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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-522629-36 | EudraCT Number |
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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).
This is a Phase 1b, open-label, multiple subcutaneous (SC) injection dose study in participants with ITP. The specific aims of this study are to determine:
This information, together with pharmacokinetic (PK) data, will help to establish doses and dosing regimens suitable for use in future studies. The effects of GL-2045 on multiple biomarkers will also be investigated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GL-2045 | Experimental | Participants will receive GL-2045 by SC injection during the treatment period. Cohort 1: Adaptive design cohort during which dose adjustment may occur. Up to 18 participants will be enrolled Cohort 2: Fixed-dose and dosing frequency testing 1 or 2 dose levels and dose regimens. Up to 24 participants will be enrolled |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GL-2045 | Drug | Administrative route: SC injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence, severity and type of adverse events and laboratory abnormalities | Screening (Days -28 to -2) to Follow-up (Day 55) | |
| Multiple measurements of change from baseline in platelet count | Day -1 to Follow-up (Day 55) |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Tumor Necrosis Factor-Alpha (TNF-α) Levels | Day 1 to Follow-up (Day 55) | |
| Change from Baseline in Classical Complement Pathway (CCP) Inhibition | Day 1 to Follow-up (Day 55) |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gliknik Clinical Trials Group | Contact | 410-665-0662 | gliknikclinicaltrialinquiries@gliknik.com |
| Name | Affiliation | Role |
|---|---|---|
| Jim Bush, MBChB, PhD | Fortrea Clinical Research Unit Ltd. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fortrea Clinical Research Unit Ltd | Recruiting | Leeds | LS11 9EH | United Kingdom |
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| ID | Term |
|---|---|
| D016553 | Purpura, Thrombocytopenic, Idiopathic |
| ID | Term |
|---|---|
| D011696 | Purpura, Thrombocytopenic |
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
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| Changes in bleeding scale | Day -1 to Follow-up (Day 55) |
| Changes from baseline in Functional Assessment of Chronic Illness Therapy (FACIT-Fatigue) Questionnaire | Day -1 to Follow-up (Day 55) |
| Changes from baseline in FACIT-Thrombocytopenia 6 Questionnaire | Day -1 to Follow-up (Day 55) |
| Area under the plasma concentration-time curve from time 0 to the time of last quantifiable concentration (AUCO-tlast) | Day 1 to Follow-up (Day 55) |
| Maximum observed concentration (Cmax) | Day 1 to Follow-up (Day 55) |
| Time of the maximum observed concentration (tmax) | Day 1 to Follow-up (Day 55) |
| Incidence of immune response to drug | Day 1 to Day 48 |
| D006425 |
| Hemic and Lymphatic Diseases |
| D057049 | Thrombotic Microangiopathies |
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| D006474 | Hemorrhagic Disorders |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |