Phase 2 N=48 Randomized Quadruple-blind Treatment

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

Primary Sjögren's Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT04605978 ↗

Enrolled (actual)

Serious AEs

8.3%

Results posted

Apr 2024

Primary outcome: Primary: Change in ESSDAI Total Score — -3.77; -5.54; 11.52; 13.12 score on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: S95011 concentrate for solution for infusion (Drug); Placebo concentrate for solution for infusion (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Institut de Recherches Internationales Servier
Primary completion: Jan 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in ESSDAI Total Score	-3.77; -5.54; 11.52; 13.12; 7.96; 8.85	—
SECONDARY ESSDAI Score by Domain and Total Score	11.5; 13.1; 9.5; 10.8; 7.8; 9.7	—
SECONDARY ESSPRI Score by Symptom and Total Score	7.14; 6.87; 6.65; 5.19; 5.54; 5.40	—
SECONDARY Quality of Life (SF-36)	38.729; 40.295; 45.139; 47.011; 40.911; 44.182	—
SECONDARY Fatigue (MFI)	15.1; 15.2; 13.2; 13.5; 14.3; 13.9	—
SECONDARY Physician's Global Assessment (PhGA) of the Disease Activity	6.0; 6.3; 3.6; 4.2	—
SECONDARY Patient's Global Assessment (PGA) of the Disease Activity	7.1; 7.1; 6.2; 5.4	—
SECONDARY Number of Participants With Adverse Events (AEs)	24; 11; 3; 1	—

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.

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

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Data sourced from ClinicalTrials.gov (NCT04605978). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.