Two-arm Study to Assess Efficacy and Safety of Ianalumab (VAY736) in Patients With Active Sjogren's Syndrome

NCT05350072 | Active Not Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: CVAY736A23012024-511069-12-00
• Study Type: interventional
• Target: 276
• Locations: 18 countries
• Sites: 78

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)

Conditions

Sjogren Syndrome

Keywords

Sjogren's syndrome; B-cell depleting; BAFF-R; VAY736; ianalumab; NEPTUNUS

Outcome Measures

Primary Outcomes (1)

• Change from baseline in EULAR Sjogren Syndrome Disease Activity Index (ESSDAI) score at Week 48 as compared to placebo

  Efficacy (Plan A: US and US reference countries and 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.

  48 weeks

Secondary Outcomes (9)

• Achieving ESSDAI response at Week 48

  48 weeks

• Achieving ESSDAI score <5 at Week 48

  48 weeks

• Achieving ESSDAI response at Week 24

  24 weeks

• Achieving SSSD response at Week 48

  48 weeks

• Change from baseline in stimulated whole salivary flow rate at Week 48

  48 weeks

Other Outcomes (3)

• Incidence of Treatment Emergent Adverse Event (TEAEs)/Serious Adverse Events (SAEs) upto the end of the study

  through study completion upto 2 years

• Incidence of anti-ianalumab antibodies in serum Anti Drug Antibody (ADA) assay) up to end of study

  through study completion up to 2 years

• Ianalumab concentration in serum during the treatment (example Ctrough) and follow-up (up to end of study)

  through study completion up to 2 years

Study Arms (2)

Arm A

EXPERIMENTAL

ianalumab

Biological: VAY736

Arm B

PLACEBO COMPARATOR

placebo

Other: Placebo

Interventions

VAY736 BIOLOGICAL

ianalumab s.c.

Arm A

Placebo OTHER

placebo s.c.

Arm B

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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 and 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
• 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 recurrent 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (78)

