Plaque Psoriasis
Conditions
Brief summary
The main purpose of this study is to assess how well JNJ-77242113 works when compared to placebo and ustekinumab in participants with moderate to severe plaque psoriasis.
Interventions
DRUGJNJ-77242113
JNJ-77242113 will be administered orally.
DRUGMatching Placebo to JNJ-77242113
Matching placebo will be administered orally.
DRUGUstekinumab
Ustekinumab will be administered subcutaneously.
DRUGMatching Placebo to Ustekinumab
Matching placebo will be administered subcutaneously.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of plaque psoriasis, with or without psoriatic arthritis (PsA), prior to the first administration of study intervention * Total body surface area (BSA) greater than or equal to (\>=)10 percent (%) at screening and baseline * Total psoriasis area and severity index (PASI) \>=12 at screening and baseline * Total investigator global assessment (IGA) \>=3 at screening and baseline * Candidate for phototherapy or systemic treatment for plaque psoriasis
Exclusion criteria
* Nonplaque form of psoriasis (for example \[e.g.\], erythrodermic, guttate, or pustular) * Current drug-induced psoriasis (e.g., a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium) * Known allergies, hypersensitivity, or intolerance to JNJ-77242113, ustekinumab, or its excipients * Major surgical procedure within 8 weeks before screening, or will not have fully recovered from surgical procedure, or has a surgical procedure planned during the time the participant is expected to participate in the study * Transplanted organ (with exception of a corneal transplant greater than \[\>\] 12 weeks before the first administration of study intervention)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| JNJ-77242113 and Placebo Group: Percentage of Participants with Investigator's Global Assessment (IGA) Score of 0 or 1 and Greater than or Equal to (>=) 2 Grade Improvement from Baseline at Week 16 | Week 16 | IGA score is given based on the investigator's assessment of the participant's plaque psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's plaque psoriasis is assessed as: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). |
| JNJ-77242113 and Placebo Group: Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 90 Response at Week 16 | Week 16 | PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In this 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 (none) to 4 (severe) and extent of involvement on a scale of 0 (indicates no involvement) to 6 (90% to 100% involvement). The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants achieving at least a 90 percent improvement from baseline in the PASI score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| JNJ-77242113 and Placebo Group: Percentage of Participants Achieving PASI 75 Response at Week 16 | Week 16 | PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In this 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 (none) to 4 (severe) and extent of involvement on a scale of 0 (indicates no involvement) to 6 (90% to 100% involvement). The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 75 response represents participants achieving at least a 75 percent improvement from baseline in the PASI score. |
| JNJ-77242113 and Placebo Group: Percentage of Participants Achieving PASI 100 Response at Week 16 | Week 16 | PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In this 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 (none) to 4 (severe) and extent of involvement on a scale of 0 (indicates no involvement) to 6 (90% to 100% involvement). The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 100 response represents participants achieving at least a 100 percent improvement from baseline in the PASI score. |
| JNJ-77242113 and Placebo Group: Percentage of Participants with IGA Score of 0 at Week 16 | Week 16 | IGA score is given based on the investigator's assessment of the participant's plaque psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's plaque psoriasis is assessed as: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). |
| JNJ-77242113 and Ustekinumab Group: Percentage of Participants with IGA Score of 0 at Week 28 | Week 28 | IGA score is given based on the investigator's assessment of the participant's plaque psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's plaque psoriasis is assessed as: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). |
| JNJ-77242113 and Ustekinumab Group: Percentage of Participants Achieving PASI 90 Response at Week 28 | Week 28 | PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In this 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 (none) to 4 (severe) and extent of involvement on a scale of 0 (indicates no involvement) to 6 (90% to 100% involvement). The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants achieving at least a 90 percent improvement from baseline in the PASI score. |
| JNJ-77242113 and Ustekinumab Group: Percentage of Participants Achieving PASI 100 Response at Week 28 | Week 28 | PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In this 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 (none) to 4 (severe) and extent of involvement on a scale of 0 (indicates no involvement) to 6 (90% to 100% involvement). The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 100 response represents participants achieving at least a 100 percent improvement from baseline in the PASI score. |
| JNJ-77242113 and Placebo Group: Percentage of Participants with PSSD Symptom Score of 0 at Week 16 | Week 16 | PSSD includes patient-reported outcome (PRO) questionnaires designed to measure the severity of psoriasis symptoms and signs over the previous 7 days for the assessment of treatment benefit. This PRO includes 11 items in total, with 5 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and 6 items covering participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding). The PSSD itch score will range from 0 to 10. Two sub scores will be derived each ranging from 0 to 100: the psoriasis symptom score and the psoriasis sign score. A higher score indicates more severe disease. |
| JNJ-77242113 and Placebo Group: Percentage of Participants with >= 4 Point Improvement from Baseline in PSSD Itch Score at Week 16 | Week 16 | PSSD includes PRO questionnaires designed to measure the severity of psoriasis symptoms and signs over the previous 7 days for the assessment of treatment benefit. This PRO includes 11 items in total, with 5 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and 6 items covering participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding). The PSSD itch score will range from 0 to 10. Two sub scores will be derived each ranging from 0 to 100: the psoriasis symptom score and the psoriasis sign score. A higher score indicates more severe disease. |
| Number of Participants Reporting Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to Week 108 | An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. SAE is any untoward medical occurrence that results in: death, is life-threatening, requires in-patient hospitalization/prolongs existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of infectious agent via medicinal product \& is medically important. |
