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HMPL-523 (Sovleplenib) til behandling af varm antistof autoimmun hæmolytisk anæmi (wAIHA)

13. maj 2026 opdateret af: Hutchmed

Et randomiseret, dobbeltblindt, placebokontrolleret fase II/III-studie til evaluering af effektivitet, sikkerhed, tolerabilitet og farmakokinetik af HMPL-523 i behandlingen af ​​autoimmun hæmolytisk anæmi med varme antistoffer

Fase II-studie: At evaluere sikkerheden og den foreløbige effekt af HMPL-523 hos voksne patienter med wAIHA

Fase III-studier: Bekræftelse af effektivitetssikkerhed og af HMPL-523 hos voksne patienter med wAIHA

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Fase II-undersøgelse: andelen af ​​patienter med samlet Hb-respons inden uge 24

Fase III-studie: andelen af ​​patienter, der opnår et varigt respons inden uge 24

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

111

Fase

  • Fase 2
  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Kina
      • Beijing, Kina
        • Peking Union Medical College Hospital
      • Tianjin, Kina
        • Hematology Hospital of Chinese Academy of Medical Sciences
    • Anhui
      • Fuyang, Anhui, Kina
        • Fuyang Hospital Of Anhui Medical University
    • Fujian
      • Fuzhou, Fujian, Kina
        • Fujian Medical University Union Hospital
    • Gansu
      • Lanzhou, Gansu, Kina
        • Lanzhou University Second Hospital
    • Guangdong
      • Guangzhou, Guangdong, Kina
        • Nanfang Hospital
      • Shenzhen, Guangdong, Kina
        • Shenzhen Second People's Hospital
      • Zhanjiang, Guangdong, Kina
        • Affiliated Hospital of Guangdong Medical University
    • Guangxi
      • Guilin, Guangxi, Kina
        • Guilin Medical College Affiliated Hospital
    • Hainan
      • Haikou, Hainan, Kina
        • Hainan General Hospital
    • Hebei
      • Baoding, Hebei, Kina
        • Affiliated Hospital of Hebei University
      • Chengde, Hebei, Kina
        • Affiliated Hospital of Chengde Medical University
    • Heilongjiang
      • Harbin, Heilongjiang, Kina
        • Harbin First Hospital
    • Henan
      • Luoyang, Henan, Kina
        • The First Affiliated Hospital of Henan University of Science and Technology
      • Xinxiang, Henan, Kina
        • Xinxiang Central Hospital
      • Zhengzhou, Henan, Kina
        • Henan Cancer Hospital
      • Zhengzhou, Henan, Kina
        • The First Affiliated Hospital of Zhengzhou University
    • Hubei
      • Wuhan, Hubei, Kina
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
      • Xiangyang, Hubei, Kina
        • Xiangyang Center Hospital
    • Hunan
      • Changde, Hunan, Kina
        • The First People's Hospital of Changde City
      • Changsha, Hunan, Kina
        • The Third Xiangya Hospital of Central South University
      • Changsha, Hunan, Kina
        • Xiangya Hospital of Central South University
      • Chenzhou, Hunan, Kina
        • Chenzhou First People's Hospital
    • Jiangsu
      • Nanjing, Jiangsu, Kina
        • Jiangsu Province Hospital
      • Nantong, Jiangsu, Kina
        • Affiliated Hospital of Nantong University
    • Jiangxi
      • Nanchang, Jiangxi, Kina
        • Jiangxi Provincial People's Hospital
      • Nanchang, Jiangxi, Kina
        • The First affiliated hospital of nanchang uiversity
    • Jilin
      • Changchun, Jilin, Kina
        • Bethune First Hospital Of Jilin University
    • Qinghai Provincial
      • Xining, Qinghai Provincial, Kina
        • Qinghai Provincial People's Hospital
    • Shaanxi
      • Xi'an, Shaanxi, Kina
        • Shaanxi Provincial People's Hospital
    • Shandong
      • Binzhou, Shandong, Kina
        • Affiliated Hospital of Binzhou Medical College
      • Yantai, Shandong, Kina
        • Yantai Yuhuangding Hospital
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Kina
        • Jinshan Hospital of Fudan University
    • Shanxi
      • Changzhi, Shanxi, Kina
        • Heping Hospital Affiliated to Changzhi Medical College
    • Sichuan
      • Luzhou, Sichuan, Kina
        • The Affiliated Hospital of Southwest Medical University
    • Xinjiang
      • Ürümqi, Xinjiang, Kina
        • Xinjiang Uygur Autonomous Region People's Hospital
    • Yunnan
      • Kunming, Yunnan, Kina
        • The Second Affiliated Hospital of Kunming Medical University
    • Zhejiang
      • Hangzhou, Zhejiang, Kina
        • The First Affiliated Hospital, Zhejiang University School of Medicine
      • Wenzhou, Zhejiang, Kina
        • The First Affiliated Hospital of WMU

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 til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  1. Frivilligt underskrevet den informerede samtykkeformular (ICF);
  2. hanner eller kvinder i alderen 18 til 75 år;
  3. Patienter diagnosticeret med primær wAIHA eller sekundær wAIHA, hvis underliggende sygdomme er stabile;
  4. Organer i god funktion.

Ekskluderingskriterier:

  1. Patienter med andre typer AIHA end wAIHA;
  2. Patienter med sekundær wAIHA med ustabil underliggende sygdom;
  3. Patienter med lægemiddelinduceret sekundær wAIHA;
  4. Patienter med infektioner, der kræver systemisk behandling;
  5. Patienter tidligere behandlet med Syk-hæmmere (f.eks. fostamatinib);
  6. Patienter med kendt allergi over for de aktive ingredienser eller hjælpestoffer i undersøgelseslægemidlet;
  7. Patienter med alvorlig psykologisk eller mental lidelse;
  8. Alkohol- eller stofmisbruger;
  9. Kvindelige patienter, der er gravide og ammende.

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: HMPL-523

Phase II: Eligible subjects will receive 300 mg HMPL-523 treatment once daily for 8 weeks and at least 16 weeks open-label treatment.

Phase III:

Part A (Randomized, Double-Blind Phase): Eligible subjects will receive 300 mg HMPL-523 treatment once daily for 24 weeks.

Part B (Open-label Phase): Eligible subjects will roll-over into the open-label phase and receive treatment with HMPL-523 at the same dose administered after 24-week randomized controlled trial phase (Part A) or in Phase II. Treatment will continue until 24 weeks after the last subject is enrolled in Part B.
Medicin: HMPL-523 (300 mg PO QD)
HMPL-523 (300 mg PO QD)
Andre navne:
  • Sovleplenib
Placebo komparator: Placebo

Phase II: Eligible subjects will receive 300 mg HMPL-523 matched placebo treatment once daily for 8 weeks.

Phase III:

Part A (Randomized, Double-Blind Phase): Eligible subjects will receive 300 mg HMPL-523 matched placebo treatment once daily for 24 weeks.
Medicin: Placebo
Placebo (300 mg PO QD)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Phase II: Overall Hb response rate
Tidsramme: 24Weeks
Phase II: Overall Hb response rate: The proportion of patients with overall Hb response by Week 24
24Weeks
Phase III(Part A): Durable Hb response rate
Tidsramme: 24Weeks
Phase III(Part A):Durable Hb response rate: The proportion of patients who achieve a durable response by Week 24 during Part A
24Weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Phase II: Overall Hb response rate
Tidsramme: 8 Weeks
Phase II: Overall Hb response rate: the proportion of patients with overall Hb response by Week 8
8 Weeks
Phase II: Durable Hb response rate
Tidsramme: 24 Weeks
Phase II: Durable Hb response rate: the proportion of patients who achieve a durable response by Week 24.
24 Weeks
Phase II: Median change in Hb
Tidsramme: 24 Weeks
Phase II: Median change from baseline in Hb at Weeks 8 and 24 of treatment.
24 Weeks
Phase II: Effects on reticulocyte count
Tidsramme: 24 Weeks
Phase II: Change from baseline in reticulocyte count at Weeks 8 and 24 of treatment.
24 Weeks
Phase II: Effects on lactate dehydrogenase
Tidsramme: 24 Weeks
Phase II: Change from baseline in lactate dehydrogenase(LDH) at Weeks 8 and 24 of treatment.
24 Weeks
Phase II: Effects on haptoglobin
Tidsramme: 24 Weeks
Phase II: Change from baseline in haptoglobin at Weeks 8 and 24 of treatment.
24 Weeks
Phase II: Effects on total bilirubin(TBIL)
Tidsramme: 24 Weeks
Phase II: Change from baseline in total bilirubin(TBIL) at Weeks 8 and 24 of treatment.
24 Weeks
Phase II: Proportion of rescue therapy
Tidsramme: 24 Weeks
Phase II: Proportion of patients who received rescue therapy by Weeks 8 and 24 of treatment.
24 Weeks
Phase II: Proportion of patients with dose reduction in baseline anti-wAIHA medications
Tidsramme: 24 Weeks
Phase II: Proportion of patients who had a dose reduction in glucocorticoids or other baseline concomitant anti-wAIHA medications by Weeks 8 and 24 of treatment.
24 Weeks
Phase II: Time to response
Tidsramme: 24 Weeks
Phase II: Time to response
24 Weeks
Phase II: Effect of study treatment on patient fatigue
Tidsramme: 24 Weeks
Phase II: Evaluation of the effect of study treatment on fatigue at Weeks 8 and 24, as assessed by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
24 Weeks
Phase II: Effect of study treatment on quality of life
Tidsramme: 24 Weeks
Phase II: Evaluation of the effect of study treatment on quality of life at Weeks 8 and 24, as assessed by the 36-Item Short Form Health Survey (SF-36).
24 Weeks
Phase III(Part A): Overall Hb response rate
Tidsramme: 24 Weeks
Phase III(Part A): Proportion of patients who achieved an overall Hb response during the 20-week and 24-week double-blind treatment periods(defined as at least one Hb value ≥100g/L with an increase of at least 20g/L from baseline, not attributable to rescue therapy).
24 Weeks
Phase III(Part A): Median change in Hb
Tidsramme: 24 Weeks
Phase III(Part A): Median change from baseline in Hb during the 20-week and 24-week double-blind treatment periods.
24 Weeks
Phase III(Part A): Effects on reticulocyte count
Tidsramme: 24 Weeks
Phase III(Part A): Change from baseline in reticulocyte count during the 20-week and 24-week double-blind treatment periods.
24 Weeks
Phase III(Part A): Effects on lactate dehydrogenase
Tidsramme: 24 Weeks
Phase III(Part A): Change from baseline in lactate dehydrogenase(LDH) during the 20-week and 24-week double-blind treatment periods.
24 Weeks
Phase III(Part A): Effects on haptoglobin
Tidsramme: 24 Weeks
Phase III(Part A): Change from baseline in haptoglobin during the 20-week and 24-week double-blind treatment periods.
24 Weeks
Phase III(Part A): Effects on total bilirubin(TBIL)
Tidsramme: 24 Weeks
Phase III(Part A): Change from baseline in total bilirubin(TBIL) during the 20-week and 24-week double-blind treatment periods.
24 Weeks
Phase III(Part A): Proportion of rescue therapy
Tidsramme: 24 Weeks
Phase III(Part A): Proportion of patients who received protocol-defined rescue therapy during the 20-week and 24-week double-blind treatment periods.
24 Weeks
Phase III (Part A): Proportion of patients reducing or discontinuing baseline anti-wAIHA medications
Tidsramme: 24 Weeks
Phase III(Part A):The proportion of patients who reduced or discontinued glucocorticoids or other baseline concomitant anti-wAIHA medications during the 20-week and 24-week double-blind treatment periods.
24 Weeks
Phase III(Part A): Time to first response
Tidsramme: 24 Weeks
Phase III(Part A): Time to first response
24 Weeks
Phase III(Part A): Duration of durable response
Tidsramme: 24 Weeks
Phase III(Part A): Duration of durable response
24 Weeks
Phase III(Part A): Cumulative duration of response
Tidsramme: 24 Weeks
Phase III(Part A): Cumulative duration of response
24 Weeks
Phase III(Part A): Effect of study treatment on patient fatigue
Tidsramme: 24 Weeks
Phase III(Part A): Effect of study treatment on patient fatigue during the 20-week and 24-week treatment periods, as assessed by the FACIT-F score (40 items; range, 0-160), including the FACIT-Fatigue subscale (13 items; range, 0-52).
24 Weeks
Phase III(Part A): Effect of study treatment on patients' quality
Tidsramme: 24 Weeks
Phase III(Part A): Effect of study treatment on patients' quality of life during the 20-week and 24-week treatment periods, as assessed by SF-36.
24 Weeks

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of Treatment-emergent Adverse Events (TEAEs)
Tidsramme: 36 Months
Incidence of treatment-emergent adverse events (TEAEs) assessed according to NCI CTCAE Version 5.0.
36 Months
Phase II:Efficacy in patients with DAT positivity confirmed by the central laboratory
Tidsramme: 24 Weeks
Phase II: Assessed by overall Hb response rate and durable response rate.
24 Weeks
Phase III(Part B): Durable Hb response rate
Tidsramme: 30 Months
Phase III(Part B): Durable Hb response rate: the proportion of patients who achieve a durable response during Part B.
30 Months

Samarbejdspartnere og efterforskere

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

Sponsor

Hutchmed

Efterforskere

  • Ledende efterforsker: Fengkui Zhang, professor, offices director

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)

30. september 2022

Primær færdiggørelse (Faktiske)

25. november 2025

Studieafslutning (Anslået)

1. november 2026

Datoer for studieregistrering

Først indsendt

31. august 2022

Først indsendt, der opfyldte QC-kriterier

7. september 2022

Først opslået (Faktiske)

10. september 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2022-523-00CH1

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Resultaterne af denne undersøgelse kan publiceres i kernetidsskrifter eller internationale videnskabelige konferencer, og de primære efterforskere, der yder væsentlige bidrag til implementeringen og styringen af ​​denne undersøgelse, og det personale, der yder store bidrag til design, fortolkning eller analyse af denne undersøgelse ( såsom sponsorens stabe eller konsulenter) kan få deres forfatterskabstilskrivning. Sponsoren lover at levere manuskriptet til efterforskeren til gennemgang før offentliggørelse af ethvert resultat af undersøgelsen. Efterforskere skal indhente sponsorens godkendelse, før de indsender akademiske artikler eller abstracts. Undersøgelsespersonalet har ret til at offentliggøre resultaterne af denne undersøgelse, dog skal kravet om beskyttelse af fortrolige oplysninger være opfyldt.

De fortrolige oplysninger er kun sponsorens ejendom, kan ikke videregives til andre uden sponsorens skriftlige godkendelse og kan ikke bruges til andre formål.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • ICF
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

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 .

Kliniske forsøg med HMPL-523 (300 mg PO QD)

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Costa Rica

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner