Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

PHASE 2a OPEN-LABEL BASKET STUDY TO EVALUATE SAFETY AND PHARMACOKINETICS OF INF904, AN ORAL C5aR1 INHIBITOR, IN SUBJECTS WITH MODERATE TO SEVERE CHRONIC SPONTANEOUS URTICARIA OR HIDRADENITIS SUPPURATIVA

This research study is looking at a new oral medicine, INF904, for adults who have troublesome skin conditions: chronic spontaneous urticaria (severe, long-lasting hives) or hidradenitis suppurativa (a painful, long-term skin condition with lumps and abscesses). This is an early-stage study, meaning it's one of the first times this medicine is being tested in a larger group of people. The main goal is to understand if the medicine is safe and what side effects it might cause. Researchers will also look at how the medicine moves through and leaves the body. By doing this, they hope to learn more about INF904 and decide if it's a good candidate for further testing in the future.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

InflaRx GmbH

Enrolment target

Start

06 Mar 2025

Moderate to Severe Chronic Spontaneous Urticaria (CSU) or Moderate to Severe Hidradenitis Suppurativa (HS)

What is this study about?

This research study is about a new medicine called INF904. It's being tested for two specific skin conditions: Chronic Spontaneous Urticaria (CSU), which causes severe, long-lasting itchy red patches or bumps on the skin, and Hidradenitis Suppurativa (HS), a painful, long-term condition that causes lumps and abscesses, often in areas where skin rubs together like the armpits or groin. If you have either of these conditions and they are quite severe, this study might be relevant to you.

The main purpose of this study is to check how safe this new medicine, INF904, is. It's an early-stage study, called a Phase 2a trial. This means it's an important step to learn more about the medicine after initial safety tests. The researchers will be carefully monitoring for any unwanted reactions, often called 'side effects,' and how severe they might be. They also want to understand if these side effects are linked to the medication.

Another key part of the study is to understand how INF904 behaves in your body. This includes how much of the medicine gets into your bloodstream, how long it stays there, and how quickly your body gets rid of it. This information helps doctors figure out the best way to give the medicine in future studies. The goal is to see if INF904 could potentially be a helpful new treatment option for people living with these challenging skin conditions.

Key takeaways

This study is testing a new oral medicine (INF904) for chronic hives or hidradenitis suppurativa.
The main goals are to check the medicine's safety and how it works in the body.
It's an early-stage trial (Phase 2a), so it's one of the first times it's being tested in people with these conditions.
Participants must be adults with moderate to severe forms of either condition.
Regular clinic visits and health checks will be part of taking part.
You can stop participating at any time if you change your mind.

Who may be eligible?

To be considered for this study, you need to be an adult, 18 years old or older. There is no upper age limit, meaning older adults can also take part.

Crucially, you must have been diagnosed with either moderately to severely active Chronic Spontaneous Urticaria (hives) or moderately to severely active Hidradenitis Suppurativa. These conditions should be causing you significant problems, not just mild symptoms.

If you fit these general criteria, the study team will then check other aspects of your health and medical history to make sure taking part is safe for you and that you meet all the specific requirements of the study.

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?
Do you have chronic spontaneous urticaria (hives) that is moderate to severe?
OR do you have hidradenitis suppurativa that is moderate to severe?
Are you able to attend regular clinic appointments?
Have you discussed your interest in a clinical trial with your local doctor?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be given the new medicine, INF904, to take by mouth. The study involves several visits to the clinic where the research team will closely monitor your health. They will perform health checks, such as measuring your vital signs (like blood pressure and heart rate), taking blood samples, and asking you about any symptoms or side effects you might experience. These assessments help the researchers understand how your body reacts to the medicine and how it’s working. You'll also be asked to accurately report any changes in your condition or any side effects. The total duration of your involvement in the study, including follow-up appointments after you stop taking the medicine, will be explained in detail by the study team.

Potential risks and benefits

Participating in a study like this means you might be one of the first people to benefit from a new treatment if INF904 is effective for your condition, which could lead to an improvement in your symptoms. However, as with any new medicine, there are potential risks, including the possibility of experiencing side effects that are currently unknown or not fully understood. The research team will explain all known potential risks in detail, and your health will be carefully monitored throughout the study. You have the right to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (4)

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

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Unverified
Greece
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Unverified
Poland
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Unverified
Germany
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Unverified
Bulgaria

Common questions

What is Chronic Spontaneous Urticaria (CSU)?

CSU is a type of chronic hives where itchy red welts appear on the skin for more than six weeks, often without a clear cause.

What is Hidradenitis Suppurativa (HS)?

HS is a long-term skin condition that causes painful lumps, boils, and abscesses, usually in areas where skin rubs together.

What does 'Phase 2a' mean?

Phase 2a means this is an early stage of testing for a new medicine. It focuses on checking safety and how the body handles the medicine in a small group of people with the condition.

Will I know if I'm getting the actual medicine?

This is an 'open-label' study, meaning both you and the study team will know that you are receiving the active study medicine, INF904.

What is INF904?

INF904 is a new experimental medicine that works by blocking a specific protein in the body, which might help reduce inflammation linked to CSU and HS.