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Studio sulla sicurezza e l'efficacia di dosi multiple di CFZ533 in due distinte popolazioni di pazienti con sindrome di Sjögren (TWINSS)

23 aprile 2026 aggiornato da: Novartis Pharmaceuticals

Uno studio multicentrico di 48 settimane, a 6 bracci, randomizzato, in doppio cieco, controllato con placebo per valutare la sicurezza e l'efficacia di dosi multiple di CFZ533 somministrate per via sottocutanea in due distinte popolazioni di pazienti con sindrome di Sjögren (TWINSS)

Questo studio valuterà la sicurezza, l'efficacia, la farmacocinetica (PK) e la farmacodinamica (PD) di dosi multiple di CFZ533 (iscalimab) in pazienti con sindrome di Sjögren.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Questo è uno studio multicentrico in doppio cieco, randomizzato, controllato con placebo su CFZ533 in 2 distinte popolazioni (coorti) di pazienti con sindrome di Sjögren: 1) malattia da moderata a grave (coinvolgimento sistemico e sintomatico) e; 2) basso coinvolgimento sistemico ma alto carico di sintomi.

Lo studio include un periodo di screening fino a 6 settimane, 48 settimane di trattamento (suddivise in periodi di trattamento di 24 settimane ciascuno) e 12 settimane di follow-up. Il trattamento in studio verrà somministrato mediante iniezioni sottocutanee bisettimanali.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

