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Taking people in United KingdomPhase 1

GL-2045 injections for adults with immune thrombocytopenia

Tests GL-2045 injections for safety and platelet response in adults with immune thrombocytopenia.

Key facts

Who runs it
Gliknik Inc.
Where
Leeds, United KingdomSee the site
Registry title
Safety and Efficacy of GL-2045 in Patients With Immune Thrombocytopenia
Status
Recruiting
Phase
Phase 1
People taking part
42 people, planned
Started
14 Apr 2026
Expected to end
6 Dec 2027
Type of study
Interventional
Treatments tested
  • GL-2045
Record updated
26 May 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with immune thrombocytopenia (ITP), a condition with a low platelet count. Their ITP must have responded before to corticosteroids or IVIg.

Age
18 to 80 years
Sex
Men and women
Disease stage
ITP or certain limited ITP conditions, with a platelet count of 10 to 49 × 10^9/L at the start.
Earlier treatment
A past response to corticosteroids or intravenous immunoglobin (IVIg) must be confirmed by a consultant hematologist. A past response to thrombopoietin receptor agonists alone is not enough. A steady corticosteroid dose for the 3 months before entry is allowed, up to prednisone 10 mg a day or equivalent. The dose cannot change during the study. No thrombopoietin receptor agonist (romiplostim (Nplate®), eltrombopag (Revolade®), avatrombopag (Doptelet®)) in the last 4 weeks or during the study.
Biomarker or test result
Platelet count of 10 to 49 × 10^9/L at the start.

Main reasons for not taking part

  • A serious side effect with IVIg in the past
  • Spleen removal within 1 year, or spleen removal planned during the study
  • Grade 2 bleeding (WHO criteria) in the 8 weeks before treatment
  • Liver, kidney or other organs not working normally
  • Pregnant or breastfeeding women

The registry criteria, word for word

Show all 11 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • Any previous or current treatments prohibited by the protocol
  • Abnormal organ function including liver and kidney
  • 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®)

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 80 years old?

Where in United Kingdom

  • Fortrea Clinical Research Unit LtdLeeds, United KingdomContact: Gliknik Clinical Trials GroupTaking people

About the trial

What the trial wants to find out

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).

The group in the trial

  • GL-2045Treatment being tested

    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

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Initial Safety and Efficacy, Sequential Group, Adaptive Dose Study of GL-2045 Subcutaneous Injection Repeat Doses in Patients With Immune Thrombocytopenia
Plain-language title
GL-2045 injections for adults with immune thrombocytopeniaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Fit questions
Built from NCT07605845, who can take part
Record updated
26 May 2026