Safety and Efficacy of GL-2045 in Patients With Immune Thrombocytopenia
The goal of this clinical trial is to demonstrate GL-2045 safety and efficacy proof of concept by demonstrating intravenous immunoglobulin (IVig)-like platelet responses in adult patients with Immune Thrombocytopenia (ITP).
| Condition(s) | Immune Thrombocytopenia |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | The goal of this clinical trial is to demonstrate GL-2045 safety and efficacy proof of concept by demonstrating intravenous immunoglobulin (IVig)-like platelet responses in adult patients with Immune Thrombocytopenia (ITP). |
| Who can participate | Key Inclusion Criteria: 1. Male or female between 18 and 80 years of age with ITP or certain limited ITP conditions. 2. Females must not be pregnant or lactating. Males and females of childbearing potential must agree to use contraception. 3. A platelet count of 10 to 49 × 10\^9/L at baseline. 4. Study subjects must have prior response to corticosteroids or to intravenous immunoglobin (IVIg) documented by a consultant hematologist. Prior response to thrombopoietin receptor agonists is insufficient for eligibility. 5. The subject may be on a stable dose of corticosteroids for the 3 months prior to study entry, limited to a daily dose of prednisone 10 mg or equivalent. No reductions or increases of steroids are allowed during the study. Key Exclusion Criteria: 1. Any serious adverse event (S |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Lead sponsor | Gliknik Inc. |
| Locations | Leeds, United Kingdom |
| Start date | 2026-04-14 |
| NCT ID | NCT07605845 |
| Official listing | https://clinicaltrials.gov/study/NCT07605845 |