GL-2045 safety and blood-count help for adults with ITP

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1b, open-label study in adults with ITP. It uses multiple subcutaneous injections of GL-2045 to assess safety, pharmacokinetics, and effects on platelet counts and patient-reported outcomes. The study will also explore biomarkers and immune responses to help guide dosing for future studies. Results will inform dose regimens and whether GL-2045 warrants further testing for efficacy and safety in ITP.

Why it matters

Who can join: the full rules

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 (SAE) with prior IVIg dosing.
2. Prior splenectomy within 1 year of randomization or planned splenectomy during the study period.
3. Participants with grade 2 bleeding by World Health Organization (WHO) bleeding criteria in the 8 weeks prior to treatment.
4. Abnormal organ function including liver and kidney.
5. Any previous or current treatments prohibited by the protocol.
6. 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®).

Where it's running

• Fortrea Clinical Research Unit Ltd
  Leeds, United Kingdom Recruiting

Study contacts

• Principal investigator: Jim Bush, MBChB, PhD — Fortrea Clinical Research Unit Ltd.
• Study coordinator: Gliknik Clinical Trials Group
• Email: gliknikclinicaltrialinquiries@gliknik.com
• Phone: 410-665-0662

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.