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Uno studio clinico per valutare Ianalumab in partecipanti con sclerosi sistemica cutanea diffusa

12 ottobre 2026 aggiornato da: Novartis Pharmaceuticals

Uno studio multicentrico randomizzato, in doppio cieco, a gruppi paralleli, controllato con placebo per valutare l'efficacia, la sicurezza e la tollerabilità di Ianalumab nei partecipanti con sclerosi sistemica cutanea diffusa

The purpose of this study is to evaluate efficacy, safety and tolerability of s.c. ianalumab administered in participants with diffuse cutaneous systemic sclerosis relative to placebo

Panoramica dello studio

Stato

Attivo, non reclutante

Condizioni

Intervento / Trattamento

Descrizione dettagliata

The study consists of the following periods:

  • Screening Period, with a duration of up to 6 weeks;
  • Treatment Period 1, with a duration of 52 weeks;
  • Treatment Period 2 (Open-label treatment), with a duration of 52 weeks;
  • Post-treatment Follow-up Period, with a duration of at least 20 weeks post last dose and up to 2 years.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

201

Fase

  • Fase 2

Accesso esteso

A disposizione al di fuori della sperimentazione clinica. Vedi record di accesso esteso.

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Argentina
      • Caba, Argentina, C1015ABO
        • Novartis Investigative Site
      • Caba, Argentina, C1427CCL
        • Novartis Investigative Site
      • San Miguel de Tucumán, Argentina, T4000AXL
        • Novartis Investigative Site
    • Buenos Aires
      • CABA, Buenos Aires, Argentina, C1221ADC
        • Novartis Investigative Site
  • Austria
      • Graz, Austria, 8036
        • Novartis Investigative Site
  • Belgio
      • Leuven, Belgio, 3000
        • Novartis Investigative Site
  • Brasile
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brasile, 40150-150
        • Novartis Investigative Site
    • Paraná
      • Curitiba, Paraná, Brasile, 80030-110
        • Novartis Investigative Site
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brasile, 90035-074
        • Novartis Investigative Site
    • São Paulo
      • Sao Jose Rio Preto, São Paulo, Brasile, 15090-000
        • Novartis Investigative Site
      • São Paulo, São Paulo, Brasile, 04038-002
        • Novartis Investigative Site
  • Cina
      • Beijing, Cina, 100191
        • Novartis Investigative Site
      • Tianjin, Cina, 300052
        • Novartis Investigative Site
    • Guangxi
      • Nanning, Guangxi, Cina, 530021
        • Novartis Investigative Site
    • Henan
      • Zhengzhou, Henan, Cina, 450003
        • Novartis Investigative Site
    • Sichuan
      • Chengdu, Sichuan, Cina, 610041
        • Novartis Investigative Site
    • Zhejiang
      • Ningbo, Zhejiang, Cina, 315016
        • Novartis Investigative Site
  • Colombia
      • Bogotá, Colombia, 110231
        • Novartis Investigative Site
      • Medellín, Colombia, 050034
        • Novartis Investigative Site
    • Antioquia
      • Medellín, Antioquia, Colombia, 050001
        • Novartis Investigative Site
    • Cundinamarca
      • Bogota, Cundinamarca, Colombia, 110111
        • Novartis Investigative Site
      • Bogota, Cundinamarca, Colombia, 110221
        • Novartis Investigative Site
    • Valle del Cauca Department
      • Cali, Valle del Cauca Department, Colombia, 760012
        • Novartis Investigative Site
  • Corea del Sud
      • Seoul, Corea del Sud, 04763
        • Novartis Investigative Site
      • Seoul, Corea del Sud, 06273
        • Novartis Investigative Site
    • Seoul
      • Seoul, Seoul, Corea del Sud, 03080
        • Novartis Investigative Site
  • Francia
      • Dijon, Francia, 21000
        • Novartis Investigative Site
      • Le Mans, Francia, 72000
        • Novartis Investigative Site
      • Lille, Francia, 59037
        • Novartis Investigative Site
      • Montpellier, Francia, 34295
        • Novartis Investigative Site
      • Paris, Francia, 75014
        • Novartis Investigative Site
      • Rennes, Francia, 35033
        • Novartis Investigative Site
      • Strasbourg, Francia, 67000
        • Novartis Investigative Site
      • Toulouse, Francia, 31054
        • Novartis Investigative Site
  • Germania
      • Berlin, Germania, 13353
        • Novartis Investigative Site
    • Bavaria
      • Würzburg, Bavaria, Germania, 97080
        • Novartis Investigative Site
    • Thuringia
      • Jena, Thuringia, Germania, 07740
        • Novartis Investigative Site
  • Giappone
      • Hiroshima, Giappone, 7348551
        • Novartis Investigative Site
      • Ishikawa, Giappone, 9208641
        • Novartis Investigative Site
      • Kyoto, Giappone, 6068507
        • Novartis Investigative Site
    • Aichi-ken
      • Nagoya, Aichi-ken, Giappone, 4578510
        • Novartis Investigative Site
      • Toyoake, Aichi-ken, Giappone, 4701192
        • Novartis Investigative Site
    • Kanagawa
      • Yokohama, Kanagawa, Giappone, 2360004
        • Novartis Investigative Site
    • Saitama
      • Iruma-gun, Saitama, Giappone, 3500495
        • Novartis Investigative Site
    • Tokyo
      • Bunkyo-ku, Tokyo, Giappone, 1138603
        • Novartis Investigative Site
      • Shinjuku Ku, Tokyo, Giappone, 1628666
        • Novartis Investigative Site
    • Toyama
      • Toyama, Toyama, Giappone, 9300194
