An experimental study to assess a diphenylcyclopropenone skin challenge model in healthy participants for the evaluation of immunomodulatory therapies
| ISRCTN | ISRCTN98453312 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN98453312 |
| Integrated Research Application System (IRAS) | 363846 |
| Sponsor | Janssen Research & Development, LLC |
| Funder | Janssen Research and Development |
- Submission date
- 04/12/2025
- Registration date
- 08/12/2025
- Last edited
- 08/12/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Developing new treatments for conditions like autoimmune diseases and cancer is time-consuming, costly, and often unsuccessful. As it is difficult to test drug effects in healthy people, early studies usually take place in diseased participants, which adds risks.
In this study, researchers will use a skin challenge model with DPCP (a chemical that causes mild skin reaction) initially by exposing the skin to it and then re-applying it. Researchers can study the immune system’s response by evaluating skin reactions after DPCP exposure.
Researchers want to assess how the immune system reacts to DPCP (given alone or along with approved available drugs) in healthy participants when their skin is exposed to it several times.
Who can participate?
Healthy participants aged between 18 to 55 years
What does the study involve?
The study consists of:
1. Screening period (Up to 28 days)
2. Sensitization and individual dose-selection period (Day 1 to Day 31):
Sensitization: DPCP will be applied on skin and removed after some time.
Individual dose-selection: Increasing dose levels of DPCP will be applied and skin will be assessed at different time points. Lowest dose that causes a mild or clearly visible skin reaction will be selected.
3. Rechallenge 1 (Approximately Day 50 to Day 57) and Randomization: DPCP will be given at selected individual dose, and skin will be assessed at different time points.
Participants will be randomly assigned after Rechallenge 1 and before Rechallenge 2:
Group 1: No treatment
Group 2: Upadacitinib by mouth
Group 3: Dupilumab under the skin
4. Rechallenge 2 (Approximately Day 71 to Day 78): DPCP will be given at selected individual dose, and skin will be assessed at different time points.
5. End of study visit (Day 85): For final assessments.
Study assessments include physical examinations, clinical laboratory tests and vital signs. All side effects will be recorded until the study ends (around 12 weeks).
What are the possible benefits and risks of participating?
Participants will not receive any benefit from taking part in this study, but the information that is learned from the study may help people with autoimmune diseases and cancer in the future.
This is an experimental medicine study. The expected risks for DPCP, based on how the drug works and results from laboratory studies are listed as follows: exaggerated immune response (hypersensitivity), local and systemic (in blood) side effects like skin inflammation caused by direct contact (contact dermatitis), red, itchy welts (urticaria), swelling, redness of skin (erythema), darkening of skin colour (hyperpigmentation) and swelling of lymph node.
The participant information sheet and informed consent form, which will be signed by every participant agreeing to take part in the study, includes a detailed section outlining the risks to participating in the study. Participants may have none, some, or all of the possible side effects listed, and they may be mild, moderate, or severe. To minimise the risk associated with taking part, participants are frequently reviewed for any side effects and other medical events. If they have any side effects or are worried about them, or have any new or unusual symptoms, participants will be encouraged to talk with their study doctor. The study doctor will also be looking out for side effects and will provide appropriate medical care.
There may also be side effects that the researchers do not expect or do not know about and that may be serious. Many side effects go away shortly after the intervention ends. However, sometimes side effects can be serious, long-lasting, or permanent. If a severe side effect or reaction occurs, the study doctor may need to stop the procedure. The study doctor will discuss the best way of managing any side effects with participants. There is always a chance that an unexpected or serious side effect may happen. This can happen to people who take drugs used in this study or any other drug.
Where is the study run from?
Janssen Research & Development, LLC
When is the study starting and how long is it expected to run for?
December 2025 to August 2026
Who is funding the study?
Janssen Research & Development, LLC
Who is the main contact?
