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A Multicenter, Randomized, Open-Label, Positive Controlled Phase III Study to Evaluate the Efficacy and Safety of VSA012 Injection in Participants With Paroxysmal Nocturnal Hemoglobinuria Who Are Naive to Complement Inhibitor Therapy

9. september 2026 opdateret af: Bisirna Therapeutics (Suzhou) Co., Ltd.
A study of the efficacy and safety of VSA012 Injection compared to eculizumab for 24 weeks in patients with PNH.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

70

Fase

  • Fase 3

Kontakter og lokationer

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

Studiekontakt

Studiesteder

  • Kina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina
        • Peking Union Medical College Hospital
        • Kontakt:
    • Changchun
      • Jilin City, Changchun, Kina
        • Jilin
    • Fujian
      • Quanzhou, Fujian, Kina
        • Quanzhou
    • Guangdong
      • Guangzhou, Guangdong, Kina
        • Guangzhou
    • Guangxi
      • Nanning, Guangxi, Kina
        • Nanning
    • Heilongjiang
      • Harbin, Heilongjiang, Kina
        • Ha'erbin
    • Henan
      • Zhengzhou, Henan, Kina
        • Zhengzhou
    • Hubei
      • Wuhan, Hubei, Kina
        • Wuhan
    • Hunan
      • Changsha, Hunan, Kina
        • Changsha
    • Jiangsu
      • Nantong, Jiangsu, Kina
        • Nantong
    • Shanxi
      • Xi’an, Shanxi, Kina
        • Xi'an
    • Sichuan
      • Chengdu, Sichuan, Kina
        • Chengdu
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, Kina
        • Institute of Hematology, Chinese Academy of Medical Sciences
    • Zhejiang
      • Hangzhou, Zhejiang, Kina
        • The First Affiliated Hospital of Zhejiang University school of medicine
        • Kontakt:

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

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Male and female participants ≥ 18 years of age and BMI ≥ 18.0 kg/m2 with a diagnosis of PNH confirmed by high-sensitivity flow cytometry with clone size≥10%.
  • Mean hemoglobin level <100 g/L at screening.
  • LDH > 1.5 x Upper Limit of Normal (ULN) at screening.
  • Vaccination against Neisseria meningitidis infection is required prior to the
  • start of study treatment. If not received previously, vaccination against
  • Streptococcus pneumoniae and Haemophilus influenzae infections should be given.

Exclusion Criteria:

  • Known or suspected hereditary or acquired complement deficiency;
  • Presence or suspicion of a systemic active bacterial, viral, or fungal infection
  • History of infection with capsular bacteria (e.g., meningococcus, pneumococcus, etc.)
  • Patients with reticulocytes <100x10^9/L; platelets <30x10^9/L; neutrophils <0.5x10^9/L.
  • Positive of HIV, HBsAg or HCVAb.
  • History of recurrent invasive infections caused by encapsulated organisms,e.g. meningococcus or pneumococcus.
  • Previous splenectomy.
  • A history of malignancy within 5 years before screening

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: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Kohorte1
Medicin: VSA012
VSA012 Injection
Aktiv komparator: Cohort2
Medicin: Eculizumab (Soliris®)
Eculizumab injection

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
The proportion of patients with sustained hemoglobin levels ≥ 120 g/L among those without RBC transfusion (defined as no red blood cell infusion after W2 to W26).
Tidsramme: between Week 2 and Week 26
between Week 2 and Week 26

Sekundære resultatmål

Resultatmål
Tidsramme
Proportion of participants achieving a sustained increase from baseline in hemoglobin levels of ≥ 20 g/L assessed among those without RBC transfusion (defined as no red blood cell infusion after W2 to W26).
Tidsramme: between Week 20 and Week 26
between Week 20 and Week 26
The proportion of patients with hemolysis controlled (defined as LDH < 1.5 ULN) among those without RBC transfusion
Tidsramme: between Week 20 and Week 26
between Week 20 and Week 26
Change (Expressed as Percentages) in Hb level from baseline
Tidsramme: between Week 20 and Week 26
between Week 20 and Week 26
The proportion of patients without RBC transfusion
Tidsramme: between Week 2 and Week 26
between Week 2 and Week 26
Change in reticulocyte count from baseline
Tidsramme: between Week 20 and Week 26
between Week 20 and Week 26
Change in Total bilirubin count from baseline
Tidsramme: between Week 20 and Week 26
between Week 20 and Week 26
Change in FACIT-F score from baseline
Tidsramme: between Week 20 and Week 26
between Week 20 and Week 26
The Clinical BTH Rate
Tidsramme: between Day 1 and Week 26
between Day 1 and Week 26
The Major Adverse Vascular Events Rate
Tidsramme: between Day 1 and Week 26
between Day 1 and Week 26
Incidence and severity of AEs
Tidsramme: between Day 1 and Week 26
between Day 1 and Week 26

Andre resultatmål

Resultatmål
Tidsramme
Incidence and severity of AEs
Tidsramme: between Day 1 and Week 26
between Day 1 and Week 26

Samarbejdspartnere og efterforskere

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

Sponsor

Bisirna Therapeutics (Suzhou) Co., Ltd.

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 (Anslået)

29. oktober 2026

Primær færdiggørelse (Anslået)

30. september 2027

Studieafslutning (Anslået)

31. december 2029

Datoer for studieregistrering

Først indsendt

4. september 2026

Først indsendt, der opfyldte QC-kriterier

9. september 2026

Først opslået (Faktiske)

11. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • VSA012-3001

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

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