Safety and Efficacy of GL-2045 in Patients With Immune Thrombocytopenia

NCT07605845 | Recruiting Phase 1

• 2 other identifiers: GL-2045-032025-522629-36
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Immune Thrombocytopenia

Keywords

Adult ITP

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• 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)

Study Arms (1)

GL-2045

EXPERIMENTAL

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

Interventions

GL-2045 DRUG

Administrative route: SC injection

GL-2045

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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®).

Sponsors & Collaborators

• Gliknik Inc.: lead

Study Sites (1)

Fortrea Clinical Research Unit Ltd

Leeds, LS11 9EH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Officials

• Jim Bush, MBChB, PhD

  Fortrea Clinical Research Unit Ltd.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gliknik Clinical Trials Group

CONTACT

410-665-0662; gliknikclinicaltrialinquiries@gliknik.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 26, 2026
• Study Start: April 14, 2026
• Primary Completion (Estimated): December 6, 2027
• Study Completion (Estimated): December 6, 2027
• Last Updated: May 26, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)