        • Novartis Investigative Site
  • Grecia
      • Alexandroupoli, Grecia, 681 00
        • Novartis Investigative Site
      • Athens, Grecia, 115 27
        • Novartis Investigative Site
      • Athens, Grecia, 115 21
        • Novartis Investigative Site
  • India
    • Kerala
      • Kochi, Kerala, India, 682018
        • Novartis Investigative Site
    • Maharashtra
      • Mumbai, Maharashtra, India, 400078
        • Novartis Investigative Site
    • National Capital Territory of Delhi
      • New Delhi, National Capital Territory of Delhi, India, 110060
        • Novartis Investigative Site
    • New Delhi
      • New Delhi, New Delhi, India, 110029
        • Novartis Investigative Site
    • Rajasthan
      • Jaipur, Rajasthan, India, 302004
        • Novartis Investigative Site
  • Italia
    • AN
      • Ancona, AN, Italia, 60020
        • Novartis Investigative Site
    • MI
      • Milan, MI, Italia, 20100
        • Novartis Investigative Site
      • Rozzano, MI, Italia, 20089
        • Novartis Investigative Site
    • MO
      • Modena, MO, Italia, 41124
        • Novartis Investigative Site
    • PA
      • Palermo, PA, Italia, 90127
        • Novartis Investigative Site
    • PV
      • Pavia, PV, Italia, 27100
        • Novartis Investigative Site
    • RM
      • Roma, RM, Italia, 00168
        • Novartis Investigative Site
    • VR
      • Verona, VR, Italia, 37134
        • Novartis Investigative Site
  • Malaysia
      • Kuala Lumpur, Malaysia, 59100
        • Novartis Investigative Site
    • Kuala Lumpur
      • Cheras, Kuala Lumpur, Malaysia, 56000
        • Novartis Investigative Site
  • Messico
    • Chihuahua
      • Chihuahua City, Chihuahua, Messico, 31000
        • Novartis Investigative Site
    • Jalisco
      • Guadalajara, Jalisco, Messico, 44650
        • Novartis Investigative Site
    • Mexico City
      • Mexico City, Mexico City, Messico, 11850
        • Novartis Investigative Site
    • Nuevo León
      • Monterrey, Nuevo León, Messico, 64460
        • Novartis Investigative Site
  • Polonia
      • Bydgoszcz, Polonia, 85-168
        • Novartis Investigative Site
      • Warsaw, Polonia, 00-874
        • Novartis Investigative Site
  • Portogallo
      • Vila Nova de Gaia, Portogallo, 4434-502
        • Novartis Investigative Site
  • Regno Unito
      • Bristol, Regno Unito, BS10 5NB
        • Novartis Investigative Site
      • London, Regno Unito, NW3 2QG
        • Novartis Investigative Site
  • Spagna
      • Barcelona, Spagna, 08041
        • Novartis Investigative Site
      • Madrid, Spagna, 28009
        • Novartis Investigative Site
      • Salamanca, Spagna, 37007
        • Novartis Investigative Site
    • Andalusia
      • Málaga, Andalusia, Spagna, 29009
        • Novartis Investigative Site
  • Stati Uniti
    • Arizona
      • Mesa, Arizona, Stati Uniti, 85202
        • Arizona Arthritis and Rheumatology Research PLLC
    • California
      • Los Angeles, California, Stati Uniti, 90095
        • UCLA
      • Newport Beach, California, Stati Uniti, 92663
        • Hoag Hospital
    • Florida
      • Clearwater, Florida, Stati Uniti, 33765
        • Clinical Res Of W Florida
      • Cooper City, Florida, Stati Uniti, 33024
        • GNP Research
      • Plantation, Florida, Stati Uniti, 33324
        • IRIS Research and Development
      • Sarasota, Florida, Stati Uniti, 34239
        • Sarasota Arthritis Res Ctr
    • Illinois
      • Chicago, Illinois, Stati Uniti, 60637
        • University of Chicago Hospitals
    • Michigan
      • Ann Arbor, Michigan, Stati Uniti, 48109
        • Uni Of Michigan Health System
    • New York
      • New York, New York, Stati Uniti, 10021
        • Hospital for Special Surgery
    • Tennessee
      • Jackson, Tennessee, Stati Uniti, 38305
        • West Tennessee Research Institute
    • Texas
      • Bellaire, Texas, Stati Uniti, 77401
        • Novel Research LLC
      • Frisco, Texas, Stati Uniti, 75035
        • Arthritis and Rheumatology Ins
      • Houston, Texas, Stati Uniti, 77054
        • Prolato Clinical Research Center
  • Tailandia
      • Bangkok, Tailandia, 10400
        • Novartis Investigative Site
    • THA
      • Khon Kaen, THA, Tailandia, 40002
        • Novartis Investigative Site
  • Taiwan
      • Changhua, Taiwan, 50006
        • Novartis Investigative Site
      • Kaohsiung City, Taiwan, 833
        • Novartis Investigative Site
      • Taichung, Taiwan, 40447
        • Novartis Investigative Site
      • Taoyuan, Taiwan, 33305
        • Novartis Investigative Site
  • Turchia (Türkiye)
    • Fatih
      • Istanbul, Fatih, Turchia (Türkiye), 34093
        • Novartis Investigative Site
    • Sihhiye Altindag
      • Ankara, Sihhiye Altindag, Turchia (Türkiye), 06230
        • Novartis Investigative Site
    • Yenimahalle
      • Ankara, Yenimahalle, Turchia (Türkiye), 06500
        • Novartis Investigative Site
  • Ungheria
      • Budapest, Ungheria, 1083
        • Novartis Investigative Site
    • Baranya
      • Pécs, Baranya, Ungheria, 7623
        • Novartis Investigative Site
    • Hajdu Bihar Megye
      • Debrecen, Hajdu Bihar Megye, Ungheria, 4032
        • Novartis Investigative Site
  • Vietnam
      • Ho Chi Minh City, Vietnam, 700000
        • Novartis Investigative Site
    • VNM
      • Ho Chi Minh City, VNM, Vietnam, 700000
        • Novartis Investigative Site