273

Fase

  • Fase 2

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
      • Buenos Aires, Argentina, C1055AAF
        • Novartis Investigative Site
      • CABA, Argentina, 1426
        • Novartis Investigative Site
  • Australia
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Novartis Investigative Site
  • Austria
      • Graz, Austria, 8036
        • Novartis Investigative Site
      • Vienna, Austria, 1090
        • Novartis Investigative Site
  • Brasile
    • Espírito Santo
      • Vitória, Espírito Santo, Brasile, 29055 450
        • Novartis Investigative Site
    • Minas Gerais
      • Juiz de Fora, Minas Gerais, Brasile, 36010 570
        • Novartis Investigative Site
    • São Paulo
      • São Paulo, São Paulo, Brasile, 01244-030
        • Novartis Investigative Site
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T 2S8
        • Novartis Investigative Site
    • Quebec
      • Rimouski, Quebec, Canada, G5L 5T1
        • Novartis Investigative Site
      • Trois-Rivières, Quebec, Canada, G9A 3Y2
        • Novartis Investigative Site
  • Chile
      • Concepción, Chile, 6740
        • Novartis Investigative Site
    • Los Ríos Region
      • Valdivia, Los Ríos Region, Chile, 5110683
        • Novartis Investigative Site
    • RM
      • Santiago, RM, Chile, 7500588
        • Novartis Investigative Site
    • Santiago Metropolitan
      • Santiago, Santiago Metropolitan, Chile, 7500571
        • Novartis Investigative Site
      • Santiago, Santiago Metropolitan, Chile, 7500710
        • Novartis Investigative Site
  • Colombia
    • Antioquia
      • Medellín, Antioquia, Colombia, 050001
        • Novartis Investigative Site
    • Atlántico
      • Barranquilla, Atlántico, Colombia, 080002
        • Novartis Investigative Site
    • Valle del Cauca Department
      • Cali, Valle del Cauca Department, Colombia, 760012
        • Novartis Investigative Site
  • Corea del Sud
    • Seocho Gu
      • Seoul, Seocho Gu, Corea del Sud, 06591
        • Novartis Investigative Site
  • Francia
      • Brest, Francia, 29200
        • Novartis Investigative Site
      • Le Kremlin-Bicêtre, Francia, 94275
        • Novartis Investigative Site
      • Lille, Francia, 59037
        • Novartis Investigative Site
      • Paris, Francia, 75014
        • Novartis Investigative Site
      • Strasbourg, Francia, 67000
        • Novartis Investigative Site
  • Germania
      • Bonn, Germania, 53105
        • Novartis Investigative Site
    • Baden-Wurttemberg
      • Freiburg im Breisgau, Baden-Wurttemberg, Germania, 79106
        • Novartis Investigative Site
    • Bavaria
      • Würzburg, Bavaria, Germania, 97080
        • Novartis Investigative Site
    • Saxony
      • Dresden, Saxony, Germania, 01307
        • Novartis Investigative Site
  • Giappone
    • Aichi-ken
      • Nagoya, Aichi-ken, Giappone, 457 8510
        • Novartis Investigative Site
    • Nagasaki
      • Sasebo, Nagasaki, Giappone, 857-1195
        • Novartis Investigative Site
    • Okayama-ken
      • Kurashiki, Okayama-ken, Giappone, 710-0824
        • Novartis Investigative Site
    • Tokyo
      • Chuo Ku, Tokyo, Giappone, 104 8560
        • Novartis Investigative Site
      • Shinjuku-ku, Tokyo, Giappone, 160 8582
        • Novartis Investigative Site
  • Grecia
      • Athens, Grecia, 115 27
        • Novartis Investigative Site
  • Israele
      • Haifa, Israele, 3104802
        • Novartis Investigative Site
      • Kfar Saba, Israele, 4428164
        • Novartis Investigative Site
      • Ramat Gan, Israele, 5265601
        • Novartis Investigative Site
  • Italia
    • MI
      • Milan, MI, Italia, 20132
        • Novartis Investigative Site
    • PI
      • Pisa, PI, Italia, 56126
        • Novartis Investigative Site
    • UD
      • Udine, UD, Italia, 33100
        • Novartis Investigative Site
  • Olanda
      • Groningen, Olanda, 9713 GZ
        • Novartis Investigative Site
    • South Holland
      • Rotterdam, South Holland, Olanda, 3015 GD
        • Novartis Investigative Site
  • Portogallo
      • Almada, Portogallo, 2805-267
        • Novartis Investigative Site
      • Lisbon, Portogallo, 1649-035
        • Novartis Investigative Site
      • Lisbon, Portogallo, 1050-034
        • Novartis Investigative Site
      • Ponte de Lima, Portogallo, 4990 041
        • Novartis Investigative Site
  • Regno Unito
      • Birmingham, Regno Unito, B15 2TH
        • Novartis Investigative Site
      • Doncaster, Regno Unito, DN2 5LT
        • Novartis Investigative Site
      • Manchester, Regno Unito, M13 9WL
        • Novartis Investigative Site
  • Romania
      • Brasov, Romania, 500283
        • Novartis Investigative Site
      • Cluj-Napoca, Romania, 400006
        • Novartis Investigative Site
  • Russia
      • Kazan', Russia, 420097
        • Novartis Investigative Site
      • Moscow, Russia, 115522
        • Novartis Investigative Site
      • Orenburg, Russia, 460000
        • Novartis Investigative Site
      • Saint Petersburg, Russia, 195257
        • Novartis Investigative Site
      • Tomsk, Russia, 634009
        • Novartis Investigative Site
      • Yekaterinburg, Russia, 620028
        • Novartis Investigative Site
  • Stati Uniti
    • Georgia
      • Suwanee, Georgia, Stati Uniti, 30024
        • North GA Rheumatology Group PC
    • Indiana
      • Indianapolis, Indiana, Stati Uniti, 46202
        • Indiana Univ School of Dentistry
    • Louisiana
      • Baton Rouge, Louisiana, Stati Uniti, 70809
        • Ochsner Health System
    • Maryland
      • Baltimore, Maryland, Stati Uniti, 21224
        • The John Hopkins Jerome L Greene Sjogren
    • Massachusetts
      • Boston, Massachusetts, Stati Uniti, 02111
        • Tufts School of Dental Medicine
    • New York
      • Mineola, New York, Stati Uniti, 11501
        • Winthrop University Hospital
    • Pennsylvania
      • Philadelphia, Pennsylvania, Stati Uniti, 19104
        • Perelman School of Medicine
    • Wisconsin
      • Madison, Wisconsin, Stati Uniti, 53792
        • Uni Wisconsin School Med Pub Health
  • Svezia
    • SE
      • Stockholm, SE, Svezia, 113 65
        • Novartis Investigative Site
  • Turchia (Türkiye)
    • Yenimahalle
      • Ankara, Yenimahalle, Turchia (Türkiye), 06500
        • Novartis Investigative Site
  • Ungheria
      • Budapest, Ungheria, 1023
        • Novartis Investigative Site
      • Szeged, Ungheria, 6720
        • Novartis Investigative Site
    • Fejér
      • Székesfehérvár, Fejér, Ungheria, 8000
        • 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

