RecruitingPHASE1INTERVENTIONAL

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

This research study is testing a new medicine called GL-2045 for adults aged 18 to 80 who have Immune Thrombocytopenia (ITP). ITP is a condition where your immune system attacks your platelets, which are blood cells that help stop bleeding. The study aims to find out if GL-2045 is safe to use and if it can effectively increase platelet counts, similar to how an existing treatment called intravenous immunoglobulin (IVIg) works. Researchers will also look at how the medicine affects things like bleeding, tiredness, and overall quality of life. This information will help them decide the best way to use GL-2045 in future studies.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Gliknik Inc.

Enrolment target

Start

14 Apr 2026

Estimated completion

06 Dec 2027

Immune Thrombocytopenia

What is this study about?

This study is investigating a new medication, GL-2045, for individuals living with Immune Thrombocytopenia (ITP). ITP is a condition where the body's immune system mistakenly attacks and destroys its own platelets, which are essential for blood clotting. This can lead to bruising, bleeding, and fatigue. The main purpose of this study is to understand if GL-2045 is a safe and effective treatment option for ITP by seeing if it can help raise platelet counts to a healthy level, similar to a common treatment called intravenous immunoglobulin (IVIg).

Researchers will be giving GL-2045 as a shot under the skin. They are especially interested in several key areas. Firstly, they will carefully monitor any side effects to make sure the medicine is safe. Secondly, they will measure how much the medicine helps to increase platelet counts. They also want to understand how GL-2045 might impact symptoms like bleeding episodes and how tired people feel, as well as their general wellbeing and quality of life.

Finally, the study will also look at how the body processes GL-2045 and how the immune system responds to it. All this information is crucial to help doctors decide the right dose and how often the medicine should be given in future, larger studies. This research could potentially offer a new treatment option for people with ITP.

Key takeaways

This is a study for a new medicine (GL-2045) for Immune Thrombocytopenia (ITP).
It aims to check the safety of GL-2045 and see if it helps increase platelet counts.
GL-2045 will be given as injections under the skin.
Researchers will also look at effects on bleeding, tiredness, and quality of life.
Participation includes regular clinic visits and close monitoring.
You can stop participating at any time.

Who may be eligible?

To join this study, you need to be an adult between 18 and 80 years old with Immune Thrombocytopenia (ITP). You must have a certain platelet count (between 10 and 49) and have shown a good response to previous treatments like steroids or IVIg. If you're a woman, you cannot be pregnant or breastfeeding, and all participants of childbearing age must agree to use effective birth control.

There are also some reasons why you might not be able to join. For example, if you've had a serious bad reaction to IVIg in the past, or if you've had your spleen removed in the last year. You also can't have severe bleeding in the 8 weeks before the study starts, or serious problems with your liver or kidneys. Certain other medical conditions or medications might also prevent you from taking part.

Quick self-check

Are you between 18 and 80 years old?
Do you have ITP and have previously responded to steroids or IVIg treatments?
Is your current platelet count between 10 and 49?
Are you willing and able to use contraception if needed?
Have you avoided other specific ITP medications (like Nplate, Revolade) in the last 4 weeks?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

This study is in its early stages (Phase 1b) and will involve receiving GL-2045 as multiple injections under the skin. You will have regular visits to the clinic where the research team will check your health, take blood for safety tests and to count your platelets, and ask you about any symptoms like bleeding or tiredness. They will also talk to you about your general quality of life. The exact number of visits and the total length of your participation will be explained by the study team. You will be monitored closely throughout the study to ensure your safety and to understand how the medicine is working.

Potential risks and benefits

Taking part in any clinical trial involves potential benefits and risks. A possible benefit of this study is that GL-2045 might help improve your platelet count and reduce your ITP symptoms, though this is not guaranteed for everyone. As with any new medicine, there are risks of side effects, which will be carefully monitored by the study team. You will be given detailed information about these potential risks before you decide to join. Remember, participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (1)

Fortrea Clinical Research Unit Ltd
Leeds, United Kingdom· Recruiting

Common questions

What is GL-2045?

GL-2045 is a new medicine being tested in this study for people with Immune Thrombocytopenia (ITP).

What is ITP?

ITP stands for Immune Thrombocytopenia. It's a condition where your immune system attacks your platelets, which are important for blood clotting.

How will GL-2045 be given?

GL-2045 will be given as several injections under the skin.

What is the main goal of this study?

The main goal is to find out if GL-2045 is safe and helps increase platelet counts in people with ITP.

Can I still take my regular steroids if I join?

You may be on a stable dose of up to 10mg prednisone (or equivalent) daily, but this dose cannot be changed during the study.

How to find out more

Gliknik Clinical Trials Group

gliknikclinicaltrialinquiries@gliknik.com 410-665-0662 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.