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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)

7. september 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

570

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

  • Navn: Novartis Pharmaceuticals
  • Telefonnummer: +41613241111

Studiesteder

  • Australien
    • Queensland
      • Maroochydore, Queensland, Australien, 4558
        • Rekruttering
        • Novartis Investigative Site
  • Canada
    • Quebec
      • Rimouski, Quebec, Canada, G5L 5T1
        • Rekruttering
        • Novartis Investigative Site
  • Forenede Stater
    • Arizona
      • Peoria, Arizona, Forenede Stater, 85381
        • Rekruttering
        • Sun Valley Arthritis Center Ltd
        • Ledende efterforsker:
          • Joy Schechtman
        • Kontakt:
    • Florida
      • Clearwater, Florida, Forenede Stater, 33765
        • Rekruttering
        • Clinical Res Of W Florida
        • Ledende efterforsker:
          • Rodney Daniel
        • Kontakt:
          • Bridget Ben-Hayon
          • Telefonnummer: +1 727 466 0078
          • E-mail: bben@crwf.com
      • Tampa, Florida, Forenede Stater, 33606
        • Rekruttering
        • Clinical Research of West Florida Inc
        • Ledende efterforsker:
          • John Carter
        • Kontakt:
    • Illinois
      • Willowbrook, Illinois, Forenede Stater, 60527
        • Rekruttering
        • Willow Rheumatology Wellness
        • Ledende efterforsker:
          • Angela R Crowley
        • Kontakt:
    • Michigan
      • Saint Clair Shores, Michigan, Forenede Stater, 48081
        • Rekruttering
        • Clinical Research Inst of MI
        • Ledende efterforsker:
          • Andrew Sulich
        • Kontakt:
    • North Carolina
      • Charlotte, North Carolina, Forenede Stater, 28202
        • Rekruttering
        • On Site Clinical Solutions Llc
        • Ledende efterforsker:
          • Rakesh C Patel
        • Kontakt:
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73116
        • Rekruttering
        • RAO Research LLC
        • Kontakt:
        • Ledende efterforsker:
          • John Goetzinger
    • Tennessee
      • Jackson, Tennessee, Forenede Stater, 38305
        • Rekruttering
        • West Tennessee Research Institute
        • Ledende efterforsker:
          • Jacob A Aelion
        • Kontakt:
      • Memphis, Tennessee, Forenede Stater, 38119
        • Rekruttering
        • Shelby Research LLC
        • Ledende efterforsker:
          • Ramesh C Gupta
        • Kontakt:
    • Texas
      • Bellaire, Texas, Forenede Stater, 77401
        • Rekruttering
        • Novel Research LLC
        • Ledende efterforsker:
          • Wajeeha Yousaf
        • Kontakt:
      • Corpus Christi, Texas, Forenede Stater, 78415
        • Rekruttering
        • Arthritis Care of Texas
        • Kontakt:
        • Ledende efterforsker:
          • Eric Ping Chiang
      • Euless, Texas, Forenede Stater, 76040
        • Rekruttering
        • Precision Comprehensive Clinical Research Solutions
        • Ledende efterforsker:
          • Renuka Basavaraju
        • Kontakt:
      • Houston, Texas, Forenede Stater, 77024
        • Rekruttering
        • Abigail Neiman MD PA
        • Ledende efterforsker:
          • Abigail Neiman
        • Kontakt:
      • League City, Texas, Forenede Stater, 77573
      • Leander, Texas, Forenede Stater, 78641
        • Rekruttering
        • TEKTON
        • Ledende efterforsker:
          • Paul K Pickrell
        • Kontakt:
    • Washington
      • Spokane, Washington, Forenede Stater, 99216
        • Rekruttering
        • Arthritis Northwest PLLC
        • Ledende efterforsker:
          • Michael C Coan
        • Kontakt:
  • Sydkorea
      • Gwangju, Sydkorea, 61469
        • Rekruttering
        • Novartis Investigative Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: VAY736 - 300 mg
VAY736 once monthly solution for injection for subcutaneous use.
Medicin: VAY736
VAY736 once monthly solution for injection for subcutaneous use.
Andre navne:
  • ianalumab
Placebo komparator: Placebo
Placebo once monthly solution for injection for subcutaneous use.
Medicin: Placebo
Placebo once monthly solution for injection for subcutaneous use.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from baseline in SSSD oral dryness score
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from baseline in SSSD summary score
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Novartis Pharmaceuticals

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

16. juli 2026

Primær færdiggørelse (Anslået)

14. august 2029

Studieafslutning (Anslået)

13. august 2033

Datoer for studieregistrering

Først indsendt

26. maj 2026

Først indsendt, der opfyldte QC-kriterier

26. maj 2026

Først opslået (Faktiske)

2. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CVAY736A22301
  • 2025 (U.S. NIH-bevilling/kontrakt: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 2025-522271-29-00 (Anden identifikator: EU CTR)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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