plaque psoriasis
Conditions
Interventions
JNJ-77242113:JNJ-77242113 tablet will be administered orally.
Placebo:Placebo tablet will be administered orally.
Group 1: JNJ-77242113Dose 1 Once Daily (QD)and Placebo,Group 2: JNJ-77242113Dose 2 QD
Sponsors
Tamura Hiroshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Participant has a diagnosis of plaque psoriasis, with or without psoriatic arthritis (PsA), for at least 6 months prior to the first administration of study intervention - Participant be a candidate for phototherapy or systemic treatment for plaque psoriasis - Participant has a total body surface area (BSA) greater than or equal to (>=)10 percent (%) at screening and baseline - Participant has a total Psoriasis area and severity index (PASI) >=12 at screening and baseline - Participant has a total Investigator global assessment (IGA) >=3 at screening and baseline
Exclusion criteria
Exclusion criteria: - Participant has a nonplaque form of psoriasis (for example, erythrodermic, guttate, or pustular) - Participant has current drug-induced psoriasis (for example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium) - Participant have previously received any other therapeutic agent directly targeted to interleukin 23 receptor (IL-23R) (including but not limited to guselkumab, tildrakizumab, or risankizumab) - Participant has received any therapeutic agent directly targeted to interleukin 17 receptor (IL-17) or interleukin 12/23 receptor (IL-12/23) (including but not limited to secukinumab, ixekizumab, brodalumab, or ustekinumab) or has received anti-tumor necrosis factor [TNF]-alpha biologic therapy (including, but not limited to adalimumab) within 12 weeks or 5 half-lives, whichever is longer, of the first administration of study intervention - Participant has received agents that deplete B cells (including, but not limited to, rituximab, or alemtuzumab) within 26 weeks of the first administration of study intervention
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Score at Week 16:Week 16:Percentage of participants achieving PASI 75 score (greater than or equal to [>=] 75 percentage [%] improvement from baseline in PASI) at Week 16 will be reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed and scored separately for erythema, induration, and scaling, which are each rated on a scale of 0 to 4 and extent of involvement on a scale of 0 to 6. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. | — |
Secondary
| Measure | Time frame |
|---|---|
| -Change from Baseline in PASI Total Score at Week 16:From baseline to Week 16:Change from baseline in PASI total score at Week 16 will be reported. -Percentage of Participants Achieving PASI 90 Score at Week 16:Week 16:Percentage of participants achieving PASI 90 score (>=90% improvement from baseline in PASI) at Week 16 will be reported. -Percentage of Participants Achieving PASI 100 Score at Week 16:Week 16:Percentage of participants achieving PASI 100 score (100% improvement from baseline in PASI) at Week 16 will be reported. -Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16:Week 16:Percentage of participants who achieve an IGA score of cleared (0) or minimal (1) at Week 16 will be reported. The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). -Percentage of Participants Achieving an IGA Score of Cleared (0) at Week 16:Week 16:Percentage of participants who achieve an IGA score of cleared (0) at Week 16 will be reported. -Change from Baseline in Body Surface Area (BSA) at Week 16:From baseline to Week 16:Change from baseline in BSA at Week 16 will be reported. Body Surface Area is a commonly used measure of severity of skin disease. It is defined as the percentage of surface area of the body involved with the condition being assessed, (that is, plaque psoriasis). -Change from Baseline in Psoriasis Symptoms and Signs Diary (PSSD) Symptoms Scores at Week 16:From baseline to Week 16:Change from baseline in PSSD symptoms scores at Week 16 will be reported. The PSSD includes patient-reported outcome (PRO) questionnaire designed to measure the severity of psoriasis symptoms and signs over the previous 7 days for the assessment of treatment benefit. The PSSD is a self-administ | — |
Countries
Canada, France, Germany, Japan, Korea, Poland, Spain, Taiwan, United Kingdom Of Great Britain, United States Of America
Contacts
Public ContactMedical Information Center
Janssen Pharmaceutical K.K.
Outcome results
None listed