A Phase 3 Evaluation of Sutacimig in Glanzmann Thrombasthenia
SOLARA: A Phase 3 Study of the Efficacy and Safety of Sutacimig in Participants With Glanzmann Thrombasthenia
Who can join
Ages 12 to 70 · All sexes
Full eligibility criteria
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.
About the study
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.
What is being tested
- Sutacimig (drug)
Sponsor: Hemab ApS · Participants: 76 · Started: Oct 27, 2026
Contact the study team
- Clinical Trials · Phone: 1 833 328 7111
Official record on ClinicalTrials.gov — NCT07935356
Locations in the U.S.
Conditions
- Bleeding
- Iron-Deficiency Anemia
- Bleeding Disorders
- Blood Disorders
- Genetic Disorders
- and Neonatal Diseases and Abnormalities Hereditary Congenital
From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.