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

ConditionImmune Thrombocytopenia
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorGliknik Inc.

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • GL-2045

    Drug

    Administrative route: SC injection

Treatment groups

42 Participants
are divided into 1 treatment group
Group A: GL-2045Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence, severity and type of adverse events and laboratory abnormalities

Time frame
Screening (Days -28 to -2) to Follow-up (Day 55)
2

Multiple measurements of change from baseline in platelet count

Time frame
Day -1 to Follow-up (Day 55)

Secondary outcomes

1

Change from Baseline in Tumor Necrosis Factor-Alpha (TNF-α) Levels

Time frame
Day 1 to Follow-up (Day 55)
2

Change from Baseline in Classical Complement Pathway (CCP) Inhibition

Time frame
Day 1 to Follow-up (Day 55)
3

Changes in bleeding scale

Time frame
Day -1 to Follow-up (Day 55)
4

Changes from baseline in Functional Assessment of Chronic Illness Therapy (FACIT-Fatigue) Questionnaire

Time frame
Day -1 to Follow-up (Day 55)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Gliknik Inc.

Lead sponsor

Source ClinicalTrials.gov
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