Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Phase 2, Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging, Efficacy, and Safety Study of Povorcitinib in Participants With Chronic Spontaneous Urticaria

This research study is looking into a new medication called Povorcitinib as a possible treatment for chronic spontaneous urticaria (CSU), which is a condition that causes persistent itchy hives. It's a 'Phase 2' study, meaning researchers are trying to find the best dose and check how well the medicine works and if it's safe. Some participants will receive the new medicine, while others will get a placebo (a dummy pill with no active drug). The main goal is to see if Povorcitinib can significantly reduce symptoms like itching and hive severity over 12 weeks, as measured by a symptom score. This helps ensure that any new treatments are effective and safe for people suffering from CSU.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Incyte Corp.

Enrolment target

Start

31 Oct 2023

Chronic Spontaneous Urticaria

What is this study about?

This study is exploring a new medicine called Povorcitinib for people who suffer from chronic spontaneous urticaria, often known as chronic hives. If you have this condition, you'll know it causes itchy, red, and swollen welts (hives) that appear without an obvious trigger and can last for six weeks or more. It can be very uncomfortable and affect your daily life.

The study is in 'Phase 2'. This stage of research is important because it's when scientists really start to understand if a new medicine works and what the right dose might be. They also keep a close eye on any side effects to make sure it's safe for people to use. To do this fairly, some participants will receive the new medicine, Povorcitinib, while others will receive a 'placebo' – this looks exactly like the real medicine but contains no active drug. This helps researchers compare the effects accurately, so they know if any improvements are genuinely due to the new medicine.

The main goal of this particular study is to see how much Povorcitinib can reduce a patient's symptoms of chronic spontaneous urticaria over 12 weeks. Researchers will measure this by looking at changes in a special score called the UAS7. This score combines how bad a person's itching is and how severe their hives are each day over a week. They also want to see how many people get their symptoms largely under control or even completely disappear by the end of the study period.

Key takeaways

This study is testing a new drug, Povorcitinib, for chronic spontaneous urticaria (chronic hives).
It's a Phase 2 study, focused on finding the right dose, checking effectiveness, and safety.
Participants will either receive the new drug or a dummy pill (placebo).
The study measures changes in itching and hive severity over 12 weeks.
It's open to adults aged 18 and older, of all sexes.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To be considered for this study, you would generally need to be an adult, aged 18 years or older. There is no upper age limit, meaning older adults are also welcome to participate.

Both men and women are invited to take part in this research. The study aims to gather information from a wide range of people to ensure the results are as widely applicable as possible.

Beyond these basic requirements, there will be specific medical criteria to ensure the study is safe for you and that the results will be clear. For example, you would need to have a confirmed diagnosis of chronic spontaneous urticaria and your symptoms would likely need to be active enough to be measured effectively by the trial's methods.

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 a diagnosis of chronic spontaneous urticaria (chronic hives)?
Are your hives currently active and bothersome?
Are you able to attend regular study appointments?
Are you comfortable with the idea of potentially receiving a placebo?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first go through a screening process to make sure it's suitable for you. Once enrolled, you would be randomly assigned to either receive the new medicine, Povorcitinib, or a matching placebo. You, and often the study doctors, wouldn't know which one you're receiving (this is called 'double-blind').

You would need to attend regular clinic visits over a period of 12 weeks. During these visits, the study team would give you your medication, ask about your symptoms, perform physical examinations, and take blood samples to check your general health and see how your body is reacting to the treatment. You would also likely be asked to keep a daily diary of your symptoms, such as the severity of your itching and hives. After the main 12-week treatment period, there would probably be a follow-up period to check on your health and any lasting effects. The total duration including screening, treatment, and follow-up would be explained to you in detail.

Potential risks and benefits

Participating in a clinical trial may offer potential benefits, such as contributing to scientific understanding and potentially receiving a new medicine that could help with your chronic spontaneous urticaria. However, there's no guarantee the medicine will help you, and you might receive a placebo. Like all medicines, Povorcitinib may have side effects, some of which might be mild and others more serious. All known and potential risks will be thoroughly explained to you before you agree to participate. You will also be closely monitored by the study team throughout the trial. Remember, taking part is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

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

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Unverified
Germany
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Unverified
Poland

Common questions

What is chronic spontaneous urticaria?

It's a skin condition where you get itchy hives (red, raised welts) that appear without warning and last for six weeks or more. It can be very uncomfortable.

What does 'Phase 2' mean for a study?

Phase 2 is when researchers check if a new medicine works, find the best dose, and keep an eye on safety. It's an important step before wider use.

What is a 'placebo'?

A placebo is a 'dummy' pill that looks just like the real medicine but contains no active drug. It helps researchers compare the effects of the new medicine fairly.

Will I know if I'm getting the real medicine or the placebo?

No, this is a 'double-blind' study, meaning neither you nor your study doctor will know who is getting which treatment. This helps ensure fair and unbiased results.

How long would I need to be in the study?

The main part of the study involves 12 weeks of treatment, with further follow-up. The exact total time would be explained in detail if you are considered for the study.