Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Proof of concept study to assess the efficacy and safety of Danicopan (factor D inhibitor) in adult patients with chronic spontaneous urticaria resistant to H1-antihistamine treatment (DANICSU).

This study is testing a new medicine called Danicopan for adults who suffer from chronic spontaneous urticaria, also known as long-lasting hives. These are hives that appear without a clear cause and haven't improved with regular antihistamine tablets. The main purpose is to find out if Danicopan is effective at reducing hives and if it's safe to use. Researchers will specifically look at how well it works for people with different levels of a certain allergy marker in their blood (called IgE). In simple terms, they want to see if this new medicine can offer relief for those whose hives are proving difficult to treat with current options.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Fraunhofer Institute For Translational Medicine And Pharmacology ITMP

Enrolment target

Start

24 Sep 2024

Chronic spontaneous urticaria

What is this study about?

Imagine you have hives that pop up regularly, without an obvious trigger, and your usual allergy pills just aren't doing the trick. This can be really frustrating and impact your daily life. This study is for people like you, who have a condition called chronic spontaneous urticaria that hasn't responded to standard treatments.

The researchers are testing a new medicine called Danicopan. This medicine works in a different way to traditional allergy pills, by targeting a specific part of the body's immune system. They want to see if taking Danicopan can help reduce the number and severity of your hives and improve your overall comfort and quality of life.

They will be carefully watching how your hives change over time and also checking for any unwanted side effects. An important part of the study is to see if the medicine works differently depending on a particular level in your blood called IgE, which is sometimes linked to allergies. This will help them understand who might benefit most from this new treatment.

Key takeaways

This study is testing a new medicine, Danicopan, for long-lasting hives.
It's for adults whose hives haven't responded to standard allergy pills.
The main goal is to see if Danicopan is safe and reduces hives.
Participants will receive injections and have regular check-ups.
Your IgE levels (an allergy marker) will be considered in the study.
You can stop participating at any time.

Who may be eligible?

To be considered for this study, you need to be an adult, 18 years old or older. The study is open to both men and women.

Your long-lasting hives (chronic spontaneous urticaria) must also be active and not have improved with the usual allergy medication (H1-antihistamines) that you might have already tried.

There will also be other specific health requirements that the study doctors will check to make sure the study is safe and suitable for you.

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 last over 6 weeks)?
Have your hives not improved with regular allergy pills?
Are you willing to attend regular clinic visits and receive injections?
Are you comfortable filling out questionnaires and having blood tests?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve regular visits to the clinic over several weeks. During these visits, you'll receive the study medicine, Danicopan, which is given as an injection. There will also be other injections involved, which are common vaccines to protect against certain types of meningitis – these are standard procedures for studies involving types of medicines like Danicopan.

Throughout the study, you'll have regular check-ups with the study team. They will ask you questions about your hives, how you're feeling, and your general health. You might also be asked to fill out questionnaires about how your hives are affecting your daily life. Blood samples will be taken to monitor your progress and check for any side effects. The total duration of your involvement in the study will be determined by the specific study plan.

Potential risks and benefits

If you take part, you might find that Danicopan helps to reduce your hives and improve your quality of life, which could be a significant benefit if other treatments haven't worked. However, as with any new medicine, there's always a possibility of side effects, which the study team will monitor closely. You will be fully informed about these potential risks before deciding to join. It's very important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your 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
Germany

Common questions

What are 'chronic spontaneous urticaria'?

These are persistent itchy red welts (hives) that appear on your skin for more than six weeks, without an obvious cause, and keep coming back.

What is Danicopan and how is it given?

Danicopan is an investigational medicine being tested for hives. It is given as an injection.

Will I still take my regular allergy medicine?

The study will look at your current medication, and the study team will advise you on what specifically you should take as part of the trial.

What does 'H1-antihistamine resistant' mean?

It means your hives haven't gotten better even after you've tried taking standard allergy pills (called H1-antihistamines).

Will I know if I'm getting the actual medicine or a dummy treatment?

In some trials, participants don't know if they're receiving the new medicine or a placebo, but the study team will explain the specific design for this trial.