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En undersøgelse af STAR-0215 ​​hos deltagere med arvelig angioødem

17. april 2026 opdateret af: Astria Therapeutics, Inc.

Et fase 1b/2 enkelt- og flerdosisstudie til vurdering af sikkerhed, tolerabilitet, klinisk aktivitet, farmakokinetik, farmakodynamik og immunogenicitet af STAR-0215 ​​hos deltagere med arvelig angioødem (ALPHA-STAR-forsøget)

Målet med dette kliniske forsøg er at teste lægemidlet STAR-0215 ​​hos deltagere med hereditært angioødem (HAE). En gruppe deltagere får 1 dosis STAR-0215, og den anden gruppe får 2 doser STAR-0215. Forskere vil studere virkningerne af STAR-0215 ​​hos deltagere med HAE, da det er første gang, at lægemidlet er givet til deltagere med HAE.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Dette er et fase 1b/2 enkelt- og flerdosisforsøg, der evaluerer sikkerhed, tolerabilitet, klinisk aktivitet, farmakokinetik, farmakodynamik og immunogenicitet af subkutan administration af STAR-0215 ​​hos deltagere med type I eller type II HAE i 2 dosiskohorter. Den første kohorte vil modtage 1 dosis STAR-0215; den anden kohorte vil modtage 2 sekventielle doser. Dette er det første forsøg med STAR-0215 ​​i deltagere med HAE og den første evaluering af et flerdosis-regime.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

29

Fase

  • Fase 2
  • Fase 1

Kontakter og lokationer

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

Studiesteder

  • Bulgarien
      • Sofia, Bulgarien, 1680
        • Diagnostical Consultative Center Convex Ltd.
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2R3
        • University of Alberta
    • Ontario
      • Ottawa, Ontario, Canada, K1H 1E4
        • Ottawa Allergy Research Corporation
  • Det Forenede Kongerige
      • Cambridge, Det Forenede Kongerige, CB2 0QQ
        • Addenbrooke's Hospital
      • Leeds, Det Forenede Kongerige, LS9 7TF
        • St. James's Hospital
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35209
        • Allervie Clinical Research
    • Arizona
      • Scottsdale, Arizona, Forenede Stater, 85251
        • Medical Research of Arizona a Division of Allergy, Asthma & Immunology Associates, LTD.
    • Arkansas
      • Bentonville, Arkansas, Forenede Stater, 72712
        • Allergy & Asthma Clinic of Northwest Arkansas
      • Little Rock, Arkansas, Forenede Stater, 72205
        • Acuro Research, Inc.
    • California
      • San Diego, California, Forenede Stater, 92122
        • UC San Diego US HAEA Angioedema Center
      • Santa Monica, California, Forenede Stater, 90404
        • Raffi Tachdjian MD, Inc
      • Walnut Creek, California, Forenede Stater, 94598
        • Allergy & Asthma Clinical Research
    • Maryland
      • Chevy Chase, Maryland, Forenede Stater, 20815
        • Institute for Asthma and Allergy, PC
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02114
        • Massachusetts General Hospital
    • Missouri
      • St Louis, Missouri, Forenede Stater, 63110
        • Washington University School of Medicine
    • Ohio
      • Columbus, Ohio, Forenede Stater, 43235
        • Optimed Research
    • Pennsylvania
      • Hershey, Pennsylvania, Forenede Stater, 17033
        • Penn State Health Milton S. Hershey Medical Center
    • Texas
      • Dallas, Texas, Forenede Stater, 75231
        • AARA Research Center
  • Tjekkiet
      • Hradec Králové, Tjekkiet, 500 05
        • Institute of Clinical Immunology/Allergology, Faculty Hospital
  • Tyskland
      • Berlin, Tyskland, 12203
        • Charité Universitätsmedizin Berlin

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:

  1. Dokumenteret diagnose af HAE (type I eller II). Følgende skal være opfyldt:

    en. Dokumenteret klinisk historie i overensstemmelse med HAE (f.eks. subkutane eller slimhinde, ikke-pruritiske hævelsesepisoder uden ledsagende nældefeber).

  2. Oplevet mindst 4 HAE-anfald inden for de 12 måneder forud for screening, pr. deltagerrapport.
  3. Oplevet mindst 2 HAE-angreb i løbet af indkøringsperioden, som bekræftet af en efterforsker baseret på opfyldelse af den protokol-specificerede definition af et HAE-angreb.

Ekskluderingskriterier:

  1. Enhver samtidig diagnose af en anden form for kronisk angioødem, såsom erhvervet C1-hæmmermangel, HAE med normal C1-INH (også kendt som HAE type III), idiopatisk angioødem eller angioødem forbundet med urticaria.

