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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 uppdaterad 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

570

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

  • Namn: Novartis Pharmaceuticals
  • Telefonnummer: +41613241111

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Trippel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: VAY736 - 300 mg
VAY736 once monthly solution for injection for subcutaneous use.
Läkemedel: VAY736
VAY736 once monthly solution for injection for subcutaneous use.
Andra namn:
  • ianalumab
Placebo-jämförare: Placebo
Placebo once monthly solution for injection for subcutaneous use.
Läkemedel: Placebo
Placebo once monthly solution for injection for subcutaneous use.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change from baseline in SSSD oral dryness score
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change from baseline in SSSD summary score
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Novartis Pharmaceuticals

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

16 juli 2026

Primärt slutförande (Beräknad)

14 augusti 2029

Avslutad studie (Beräknad)

13 augusti 2033

Studieregistreringsdatum

Först inskickad

26 maj 2026

Först inskickad som uppfyllde QC-kriterierna

26 maj 2026

Första postat (Faktisk)

2 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

9 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

7 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

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

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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