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Descrizione

Criterio di inclusione:

  • Consenso informato firmato
  • Paziente maschio o femmina ≥ 18 anni di età
  • Classificazione della sindrome di Sjögren secondo i criteri ACR/EULAR 2016 (Shiboski et al 2017)
  • Sieropositivo per anticorpi anti-Ro/SSA
  • Flusso salivare intero stimolato di ≥ 0,1 ml/min

Criteri di inclusione specifici per la Coorte 1:

  • ESSDAI ≥ 5 all'interno degli 8 domini di organi predefiniti
  • Punteggio ESSPRI ≥5

Criteri di inclusione specifici per la coorte 2:

  • ESSDAI <5 entro 8 domini valutati per il criterio di inclusione per la coorte 1
  • Punteggio secondario di fatica ESSPRI ≥ 5 o punteggio secondario di secchezza ESSPRI ≥ 5

Criteri di esclusione:

  • La sindrome di Sjögren si sovrappone a sindromi in cui un'altra malattia reumatica autoimmune costituisce la malattia principale
  • Uso di altri farmaci sperimentali
  • Uso precedente di terapie di deplezione delle cellule B, abatacept o qualsiasi altro immunosoppressore a meno che non sia specificamente consentito dal protocollo.
  • Uso di steroidi a dosi >10 mg/die.
  • Rosacea oculare incontrollata (che colpisce gli annessi oculari), blefarite posteriore o malattia della ghiandola di Meibomio (questo criterio si applica solo ai pazienti considerati per la Coorte 2)
  • Infezioni virali, batteriche o di altro tipo attive che richiedono un trattamento sistemico
  • Ricezione di vaccino vivo/attenuato entro un periodo di 2 mesi prima della randomizzazione.
  • Infezione cronica da epatite B (HBV) o epatite C (HCV).
  • Evidenza di infezione da tubercolosi attiva (TB).

