Safety and Efficacy of GL-2045 in Patients With Immune Thrombocytopenia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: GL-2045.
- Who it may be relevant to
- Registry conditions: Immune Thrombocytopenia. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Initial Safety and Efficacy, Sequential Group, Adaptive Dose Study of GL-2045 Subcutaneous Injection Repeat Doses in Patients With Immune Thrombocytopenia
Overview
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).
Detailed description
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:
* The safety of the study drug when given to participants with ITP * The effect of the study drug on safety blood tests and blood platelet counts * How the study drug affects certain responses in the body such as severity of bleeding, levels of fatigue and health-related quality of life * How much of the study drug gets into the bloodstream * The body's immune response to the study drug
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.
Interventions
- Drug GL-2045
Administrative route: SC injection
Primary outcome measures
- Incidence, severity and type of adverse events and laboratory abnormalities [Time frame: Screening (Days -28 to -2) to Follow-up (Day 55)]
- Multiple measurements of change from baseline in platelet count [Time frame: Day -1 to Follow-up (Day 55)]
Secondary outcome measures (9)
- Change from Baseline in Tumor Necrosis Factor-Alpha (TNF-α) Levels [Time frame: Day 1 to Follow-up (Day 55)]
- Change from Baseline in Classical Complement Pathway (CCP) Inhibition [Time frame: Day 1 to Follow-up (Day 55)]
- Changes in bleeding scale [Time frame: Day -1 to Follow-up (Day 55)]
- Changes from baseline in Functional Assessment of Chronic Illness Therapy (FACIT-Fatigue) Questionnaire [Time frame: Day -1 to Follow-up (Day 55)]
- Changes from baseline in FACIT-Thrombocytopenia 6 Questionnaire [Time frame: 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) [Time frame: Day 1 to Follow-up (Day 55)]
- Maximum observed concentration (Cmax) [Time frame: Day 1 to Follow-up (Day 55)]
- Time of the maximum observed concentration (tmax) [Time frame: Day 1 to Follow-up (Day 55)]
- Incidence of immune response to drug [Time frame: Day 1 to Day 48]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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®).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United Kingdom · 1 center
- Fortrea Clinical Research Unit Ltd — Leeds
Identifiers
NCT: NCT07605845 · GL-2045-03 · 2025-522629-36