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

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

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN98453312
Enrollment
36
Registered
2025-12-08
Start date
2025-12-17
Completion date
Unknown
Last updated
2026-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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 alloc

Sponsors

Janssen Research & Development, LLC
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

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

Exclusion criteria

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

Countries

England, United Kingdom

Contacts

Public ContactLouis Bornman
janssenukregistryqueries@its.jnj.com+44 (0)1494567444

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: May 30, 2026