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: Cohort 1 / Arm A
3 weekly subcutaneous (s.c.) loading doses of iscalimab were 600 mg on Weeks 0, 1 and 2. From Week 2 and up to Week 46 (last dose), iscalimab was administered s.c. bi-weekly at 600 mg. To maintain blinding in Period 2, placebo was administered at Week 25.
Droga: CFZ533
Biologico
Altri nomi:
  • iscalimab
Sperimentale: Cohort 1 / Arm B
3 weekly subcutaneous (s.c.) loading doses of iscalimab were 600 mg on Week 0, and 300 mg on Week 1 and Week 2. From Week 2 and up to Week 46 (last dose), iscalimab was administered s.c. bi-weekly at 300 mg. To maintain blinding in Period 2, placebo was administered at Week 25.
Droga: CFZ533
Biologico
Altri nomi:
  • iscalimab
Sperimentale: Cohort 1 / Arm C
3 weekly subcutaneous (s.c.) loading doses of iscalimab were 600 mg on Week 0, and 150 mg on Week 1 and Week 2. From Week 2 and up to Week 46 (last dose), iscalimab was administered s.c. bi-weekly at 150 mg. To maintain blinding in Period 2, placebo was administered at Week 25.
Droga: CFZ533
Biologico
Altri nomi:
  • iscalimab
Comparatore placebo: Cohort 1 / Arm D (Period 1)
Placebo treatment is administered subcutaneous (s.c.) weekly for the first 3 doses, then bi-weekly from Week 2 to Week 22 in Period 1.
Altro: Placebo
placebo liquido per iniezioni
Sperimentale: Cohort 1 / Arm D1 (Period 2)
Period 2: 3 weekly subcutaneous (s.c.) loading doses of 600 mg iscalimab on Week 24, 25 and 26. After Week 26 and up to Week 46 (last dose), iscalimab was administered bi-weekly at 600 mg.
Droga: CFZ533
Biologico
Altri nomi:
  • iscalimab
Sperimentale: Cohort 2 / Arm E
3 weekly subcutaneous (s.c.) loading doses of iscalimab were 600 mg on Week 0, 1 and 2. From Week 2 and up to Week 46 (last dose), iscalimab was administered s.c. bi-weekly at 600 mg. To maintain blinding in Period 2, placebo was administered at Week 25.
Droga: CFZ533
Biologico
Altri nomi:
  • iscalimab
Comparatore placebo: Cohort 2 / Arm F (Period 1)
Placebo treatment was administered subcutaneous (s.c.) weekly for the first 3 doses, then bi-weekly from Week 2 to Week 22 in Period 1.
Altro: Placebo
placebo liquido per iniezioni
Sperimentale: Cohort 2 / Arm F1 (Period 2)
Period 2: 3 weekly subcutaneous (s.c.) loading doses of iscalimab: 600 mg on Week 24, and 300 mg on Week 25 and Week 26. After Week 26, iscalimab was administered s.c. bi-weekly at 300 mg.
Droga: CFZ533
Biologico
Altri nomi:
  • iscalimab

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Cohort 1: Change in EULAR Sjögren Syndrome Disease Activity Index (ESSDAI) Score From Baseline at 24 Weeks as Compared to Placebo
Lasso di tempo: Baseline, Week 24
ESSDAI is a validated disease outcome measure for SjS that contains 12 organ-specific domains contributing to disease activity. For each domain, features of disease activity are scored in 3 or 4 levels according to their severity. These scores are then summed across the 12 domains in a weighted manner to provide the total score. The domains (weights) are as follows: constitutional (3), lymphadenopathy (4), glandular (2), articular (2), cutaneous (3), pulmonary (5), renal (5), muscular (6), peripheral nervous system (PNS) (5), central nervous system (CNS) (5), hematological (2) and biological (1). The total score may vary between 0-123. It is considered low activity an ESSDAI < 5; moderate activity 5-13, and high activity if ESSDAI is >= 14.
Baseline, Week 24
Cohort 2: Change in EULAR Sjögren Syndrome Patient Reported Index (ESSPRI) Score From Baseline at 24 Weeks as Compared to Placebo.
Lasso di tempo: Baseline, Week 24
The ESSPRI is a self-evaluation index for measuring symptoms including pain, fatigue and dryness. Each symptom was measured with a single 0 (no symptoms) to 10 (severe symptoms) numerical scale and the final ESSPRI score is calculated by averaging these domains with a maximum severity score of 10.
Baseline, Week 24

