RecruitingPhase 1NCT07605845
Safety and Efficacy of GL-2045 in Patients With Immune Thrombocytopenia
Initial Safety and Efficacy, Sequential Group, Adaptive Dose Study of GL-2045 Subcutaneous Injection Repeat Doses in Patients With Immune Thrombocytopenia
Sponsor
Gliknik Inc.
Enrollment
42 participants
Start Date
Apr 14, 2026
Study Type
INTERVENTIONAL
Conditions
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).
Eligibility
Min Age: 18 YearsMax Age: 80 Years
Inclusion Criteria5
- Male or female between 18 and 80 years of age with ITP or certain limited ITP conditions.
- Females must not be pregnant or lactating. Males and females of childbearing potential must agree to use contraception.
- A platelet count of 10 to 49 × 10\^9/L at baseline.
- 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.
- 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.
Exclusion Criteria6
- Any serious adverse event (SAE) with prior IVIg dosing.
- Prior splenectomy within 1 year of randomization or planned splenectomy during the study period.
- Participants with grade 2 bleeding by World Health Organization (WHO) bleeding criteria in the 8 weeks prior to treatment.
- Abnormal organ function including liver and kidney.
- Any previous or current treatments prohibited by the protocol.
- Treatment within the last 4 weeks or intention to treat during the study with a thrombopoietin receptor agonist including romiplostim (Nplate®), eltrombopag (Revolade®), or avatrombopag (Doptelet®).
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
DRUGGL-2045
Administrative route: SC injection
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07605845
Related Trials
Study to Assess the Safety and Tolerability of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Disorders
NCT0710456540 locations
Contribution of Anti-platelet Antibodies Identified With MAIPA Assay in the Demonstration of the Auto-immune Character of a Thrombocytopenia at Diagnosis
NCT048004581 location
Phase I Study of SHR-2173 Injection in Patients With Primary Immune Thrombocytopenia
NCT072067581 location
Study to Evaluate the Efficacy and Safety of Oral Rilzabrutinib in Adults With Immune Thrombocytopenia (ITP) Who Failed First-line Treatment
NCT0700796230 locations
Anti-CD38 Monoclonal Antibody Versus Rituximab in the Management of Primary Immune Thrombocytopenia (ITP)
NCT072975631 location