Medvin Clinical Research

Van Nuys, California, 91405, United States

Location

West Broward Rheumatology Associates Inc

Tamarac, Florida, 33321, United States

Location

Indiana Univ School of Dentistry

Indianapolis, Indiana, 46202, United States

Location

Ochsner Health System

Baton Rouge, Louisiana, 70809, United States

Location

The John Hopkins Jerome L Greene Sjogren

Baltimore, Maryland, 21224, United States

Location

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

Carolina Arthritis Associates

Wilmington, North Carolina, 28401, United States

Location

STAT Research Inc

Dayton, Ohio, 45402, United States

Location

Altoona Center for Clin Res

Duncansville, Pennsylvania, 16635, United States

Location

Prisma Health

Columbia, South Carolina, 29203, United States

Location

Precision Comprehensive Research

Colleyville, Texas, 76034, United States

Location

Metroplex Clinical Research

Dallas, Texas, 75231, United States

Location

Baylor College Of Medicine

Houston, Texas, 77030, United States

Location

Houston Rheumatology & Arthrit

Katy, Texas, 77494, United States

Location

Novartis Investigative Site

Graz, 8036, Austria

Location

Novartis Investigative Site

Stockerau, 2000, Austria

Location

Novartis Investigative Site

Leuven, 3000, Belgium

Location

Novartis Investigative Site

Vitória, Espírito Santo, 29055 450, Brazil

Location

Novartis Investigative Site

Juiz de Fora, Minas Gerais, 36010 570, Brazil

Location

Novartis Investigative Site

Ribeirão Preto, São Paulo, 14048-900, Brazil

Location

Novartis Investigative Site

São Paulo, 01409-902, Brazil

Location

Novartis Investigative Site

Santiago, Santiago Metropolitan, 7500571, Chile

Location

Novartis Investigative Site

Santiago, Santiago Metropolitan, 7500710, Chile

Location

Novartis Investigative Site

Guangzhou, Guangdong, 510630, China

Location

Novartis Investigative Site

Shenzhen, Guangdong, 518020, China

Location

Novartis Investigative Site

Wuhan, Hubei, 430030, China

Location

Novartis Investigative Site

Baotou, Inner Mongolia, 014010, China

Location

Novartis Investigative Site

Hohhot, Inner Mongolia, 010050, China

Location

Novartis Investigative Site

Nanchang, Jiangxi, 330006, China

Location

Novartis Investigative Site

Shenyang, Liaoning, 110011, China

Location

Novartis Investigative Site

Linyi, Shandong, 276000, China

Location

Novartis Investigative Site

Taiyuan, Shanxi, 030000, China

Location

Novartis Investigative Site

Xian, Shanxi, 710061, China

Location

Novartis Investigative Site

Beijing, 100050, China

Location

Novartis Investigative Site

Brno, 638 00, Czechia

Location

Novartis Investigative Site

Prague, 148 00, Czechia

Location

Novartis Investigative Site

Uherské Hradiště, 686 01, Czechia

Location

Novartis Investigative Site

Caen, 14033, France

Location

Novartis Investigative Site

Dijon, 21000, France

Location

Novartis Investigative Site

Lille, 59037, France

Location

Novartis Investigative Site

Marseille, 13005, France

Location

Novartis Investigative Site

Paris, 75010, France

Location

Novartis Investigative Site

Paris, 75013, France

Location

Novartis Investigative Site

Saint-Priest-en-Jarez, 42270, France

Location

Novartis Investigative Site

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

Novartis Investigative Site

Würzburg, Bavaria, 97080, Germany

Location

Novartis Investigative Site

Berlin, 13353, Germany

Location

Novartis Investigative Site

Erlangen, 91056, Germany

Location

Novartis Investigative Site

Gommern, 39245, Germany

Location

Novartis Investigative Site

Ludwigshafen, 67063, Germany

Location

Novartis Investigative Site

Guatemala City, 01009, Guatemala

Location

Novartis Investigative Site

Guatemala City, 01010, Guatemala

Location

Novartis Investigative Site

Guatemala City, 01011, Guatemala

Location

Novartis Investigative Site

Quetzaltenango, 9001, Guatemala

Location

Novartis Investigative Site

Vilnius, 08406, Lithuania

Location

Novartis Investigative Site

Guadalajara, Jalisco, 44650, Mexico

Location

Novartis Investigative Site

Mexico City, Mexico City, 06700, Mexico

Location

Novartis Investigative Site

Wroclaw, Lower Silesian Voivodeship, 52-210, Poland

Location

Novartis Investigative Site

Bydgoszcz, 85-168, Poland

Location

Novartis Investigative Site

Krakow, 30-002, Poland

Location

Novartis Investigative Site

Lublin, 20-090, Poland

Location

Novartis Investigative Site

Braga, 4710243, Portugal

Location

Novartis Investigative Site

Guarda, 6301-858, Portugal

Location

Novartis Investigative Site

Lisbon, 1050-034, Portugal

Location

Novartis Investigative Site

Lisbon, 1349-019, Portugal

Location

Novartis Investigative Site

Lisbon, 1649-035, Portugal

Location

Novartis Investigative Site

Singapore, S308433, Singapore

Location

Novartis Investigative Site

Gwangju, 61469, South Korea

Location

Novartis Investigative Site

Seoul, 06591, South Korea

Location

Novartis Investigative Site

Badalona, Barcelona, 08916, Spain

Location

Novartis Investigative Site

Sabadell, Barcelona, 08208, Spain

Location

Novartis Investigative Site

Bilbao, Bizkaia, 48013, Spain

Location

Novartis Investigative Site

A Coruña, 15006, Spain

Location

Novartis Investigative Site

Madrid, 28034, Spain

Location

Novartis Investigative Site

Ankara, Bilkent Cankaya, 06800, Turkey (Türkiye)

Location

Novartis Investigative Site

Ankara, Sihhiye-Altindag, 06230, Turkey (Türkiye)

Location

Novartis Investigative Site

Ankara, Yenimahalle, 06500, Turkey (Türkiye)

Location

Novartis Investigative Site

Kocaeli, 41380, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sjogren's Syndrome

Interventions

ianalumab

Condition Hierarchy (Ancestors)

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; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2022
• First Posted: April 27, 2022
• Study Start: July 28, 2022
• Primary Completion: May 7, 2025
• Study Completion (Estimated): May 6, 2027
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

CN (11); PL (4); TU (4); KR (2); FR (7); CL (2); CZ (3); AU (2); PT (5); ME (2); US (14); BR (4); SG (1); ES (5); LI (1); DE (6); BE (1); GU (4)