NCT07935356 · Hemab ApS
A Phase 3 Evaluation of Sutacimig in Glanzmann Thrombasthenia
(SOLARA)
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
Sutacimig
Sutacimig will be administered by subcutaneous injection.
Primary outcome measures
Annualized Treated Bleed Rate (ATBR)
Time frame: From the first dose through Week 48
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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:
- Abnormal platelet aggregometry AND flow cytometry
- 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.
Where
- La Jolla, California
- Los Angeles, California
- Sacramento, California
- San Francisco, California
- Indianapolis, Indiana
- Minneapolis, Minnesota
- New York, New York
- Durham, North Carolina
- Houston, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 13, 2026 · Source of record for eligibility and locations