A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Participants with Plaque Psoriasis Involving Special Areas
Key facts
- Where
- Budapest III, Debrecen, Kaposvár, Pécs, Szeged, Szolnok és Veszprém, MagyarországSee the 8 sites
- Phase
- 3. fázis
Where in Magyarország
- Obudai Egeszsegugyi Centrum Kft.Budapest III, MagyarországNo longer taking part
- Derma-B Kft.Debrecen, MagyarországNo longer taking part
- University of DebrecenDebrecen, MagyarországNo longer taking part
- Somogy Vármegyei Kaposi Mór Oktató KórházKaposvár, MagyarországNo longer taking part
- University of PecsPécs, MagyarországNo longer taking part
- University of SzegedSzeged, MagyarországNo longer taking part
- Allergo-Derm Bakos KftSzolnok, MagyarországNo longer taking part
- Medmare Bt.Veszprém, MagyarországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Janssen - Cilag International
- Trial code
- EU 2023-505122-34-00
- Record updated
- 2026. augusztus 28.
- Original description
To evaluate the efficacy of JNJ-77242113 in participants with plaque psoriasis with at least moderate severity affecting special areas or lower BSA (range: ≥5% to <10%) moderate to severe plaque psoriasis.Read full original descriptionShow less
A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Participants with Plaque Psoriasis involving Special Areas
To evaluate the efficacy of JNJ-77242113 in participants with plaque psoriasis with at least moderate severity affecting special areas or lower BSA (range: ≥5% to <10%) moderate to severe plaque psoriasis.
Inclusion: ≥12 years of age at the screening visit; Diagnosis of plaque psoriasis, with or without PsA, for at least 26 weeks prior to the first administration of study intervention; Candidate for phototherapy or systemic treatment for plaque psoriasis; Need to meet criteria (a) and/or (b) a. Total BSA ≥1% at screening and baseline, AND IGA (overall) ≥2 at screening and baseline AND at least one of the following: - ss-IGA score ≥3 at screening and baseline, and/or - sPGA-G ≥3 at screening and baseline, and/or - hf-PGA score ≥3 at screening and baseline; Failed to respond to at least 1 topical therapy used for treatment of psoriasis.
Exclusion: Current drug-induced psoriasis; A current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal, liver, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances; Known allergies, hypersensitivity, or intolerance to JNJ-77242113 or its excipients; Nonplaque form of psoriasis; Dermatoses other than plaque psoriasis or palmoplantar pustulosis of the palmoplantar area.