All studies
Active not recruitingPHASE3INTERVENTIONAL

A Study of JNJ-77242113 for the Treatment of Participants With Plaque Psoriasis Involving Special Areas (Scalp, Genital, and/or Palms of the Hands and the Soles of the Feet)

Doctors are running a study to test a new medicine called JNJ-77242113. This medicine is for people who have plaque psoriasis, especially when it affects tricky areas like the scalp, genital area, or the palms of their hands and soles of their feet. These areas can be particularly challenging to treat. The main goal of this study is to find out how well JNJ-77242113 works compared to a 'placebo' – which is a dummy treatment with no active medicine. By comparing the two, researchers can understand if the new medicine is an effective option for people dealing with psoriasis in these specific parts of the body.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
Janssen Research & Development, LLC
Enrolment target
311
Start
12 Oct 2023
Estimated completion
17 Feb 2027

What is this study about?

This research study is focused on a new medicine, JNJ-77242113, for people living with plaque psoriasis. You might know plaque psoriasis as a long-term skin condition that causes red, scaly patches. This study is particularly interested in psoriasis that affects what we call 'special areas' – these include the scalp, the sensitive genital area, and the palms of your hands and soles of your feet. Psoriasis in these areas can be very uncomfortable, painful, and impact daily life significantly.

The main aim of this study is to see if JNJ-77242113 can effectively clear up these patches and reduce symptoms in these difficult-to-treat areas. They will compare it to a 'placebo', which looks like the real medicine but contains no active ingredients. This helps doctors know for sure if any improvements are due to the new medicine or something else. Understanding how well this medicine works could lead to new treatment options for people who find their psoriasis particularly bothersome in these areas.

Taking part in a study like this helps us learn more about new medicines and how they can help people. If this new medicine proves to be safe and effective, it could offer hope for individuals who haven't found enough relief from current treatments for their plaque psoriasis in these specific body parts.

Key takeaways

  • Tests a new medicine, JNJ-77242113, for plaque psoriasis.
  • Focuses on hard-to-treat areas: scalp, genitals, hands, and feet.
  • Compares the new medicine to a placebo (dummy treatment).
  • Open to people aged 12 and above.
  • Requires previous failed treatment with topical creams.
  • Aims to find better options for specific psoriasis conditions.

Who may be eligible?

To join this study, you need to have been diagnosed with plaque psoriasis for at least six months. You should also be someone whose doctor thinks you need stronger treatments for your psoriasis, like light therapy or medicines that affect your whole body. Your psoriasis should cover at least 1% of your body, and your doctor should rate it as at least 'mild' in severity. Critically, you must have noticeable psoriasis on at least one of these 'special areas': your scalp, genital area, or the palms of your hands and soles of your feet.

Also, you need to have tried at least one skin cream or ointment (like steroid creams or Vitamin D creams) for your psoriasis that hasn't worked well enough for you. The study is open to anyone aged 12 years and over. You cannot have other types of psoriasis like erythrodermic (very red over most of the body) or pustular (with pus-filled bumps). They also can't accept you if you have another skin problem that looks like psoriasis in the same area, or if your psoriasis was clearly caused by a specific medicine you're taking.

Finally, if you have any serious, uncontrolled health problems with your kidneys, liver, heart, lungs, stomach, hormones, nervous system, blood, joints, or mental health, you might not be able to take part. It's also important that you don't have known allergies to the study medicine or its ingredients.

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.

  1. Do you have plaque psoriasis that has been diagnosed for at least 6 months?
  2. Does your doctor think you need stronger psoriasis treatments (like light therapy or full-body medicines)?
  3. Do you have noticeable psoriasis on your scalp, genital area, palms, or soles?
  4. Have skin creams or ointments for your psoriasis not worked well enough?
  5. Are you 12 years old or older?
  6. Do you not have other serious, uncontrolled health problems like kidney or heart disease?
Answer every question to see your result.

What does participation involve?

Unfortunately, the detailed information about what taking part involves – such as the number of visits, specific assessments, total duration, or follow-up schedule – is not provided in the brief summary. However, in a Phase 3 study like this, you would typically expect regular visits to the study clinic where you might have physical examinations, blood tests, and assessments of your psoriasis. You would be given the study medicine (either JNJ-77242113 or the placebo) to take, likely for several months. There would also be follow-up visits after you stop taking the medicine to check on your health. The total duration of participation in a study like this can vary but often lasts for many months, sometimes even over a year.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as access to a new medicine before it's widely available and closer monitoring of your health by study doctors. However, there are also potential risks; the new medicine might cause side effects, or it might not work for you. There's also a chance you could receive the placebo (dummy treatment) and not the active medicine. You are always free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (90)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Center for Dermatology and Plastic Surgery
    Verified postcode
    Scottsdale, United States
  • Johnson Dermatology
    Verified postcode
    Fort Smith, United States
  • California Dermatology & Clinical Research Institute
    Verified postcode
    Encinitas, United States
  • Forcare Clinical Research Inc
    Verified postcode
    Tampa, United States
  • Hamilton Research LLC
    Verified postcode
    Alpharetta, United States
  • Arlington Dermatology
    Verified postcode
    Rolling Meadows, United States
  • Dundee Dermatology
    Verified postcode
    West Dundee, United States
  • Dawes Fretzin Clinical Research Group LLC
    Verified postcode
    Indianapolis, United States
  • Indiana Clinical Trial Center
    Verified postcode
    Plainfield, United States
  • Dermatology and Advanced Aesthetics
    Verified postcode
    Lake Charles, United States
  • Allcutis Research 1
    Verified postcode
    Beverly, United States
  • Hamzavi Dermatology
    Unverified
    Fort Gratiot, United States

Common questions

What is JNJ-77242113?

It is a new medicine being tested to see if it can help people with plaque psoriasis.

What is plaque psoriasis?

It's a common, long-term skin condition that causes red, scaly patches on your skin.

What are 'special areas' in this study?

These are areas like the scalp, genital region, and the palms of your hands and soles of your feet.

What is a placebo?

It's a 'dummy' treatment that looks like the real medicine but contains no active ingredients. It's used to compare against the new medicine.

Who can join this study?

People aged 12 and older with plaque psoriasis, especially in special areas, who haven't found enough relief from creams and whose doctor thinks they need stronger treatment.

How to find out more

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

Discussion

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