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

9 november 2026 uppdaterad 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

76

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

12 år till 70 år (Barn, Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Läkemedel: Sutacimig

Sutacimig will be administered by subcutaneous injection.

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Annualized Treated Bleed Rate (ATBR)
Tidsram: From the first dose through Week 48
From the first dose through Week 48

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Hemab ApS

Utredare

  • Studierektor: Medical Director, Hemab

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

27 oktober 2026

Primärt slutförande (Beräknad)

1 november 2029

Avslutad studie (Beräknad)

1 januari 2030

Studieregistreringsdatum

Först inskickad

9 november 2026

Först inskickad som uppfyllde QC-kriterierna

9 november 2026

Första postat (Faktisk)

13 november 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

13 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

9 november 2026

Senast verifierad

1 november 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • HMB-001-103
  • U1111-1342-3293 (Annan identifierare: Universal Trial Number)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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