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Two Arm, Double-blind, Phase III Study Assessing Efficacy and Safety of Ianalumab Versus Placebo, in Participants With Sjögren's Disease With High Symptom Burden (THALASSA)

17 de agosto de 2026 actualizado por: Novartis Pharmaceuticals

A Randomized, Double-blind, Placebo-controlled, 2-arm Multicenter Phase III Study to Assess the Efficacy and Safety of Ianalumab in Participants With Sjogren's Disease With High Symptom Burden (THALASSA)

The purpose of this study is to demonstrate the efficacy and safety of ianalumab (VAY736) 300 mg administered subcutaneously (s.c.) monthly for 52 weeks in adult participants with Sjögren's disease who have high symptom burden.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

This is a double-blind, randomized, placebo-controlled multicenter 2-arm Phase III study, evaluating 300 mg ianalumab s.c. against placebo s.c. in adult participants with Sjögren's disease with high symptom burden.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

570

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

  • Nombre: Novartis Pharmaceuticals
  • Número de teléfono: +41613241111

Ubicaciones de estudio

  • Australia
    • Queensland
      • Maroochydore, Queensland, Australia, 4558
        • Reclutamiento
        • Novartis Investigative Site
  • Canadá
    • Quebec
      • Rimouski, Quebec, Canadá, G5L 5T1
        • Reclutamiento
        • Novartis Investigative Site
  • Estados Unidos
    • Arizona
      • Peoria, Arizona, Estados Unidos, 85381
        • Reclutamiento
        • Sun Valley Arthritis Center Ltd
        • Investigador principal:
          • Joy Schechtman
        • Contacto:
    • Florida
      • Clearwater, Florida, Estados Unidos, 33765
        • Reclutamiento
        • Clinical Res Of W Florida
        • Investigador principal:
          • Rodney Daniel
        • Contacto:
          • Bridget Ben-Hayon
          • Número de teléfono: +1 727 466 0078
          • Correo electrónico: bben@crwf.com
      • Tampa, Florida, Estados Unidos, 33606
        • Reclutamiento
        • Clinical Research of West Florida Inc
        • Investigador principal:
          • John Carter
        • Contacto:
          • Sydney K Mullen
          • Número de teléfono: +1 813 870 1292
          • Correo electrónico: smullen@crwf.com
    • Michigan
      • Saint Clair Shores, Michigan, Estados Unidos, 48081
        • Reclutamiento
        • Clinical Research Inst of MI
        • Investigador principal:
          • Andrew Sulich
        • Contacto:
    • North Carolina
      • Charlotte, North Carolina, Estados Unidos, 28202
        • Reclutamiento
        • On Site Clinical Solutions Llc
        • Investigador principal:
          • Rakesh C Patel
        • Contacto:
    • Oklahoma
      • Oklahoma City, Oklahoma, Estados Unidos, 73116
        • Reclutamiento
        • RAO Research LLC
        • Contacto:
        • Investigador principal:
          • John Goetzinger
    • Texas
      • Bellaire, Texas, Estados Unidos, 77401
        • Reclutamiento
        • Novel Research LLC
        • Investigador principal:
          • Wajeeha Yousaf
        • Contacto:
      • Corpus Christi, Texas, Estados Unidos, 78415
        • Reclutamiento
        • Arthritis Care of Texas
        • Contacto:
        • Investigador principal:
          • Eric Ping Chiang
      • Euless, Texas, Estados Unidos, 76040
        • Reclutamiento
        • Precision Comprehensive Clinical Research Solutions
        • Investigador principal:
          • Renuka Basavaraju
        • Contacto:
      • Houston, Texas, Estados Unidos, 77024
        • Reclutamiento
        • Abigail Neiman MD PA
        • Investigador principal:
          • Abigail Neiman
        • Contacto:
      • League City, Texas, Estados Unidos, 77573
        • Reclutamiento
        • Accurate Clinical Research
        • Investigador principal:
          • Sabeen Najam
        • Contacto:
      • Leander, Texas, Estados Unidos, 78641
        • Reclutamiento
        • TEKTON
        • Investigador principal:
          • Paul K Pickrell
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • Male or female participants ≥ 18 years of age or as per country-specific legal adult age, whichever is higher
  • Classification of Sjögren's disease according to ACR/EULAR 2016 criteria.
  • Seropositive for anti-Ro/SSA antibodies at screening
  • SSSD oral dryness score ≥ 5 and overall SSSD summary score ≥5 collected over 14 consecutive days during the Screening 2 period
  • Screening ESSDAI biologic and/or hematologic domain > 0 Note: laboratory abnormalities for scoring must be confirmed as associated with Sjögren's disease and not be due to other underlying conditions.
  • Stimulated whole salivary flow (sSF) rate > 0.3 mL/min at screening
  • Participants taking hydroxychloroquine (≤ 400 mg/day) are allowed to continue their medication, and must have been on a stable dose for at least 4 weeks prior to screening, which should be maintained throughout the 52 weeks of the blinded treatment period.
  • Predniso(lo)ne ≤ 5 mg/day or equivalent are allowed for up to 16 weeks post-randomization.

