Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Antatt)

570

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

  • Navn: Novartis Pharmaceuticals
  • Telefonnummer: +41613241111

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: VAY736 - 300 mg
VAY736 once monthly solution for injection for subcutaneous use.
Legemiddel: VAY736
VAY736 once monthly solution for injection for subcutaneous use.
Andre navn:
  • ianalumab
Placebo komparator: Placebo
Placebo once monthly solution for injection for subcutaneous use.
Legemiddel: Placebo
Placebo once monthly solution for injection for subcutaneous use.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Novartis Pharmaceuticals

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

16. juli 2026

Primær fullføring (Antatt)

14. august 2029

Studiet fullført (Antatt)

13. august 2033

Datoer for studieregistrering

Først innsendt

26. mai 2026

Først innsendt som oppfylte QC-kriteriene

26. mai 2026

Først lagt ut (Faktiske)

2. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

7. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (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

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere