatigue (MFI)
Assessment method [4] 0 0
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.
Timepoint [4] 0 0
At baseline and week 13
Secondary outcome [5] 0 0
Physician's Global Assessment (PhGA) of the Disease Activity
Assessment method [5] 0 0
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.
Timepoint [5] 0 0
At baseline and week 13
Secondary outcome [6] 0 0
Patient's Global Assessment (PGA) of the Disease Activity
Assessment method [6] 0 0
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.
Timepoint [6] 0 0
At baseline and week 13
Secondary outcome [7] 0 0
Number of Participants With Adverse Events (AEs)
Assessment method [7] 0 0
Safety criterion
Timepoint [7] 0 0
Through study completion, up to Week 28

Eligibility
Key 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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/08/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/05/2023
Sample size
Target
Accrual to date
Final
48
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
The Queen Elizabeth Hospital Rheumatology Unit - Woodville
Recruitment postcode(s) [1] 0 0
5011 - Woodville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
United States of America
State/province [2] 0 0
Pennsylvania
Country [3] 0 0
France
State/province [3] 0 0
Bordeaux
Country [4] 0 0
France
State/province [4] 0 0
Le Kremlin-Bicêtre
Country [5] 0 0
France
State/province [5] 0 0
Paris
Country [6] 0 0
Germany
State/province [6] 0 0
Erlangen
Country [7] 0 0
Germany
State/province [7] 0 0
Freiburg
Country [8] 0 0
Hungary
State/province [8] 0 0
Debrecen
Country [9] 0 0
Hungary
State/province [9] 0 0
Gyula
Country [10] 0 0
Hungary
State/province [10] 0 0
Székesfehérvár
Country [11] 0 0
Spain
State/province [11] 0 0
Barcelona
Country [12] 0 0
Spain
State/province [12] 0 0
Santiago De Compostela
Country [13] 0 0
Spain
State/province [13] 0 0
Sevilla
Country [14] 0 0
United Kingdom
State/province [14] 0 0
Birmingham
Country [15] 0 0
United Kingdom
State/province [15] 0 0
Newcastle Upon Tyne
Country [16] 0 0
United Kingdom
State/province [16] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Other
Name
Institut de Recherches Internationales Servier
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
ADIR, a Servier Group company
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04605978