Exclusion Criteria:

  • Presence of another autoimmune rheumatic disease that is active and constitutes the principal illness, specifically:
  • Systemic sclerosis (SSc)
  • Any other associated connective tissue disease (e.g., lupus nephritis (LN), large vessel vasculitis (LVV), Sharp syndrome (mixed connective tissue disease)) that is active and requires immunosuppressive treatment outside the scope of this trial and would impede on Sjögren's disease organ domain assessments.
  • Concurrent diagnosis or history of fibromyalgia or overlapping inflammatory diseases
  • Prior treatment with B-cell-depleting therapy (e.g., rituximab, other anti-CD20 mAb, anti-CD22 mAb, or anti-CD52 mAb) within:
  • 36 weeks prior to randomization, or
  • As long as B-cell count is less than the lower limit of normal (LLN) or baseline value prior to receipt of previous B-cell-depleting therapy (whichever is lower) at Screening.
  • Prior treatment with ianalumab
  • Prior treatment with any of the following within the given period prior to Screening:
  • Within 5 half-lives prior to Screening: iscalimab (anti-CD 40 mAb), belimumab (anti-BAFF mAb), abatacept (CTLA4-Fc Ig), anti-tumor necrosis factor alpha (TNFα) biologic agents, immunoglobulins (i.v./s.c.), plasmapheresis, any other investigational biologic medicines under investigation for Sjögren's disease
  • Within 4 weeks OR drug-specific 5 half-lives elimination period (if longer than 4 weeks) prior to screening: i.v. or oral cyclophosphamide, mycophenolate mofetil (MMF), methotrexate, azathioprine, i.v. or oral cyclosporine A or any other immunosuppressants (e.g., JAK inhibitors or other kinase inhibitors).
  • History of hypersensitivity to any of the study drugs or their 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).

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: VAY736 - 300 mg
VAY736 once monthly solution for injection for subcutaneous use.
Droga: VAY736
VAY736 once monthly solution for injection for subcutaneous use.
Otros nombres:
  • ianalumab
Comparador de placebos: Placebo
Placebo once monthly solution for injection for subcutaneous use.
Droga: Placebo
Placebo once monthly solution for injection for subcutaneous use.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change from baseline in SSSD oral dryness score
Periodo de tiempo: Baseline to Week 52
The Sjögren's Syndrome Symptom Diary (SSSD) oral dryness score is a patient-reported measure assessing severity of mouth dryness. The mouth dryness symptom is scored daily on a numerical scale (higher scores = worse symptoms).
Baseline to Week 52

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change from baseline in SSSD summary score
Periodo de tiempo: Baseline to Week 52
The SSSD summary score is calculated over a defined time window. Each symptom is scored daily on a numerical scale (higher scores = worse symptoms).
Baseline to Week 52
Change from baseline in ESSPRI score
Periodo de tiempo: Baseline to Week 52
The EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) score is a validated patient-reported outcome assessing three symptom domains: dryness, pain and fatigue. Scores range from 0 (no symptoms) to 10 (worst imaginable symptoms).
Baseline to Week 52
Change from baseline in stimulated whole salivary flow (sSF)
Periodo de tiempo: Baseline to Week 52
The stimulated whole salivary flow rate, is an objective functional assessment of salivary gland activity, measuring saliva production under stimulation. Higher values indicate better salivary gland function.
Baseline to Week 52
Change from baseline in Patient's Global Assessment (PaGA) NRS score
Periodo de tiempo: Baseline to Week 52
The Patient's Global Assessment of disease activity captures the patient's overall perception of disease activity. It is assessed using a Numerical Rating Scale (NRS) from 0 to 10. Higher scores indicate worse perceived disease activity.
Baseline to Week 52
Proportion of participants achieving SSSD response
Periodo de tiempo: Week 52
Proportion of participants achieving a clinically meaningful improvement in the SSSD summary score at Week 52.
Week 52
Proportion of participants achieving ESSPRI response
Periodo de tiempo: Week 52
Proportion of participants achieving a clinically meaningful improvement in the ESSPRI score at Week 52.
Week 52
Change from baseline in SSSD eye dryness score
Periodo de tiempo: Baseline to Week 52
The SSSD eye dryness item score is a patient-reported measure assessing severity of eye dryness. The eye dryness symptom is scored daily on a numerical scale (higher scores = worse symptoms).
Baseline to Week 52
Change from baseline in FACIT-Fatigue score
Periodo de tiempo: Baseline to Week 52
The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) score is a 13-item questionnaire assessing fatigue and its impact on daily activities over the previous 7 days. Higher scores indicate less fatigue / better functioning.
Baseline to Week 52
Change from baseline in Sjögren's-Related Quality of Life (SRQoL) score
Periodo de tiempo: Baseline to Week 52
The Sjögren's-Related Quality of Life (SRQoL) score is a disease-specific quality-of-life instrument evaluating the impact of Sjögren's disease on physical, emotional, social and daily functioning. Lower scores indicate better quality of life.
Baseline to Week 52

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Novartis Pharmaceuticals

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

16 de julio de 2026

Finalización primaria (Estimado)

14 de agosto de 2029

Finalización del estudio (Estimado)

13 de agosto de 2033

Fechas de registro del estudio

Enviado por primera vez

26 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

26 de mayo de 2026

Publicado por primera vez (Actual)

2 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

18 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

17 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • CVAY736A22301
  • 2025-522271-29-00 (Otro identificador: EU CTR)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect 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

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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