A Phase 3 Evaluation of Sutacimig in Glanzmann Thrombasthenia
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Official title
SOLARA: A Phase 3 Study of the Efficacy and Safety of Sutacimig in Participants With Glanzmann Thrombasthenia
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07935356
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 76 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 12 Years to 70 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 27, 2026 (Actual)
- Primary completion
- Nov 2029 (Estimated)
- Completion
- Jan 2030 (Estimated)
- Last update posted
- Nov 13, 2026
2026 – 2030
United States locations
- U.S. sites
- 9
- U.S. states
- 6
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California San Diego (UC San Diego) Health - Jacobs Medical Center | La Jolla | California | 92037 | Recruiting |
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | Recruiting |
| University of California Davis (UC Davis) Medical Center | Sacramento | California | 95817 | Recruiting |
| University of California San Francisco (UCSF) Medical Center | San Francisco | California | 94143 | Recruiting |
| Innovative Hematology - Indiana Hemophilia & Thrombosis Center | Indianapolis | Indiana | 46260 | Recruiting |
| M Health Fairview - University of Minnesota Medical Center | Minneapolis | Minnesota | 55455 | Recruiting |
| New York-Presbyterian - Weill Cornell Medical Center | New York | New York | 10065 | Recruiting |
| Science 37 | Durham | North Carolina | 27709 | Recruiting |
| Gulf States Hemophilia and Thrombophilia Center - Texas Medical Center | Houston | Texas | 77030 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07935356, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 13, 2026 · Synced Nov 14, 2026
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