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Undersøgelse af sikkerhed og effekt af multiple doser af CFZ533 i to forskellige populationer af patienter med Sjögrens syndrom (TWINSS)

23. april 2026 opdateret af: Novartis Pharmaceuticals

Et 48-ugers, 6-arm, randomiseret, dobbeltblindt, placebokontrolleret multicenterforsøg for at vurdere sikkerheden og effektiviteten af ​​multiple CFZ533-doser administreret subkutant i to forskellige populationer af patienter med Sjögrens syndrom (TWINSS)

Denne undersøgelse vil evaluere sikkerhed, effekt, farmakokinetik (PK) og farmakodynamik (PD) af multiple doser af CFZ533 (iscalimab) hos patienter med Sjögrens syndrom.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Dette er en dobbeltblind, randomiseret, placebokontrolleret, multicenterundersøgelse af CFZ533 i 2 forskellige populationer (kohorter) af patienter med Sjögrens syndrom: 1) moderat til svær sygdom (systemisk og symptomatisk involvering) og; 2) lav systemisk involvering men høj symptombyrde.

Undersøgelsen omfatter op til 6 ugers screeningsperiode, 48 ugers behandling (opdelt i behandlingsperioder på hver 24 uger) og 12 ugers opfølgning. Studiebehandlingen vil blive administreret som subkutane injektioner hver anden uge.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

273

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Argentina
      • Buenos Aires, Argentina, C1055AAF
        • Novartis Investigative Site
      • CABA, Argentina, 1426
        • Novartis Investigative Site
  • Australien
    • Western Australia
      • Nedlands, Western Australia, Australien, 6009
        • Novartis Investigative Site
  • Brasilien
    • Espírito Santo
      • Vitória, Espírito Santo, Brasilien, 29055 450
        • Novartis Investigative Site
    • Minas Gerais
      • Juiz de Fora, Minas Gerais, Brasilien, 36010 570
        • Novartis Investigative Site
    • São Paulo
      • São Paulo, São Paulo, Brasilien, 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
  • Det Forenede Kongerige
      • Birmingham, Det Forenede Kongerige, B15 2TH
        • Novartis Investigative Site
      • Doncaster, Det Forenede Kongerige, DN2 5LT
        • Novartis Investigative Site
      • Manchester, Det Forenede Kongerige, M13 9WL
        • Novartis Investigative Site
  • Forenede Stater
    • Georgia
      • Suwanee, Georgia, Forenede Stater, 30024
        • North GA Rheumatology Group PC
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46202
        • Indiana Univ School of Dentistry
    • Louisiana
      • Baton Rouge, Louisiana, Forenede Stater, 70809
        • Ochsner Health System
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21224
        • The John Hopkins Jerome L Greene Sjogren
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02111
        • Tufts School of Dental Medicine
    • New York
      • Mineola, New York, Forenede Stater, 11501
        • Winthrop University Hospital
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • Perelman School of Medicine
    • Wisconsin
      • Madison, Wisconsin, Forenede Stater, 53792
        • Uni Wisconsin School Med Pub Health
  • Frankrig
      • Brest, Frankrig, 29200
        • Novartis Investigative Site
      • Le Kremlin-Bicêtre, Frankrig, 94275
        • Novartis Investigative Site
      • Lille, Frankrig, 59037
        • Novartis Investigative Site
      • Paris, Frankrig, 75014
        • Novartis Investigative Site
      • Strasbourg, Frankrig, 67000
        • Novartis Investigative Site
  • Grækenland
      • Athens, Grækenland, 115 27
        • Novartis Investigative Site
  • Holland
      • Groningen, Holland, 9713 GZ
        • Novartis Investigative Site
    • South Holland
      • Rotterdam, South Holland, Holland, 3015 GD
        • Novartis Investigative Site
  • Israel
      • Haifa, Israel, 3104802
        • Novartis Investigative Site
      • Kfar Saba, Israel, 4428164
        • Novartis Investigative Site
      • Ramat Gan, Israel, 5265601
        • Novartis Investigative Site
  • Italien
    • MI
      • Milan, MI, Italien, 20132
        • Novartis Investigative Site
    • PI
      • Pisa, PI, Italien, 56126
        • Novartis Investigative Site
    • UD
      • Udine, UD, Italien, 33100
        • Novartis Investigative Site
  • Japan
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 457 8510
        • Novartis Investigative Site
    • Nagasaki
      • Sasebo, Nagasaki, Japan, 857-1195
        • Novartis Investigative Site
    • Okayama-ken
      • Kurashiki, Okayama-ken, Japan, 710-0824
        • Novartis Investigative Site
    • Tokyo
      • Chuo Ku, Tokyo, Japan, 104 8560
        • Novartis Investigative Site
      • Shinjuku-ku, Tokyo, Japan, 160 8582
        • Novartis Investigative Site
  • Portugal
      • Almada, Portugal, 2805-267
        • Novartis Investigative Site
      • Lisbon, Portugal, 1649-035
        • Novartis Investigative Site
      • Lisbon, Portugal, 1050-034
        • Novartis Investigative Site
      • Ponte de Lima, Portugal, 4990 041
        • Novartis Investigative Site
  • Rumænien
      • Brasov, Rumænien, 500283
        • Novartis Investigative Site
      • Cluj-Napoca, Rumænien, 400006
        • Novartis Investigative Site
  • Rusland
      • Kazan', Rusland, 420097
        • Novartis Investigative Site
      • Moscow, Rusland, 115522
        • Novartis Investigative Site
      • Orenburg, Rusland, 460000
        • Novartis Investigative Site
      • Saint Petersburg, Rusland, 195257
        • Novartis Investigative Site
      • Tomsk, Rusland, 634009
        • Novartis Investigative Site
      • Yekaterinburg, Rusland, 620028
        • Novartis Investigative Site
  • Sverige
    • SE
      • Stockholm, SE, Sverige, 113 65
        • Novartis Investigative Site
  • Sydkorea
    • Seocho Gu
      • Seoul, Seocho Gu, Sydkorea, 06591
        • Novartis Investigative Site
  • Tyrkiet (Türkiye)
    • Yenimahalle
      • Ankara, Yenimahalle, Tyrkiet (Türkiye), 06500
        • Novartis Investigative Site
  • Tyskland
      • Bonn, Tyskland, 53105
        • Novartis Investigative Site
    • Baden-Wurttemberg
      • Freiburg im Breisgau, Baden-Wurttemberg, Tyskland, 79106
        • Novartis Investigative Site
    • Bavaria
      • Würzburg, Bavaria, Tyskland, 97080
        • Novartis Investigative Site
    • Saxony
      • Dresden, Saxony, Tyskland, 01307
        • Novartis Investigative Site
  • Ungarn
      • Budapest, Ungarn, 1023
        • Novartis Investigative Site
      • Szeged, Ungarn, 6720
        • Novartis Investigative Site
    • Fejér
      • Székesfehérvár, Fejér, Ungarn, 8000
        • Novartis Investigative Site
  • Østrig
      • Graz, Østrig, 8036
        • Novartis Investigative Site
      • Vienna, Østrig, 1090
        • 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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  • Underskrevet informeret samtykke
  • Mandlig eller kvindelig patient ≥ 18 år
  • Klassificering af Sjögrens syndrom i henhold til ACR/EULAR 2016 kriterier (Shiboski et al 2017)
  • Seropositiv for anti-Ro/SSA antistoffer
  • Stimuleret hel spytstrømningshastighed på ≥ 0,1 ml/min