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Cohort 1: Change From Baseline in ESSPRI at Week 24
Lasso di tempo: Baseline, Week 24
The ESSPRI is a self-evaluation index for measuring symptoms including pain, fatigue and dryness. Each symptom was measured with a single 0 (no symptoms) to 10 (severe symptoms) numerical scale and the final ESSPRI score is calculated by averaging these domains with a maximum severity score of 10.
Baseline, Week 24
Cohort 1: Change From Baseline in Score of Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Questionnaire at Week 24
Lasso di tempo: Baseline, 24 weeks
The FACIT F (Functional Assessment of Chronic Illness Therapy-Fatigue) is a validated 13 item patient reported outcome measure assessing fatigue and its impact on daily functioning over the past 7 days, with total scores ranging from 0 to 52, where higher scores indicate less fatigue.
Baseline, 24 weeks
Cohort 1: Change From Baseline in Physician Global Assessment (PhGA) at Week 24
Lasso di tempo: Baseline, 24 weeks
Physician's global assessment (PhGA) of disease activity was performed using a Visual Analog Scale (VAS) - an unnumbered 100 mm horizontal line ranging from "no disease activity" (score 0) to "maximal disease activity" (score 100). The assessment of patient's condition on the day is made by placing a vertical mark across the line.
Baseline, 24 weeks
Cohort 2: Change From Baseline in Score of Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Questionnaire at Week 24
Lasso di tempo: Baseline, 24 weeks
The FACIT F (Functional Assessment of Chronic Illness Therapy-Fatigue) is a validated 13 item patient reported outcome measure assessing fatigue and its impact on daily functioning over the past 7 days, with total scores ranging from 0 to 52, where higher scores indicate less fatigue.
Baseline, 24 weeks
Cohort 2: Change From Baseline in Physician Global Assessment (PhGA) at Week 24
Lasso di tempo: Baseline, 24 weeks
Physician's global assessment (PhGA) of disease activity was performed using a Visual Analog Scale (VAS) - an unnumbered 100 mm horizontal line ranging from "no disease activity" (score 0) to "maximal disease activity" (score 100). The assessment of patient's condition on the day is made by placing a vertical mark across the line.
Baseline, 24 weeks
Cohort 2: Change From Baseline in ESSDAI at Week 24
Lasso di tempo: Baseline, week 24
ESSDAI is a validated disease outcome measure for SjS that contains 12 organ-specific domains contributing to disease activity. For each domain, features of disease activity are scored in 3 or 4 levels according to their severity. These scores are then summed across the 12 domains in a weighted manner to provide the total score. The domains (weights) are as follows: constitutional (3), lymphadenopathy (4), glandular (2), articular (2), cutaneous (3), pulmonary (5), renal (5), muscular (6), peripheral nervous system (PNS) (5), central nervous system (CNS) (5), hematological (2) and biological (1). The final score may vary between 0-123. It is considered low activity an ESSDAI < 5; moderate activity 5-13, and high activity if ESSDAI is >= 14.
Baseline, week 24
Cohort 2: Proportion of Subjects With at Least 12 Points Improvement Measured by Score of Impact of Dry Eye on Everyday Life (IDEEL) Questionnaire Symptom Bother Module at Week 24.
Lasso di tempo: Baseline, Week 24

The Impact of Dry Eye on Everyday Life (IDEEL) questionnaire is a comprehensive dry eye specific questionnaire to evaluate treatment satisfaction, symptom-related bother and impact on daily life in a population with dry eye. This study only utilized the Dry Eye Symptom-Bother module.

The Dry Eye Symptom-Bother module of IDEEL is composed of a single dimension (20 items). A 4-point Likert-like scale is used: from "not at all" to "very much". Patients could also answer "I did not have this symptom / Not applicable". One item is scored on a 5-point Likert-like scale from "none of the time" to "all of the time". The range for the symptom-bother score is 0 to 100, with higher scores indicating greater symptom bother.
Baseline, Week 24
Cohort 1: Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs) up to Week 24
Lasso di tempo: Up to Week 24

The distribution of adverse events in Treatment Period 1 was done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Serious Adverse Event (TESAEs) and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters.

Analyses of data in the Safety Set (SAF) up to Week 24 (Period 1) is presented by actual treatment during Period 1, with data from separate cohort for the CFZ533 600mg and for the Placebo groups: CFZ533 600 mg, CFZ533 300 mg, CFZ533 150 mg and placebo.
Up to Week 24
Cohort 1: Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs) in All Study Periods
Lasso di tempo: up to 14 weeks following the last dose of study treatment, up to maximum Week 60

The distribution of adverse events was done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Serious Adverse Event (TESAEs) and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters.

Analyses of data in the Safety Set (SAF) for period 2/3 or overall study is presented by actual treatment sequence during periods 1 and 2, where the CFZ533 600 mg - CFZ533 600 mg sequence included data from patients in separate cohort. CFZ533 600 mg 24 Weeks arm includes only patients from Placebo - CFZ533 600 mg arm, who took at least one CFZ533 600 mg dose in Period 2 (Patients who received Placebo in Period 1 and discontinued before Week 24 are not included). CFZ533 600 mg 48 Weeks arm includes all subjects from CFZ533 600 mg - CFZ533 600 mg arm, and subjects from CFZ533 150 mg - CFZ533 150 mg and CFZ533 300 mg - CFZ533 300 mg arms but only took the first or the first two loading dose(s) in period 1.
up to 14 weeks following the last dose of study treatment, up to maximum Week 60
Cohort 2: Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs) up to Week 24
Lasso di tempo: Up to Week 24

The distribution of adverse events was done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Serious Adverse Event (TESAEs) and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters.

Analyses of data in the Safety Set (SAF) up to Week 24 (Period 1) is presented by actual treatment during Period 1, with data from separate cohort for the CFZ533 600mg and for the Placebo groups: CFZ533 600 mg and placebo.
Up to Week 24
Cohort 2: Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs) in All Study Periods
Lasso di tempo: up to 14 weeks following the last dose of study treatment, up to maximum Week 60

The distribution of adverse events was done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Serious Adverse Event (TESAEs) and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters.

Analyses of data in the Safety Set (SAF) for period 2/3 or overall study is presented by actual treatment sequence during periods 1 and 2, where the CFZ533 600 mg - CFZ533 600 mg sequence included data from patients in separate cohort. CFZ533 300 mg 24 Weeks includes only patients from Placebo - CFZ533 300 mg arm, who received Placebo in Period 1, and either took CFZ533 600 mg loading dose + at least two CFZ533 300 mg subsequent doses in Period 2 or missed CFZ533 600 mg loading dose and took at least one CFZ533 300 mg dose in Period 2 (Patients who received Placebo in Period 1 and discontinued before Week24 are not included). CFZ533 600 mg 48 Weeks arm includes all subjects from CFZ533 600 mg - CFZ533 600 mg arm.
up to 14 weeks following the last dose of study treatment, up to maximum Week 60
Cohort 1: Change From Baseline in Serum Free Light Kappa (FLCκ) Chains Levels
Lasso di tempo: Baseline, Week 4, Week 12, Week 24 (End Treatment Period 1), Week 32, Week 40, Week 48 (End Treatment Period 2), FUP2 (Week 56), FUP 3 (Week 60)
Serum samples for free light kappa (FLCκ) chains were collected and analyzed.
Baseline, Week 4, Week 12, Week 24 (End Treatment Period 1), Week 32, Week 40, Week 48 (End Treatment Period 2), FUP2 (Week 56), FUP 3 (Week 60)
Cohort 2: Change From Baseline in Serum Free Light Kappa (FLCκ) Chains Levels
Lasso di tempo: Baseline, Week 4, Week 12, Week 24 (End Treatment Period 1), Week 32, Week 40, Week 48 (End Treatment Period 2), FUP2 (Week 56), FUP 3 (Week 60)
Serum samples for free light kappa (FLCκ) chains were collected and analyzed.
Baseline, Week 4, Week 12, Week 24 (End Treatment Period 1), Week 32, Week 40, Week 48 (End Treatment Period 2), FUP2 (Week 56), FUP 3 (Week 60)
Cohort 1: Change From Baseline in Immunoglobulin G (IgG) Levels
Lasso di tempo: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 (End Treatment Period 1), Week 28, Week 32, Week 40, Week 48 (End Treatment Period 2), FUP1 (Week 52), FUP2 (Week 56), FUP 3 (Week 60)
Plasma samples for Immunoglobulin G (IgG) were collected and analyzed.
Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 (End Treatment Period 1), Week 28, Week 32, Week 40, Week 48 (End Treatment Period 2), FUP1 (Week 52), FUP2 (Week 56), FUP 3 (Week 60)
Cohort 2: Change From Baseline in Immunoglobulin G (IgG) Levels
