Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

HLH-JAK - Treatment of non severe Hemophagocytosis Lymphohistiocytosis with ITACITINIB a Phase II prospective trial

This research is looking into a new medicine, Itacitinib, for adults who have a form of HLH (Hemophagocytic Lymphohistiocytosis) that isn't severe. HLH is a rare condition where the immune system becomes overactive and can damage organs. This study, called a Phase II trial, aims to see if Itacitinib can effectively reduce the symptoms of HLH within 15 days of starting treatment. They are particularly interested in people whose HLH is new, keeps coming back, or hasn't responded to other treatments. The main goal is to find out how many people show a good improvement in their symptoms after taking the medicine.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Assistance Publique Hopitaux De Paris, Assistance Publique Hopitaux De Paris

Enrolment target

Start

29 Jul 2024

Adults patients having non severe HLH

What is this study about?

This study is called HLH-JAK, and it's looking into a new medicine named Itacitinib. The main goal is to see if this medicine can help adults who have a specific, less severe type of a rare immune system condition called Hemophagocytic Lymphohistiocytosis, or HLH. In HLH, your immune system, which normally fights off infections, becomes overactive and can accidentally harm healthy parts of your body.

Doctors are particularly interested in people whose HLH is either primary (meaning it's new), refractory (meaning it hasn't responded well to previous treatments), or relapsed (meaning it has come back after getting better). The researchers want to know if Itacitinib can improve the signs and symptoms of HLH, both those you can feel (clinical symptoms) and those doctors see in tests (biological symptoms), quite quickly – specifically within 15 days of starting the treatment.

This is a Phase II trial, which means it’s an early-stage study to find out if the medicine works and is safe enough to test in larger groups of people. If Itacitinib proves effective in calming down the overactive immune system in these patients, it could potentially become a new treatment option for HLH in the future.

Key takeaways

This study is testing a new medicine called Itacitinib for adults with non-severe HLH.
It aims to see if the medicine improves symptoms within 15 days.
It's for new, returning, or unresponsive HLH cases.
This is an early-stage study to understand if the medicine works and is safe.
Participants must be 18 or older with non-severe HLH.

Who may be eligible?

To be considered for this study, you must be an adult, aged 18 or older. There is no upper age limit, meaning people of all adult ages can potentially take part. Both men and women are welcome to join the study.

The most important health requirement is that you have a form of Hemophagocytic Lymphohistiocytosis (HLH) that is considered 'non-severe'. This means your HLH symptoms and the way your body is reacting are not currently life-threatening or extremely severe. Your doctor will be able to confirm if your specific HLH falls into this category.

You would also be considered if your HLH is newly diagnosed (primitive), hasn't responded to other treatments (refractory), or has come back after a period of improvement (relapsed).

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with Hemophagocytic Lymphohistiocytosis (HLH)?
Has your doctor told you your HLH is currently 'non-severe'?
Is your HLH either newly diagnosed, has returned, or hasn't responded to previous treatments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the study medicine, Itacitinib. The main goal is to see how your body responds to the medicine within the first 15 days. This means doctors would closely monitor your symptoms and perform tests, likely including blood tests, to see if your HLH is improving. You would have regular appointments to check on your health and any side effects. The exact number of visits and tests would be explained to you by the study team, but they would be focusing on your progress during the initial treatment period. We don't have details on the total duration of the medicine or participation beyond the initial 15-day assessment, but the study team would provide a full schedule.

Potential risks and benefits

Taking part in this study might offer a potential benefit: you could be among the first to receive a new medicine that might help control your HLH symptoms if other treatments haven't worked or your HLH is new. However, like all medicines, Itacitinib may have side effects, and these will be carefully explained to you by the study team. They will monitor you closely for any unwanted effects. You always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is HLH?

HLH is a rare condition where your immune system becomes overactive and can damage healthy parts of your body instead of just fighting off infections.

What is Itacitinib?

Itacitinib is the new medicine being tested in this study. It aims to help calm down the overactive immune system in people with HLH.

How long will I be in the study?

The study focuses on how you respond to the medicine within the first 15 days of treatment. The full duration of your participation will be explained by the study team.

What is a 'non-severe' HLH?

This means your HLH symptoms and the way your body is reacting are not currently life-threatening or extremely serious. Your doctor will confirm if you fit this description.

Can women take part?

Yes, both men and women are eligible to take part in this study.

How to find out more

Official trial record

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