  2. Brug af terapier ordineret til forebyggelse af HAE-anfald før screening:

    1. lanadelumab inden for 90 dage
    2. berotralstat inden for 21 dage
    3. alle andre profylaktiske terapier inden for 7 dage
  3. Enhver eksponering for angiotensin-konverterende enzymhæmmere eller enhver østrogenholdig medicin med systemisk absorption (såsom hormonelle præventionsmidler eller hormonsubstitutionsterapi) inden for 28 dage før screening.
  4. Enhver eksponering for androgener (for eksempel stanozolol, danazol, oxandrolon, methyltestosteron, testosteron) inden for 7 dage før 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: Ikke-randomiseret
  • Interventionel model: Sekventiel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Cohort 1 - Single Dose
Participants received 1 dose (450 milligrams [mg]) of navenibart.
Medicin: Navenibart
Navenibart will be administered as a subcutaneous bolus injection.
Andre navne:
  • STAR-0215
Eksperimentel: Cohort 2 - Multiple Dose
Participants received 2 doses (600 mg, 300 mg) of navenibart administered 3 months apart.
Medicin: Navenibart
Navenibart will be administered as a subcutaneous bolus injection.
Andre navne:
  • STAR-0215
Eksperimentel: Cohort 3 - Multiple Dose
Participants received 2 doses (600 mg) of navenibart administered 1 month apart.
Medicin: Navenibart
Navenibart will be administered as a subcutaneous bolus injection.
Andre navne:
  • STAR-0215

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants Experiencing Treatment-emergent Adverse Events
Tidsramme: Day 1 through Day 448 (Cohort 1), Day 531 (Cohort 2), Day 475 (Cohort 3)
An adverse event was any untoward medical occurrence in a clinical investigation participant who was administered a pharmaceutical product that did not necessarily have a causal relationship with the treatment. A treatment-emergent adverse event was defined as any adverse event with an onset at the time of or following the start of treatment with study drug, or medical conditions present before the start of treatment that increased in severity or relationship at the time of or following the start of treatment. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' section.
Day 1 through Day 448 (Cohort 1), Day 531 (Cohort 2), Day 475 (Cohort 3)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percent Change From Baseline in Monthly Hereditary Angioedema (HAE) Attack Rate
Tidsramme: Baseline, Day 168 (Cohort 1), Day 251 (Cohort 2), Day 195 (Cohort 3)
An attack was considered an HAE attack if at least 1 of the following criteria was met (per the investigator): peripheral angioedema (cutaneous swelling involving an extremity, the face, neck, torso, and/or genitourinary region); abdominal angioedema (abdominal pain, with or without abdominal distention, nausea, vomiting, or diarrhea); laryngeal angioedema (stridor, dyspnea, difficulty speaking, difficulty swallowing, throat tightening, or swelling of the tongue, palate, uvula, or larynx). The HAE attack rate was the number of unique investigator-confirmed HAE attacks per month.
Baseline, Day 168 (Cohort 1), Day 251 (Cohort 2), Day 195 (Cohort 3)
Number of Participants Who Were HAE Attack Free
Tidsramme: Baseline through Day 168 (Cohort 1), Day 251 (Cohort 2), Day 195 (Cohort 3)
An attack was considered an HAE attack if at least 1 of the following criteria was met (per the investigator): peripheral angioedema (cutaneous swelling involving an extremity, the face, neck, torso, and/or genitourinary region); abdominal angioedema (abdominal pain, with or without abdominal distention, nausea, vomiting, or diarrhea); laryngeal angioedema (stridor, dyspnea, difficulty speaking, difficulty swallowing, throat tightening, or swelling of the tongue, palate, uvula, or larynx).
Baseline through Day 168 (Cohort 1), Day 251 (Cohort 2), Day 195 (Cohort 3)
Severity of HAE Attacks Experienced by Participants
Tidsramme: Day 1 through Day 168 (Cohort 1), Day 251 (Cohort 2), and Day 195 (Cohort 3)
An attack was considered an HAE attack if at least 1 of the following criteria was met (per the investigator): peripheral angioedema (cutaneous swelling involving an extremity, the face, neck, torso, and/or genitourinary region); abdominal angioedema (abdominal pain, with or without abdominal distention, nausea, vomiting, or diarrhea); laryngeal angioedema (stridor, dyspnea, difficulty speaking, difficulty swallowing, throat tightening, or swelling of the tongue, palate, uvula, or larynx). All HAE attacks were classified by the investigator according to severity: mild (transient or mild discomfort); moderate (mild to moderate limitation in activity, some assistance with daily activities needed); severe (marked limitation in activity, assistance with daily activities required).
Day 1 through Day 168 (Cohort 1), Day 251 (Cohort 2), and Day 195 (Cohort 3)
Duration of HAE Attacks
Tidsramme: Day 1 through Day 168 (Cohort 1), Day 251 (Cohort 2), and Day 195 (Cohort 3)
An attack was considered an HAE attack if at least 1 of the following criteria was met (per the investigator): peripheral angioedema (cutaneous swelling involving an extremity, the face, neck, torso, and/or genitourinary region); abdominal angioedema (abdominal pain, with or without abdominal distention, nausea, vomiting, or diarrhea); laryngeal angioedema (stridor, dyspnea, difficulty speaking, difficulty swallowing, throat tightening, or swelling of the tongue, palate, uvula, or larynx).
Day 1 through Day 168 (Cohort 1), Day 251 (Cohort 2), and Day 195 (Cohort 3)
Number of HAE Attacks Requiring On-demand Therapy
Tidsramme: Day 1 through Day 168 (Cohort 1), Day 251 (Cohort 2), and Day 195 (Cohort 3)
An attack was considered an HAE attack if at least 1 of the following criteria was met (per the investigator): peripheral angioedema (cutaneous swelling involving an extremity, the face, neck, torso, and/or genitourinary region); abdominal angioedema (abdominal pain, with or without abdominal distention, nausea, vomiting, or diarrhea); laryngeal angioedema (stridor, dyspnea, difficulty speaking, difficulty swallowing, throat tightening, or swelling of the tongue, palate, uvula, or larynx).
Day 1 through Day 168 (Cohort 1), Day 251 (Cohort 2), and Day 195 (Cohort 3)
Time to First HAE Attack After First and Last Dosing
Tidsramme: Day 1 through Day 168 (Cohort 1), Day 251 (Cohort 2), and Day 195 (Cohort 3)
An attack was considered an HAE attack if at least 1 of the following criteria was met (per the investigator): peripheral angioedema (cutaneous swelling involving an extremity, the face, neck, torso, and/or genitourinary region); abdominal angioedema (abdominal pain, with or without abdominal distention, nausea, vomiting, or diarrhea); laryngeal angioedema (stridor, dyspnea, difficulty speaking, difficulty swallowing, throat tightening, or swelling of the tongue, palate, uvula, or larynx). The time to first HAE attack was calculated by: ([First HAE attack or censor date] - First Treatment date) +1. If a participant did not have an HAE attack, they were censored to the end of study date.
Day 1 through Day 168 (Cohort 1), Day 251 (Cohort 2), and Day 195 (Cohort 3)
Proportion of HAE Attack-free Days
Tidsramme: Day 1 through Day 168 (Cohort 1), Day 251 (Cohort 2), and Day 195 (Cohort 3)
An attack was considered an HAE attack if at least 1 of the following criteria was met (per the investigator): peripheral angioedema (cutaneous swelling involving an extremity, the face, neck, torso, and/or genitourinary region); abdominal angioedema (abdominal pain, with or without abdominal distention, nausea, vomiting, or diarrhea); laryngeal angioedema (stridor, dyspnea, difficulty speaking, difficulty swallowing, throat tightening, or swelling of the tongue, palate, uvula, or larynx). The proportion of HAE attack-free days was calculated by: (the number of HAE attack-free days/duration of evaluation period in days).
Day 1 through Day 168 (Cohort 1), Day 251 (Cohort 2), and Day 195 (Cohort 3)
Maximum Drug Concentration (Cmax) of Navenibart
Tidsramme: Day 1 (pre-dose, 4 hours post dose) up to Day 168 (Cohort 1); Day 1 (pre-dose, 4 hours post dose) up to Day 251 (Cohort 2); Day 1 (pre-dose, 4 hours post dose) up to Day 195 (Cohort 3)
Blood samples were collected at designated timepoints to measure the Cmax of navenibart. Results reported as micrograms/milliliter (mcg/mL).
Day 1 (pre-dose, 4 hours post dose) up to Day 168 (Cohort 1); Day 1 (pre-dose, 4 hours post dose) up to Day 251 (Cohort 2); Day 1 (pre-dose, 4 hours post dose) up to Day 195 (Cohort 3)
Percent Change From Baseline in Plasma Levels of Cleaved High-molecular-weight Kininogen (cHMWK)
Tidsramme: Baseline, Day 56 (Cohort 1), Day 90 (Cohort 2), Day 41 (Cohort 3)
Blood samples were collected to measure the plasma levels of cHMWK (a measure of plasma kallikrein activity). Results reported as percent change in percentage cHMWK (%cHMWK). A decrease in %cHMWK is reflective of the pharmacodynamic activity of navenibart.
Baseline, Day 56 (Cohort 1), Day 90 (Cohort 2), Day 41 (Cohort 3)
Number of Participants With Treatment-emergent Anti-drug Antibodies (ADAs) to Navenibart
Tidsramme: Day 1 (pre-dose) up to Day 168 (Cohort 1); Day 1 (pre-dose) up to Day 251 (Cohort 2); Day 1 (pre-dose) up to Day 195 (Cohort 3)
Blood samples were collected at designated timepoints to assess the formation of navenibart ADAs in serum.
Day 1 (pre-dose) up to Day 168 (Cohort 1); Day 1 (pre-dose) up to Day 251 (Cohort 2); Day 1 (pre-dose) up to Day 195 (Cohort 3)

Samarbejdspartnere og efterforskere

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

Sponsor

Astria Therapeutics, Inc.

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)

21. februar 2023

Primær færdiggørelse (Faktiske)

13. marts 2025

Studieafslutning (Faktiske)

13. marts 2025

Datoer for studieregistrering

Først indsendt

6. januar 2023

Først indsendt, der opfyldte QC-kriterier

13. januar 2023

Først opslået (Faktiske)

23. januar 2023

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • STAR-0215-201
  • 2022-502953-32 (EudraCT nummer)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

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 .

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