Lasso di tempo: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 (End Treatment Period 1), Week 28, Week 32, Week 40, Week 48 (End Treatment Period 2), FUP1 (Week 52), FUP2 (Week 56), FUP 3 (Week 60)
Plasma samples for Immunoglobulin G (IgG) were collected and analyzed.
Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 (End Treatment Period 1), Week 28, Week 32, Week 40, Week 48 (End Treatment Period 2), FUP1 (Week 52), FUP2 (Week 56), FUP 3 (Week 60)
Cohort 1: Change From Baseline in Immunoglobulin M (IgM) Levels
Lasso di tempo: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 (End Treatment Period 1), Week 28, Week 32, Week 40, Week 48 (End Treatment Period 2), FUP1 (Week 52), FUP2 (Week 56), FUP 3 (Week 60)
Plasma samples for Immunoglobulin M (IgM) were collected and analyzed.
Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 (End Treatment Period 1), Week 28, Week 32, Week 40, Week 48 (End Treatment Period 2), FUP1 (Week 52), FUP2 (Week 56), FUP 3 (Week 60)
Cohort 2: Change From Baseline in Immunoglobulin M (IgM) Levels
Lasso di tempo: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 (End Treatment Period 1), Week 28, Week 32, Week 40, Week 48 (End Treatment Period 2), FUP1 (Week 52), FUP2 (Week 56), FUP 3 (Week 60)
Plasma samples for Immunoglobulin M (IgM) were collected and analyzed.
Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 (End Treatment Period 1), Week 28, Week 32, Week 40, Week 48 (End Treatment Period 2), FUP1 (Week 52), FUP2 (Week 56), FUP 3 (Week 60)
Cohort 1: Change From Baseline in Plasma CXCL-13 Levels
Lasso di tempo: Baseline, Week 4, Week 12, Week 24 (End Treatment Period 1), Week 32, Week 48 (End Treatment Period 2), FUP 3 (Week 60)
Plasma samples for Chemokine (C-X-C motif) ligand 13 (CXCL13), also known as B lymphocyte chemoattractant (BLC) or B cell-attracting chemokine 1 (BCA-1) were collected and analyzed.
Baseline, Week 4, Week 12, Week 24 (End Treatment Period 1), Week 32, Week 48 (End Treatment Period 2), FUP 3 (Week 60)
Cohort 2: Change From Baseline in Plasma CXCL-13 Levels
Lasso di tempo: Baseline, Week 4, Week 12, Week 24 (End Treatment Period 1), Week 32, Week 48 (End Treatment Period 2), FUP 3 (Week 60)
Plasma samples for Chemokine (C-X-C motif) ligand 13 (CXCL13), also known as B lymphocyte chemoattractant (BLC) or B cell-attracting chemokine 1 (BCA-1) were collected and analyzed.
Baseline, Week 4, Week 12, Week 24 (End Treatment Period 1), Week 32, Week 48 (End Treatment Period 2), FUP 3 (Week 60)

Collaboratori e investigatori

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

Sponsor

Novartis Pharmaceuticals

Investigatori

  • Direttore dello studio: Study Director 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)

1 ottobre 2019

Completamento primario (Effettivo)

28 settembre 2022

Completamento dello studio (Effettivo)

6 giugno 2023

Date di iscrizione allo studio

Primo inviato

25 marzo 2019

Primo inviato che soddisfa i criteri di controllo qualità

4 aprile 2019

Primo Inserito (Effettivo)

5 aprile 2019

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

18 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

23 aprile 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CCFZ533B2201
  • 2018-004476-35 (Numero EudraCT)

Piano per i dati dei singoli partecipanti (IPD)

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

SÌ

Descrizione del piano IPD

Novartis si impegna a condividere l'accesso ai dati a livello di paziente e a supportare i documenti clinici di studi idonei con ricercatori esterni qualificati. Le richieste vengono esaminate e approvate da un comitato di revisione indipendente sulla base del merito scientifico. Tutti i dati forniti sono resi anonimi per proteggere la privacy dei pazienti che hanno partecipato allo studio in linea con le leggi e i regolamenti applicabili.

Questa disponibilità dei dati dello studio è conforme ai criteri e al processo descritti su 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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