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 70 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Key Inclusion Criteria:

  • Male and female participants >= 18 and =< 70 years (at the time of the screening visit).

  • Diagnosis of systemic sclerosis, as defined by the 2013 American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) classification criteria for SSc (van den Hoogen et al 2013) and meet the dcSSc subset classification according to LeRoy (LeRoy 1988)

  • Disease duration of =< 60 months (defined as time from the first non-Raynaud phenomenon manifestation, e.g., puffy hands, scleroderma, digital ulcers, arthralgia, dyspnea)

  • mRSS units of >= 15 and =< 45 at the time of the screening visit

  • Active disease that meets at least one of the following criteria at screening:

    • Disease duration of =< 18 months defined as time from the first non-Raynaud phenomenon manifestation
    • Increase in mRSS of >= 3 units compared with the most recent assessment performed within the previous 6 months
    • Involvement of one new body area and an increase in mRSS of >= 2 units compared with the most recent assessment performed within the previous 6 months
    • Involvement of two new body areas within the previous 6 months
    • Elevated acute phase reactants (ESR) >= 30 mm/hr or high-sensitivity C-reactive protein (hsCRP) >= 6 mg/L)
    • Presence of SSc-interstitial lung disease (ILD) and ATA autoantibody positivity
    • Modified EUSTAR disease activity index (mDAI) ≥ 2.5

  • Participant must be positive for at least one of the following autoantibodies:

    • anti-topoisomerase I (ATA) (also known as anti-SCL-70)
    • anti-RNA polymerase III (anti-RNAP3)
    • anti-nuclear antibody (ANA) (≥ 1:80) Participants who are positive only for ANA (while being negative for both ATA /anti-RNAP3) will be limited to 30% of the overall randomized study population.

Key Exclusion Criteria:

