Recruiting
Phase 3

Sutacimig

Sponsor:

Hemab ApS

Code:

NCT07935356

Conditions

Thrombasthenia

Eligibility Criteria

Sex: All

Age: 12 - 70

Healthy Volunteers: Not accepted

Interventions

Sutacimig

Study Details

Brief summary:

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.

Conditions

Thrombasthenia

Study ID

NCT07935356

Start date

Oct 27, 2026

Status verified date

Nov, 2026

Completion date

Jan, 2030

Anticipated

Primary completion date

Nov, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 70

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

76 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

Sutacimig

Sutacimig will be administered by subcutaneous injection.

Primary outcome measure

  • Annualized Treated Bleed Rate (ATBR) [ Time Frame: From the first dose through Week 48 ]

Central Contacts and Locations

Central contacts

Clinical Trials

1 833 328 7111clinicaltrials@hemab.com

Locations

University of California San Diego (UC San Diego) Health - Jacobs Medical Center

Recruiting

La Jolla, California, United States, 92037

Children's Hospital Los Angeles

Recruiting

Los Angeles, California, United States, 90027

University of California Davis (UC Davis) Medical Center

Recruiting

Sacramento, California, United States, 95817

University of California San Francisco (UCSF) Medical Center

Recruiting

San Francisco, California, United States, 94143

Innovative Hematology - Indiana Hemophilia & Thrombosis Center

Recruiting

Indianapolis, Indiana, United States, 46260

M Health Fairview - University of Minnesota Medical Center

Recruiting

Minneapolis, Minnesota, United States, 55455

New York-Presbyterian - Weill Cornell Medical Center

Recruiting

New York, New York, United States, 10065

Science 37

Recruiting

Durham, North Carolina, United States, 27709

Gulf States Hemophilia and Thrombophilia Center - Texas Medical Center

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

Hemab ApS

Last update posted

Nov 13, 2026

Last verified

Nov, 2026

Keywords

  • Glanzmann
  • Glanzmann Thrombasthenia
  • Bleeding
  • Glanzmann's thrombasthenia
  • GT
  • Thrombasthenia
  • Inherited Platelet Function Disorder
  • Rare Bleeding Disorder
  • ITGA2B
  • ITGB3
  • GPIIb/IIIa
  • Sutacimig
  • HMB-001
  • Epistaxis
  • Iron Deficiency Anemia
  • Blood Coagulation Disorders
  • Inherited Blood Coagulation Disorders
  • Hematologic Diseases
  • Hemic and Lymphatic Diseases
  • Blood Platelet Disorders
  • Hemorrhagic Disorders
  • Genetic Diseases, Inborn
  • Congenital Hereditary, Neonatal Diseases and Abnormalities

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-14. This information was provided to ClinicalTrials.gov by Hemab ApS on 2026-11-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.