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

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).

Study Overview

• Status: Recruiting
• Conditions: Immune Thrombocytopenia
• Intervention / Treatment: Drug: GL-2045

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.

• Study Type: Interventional
• Enrollment (Estimated): 42
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Gliknik Clinical Trials Group; Phone Number: 410-665-0662; Email: gliknikclinicaltrialinquiries@gliknik.com

Study Locations

• United Kingdom
  • Leeds, United Kingdom, LS11 9EH
    • Recruiting
    • Fortrea Clinical Research Unit Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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®).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GL-2045; 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	Drug: GL-2045; Administrative route: SC injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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)
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

Collaborators and Investigators

• Sponsor: Gliknik Inc.
• Investigators: Principal Investigator: Jim Bush, MBChB, PhD, Fortrea Clinical Research Unit Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2026
• Primary Completion (Estimated): December 6, 2027
• Study Completion (Estimated): December 6, 2027

Study Registration Dates

• First Submitted: April 29, 2026
• First Submitted That Met QC Criteria: May 18, 2026
• First Posted (Actual): May 26, 2026

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Adult ITP
• Additional Relevant MeSH Terms: Cytopenia; Pathologic Processes; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Skin Manifestations; Hematologic Diseases; Blood Coagulation Disorders; Hemorrhagic Disorders; Blood Platelet Disorders; Thrombotic Microangiopathies; Purpura, Thrombocytopenic; Purpura; Thrombocytopenia; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hemic and Lymphatic Diseases; Purpura, Thrombocytopenic, Idiopathic
• Other Study ID Numbers: GL-2045-03; 2025-522629-36 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No