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Trial record 1 of 1 for:    NCT05350072
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Two-arm Study to Assess Efficacy and Safety of Ianalumab (VAY736) in Patients With Active Sjogren's Syndrome (NEPTUNUS-1)

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ClinicalTrials.gov Identifier: NCT05350072
Recruitment Status : Recruiting
First Posted : April 27, 2022
Last Update Posted : May 24, 2023
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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Brief Summary:
A randomized, double-blind, placebo controlled, 2-arm multicenter phase 3 study to assess the efficacy and safety of ianalumab in patients with active Sjogren's syndrome (NEPTUNUS-1)

Condition or disease Intervention/treatment Phase
Sjogren Syndrome Biological: VAY736 Other: Placebo Phase 3

Detailed Description:
Two-arm study of the clinical efficacy, safety and tolerability of ianalumab (VAY736) in patients with active Sjogren's syndrome. The purpose of the study is to demonstrate the clinical efficacy, safety and tolerability of ianalumab (VAY736) administered subcutaneously (s.c.) monthly compared to placebo in patients with active Sjogren's syndrome.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 268 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Participants, investigators, investigator staff, persons performing the assessments and Novartis Clinical Trial Team will remain blinded to the identity of the treatment from the time of randomization until the final database lock.
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo Controlled, 2-arm Multicenter Phase 3 Study to Assess the Efficacy and Safety of Ianalumab in Patients With Active Sjogren's Syndrome (NEPTUNUS-1)
Actual Study Start Date : July 28, 2022
Estimated Primary Completion Date : March 6, 2026
Estimated Study Completion Date : March 9, 2028

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm A
ianalumab
 Biological: VAY736
ianalumab s.c.
Placebo Comparator: Arm B
placebo
 Other: Placebo
placebo s.c.


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in EULAR Sjogren Syndrome Disease Activity Index (ESSDAI) score at Week 48 as compared to placebo [ Time Frame: 48 weeks ]
    Efficacy (Plan A: US and US reference countries and Plan B: EU, other non-US Regions and EU reference countries)


Secondary Outcome Measures :
  1. Proportion of patients achieving ≥3 points reduction from baseline in ESSDAI score at Week 48 [ Time Frame: 48 weeks ]
    Efficacy (Plan A and B)

  2. Proportion of patients achieving ESSDAI <5 at Week 48 [ Time Frame: 48 weeks ]
    Efficacy (Plan A and B)

  3. Proportion of patients achieving ≥3 points reduction from baseline in ESSDAI score at Week 24 [ Time Frame: 24 weeks ]
    Efficacy (Plan A and B)

  4. Change from baseline in stimulated whole salivary flow rate at Week 48 [ Time Frame: 48 weeks ]
    Efficacy (Plan A and B)

  5. Change from baseline in Physician's Global Assessment (PhGA) of disease activity at Week 48 [ Time Frame: 48 weeks ]
    Efficacy (Plan A and B)

  6. Change from baseline in Patient's Global Assessment (PaGA) of disease activity at Week 48 [ Time Frame: 48 weeks ]
    Efficacy (Plan A and B)

  7. Change from baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) score at Week 48 [ Time Frame: 48 weeks ]
    Efficacy (Plan A and B)

  8. Proportion of patients achieving meaningful improvement in SSSD score at Week 48 [ Time Frame: 48 weeks ]
    Efficacy (Plan A)

  9. Proportion of patients achieving ≥1 point or 15% reduction from baseline in EULAR Sjögren Syndrome Patient Reported Index (ESSPRI) at Week 48 [ Time Frame: 48 weeks ]
    Efficacy (Plan B)


Other Outcome Measures:
  1. Proportion of patients achieving ≥1 point or 15% reduction from baseline in ESSPRI at Week 48 [ Time Frame: 48 weeks ]
    Efficacy (Plan A)

  2. Proportion of patients achieving meaningful improvement in SSSD score at Week 48 [ Time Frame: 48 weeks ]
    Efficacy (Plan B)

  3. Change from baseline in Schirmer's test over 48 weeks [ Time Frame: 48 weeks ]
    Efficacy (Plan A and B)

  4. Change from baseline in Clinical Disease Activity Index (CDAI) score over 48 weeks [ Time Frame: 48 weeks ]
    Efficacy (Plan A and B)

  5. Change from baseline in Clinical European League Against Rheumatism Sjogrens Syndrome Disease Activity Index (ClinESSDAI) at Week 48 [ Time Frame: 48 weeks ]
    Efficacy (Plan A and B)

