A Randomized, Double-blind, Placebo Controlled, 3-arm Multicenter Phase 3 Study to Assess the Efficacy and Safety of Ianalumab in Patients With Active Sjogren's Syndrome (NEPTUNUS-2)
Overview
- Phase
- Phase 3
- Intervention
- VAY736
- Conditions
- Sjogren Syndrome
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 506
- Locations
- 170
- Primary Endpoint
- Plan A and B - Change from baseline in ESSDAI score at Week 48
- Status
- Active, not recruiting
- Last Updated
- last month
Overview
Brief Summary
A randomized, double-blind, placebo controlled, 3-arm multicenter phase 3 study to assess the efficacy and safety of ianalumab in patients with active Sjogren's syndrome (NEPTUNUS-2)
Detailed Description
Three-arm study of the clinical efficacy, safety and tolerability of ianalumab (VAY736) in patients with active Sjogren's syndrome. The purpose of this study is to demonstrate the clinical efficacy, safety and tolerability of ianalumab (VAY736) administered subcutaneously (s.c.) monthly or every 3 months compared to placebo in patients with active Sjogren's syndrome.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Signed informed consent must be obtained prior to participation in the study
- •Women and men ≥ 18 years of age
- •Classification of Sjögren's syndrome according to the ACR/EULAR 2016 criteria
- •Time since diagnosis of Sjögren's of ≤ 7.5 years at screening
- •Positive anti-Ro/SSA antibody at screening
- •Patients negative for anti-Ro/SSA antibody are eligible, if they have a positive salivary gland biopsy confirmed by central expert review
- •Enrollment of anti-Ro/SSA-negative patients will be limited up to ≤10% of the study population
- •Screening ESSDAI score of ≥ 5 within the following 8 domains: constitutional, lymphadenopathy, glandular, articular, cutaneous, renal, hematological and biologic.
- •Stimulated whole salivary flow (sSF) rate of ≥ 0.05 mL/min at screening
- •Ability to communicate well with the Investigator, understand and agree to comply with the requirements of the study
Exclusion Criteria
- •Presence of another autoimmune rheumatic disease that is active and constitutes the principal illness
- •Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days or until the expected pharmacodynamic effect has returned to baseline, whichever is longer
- •Prior treatment with ianalumab
- •Prior use of a B-cell depleting therapy other than ianalumab within 36 weeks prior to randomization or as long as B-cell count is less than the lower limit of normal or baseline value prior to receipt of previous B cell-depleting therapy (whichever is lower)
- •Prior treatment with any of the following:
- •Within 24 weeks prior to randomization: iscalimab (anti CD-40 mAb), belimumab , abatacept, anti-tumor necrosis factor alpha biologic agents, immunoglobulins plasmapheresis;
- •Within 12 weeks prior to randomization: i.v. or oral cyclophosphamide, mycophenolate mofetil, i.v. or oral cyclosporine A or any other immunosuppressants (e.g., JAK inhibitors or other kinase inhibitors) unless explicitly allowed by protocol
- •Use of corticosteroids (predniso(lo)ne or equivalent corticosteroid) at dose \>10 mg/day
- •Any one of the following laboratory values at screening:
- •Hemoglobin levels \< 8.0 g/dL
Arms & Interventions
Arm A
ianalumab exposure level 1
Intervention: VAY736
Arm B
ianalumab exposure level 2
Intervention: VAY736
Arm C
placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Plan A and B - Change from baseline in ESSDAI score at Week 48
Time Frame: 48 weeks
* Plan A - United States of America and US reference countries * Plan B - EU, China, other non-US Regions and EU reference countries Dose response measured by change multi-dimensional disease activity as assessed by the physician. Score range is 0-123. Higher scores on the EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) scale are associated with poorer health states A negative change from baseline indicates improvement in disease status.
Secondary Outcomes
- Change from baseline in SSSD score at Week 48(48 weeks)
- Percentage of participants achieving ESSDAI response at Week 48**(48 weeks)
- Percentage of participants achieving ESSDAI score <5 at Week 48(48 weeks)
- Percentage of participants achieving SSSD response at Week 48**(48 weeks)
- Change from baseline in stimulated whole salivary flow rate at Week 48(48 weeks)
- Change from baseline in PhGA at Week 48(48 weeks)
- Change from baseline in PaGA at Week 48(48 weeks)
- Change from baseline in FACIT-F score at Week 48(48 weeks)
- Change from baseline in ESSPRI score at Week 48(48 weeks)
- Percentage of participants achieving ESSPRI response at Week 48**(48 Weeks)