CompletedPhase IInterventional

An experimental study to assess a diphenylcyclopropenone skin challenge model in healthy participants for the evaluation of immunomodulatory therapies

This study is exploring a new way to test how medicines affect the immune system. Researchers will use a chemical called DPCP, which causes a mild, temporary skin reaction, on healthy volunteers aged 18-55. By observing these reactions, they hope to create a safer testing method for treatments for conditions like autoimmune diseases and cancer. The study involves applying DPCP to the skin, with some participants also receiving approved medications (Upadacitinib or Dupilumab) to see how these affect the skin's reaction. This research could speed up the development of new drugs and make early testing safer for patients in the future.

At a glance

Status

Completed

Phase

Phase I

Sponsor

Janssen Research & Development, LLC

Enrolment target

Start

17 Dec 2025

Estimated completion

13 May 2026

Diphenylcyclopropenone skin challenge models are studied in healthy participants for the evaluation of immunomodulatory therapies

What is this study about?

Imagine scientists trying to create new treatments for serious conditions like autoimmune diseases or cancer. Normally, they have to test these new drugs on people who are already ill. This can be risky and expensive. This study is trying to find a clever new way to test how well medicines can change, or 'modulate', our body’s immune system – the system that fights off illness.

Researchers are using a chemical called diphenylcyclopropenone (DPCP). When applied to the skin, DPCP causes a harmless, temporary, mild skin reaction. By carefully watching how the skin reacts after DPCP is applied, they can learn a lot about how the immune system is working. This is a bit like giving the immune system a small puzzle to solve and seeing how quickly and effectively it responds.

The main aim is to see if this 'skin challenge model' is a good way to test new medicines without always needing to involve patients who are already sick. If successful, this method could help develop new drugs more quickly and safely in the future, ultimately benefiting people with various diseases. Participants will help contribute to this important scientific progress.

Key takeaways

This study uses a mild skin reaction to learn about the immune system.
It aims to find safer ways to test new medicines for serious diseases.
Healthy volunteers aged 18-55 are needed.
Participation involves skin applications of DPCP and sometimes medication.
The study lasts about 12 weeks with close medical monitoring.
No direct personal health benefit, but could help future patients.

Who may be eligible?

To join this study, you need to be a healthy adult between 18 and 55 years old. This means that based on checks by the study team, you should be in good general health.

There are also some specific health checks. For example, your weight needs to be in a certain range, and for women, you must not be pregnant or breastfeeding and be willing to use effective contraception during and shortly after the study. We also need people who haven't smoked or used nicotine products recently.

You cannot join if you have certain existing health conditions, such as long-term heart, lung, stomach, or skin problems, or if you've had cancer in the past or a severe allergic reaction to medicines or food. Also, if you've ever been exposed to DPCP or the study drugs (Upadacitinib or Dupilumab) before, you won't be able to participate.

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 between 18 and 55 years old?
Are you generally healthy and don't have any long-term medical conditions?
Do you refrain from smoking or using nicotine products for at least the last 6 months?
If you are a woman, are you not pregnant or breastfeeding and willing to use effective birth control?
Have you never been exposed to DPCP or the study drugs (Upadacitinib, Dupilumab) before?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the study will last about 12 weeks, from start to finish. Here’s a general idea of what it would involve:

First, there's a 'screening period' of up to 4 weeks where you'll have various checks like a physical exam, blood tests, and vital signs to make sure you're healthy enough to join.

Next, over about a month, DPCP will be applied to your skin. First, it's a small application to get your skin used to it. Then, different strengths of DPCP will be applied to find the lowest dose that causes a mild, visible skin reaction unique to you. After this, around Day 50, DPCP will be applied again, and your skin reaction will be checked. This is called 'Rechallenge 1'.

After Rechallenge 1, you'll be randomly put into one of three groups: one group won't take any study medication, another group will take a medicine called Upadacitinib by mouth, and the third group will have a medicine called Dupilumab injected under the skin. Around Day 71, DPCP will be applied to your skin for a final time ('Rechallenge 2') to see how your skin reacts with or without the study medications. Throughout the study, we'll monitor your health, take blood samples, and record any side effects until your final visit around Day 85.

Potential risks and benefits

It's important to understand that participating in this study won't directly benefit your health. However, the information gathered could be very valuable, helping scientists develop better treatments for people with autoimmune diseases and cancer in the future. As with any study involving new approaches or medicines, there are potential risks. The DPCP might cause skin reactions like redness, itching, swelling, or a temporary darkening of the skin. While these are usually mild and temporary, there’s a chance you could have a stronger allergic reaction or other unexpected side effects. The study team will carefully monitor you for any side effects throughout and after the study and will provide appropriate medical care if needed. You will receive detailed information about all potential risks, and you can withdraw from the study at any time if you change your mind.

Locations (1)

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

Hammersmith Medicines Research (HMR)
City only
London, England

Common questions

What is DPCP and why is it used?

DPCP (diphenylcyclopropenone) is a chemical that causes a mild, temporary skin reaction. Researchers use it to gently 'challenge' your immune system and see how it responds, which helps them understand how new medicines might work.

Will I get sick from this study?

The study is designed for healthy people, and the skin reactions from DPCP are expected to be mild and temporary. Your health will be closely monitored by doctors throughout the study to ensure your safety.

What happens if I have a side effect?

The study doctor and nurses will be looking out for any side effects. If you experience anything unusual or concerning, you should tell them immediately. They will provide appropriate medical care and discuss how to manage it.

Will I know which treatment group I'm in?

No, you will be randomly assigned to one of the treatment groups (either no treatment, Upadacitinib by mouth, or Dupilumab under the skin) after the first skin challenge. This helps ensure the study results are fair and unbiased.

How long will I have to commit to this study?

The entire study, from your initial checks to your final follow-up visit, will last for approximately 12 weeks (about 3 months).

How to find out more

Louis Bornman

janssenukregistryqueries@its.jnj.com +44 (0)1494567444 Official trial record

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