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Clinical Trials/NCT04605978
NCT04605978CompletedPhase 2

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

Institut de Recherches Internationales Servier19 sites in 7 countries48 target enrollmentStarted: August 3, 2021Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
48
Locations
19
Primary Endpoint
Change in ESSDAI Total Score
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

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.

Intervention: S95011 concentrate for solution for infusion (Drug)

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.

Intervention: Placebo concentrate for solution for infusion (Drug)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Patient's Global Assessment (PGA) of the Disease Activity(At baseline and week 13)
  • ESSDAI Score by Domain and Total Score(At baseline, week 4 and week 13)
  • Fatigue (MFI)(At baseline and week 13)
  • Physician's Global Assessment (PhGA) of the Disease Activity(At baseline and week 13)
  • ESSPRI Score by Symptom and Total Score(At baseline, week 4 and week 13)
  • Quality of Life (SF-36)(At baseline and week 13)
  • Number of Participants With Adverse Events (AEs)(Through study completion, up to Week 28)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (19)

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