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A Phase 3 Evaluation of Sutacimig in Glanzmann Thrombasthenia (SOLARA)

9. november 2026 opdateret af: Hemab ApS

SOLARA: A Phase 3 Study of the Efficacy and Safety of Sutacimig in Participants With Glanzmann Thrombasthenia

Glanzmann thrombasthenia (GT) is a serious inherited bleeding disorder. In GT, platelets, the blood cells that normally stick together at the site of an injury to stop bleeding, are unable to properly do so. As a result, bleeding does not stop as it should. Bleeding in GT often starts without warning, can happen frequently, and can be severe. It most commonly affects the nose, mouth and gums, gastrointestinal tract, and skin, and many women and girls with GT experience heavy menstrual bleeding. Over time, bleeding can lead to iron deficiency and anemia. Some bleeding episodes require emergency care, hospitalization, transfusion, or surgery, and some can be life-threatening.

Sutacimig is an investigational medicine given as an injection under the skin (subcutaneous injection). It is designed to help platelets work at the site of bleeding despite the underlying defect in GT. It is intended to be given regularly to help prevent bleeding (prophylaxis), rather than only to treat bleeding after it starts.

The purpose of this study is to find out whether sutacimig, given as prophylaxis, reduces the number of treated bleeding episodes in people with GT compared with no prophylaxis, and to evaluate its safety and tolerability.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

76

Fase

  • Fase 3

Kontakter og lokationer

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

Studiekontakt

Studiesteder

  • Forenede Stater
    • California
      • La Jolla, California, Forenede Stater, 92037
        • Rekruttering
        • University of California San Diego (UC San Diego) Health - Jacobs Medical Center
      • Los Angeles, California, Forenede Stater, 90027
        • Rekruttering
        • Children's Hospital Los Angeles
      • Sacramento, California, Forenede Stater, 95817
        • Rekruttering
        • University of California Davis (UC Davis) Medical Center
      • San Francisco, California, Forenede Stater, 94143
        • Rekruttering
        • University of California San Francisco (UCSF) Medical Center
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46260
        • Rekruttering
        • Innovative Hematology - Indiana Hemophilia & Thrombosis Center
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55455
        • Rekruttering
        • M Health Fairview - University of Minnesota Medical Center
    • New York
      • New York, New York, Forenede Stater, 10065
        • Rekruttering
        • New York-Presbyterian - Weill Cornell Medical Center
    • North Carolina
      • Durham, North Carolina, Forenede Stater, 27709
        • Rekruttering
        • Science 37
    • Texas
      • Houston, Texas, Forenede Stater, 77030
        • Rekruttering
        • Gulf States Hemophilia and Thrombophilia Center - Texas Medical Center

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

12 år til 70 år (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Has the ability to provide informed consent to participate in the clinical study before completing any study-related procedures, and has an understanding, ability, and willingness to comply with clinical study procedures and restrictions.

  • Adults 18 to 70 years.

  • Adolescents 12 to <18 years, dependent on geographical location.

  • Has clinical bleeding phenotype consistent with Glanzmann thrombasthenia (GT) and documentation of either diagnostic laboratory criteria (a) or (b) below:

    1. Abnormal platelet aggregometry AND flow cytometry
    2. A confirmed genetic mutation in ITGA2B or ITGB3.

  • Participants have experienced at least four treated bleeding events related to GT within the 12 months prior to Screening.

Exclusion Criteria:

  • Prior exposure to sutacimig.
  • History of clinically significant hypersensitivity associated with monoclonal antibody therapies.
  • Congenital or acquired bleeding disorders other than GT.
  • Medical condition (other than GT) that constitutes an increased risk of having uncontrolled bleeding events during the study or other conditions per Investigator discretion.
  • History of venous or arterial thromboembolic (TE) event or TE disease except for catheter-associated vein thrombosis.
  • Co-existing thrombophilia disorder.

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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Sutacimig

Participants will receive sutacimig 0.2 milligrams per kilogram (mg/kg) by subcutaneous injection once weekly for 48 weeks. Upon completion of the 48-week treatment period, participants will be offered the opportunity to transition to a separate open-label extension (OLE) study for continued assessment of the prophylactic treatment with sutacimig.
Medicin: Sutacimig

Sutacimig will be administered by subcutaneous injection.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Annualized Treated Bleed Rate (ATBR)
Tidsramme: From the first dose through Week 48
From the first dose through Week 48

Sekundære resultatmål

Resultatmål
Tidsramme
High-Intensity Annualized Treated Bleed Rate (Hi-ATBR)
Tidsramme: From the first dose through Week 48
From the first dose through Week 48
Annualized Treated Bleed Days (ATBD)
Tidsramme: From the first dose through Week 48
From the first dose through Week 48
Annualized Treated Bleed Rate (ATBR) by Bleeding Event Type
Tidsramme: From the first dose through Week 48
From the first dose through Week 48
Annualized Treated Bleed Rate (ATBR) by Bleeding Event Cause
Tidsramme: From the first dose through Week 48
From the first dose through Week 48
Percentage of Participants With Reductions in Annualized Treated Bleed Rate (ATBR)
Tidsramme: From the first dose through Week 48
From the first dose through Week 48
Percentage of Participants With Reductions in High-Intensity Annualized Treated Bleed Rate (Hi-ATBR)
Tidsramme: From the first dose through Week 48
From the first dose through Week 48
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Tidsramme: From the first dose through Week 56
From the first dose through Week 56
Number of Participants With Physical Examination Abnormalities
Tidsramme: From the first dose through Week 56
From the first dose through Week 56
Number of Participants With Vital Sign Abnormalities
Tidsramme: From the first dose through Week 56
From the first dose through Week 56
Number of Participants With Clinical Laboratory Test Abnormalities
Tidsramme: From the first dose through Week 56
From the first dose through Week 56
Number of Participants With Anti-Drug Antibody (ADA) Development
Tidsramme: From the first dose through Week 56
From the first dose through Week 56
Number of Participants With Changes in Electrocardiogram (ECG) Parameters
Tidsramme: From the first dose through Week 56
From the first dose through Week 56
Plasma Concentration for Sutacimig
Tidsramme: Baseline through Week 56
Baseline through Week 56

Samarbejdspartnere og efterforskere

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

Sponsor

Hemab ApS

Efterforskere

  • Studieleder: Medical Director, Hemab

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)

27. oktober 2026

Primær færdiggørelse (Anslået)

1. november 2029

Studieafslutning (Anslået)

1. januar 2030

Datoer for studieregistrering

Først indsendt

9. november 2026

Først indsendt, der opfyldte QC-kriterier

9. november 2026

Først opslået (Faktiske)

13. november 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HMB-001-103
  • U1111-1342-3293 (Anden identifikator: Universal Trial Number)

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

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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