A DPCP Skin Challenge Model for Immunomodulatory Therapies study
Research type
Research Study
Full title
An Experimental Study to Assess a Diphenylcyclopropenone Skin Challenge Model in Healthy Participants for the Evaluation of Immunomodulatory Therapies (HMR code: 25-013)
IRAS ID
363846
Contact name
Elena Bolanos Cascales
Contact email
Sponsor organisation
Janssen Research & Development
ISRCTN Number
ISRCTN98453312
Duration of Study in the UK
0 years, 8 months, 2 days
Research summary
Developing new treatments for conditions like autoimmune diseases and cancer is time-consuming, costly, and often unsuccessful. As it’s difficult to test drug effects in healthy people, early studies usually take place in diseased participants, adding 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.
*Placing DPCP on skin to cause a temporary, mild reaction such as redness or irritation.
Researchers will assess how the immune system reacts to DPCP (given alone or along with approved drugs) in healthy participants (aged 18–55 years) when their skin is exposed to it several times.
Study consists of:
1. Screening period
2. Sensitization and individual dose-selection period (Days 1–31):
a. Sensitization: DPCP will be applied on skin and removed after some time.
b. Individual dose-selection: Increasing dose levels of DPCP will be applied and skin will be assessed. Lowest dose that causes a mild or clearly visible skin reaction will be selected.
3. Rechallenge 1 (Approximately Days 50–57) and Randomization: DPCP will be given at selected individual dose, and skin will be assessed at different time points.
Participants will be randomly assigned to below arms after Rechallenge 1 and before Rechallenge 2:
*Arm 1: No treatment
*Arm 2: Upadacitinib by mouth
*Arm 3: Dupilumab injection under the skin
4. Rechallenge 2 (Approximately Days 71–78): DPCP will be given at selected individual dose, and skin will be assessed at different time points.
5. End of study visit (Day 85): Final assessments.
Study assessments include physical examinations, clinical laboratory tests and vital signs. Side effects will be recorded until study end (around 12 weeks).REC name
South Central - Oxford A Research Ethics Committee
REC reference
25/SC/0358
Date of REC Opinion
17 Dec 2025
REC opinion
Further Information Favourable Opinion