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

9. november 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

76

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

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

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Legemiddel: Sutacimig

Sutacimig will be administered by subcutaneous injection.

Hva måler studien?

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Hemab ApS

Etterforskere

  • Studieleder: Medical Director, Hemab

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

27. oktober 2026

Primær fullføring (Antatt)

1. november 2029

Studiet fullført (Antatt)

1. januar 2030

Datoer for studieregistrering

Først innsendt

9. november 2026

Først innsendt som oppfylte QC-kriteriene

9. november 2026

Først lagt ut (Faktiske)

13. november 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

13. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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