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

Servier

Status and phase: Completed; Phase 2

Conditions: Primary Sjögren's Syndrome

Treatments: Drug: Placebo concentrate for solution for infusion; Drug: S95011 concentrate for solution for infusion

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04605978

2020-001526-59 (EudraCT Number)

CL2-95011-001

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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48 participants in 2 patient groups, including a placebo group

S95011 concentrate for solution for infusion

Experimental group

Description:

S95011 is administrated by one IV infusion every 2 weeks for the first month and then every 3 weeks.

Treatment:

Drug: S95011 concentrate for solution for infusion

S95011 Placebo concentrate for solution for infusion

Placebo Comparator group

Description:

S95011 placebo is administrated by one IV infusion every 2 weeks for the first month and then every 3 weeks.

Treatment:

Drug: Placebo concentrate for solution for infusion