Inklusionskriterier, der er specifikke for kohorte 1:

  • ESSDAI ≥ 5 inden for de 8 foruddefinerede organdomæner
  • ESSPRI-score på ≥5

Inklusionskriterier, der er specifikke for kohorte 2:

  • ESSDAI < 5 inden for 8 domæner scoret for inklusionskriteriet for kohorte 1
  • ESSPRI træthedsunderscore ≥ 5 eller ESSPRI tørhedsunderscore ≥ 5

Ekskluderingskriterier:

  • Sjögrens syndrom overlapper syndromer, hvor en anden autoimmun gigtsygdom udgør hovedsygdommen
  • Brug af andre forsøgsmedicin
  • Forudgående brug af B-celle-depleterende terapier, abatacept eller andre immunsuppressive midler, medmindre protokollen specifikt er tilladt.
  • Brug af steroider ved dosis >10 mg/dag.
  • Ukontrolleret okulær rosacea (påvirker øjets adnexa), posterior blepharitis eller meibomisk kirtelsygdom (dette kriterium gælder kun for patienter, der overvejes til kohorte 2)
  • Aktive virale, bakterielle eller andre infektioner, der kræver systemisk behandling
  • Modtagelse af levende/svækket vaccine inden for en 2-måneders periode før randomisering.
  • Kronisk infektion med hepatitis B (HBV) eller hepatitis C (HCV).
  • Bevis på aktiv tuberkulose (TB) infektion.

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: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: CFZ533
Biologisk
Andre navne:
  • iscalimab
Eksperimentel: 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.
Medicin: CFZ533
Biologisk
Andre navne:
  • iscalimab
Eksperimentel: 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.
Medicin: CFZ533
Biologisk
Andre navne:
  • iscalimab
Placebo komparator: 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.
Andet: Placebo
flydende placebo til injektioner
Eksperimentel: 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.
Medicin: CFZ533
Biologisk
Andre navne:
  • iscalimab
Eksperimentel: 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.
Medicin: CFZ533
Biologisk
Andre navne:
  • iscalimab
Placebo komparator: 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.
Andet: Placebo
flydende placebo til injektioner
Eksperimentel: 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.
Medicin: CFZ533
Biologisk
Andre navne:
  • iscalimab

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Cohort 1: Change in EULAR Sjögren Syndrome Disease Activity Index (ESSDAI) Score From Baseline at 24 Weeks as Compared to Placebo
Tidsramme: 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.
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Cohort 1: Change From Baseline in ESSPRI at Week 24
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Samarbejdspartnere og efterforskere

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

Sponsor

Novartis Pharmaceuticals

Efterforskere

  • Studieleder: Study Director Novartis Pharmaceuticals, Novartis Pharmaceuticals

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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)

1. oktober 2019

Primær færdiggørelse (Faktiske)

28. september 2022

Studieafslutning (Faktiske)

6. juni 2023

Datoer for studieregistrering

Først indsendt

25. marts 2019

Først indsendt, der opfyldte QC-kriterier

4. april 2019

Først opslået (Faktiske)

5. april 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Novartis er forpligtet til at dele adgang til data på patientniveau og understøttende kliniske dokumenter fra kvalificerede undersøgelser med kvalificerede eksterne forskere. Anmodninger gennemgås og godkendes af et uafhængigt bedømmelsespanel på baggrund af videnskabelig fortjeneste. Alle data, der leveres, er anonymiserede for at beskytte privatlivets fred for patienter, der har deltaget i forsøget i overensstemmelse med gældende love og regler.

Tilgængeligheden af ​​denne forsøgsdata er i overensstemmelse med kriterierne og processen beskrevet på 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 .

Abonner