Primary Sjögren's SyndromePhase 2NCT04605978
Efficacy and Safety of S95011 in Primary Sjögren's Syndrome Patients
A Phase 2 study testing S95011 concentrate for solution for infusion in people with Primary Sjögren's Syndrome, run by Institut de Recherches Internationales Servier at 19 sites in 7 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Sjögren's Syndrome
- What is being tested?
- S95011 concentrate for solution for infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 19 sitesin 7 countries
- Study dates
- 3 Aug 2021to 9 May 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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,
Show all 16Show fewer
- 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
Trial locations and contacts
19 sites in 7 countries.
19 sites in 7 countries
France5 sites
Hôpital Saint-André
Bordeaux, 33000
CHU de Bicêtre
Le Kremlin-Bicêtre, 94275
Hôpital Laribiosière
Paris, 75010
Hôpital Pitié-Salpêtrière
Paris, 75013
Hôpital Saint Antoine
Paris, 75571
Hungary3 sites
Debreceni Egyetem Orvos és Egészségtudományi Centrum Belgyógyászat C épület - Klinikai Immunológiai Tanszék
Debrecen, 4032
Békés Megyei Központi Kórház, Pándy Kálmán Tagkórház, Infektológia-Hepatológia
Gyula, 5700
Vita Verum Medical Bt. Berényi u. 72-100. 95. számú épület 16. Rendelő
Székesfehérvár, 8000
Spain3 sites
CLINICA SAGRADA FAMILIA Servicio de Reumatología y Unidad de Ensayos Clínicos
Barcelona, 08022
CLINICAL GAIAS SANTIAGO Servicio de Reumatología
Santiago de Compostela, 15702
Hospital Infanta Luisa Quirón Salud Servicio de Reumatología
Seville, 41010
United Kingdom3 sites
Queen Elizabeth Hospital, University Hospitals Birmingham NHS Foundation Trust
Birmingham, B15 2TH
Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, NE7 7DN
Southampton General Hospital, University Hospital Southampton NHS Trust
Southampton, SO16 6YD
United States2 sites
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Colorado Arthritis Associates
Lakewood, Colorado, 80228
Germany2 sites
Universitätsklinikum Erlangen Medizinische Klinik 3 Rheumatologie und Immunologie
Erlangen, 91054
Universitätsklinikum Freiburg Department Innere Medizin Klinik für Rheumatologie und Klinische Immunologie
Freiburg im Breisgau, 79106
Australia1 site
The Queen Elizabeth Hospital Rheumatology Unit
Woodville, 5011
About this study
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
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
- Being tested
- S95011 concentrate for solution for infusion, Placebo concentrate for solution for infusion
- Keywords
- Sjögren, Sjögren's Syndrome, Autoimmune disease, Systemic, Xerostomia, xerophthalmia, Salivary gland disease, Arthritis, Joint disease, Monoclonal antibody
- Medical subject headings
- Sjogren's Syndrome, Autoimmune Diseases, Xerostomia, Xerophthalmia, Salivary Gland Diseases, Arthritis, Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S95011 concentrate for solution for infusionDrug
IV administration every 2 weeks until week 4 and then every 3 weeks until week 10.
Placebo concentrate for solution for infusionDrug
IV administration every 2 weeks until week 4 and then every 3 weeks until week 10.
| Study group | Role | What they receive |
|---|---|---|
| S95011 concentrate for solution for infusion | Experimental | S95011 is administrated by one IV infusion every 2 weeks for the first month and then every 3 weeks. Receives: Drug: S95011 concentrate for solution for infusion |
| S95011 Placebo concentrate for solution for infusion | Placebo comparator | S95011 placebo is administrated by one IV infusion every 2 weeks for the first month and then every 3 weeks. Receives: Drug: Placebo concentrate for solution for infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to week 13
Secondary outcomes (7)
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.
Measured: At baseline, week 4 and week 13
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.
Measured: At baseline, week 4 and week 13
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.
Measured: At baseline and week 13
Fatigue (MFI)
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.
Measured: At baseline and week 13
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.
Measured: At baseline and week 13
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.
Measured: At baseline and week 13
Number of Participants With Adverse Events (AEs)
Safety criterion
Measured: Through study completion, up to Week 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start3 Aug 2021
- Primary completion16 Jan 2023
- Study completion9 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Primary Sjögren's SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Recherches Internationales Servier
- Sponsor type
- University, hospital or other
- Collaborators
- ADIR, a Servier Group company
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04605978
- Sponsor's protocol ID
- CL2-95011-001
- Other IDs
- 2020-001526-59
- Status last verified
- Apr 2024
- First submitted
- 19 Oct 2020
- Last updated
- 23 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04605978
- Acronym / sponsor ID
- CL2-95011-001
- Conditions
- Primary Sjögren's Syndrome
- Keywords
- Sjögren, Sjögren's Syndrome, Autoimmune disease, Systemic, Xerostomia, xerophthalmia, Salivary gland disease, Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Institut de Recherches Internationales ServierUniversity, hospital or other
- Collaborators
- ADIR, a Servier Group company
- Study start
- 3 Aug 2021 (actual)
- Primary completion
- 16 Jan 2023 (actual)
- Study completion
- 9 May 2023 (actual)
- First posted
- 28 Oct 2020 (actual)
- Results
- Posted 23 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| S95011 concentrate for solution for infusion | Experimental | Drug: S95011 concentrate for solution for infusionS95011 is administrated by one IV infusion every 2 weeks for the first month and then every 3 weeks. |
| S95011 Placebo concentrate for solution for infusion | Placebo comparator | Drug: Placebo concentrate for solution for infusionS95011 placebo is administrated by one IV infusion every 2 weeks for the first month and then every 3 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (16 listed)
- Prior administration within the timeframe described in the protocol of any of the following:
- Meeting any of the following conditions:
- Secondary Sjögren's Syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S95011 concentrate for solution for infusionIV administration every 2 weeks until week 4 and then every 3 weeks until week 10. | Drug | S95011 concentrate for solution for infusion |
| Placebo concentrate for solution for infusionIV administration every 2 weeks until week 4 and then every 3 weeks until week 10. | Drug | S95011 Placebo concentrate for solution for infusion |
Primary outcome
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.
7 secondary outcomes
ESSDAI Score by Domain and Total Score
Time frame: At baseline, week 4 and week 13
ESSPRI Score by Symptom and Total Score
Time frame: At baseline, week 4 and week 13
Quality of Life (SF-36)
Time frame: At baseline and week 13
Fatigue (MFI)
Time frame: At baseline and week 13
Physician's Global Assessment (PhGA) of the Disease Activity
Time frame: At baseline and week 13
Patient's Global Assessment (PGA) of the Disease Activity
Time frame: At baseline and week 13
Number of Participants With Adverse Events (AEs)
Time frame: Through study completion, up to Week 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Find Results on Servier Clinical Trial Data websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
19 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing S95011 concentrate for solution for infusion in people with Primary Sjögren's Syndrome, run by Institut de Recherches Internationales Servier at 19 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in France, Hungary, Spain, United Kingdom, United States and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ESSDAI Total Score (time frame: From baseline to week 13). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2024.