  6. Incidence of Treatment Emergent Adverse Event (TEAEs)/Serious Adverse Events (SAEs) from Week 52 to end of study [ Time Frame: 52 weeks ]
    Safety (Plan A and B)

  7. Incidence of Treatment Emergent Adverse Event (TEAEs)/Serious Adverse Events (SAEs) from Week 52 to end of study [ Time Frame: Week 52 through study completion up to 2 years ]
    Safety (Plan A and B)

  8. Incidence of anti-ianalumab antibodies in serum Anti Drug Antibody (ADA) assay) up to end of study [ Time Frame: through study completion up to 2 years ]
    Immunogenicity (Plan A and B)

  9. Ianalumab concentration in serum during the treatment and follow-up (up to end of study) [ Time Frame: through study completion up to 2 years ]
    Pharmacokinetics (Plan A and B)


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • Patients taking hydroxychloroquine (≤ 400 mg/day), methotrexate (≤ 25 mg/week) or azathioprine (≤ 150 mg/day) alone or in combination, are allowed to continue their medication, and must have been on a stable dose for at least 30 days prior to randomization.
  • Patients taking systemic corticosteroids have to be on a stable dose of ≤ 10 mg/day predniso(lo)ne or equivalent for at least 30 days before randomization.

  • Patients taking

    • disease-modifying antirheumatic drugs (DMARDs) other than specifically allowed by protocol
    • the following Traditional Chinese Medicines: Total glucoside of peony (TGP) or Tripterium glycosides (TG)
  • must discontinue these medications at least 30 days prior to randomization, except for leflunomide, which has to be discontinued for 8 weeks prior to randomization unless a cholestyramine wash-out has been performed.

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 longer3. 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 <50 cells/μL
  • Prior treatment with any of the following within 6 months prior to randomization:
  • iscalimab, belimumab , abatacept, anti-tumor necrosis factor alpha biologic agents, immunoglobulins plasmapheresis; i.v. or oral cyclophosphamide and mycophenolate mofetil, i.v. or oral cyclosporine A; 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
    • White blood cells (WBC) count < 2.0 x 10E3/µL
    • Platelet count < 80 x 10E3/µL
    • Absolute neutrophil count (ANC) < 0.8 x 10E3/µL
  • Active viral, bacterial or other infections requiring systemic treatment at the time of screening or randomization, or history of recurrent clinically significant infection or of bacterial infections with encapsulated organisms
  • History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes (e.g., mAb of IgG1 class) or to any of the constituents of the study drug formulation (sucrose, L-histidine hydrochloride/ L-histidine, polysorbate 20)
  • History of major organ, hematopoietic stem cell or bone marrow transplant
  • Required regular use of medications known to cause dry mouth/eyes as a regular and major side effect, and which have not been on a stable dose for at least 30 days prior to Screening, or any anticipated change in the treatment regimen during the course of the study
  • Use of topical ocular prescription medications (excluding artificial tears, gels, lubricants) that have not been on a stable dose for at least 90 days prior to randomization, or any anticipated change in the treatment regimen during the course of the study
  • Receipt of live/attenuated vaccine within a 4-week period prior to randomization
  • History of primary or secondary immunodeficiency, including a positive human immunodeficiency virus (HIV) test result
  • History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer or Sjögren's related lymphoma), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
  • History of sarcoidosis
  • Any surgical, medical (e.g., uncontrolled hypertension, heart failure or diabetes mellitus), psychiatric or additional physical condition that the Investigator feels may jeopardize the patient in case of participation in this study
  • Chronic infection with hepatitis B (HBV) or hepatitis C (HCV). Positive serology for hepatitis B surface antigen (HBsAg) excludes the subject.
  • Evidence of active tuberculosis (TB) infection (after anti-TB treatment, patients with history of or latent TB may become eligible according to national guidelines)
  • Pregnant or nursing (lactating) women,
  • Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while on study treatment and for 6 months after stopping of investigational medication.
  • Patients with a known history of non-compliance to medication, or who were unable or unwilling to complete PRO questionnaires, or who are unable or unwilling to use the device for collection of PROs.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05350072


Contacts
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Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111

Locations
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Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT05350072    
Other Study ID Numbers: CVAY736A2301
2020-005661-14 ( EudraCT Number )
First Posted: April 27, 2022    Key Record Dates
Last Update Posted: May 24, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Time Frame: 2028

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Sjogren's syndrome
B-cell depleting
BAFF-R
 VAY736
ianalumab
NEPTUNUS
Additional relevant MeSH terms:
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Sjogren's Syndrome
Syndrome
Disease
Pathologic Processes
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Xerostomia
 Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases