Plaque Psoriasis Skin and Connective Tissue Diseases
Conditions
Interventions
Study will be conducted in 3 periods:
1. Screening period (5 weeks)
2. Double-blind 12 weeks) treatment period: Participants will be randomly (like flip of a coin)
divided into 5 groups (1:1:1:1:1) to
Sponsors
Janssen-Cilag International NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Be =18 years of age at screening, inclusive 2. Diagnosis of plaque psoriasis, with or without psoriatic arthritis (PsA), for at least 26 weeks prior to the first administration of study intervention 3. Total body surface area (BSA) greater than or equal to (>=)10 percent (%) at screening and baseline 4. Total Psoriasis area and severity index (PASI) >=12 at screening and baseline 5. Total Investigator global assessment (IGA) >=3 at screening and baseline 6. Candidate for phototherapy or systemic treatment for plaque Psoriasis
Exclusion criteria
Exclusion criteria: 1. Nonplaque form of psoriasis (eg, erythrodermic, guttate, or pustular) 2. Current drug-induced psoriasis (eg, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium) 3. Known allergies, hypersensitivity, or intolerance to JNJ-81241459 or its excipients (refer to the JNJ-81241459 IB) 4. Previously received JNJ-81241459 5. Experienced primary efficacy failure (no response within 12 weeks) or a clinical adverse event related to agents directly targeting interleukin 17 receptor (IL-17)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Score at Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percentage of Participants Achieving PASI 90 at Week 12 2. Percentage of Participants Achieving PASI 100 at Week 12 3. Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) and a Greater Than or Equal to [>=] 2 Grade Improvement From Baseline at Week 12 4. Percentage of Participants Achieving an IGA score of cleared (0) at Week 12 5. Change from Baseline in Body Surface Area (BSA) at Week 12 6. Change from baseline in PASI total score at Week 12 7. Percent Change from Baseline in PASI Total Score at Week 12 8. Percentage of Participants Achieving Psoriasis Symptoms and Signs Diary (PSSD) Symptoms Score=0 at Week 12 9. Percentage of Participants Achieving PSSD sign score of 0 at Week 12 10. Percentage of Participants Achieving =4-point improvement from baseline in PSSD Itch score at Week 12 11. Change from baseline in PSSD symptom score at Week 12 12. Change from baseline in PSSD sign score at Week 12 13. Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 12 14. Change from baseline DLQI total score at Week 12 15. Number of Participants with Adverse Events (AEs) 16. Number of Participants with Serious Adverse Events (SAEs) | — |
Countries
Canada, France, Germany, Japan, Poland, Spain, United Kingdom
Outcome results
None listed