janssenukregistryqueries@its.jnj.com
Contact information
Principal investigator
Hammersmith Medicines Research (HMR)
Cumberland Avenue
Park Royal
London
NW10 7EW
United Kingdom
| Phone | +44 (0)20 8961 4130 |
|---|---|
| rec@hmrlondon.com |
Scientific
50-100 Holmers Farm Way
High Wycombe
HP12 4EG
United Kingdom
| Phone | +44 (0)8007318450 / +44 (0)1494567444 |
|---|---|
| medinfo@its.jnj.com |
Public
50-100 Holmers Farm Way
High Wycombe
HP12 4EG
United Kingdom
| Phone | +44 (0)1494567444 |
|---|---|
| janssenukregistryqueries@its.jnj.com |
Study information
| Primary study design | Interventional | |
|---|---|---|
| Allocation | Randomized controlled trial | |
| Masking | Open (masking not used) | |
| Control | Uncontrolled | |
| Assignment | Parallel | |
| Purpose | Basic science | |
| Scientific title | An experimental study to assess a diphenylcyclopropenone skin challenge model in healthy participants for the evaluation of immunomodulatory therapies | |
| Study acronym | NOPRODPCNAP0003 | |
| Study objectives | To study cutaneous inflammatory responses when exposed to diphenylcyclopropenone (DPCP) over time after an initial exposure, by examining the skin of healthy adults. | |
| Ethics approval(s) |
Submitted 03/12/2025, South Central - Oxford A Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)207 104 8241; oxforda.rec@hra.nhs.uk), ref: IRAS 363846 | |
| Health condition(s) or problem(s) studied | Diphenylcyclopropenone skin challenge models are studied in healthy participants for the evaluation of immunomodulatory therapies | |
| Intervention | Participants will be allocated to a treatment arm according to a randomisation schedule prepared by a statistician at Janssen Research & Development, using an appropriate computer program. We'll allocate participants to group based on their availability and the scheduled trial dates. We'll allocate participant numbers in the order in which participants arrive on the ward and are entered into the study. Arm 1: DPCP + No Intervention Participants will undergo sensitization period involving the application of DPCP to elicit a delayed-type hypersensitivity reaction. Following initial sensitization, a dose needed to elicit a response level of "weak positive (+)" or "definitive positive (++)" will be determined. DPCP will be administered at the selected dose in rechallenge 1. Participants in Arm 1 will not receive any study agent prior to rechallenge 2 and will be exposed to DPCP at the selected dose in rechallenge 2 and will undergo study assessments for up to Day 85. Diphenylcyclopropenone(DPCP) will be administered topically. Arm 2: DPCP + Upadacitinib Participants will undergo sensitization period involving the application of DPCP to elicit a delayed-type hypersensitivity reaction. Following initial sensitization, a dose needed to elicit a response level of "weak positive (+)" or "definitive positive (++)" will be determined. DPCP will be administered at the selected dose in rechallenge 1. Participants will then receive upadacitinib from Day 68 to Day 78, and will undergo rechallenge 2 where DPCP will be administered again at the selected dose followed by study assessments for up to Day 85. Diphenylcyclopropenone(DPCP) will be administered topically. Upadacitinib will be administered orally. Arm 3: DPCP + Dupilumab Participants will undergo sensitization period involving the application of DPCP to elicit a delayed-type hypersensitivity reaction. Following initial sensitization, a dose needed to elicit a response level of "weak positive (+)" or "definitive positive (++)" will be determined. DPCP will be administered at the selected dose in rechallenge 1. Participants will then receive dupilumab on Day 64, and will undergo rechallenge 2 where DPCP will be administered again at the selected dose followed by study assessments for up to Day 85. Diphenylcyclopropenone (DPCP) will be administered topically. Upadacitinib will be administered subcutaneously. | |
| Intervention type | Drug | |
| Phase | Phase I | |
| Drug / device / biological / vaccine name(s) | Diphenylcyclopropenone (DPCP), Upadacitinib (RINVOQ), Dupilumab (DUPIXENT) | |
| Primary outcome measure(s) |
| |
| Key secondary outcome measure(s) | ||
| Completion date | 07/08/2026 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 55 Years |
| Sex | All |
| Target sample size at registration | 36 |
| Key inclusion criteria | 1. Be healthy on the basis of physical examination, medical history, vital signs performed at screening 2. Be healthy on the basis of clinical laboratory tests performed at screening 3. Have a body weight of no less than 50 kg and body mass index within the range of 18 and 30 kg/m^2 (inclusive) 4. During study participation and, if applicable, for 30 days after the last dose of study agent a female participant must: 4.1. Be willing to use highly effective methods of contraception 4.2. Not breastfeed or be pregnant 4.3. Not donate gametes (for example, eggs) or freeze for future use for the purpose of assisted reproduction 4.4. Have a negative highly-sensitive (for example, beta-human chorionic gonadotropin [hCG]) pregnancy test before starting the intervention period and agree to further pregnancy tests 5. Must be a non-smoker/vaper (not smoked/vaped for at least 6 months prior to screening) and has not used nicotine-containing products (for example, nicotine patch) for 3 months prior to screening |
| Key exclusion criteria | 1. History of or current clinically meaningful cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, metabolic, thrombotic or dermatologic disturbances 2. Current or chronic history of non-infectious liver disease 3. History of malignancy before screening 4. Known prior exposure to DPCP, upadacitinib or dupilumab 5. History of severe allergic reaction, angioedema, or anaphylaxis to drugs or food |
| Date of first enrolment | 17/12/2025 |
| Date of final enrolment | 15/05/2026 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Park Royal
London
NW10 7EW
England
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Editorial Notes
08/12/2025: Study's existence confirmed by the South Central - Oxford A Research Ethics Committee.