  • Rheumatic disease other than dcSSc, including limited cutaneous disease (lcSSc) or sine scleroderma at the screening visit. Secondary Sjogren's disease and scleroderma myopathy are not exclusionary.
  • Positive anti-centromere antibody (ACA+) without positive ATA or anti-RNAP3 autoantibody result at the screening visit
  • Previous improvement (decrease) in mRSS > 10 units
  • Pulmonary disease with FVC ≤ 50% of predicted or diffusing capacity of the lung for carbon monoxide (DLCO, corrected for hemoglobin) ≤ 40% of predicted at the screening visit
  • WHO Functional Class 3 or higher assessment for pulmonary arterial hypertension (PAH, as defined on right heart catheterization), receiving IV therapy for PAH or evidence of other moderately severe pulmonary disease
  • Participants treated with cyclophosphamide within 12 weeks prior to Baseline.
  • Prior use of a B-cell depleting therapy other than ianalumab (e.g., rituximab, other anti-CD20 mAb, anti-CD22 mAb, or anti-CD52 mAb) administered 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 B cell-depleting therapy (whichever is lower).
  • Treatment with biologic agents, such as intravenous immunoglobulin or monoclonal antibodies, including marketed drugs, within 12 weeks or 5 half-lives (whichever is longer) prior to baseline visit, unless explicitly allowed in inclusion criteria.
  • Treatment with any investigational agent within ≤ 4 weeks (or 5 half-lives of the investigational drug, whichever is longer) of the baseline visit.
  • Use of anti-fibrotic agents including colchicine, D-penicillamine, pirfenidone, or tyrosine kinase inhibitors (e.g., nintedanib, nilotinib, imatinib, dasatinib) in the 4 weeks prior to baseline visit. Patients with SSc-ILD requiring antifibrotics for management of ILD during the study, as per investigator judgement, should be excluded.
  • Previous treatment with chlorambucil, bone marrow transplantation or total lymphoid irradiation.
  • Women of childbearing potential, defined as all women physiologically capable of becoming pregnant from menarche until becoming post-menopausal, unless they are using highly effective methods of contraception (failure rate < 1% per year) while taking study treatment and for 6 months after stopping study treatment.

Other protocol-defined inclusion/exclusion criteria may apply.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: VAY736 (Ianalumab)

Treatment Period 1:

Ianalumab subcutaneous (s.c.) injection as defined in the protocol

Treatment Period 2:

Open-label (OL) Ianalumab subcutaneous (s.c.) injection as defined in the protocol
Droga: Ianalumab

subcutaneous (s.c.) injection as defined in the protocol

Altri nomi:
  • VAY736
Comparatore placebo: Placebo

Treatment Period 1:

Placebo to Ianalumab subcutaneous (s.c.) injection as defined in the protocol

Treatment Period 2:

Open-label (OL) Ianalumab subcutaneous (s.c.) injection as defined in the protocol
Droga: Ianalumab

subcutaneous (s.c.) injection as defined in the protocol

Altri nomi:
  • VAY736
Droga: Placebo

Ianalumab matching placebo subcutaneous (s.c.) injection as defined in the protocol

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
3/5 rCRISS25 response
Lasso di tempo: Week 52

To demonstrate the superiority of ianalumab, compared to placebo, in achieving 3/5 Revised Composite Response Index in Systemic Sclerosis 25 (rCRISS25) response at Week 52
Week 52

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from baseline in FVC% predicted at Week 52
Lasso di tempo: Week 52

To demonstrate the superiority of ianalumab, compared to placebo, on change from baseline in percent-predicted forced vital capacity (FVC%) at Week 52
Week 52
Change from baseline in mRSS at Week 52
Lasso di tempo: Week 52

To demonstrate the superiority of ianalumab, compared to placebo, on change from baseline in modified Rodnan Skin Score (mRSS) at Week 52
Week 52
Change from baseline in HAQ-DI at Week 52
Lasso di tempo: Week 52

To demonstrate the superiority of ianalumab, compared to placebo, on change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 52
Week 52
Ianalumab concentrations in serum during treatment and Follow-up Period
Lasso di tempo: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52, Week 64, Week 76, Week 88, Week 104, Week 108, Week 112, Week 116, Week 120, Week 124 and Week 208

To assess the pharmacokinetics of ianalumab
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52, Week 64, Week 76, Week 88, Week 104, Week 108, Week 112, Week 116, Week 120, Week 124 and Week 208
Incidence and titer of anti-drug (ianalumab) antibodies (ADAs) in serum over time
Lasso di tempo: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52, Week 64, Week 76, Week 88, Week 104, Week 124, Week 208

To evaluate the immunogenicity of ianalumab
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52, Week 64, Week 76, Week 88, Week 104, Week 124, Week 208
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Lasso di tempo: Up to Week 208

The distribution of adverse events for ianalumab will be done via the analysis of frequencies for Adverse Event (AEs) and Serious Adverse Event (SAEs) through the monitoring of relevant clinical and laboratory safety parameters.
Up to Week 208

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Novartis Pharmaceuticals

Investigatori

  • Direttore dello studio: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

9 ottobre 2024

Completamento primario (Stimato)

30 luglio 2027

Completamento dello studio (Stimato)

31 luglio 2034

Date di iscrizione allo studio

Primo inviato

17 giugno 2024

Primo inviato che soddisfa i criteri di controllo qualità

17 giugno 2024

Primo Inserito (Effettivo)

24 giugno 2024

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

13 ottobre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

12 ottobre 2026

Ultimo verificato

1 ottobre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CVAY736S12201
  • 2024-511933-36-00 (Identificatore di registro: EU CT number)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano 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

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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