Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy, Safety, and Tolerability of Abrocitinib in Subjects with Moderate to Severe Chronic Hand Eczema Refractory to Corticosteroid Therapy

This research study is for adults in the UK who have ongoing, moderate to severe eczema on their hands. This is the kind of eczema that hasn’t gotten better with steroid creams or ointments. The study is testing a new medicine called Cibinqo, given as tablets, against a dummy pill (placebo) to see if it can help improve hand eczema symptoms. Researchers want to find out how well Cibinqo works, if it's safe, and if people can tolerate it without too many side effects. They'll be looking at things like how much the eczema improves, how it affects daily life, and any pain or itching experienced over 16 weeks.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Innovaderm Research Inc.

Enrolment target

Start

10 Jun 2024

Moderate to severe chronic hand eczema

What is this study about?

This study is focusing on a specific type of eczema called chronic hand eczema. 'Chronic' means it's long-lasting, and 'moderate to severe' indicates it's quite troublesome. The study is for people whose hand eczema hasn't responded well to standard treatments like corticosteroid creams, which are often the first line of defense. The new medicine being tested is called Cibinqo, and it's given as a tablet. Researchers want to understand if Cibinqo can significantly improve the symptoms of hand eczema and make daily life easier for those affected.

This is a 'Phase 2' study, which means it's one of the earlier stages of testing a new medicine. It's designed to get a better idea of how well the drug works and its safety profile in a larger group of people than in a very early 'Phase 1' study. Participants will be split into groups, with some receiving Cibinqo and others receiving a placebo (a tablet that looks the same but contains no active medicine). This helps researchers to fairly compare the new medicine's effects.

The main thing the researchers will be watching for is whether Cibinqo can reduce the severity of hand eczema symptoms after 16 weeks. They'll also be looking at other important aspects like how quickly improvements might be seen, how much the eczema affects a person's quality of life and their daily activities, and if it reduces pain and itching. Safety is also a top priority, so they'll be closely monitoring for any side effects.

Key takeaways

This study is testing a new tablet medicine, Cibinqo, for severe, long-lasting hand eczema.
It's for adults whose hand eczema hasn't gotten better with standard steroid treatments.
Participants will take either Cibinqo or a dummy pill for 16 weeks.
Researchers will check how well the medicine works and if it's safe.
Taking part could mean getting access to a new treatment, but there are always risks with new medicines.
You can leave the study at any time.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or older, and have long-lasting eczema on your hands that's considered moderate to severe. Importantly, your hand eczema must not have improved enough with regular steroid creams or ointments.

The study welcomes both men and women to participate.

There might be other health conditions or medications that would prevent someone from joining, as the researchers need to make sure it's safe for everyone involved. If you're interested, the study team will go through a detailed check to see if you meet all the necessary requirements.

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 (long-lasting) eczema on your hands?
Is your hand eczema considered moderate to severe?
Has your hand eczema not improved sufficiently with steroid creams or ointments?
Are you able to attend regular clinic visits for 16 weeks?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given either the study medicine, Cibinqo, or a dummy pill (placebo) to take regularly throughout the study. You won’t know which one you’re receiving. You'll have several visits to the study clinic over a period of 16 weeks. These visits will involve various assessments, including checking your hand eczema, possibly taking photographs, blood tests, and physical examinations to monitor your health and how the medicine is affecting you. You'll also be asked to answer questionnaires about your symptoms, pain, itching, and how your eczema affects your daily life. After the 16 weeks, there might be a follow-up period to ensure your well-being. The study team will explain everything in detail, including the exact schedule of visits and what each visit will involve.

Potential risks and benefits

Participating in this study might offer a potential benefit, which is the chance to receive a new medicine that could improve your chronic hand eczema, especially if other treatments haven't worked well for you. However, there are potential risks, such as experiencing side effects from the study medicine, or if you receive the placebo, your eczema might not improve. All medical treatments carry some risk, and the study team will carefully monitor you for any problems. You have the full 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
Poland

Common questions

What is Cibinqo?

Cibinqo is the name of the new medicine being tested in this study for chronic hand eczema. It's taken as a tablet.

What is a placebo?

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

How long will the study last for me?

The main part of the study where you take the medicine and have regular checks will last for 16 weeks, with potential follow-up visits after this.

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

No, this is a 'double-blind' study, meaning neither you nor the study doctors will know whether you are receiving Cibinqo or the placebo. This helps make the study results more reliable.

What if my hand eczema gets worse during the study?

The study team will closely monitor your condition. If your eczema worsens or you're experiencing significant discomfort, they will discuss your options and can remove you from the study if necessary.