| JNJ-77242113 and Placebo Group: Percentage of Participants with PSSD Sign Score of 0 at Week 16 | Week 16 | PSSD includes PRO questionnaires designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. This PRO includes 11 items in total, with 6 items covering participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding). A 0 to 10 numerical rating scale for severity is used to rank the psoriasis sign score. A higher score indicates more severe disease. |
| JNJ-77242113 and Placebo Group: Change from Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16 | Baseline up to Week 16 | DLQI will be utilized in the adult population and is a dermatology specific health related quality of life (HRQoL) instrument designed to assess the impact of the disease on the HRQoL It is a 10-item questionnaire that can be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. The total score ranges from 0 to 30 with a higher score indicating greater impact on HRQoL. |
| JNJ-77242113 and Placebo Group: Percentage of Participants with DLQI Score of 0 or 1 at Week 16 | Week 16 | DLQI will be utilized in the adult population and is a dermatology specific HRQoL instrument designed to assess the impact of the disease on the HRQoL It is a 10 item questionnaire that can be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. The total score ranges from 0 to 30 with a higher score indicating greater impact on HRQoL. |
| JNJ-77242113 and Placebo Group: Change from Baseline in Body Surface Area (BSA) Score at Week 16 | Baseline up to Week 16 | BSA is a commonly used measure of involvement 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). The handprint method for assessing BSA will be used, where the surface area of the participant's hand including the palm and all 5 digits is used as a guide to estimate 1% BSA. |
| JNJ-77242113 and Ustekinumab Group: Percentage of Participants with >= 4 Point Improvement from Baseline in PSSD Itch Score at Week 28 | Week 28 | PSSD includes PRO questionnaires designed to measure the severity of psoriasis symptoms and signs over the previous 7 days for the assessment of treatment benefit. This PRO includes 11 items in total, with 5 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and 6 items covering participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding). The PSSD itch score will range from 0 to 10. Two sub scores will be derived each ranging from 0 to 100: the psoriasis symptom score and the psoriasis sign score. A higher score indicates more severe disease. |
| JNJ-77242113 and Ustekinumab Group: Change from Baseline in PSSD Sign Score at Week 28 | Baseline up to Week 28 | PSSD includes PRO questionnaires designed to measure the severity of psoriasis symptoms and signs over the previous 7 days for the assessment of treatment benefit. This PRO includes 11 items in total, with 5 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and 6 items covering participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding). The PSSD itch score will range from 0 to 10. Two sub scores will be derived each ranging from 0 to 100: the psoriasis symptom score and the psoriasis sign score. A higher score indicates more severe disease. |
| JNJ-77242113 and Ustekinumab Group: Change from Baseline in PSSD Symptom Score at Week 28 | Baseline up to Week 28 | PSSD includes PRO questionnaires designed to measure the severity of psoriasis symptoms and signs over the previous 7 days for the assessment of treatment benefit. This PRO includes 11 items in total, with 5 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and 6 items covering participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding). The PSSD itch score will range from 0 to 10. Two sub scores will be derived each ranging from 0 to 100: the psoriasis symptom score and the psoriasis sign score. A higher score indicates more severe disease. |
| JNJ-77242113 and Ustekinumab Group: Percentage of Participants with PSSD Sign Score of 0 at Week 28 | Week 28 | PSSD includes PRO questionnaires designed to measure the severity of psoriasis symptoms and signs over the previous 7 days for the assessment of treatment benefit. This PRO includes 11 items in total, with 5 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and 6 items covering participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding). The PSSD itch score will range from 0 to 10. Two sub scores will be derived each ranging from 0 to 100: the psoriasis symptom score and the psoriasis sign score. A higher score indicates more severe disease. |
| JNJ-77242113 and Ustekinumab Group: Percentage of Participants with PSSD Symptom Score of 0 at Week 28 | Week 28 | PSSD includes PRO questionnaires designed to measure the severity of psoriasis symptoms and signs over the previous 7 days for the assessment of treatment benefit. This PRO includes 11 items in total, with 5 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and 6 items covering participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding). The PSSD itch score will range from 0 to 10. Two sub scores will be derived each ranging from 0 to 100: the psoriasis symptom score and the psoriasis sign score. A higher score indicates more severe disease. |
| JNJ-77242113 and Ustekinumab Group: Change from Baseline in DLQI Score at Week 28 | Baseline up to Week 28 | DLQI will be utilized in the adult population and is a dermatology specific HRQoL instrument designed to assess the impact of the disease on the HRQoL It is a 10-item questionnaire that can be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. The total score ranges from 0 to 30 with a higher score indicating greater impact on HRQoL. |
| JNJ-77242113 and Ustekinumab Group: Percentage of Participants with DLQI Score of 0 or 1 at Week 28 | Week 28 | DLQI will be utilized in the adult population and is a dermatology specific HRQoL instrument designed to assess the impact of the disease on the HRQoL. It is a 10-item questionnaire that can be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. The total score ranges from 0 to 30 with a higher score indicating greater impact on HRQoL. |
| JNJ-77242113 and Ustekinumab Group: Change from Baseline in BSA Score at Week 16 | Baseline up to Week 16 | BSA is a commonly used measure of involvement of skin disease. It is defined as the percentage of surface area of the body involved with the condition being assessed, (ie, plaque psoriasis). The handprint method for assessing BSA will be used, where the surface area of the participant's hand including the palm and all 5 digits is used as a guide to estimate 1% BSA. |
| JNJ-77242113 and Ustekinumab Group: Percentage of Participants with IGA Score of 0 at Week 16 | Week 16 | IGA score is given based on the investigator's assessment of the participant's plaque psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's plaque psoriasis is assessed as: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). |
| JNJ-77242113 and Ustekinumab Group: Percentage of Participants Achieving PASI 90 Response at Week 16 | Week 16 | PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In this 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 (none) to 4 (severe) and extent of involvement on a scale of 0 (indicates no involvement) to 6 (90% to 100% involvement). The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants achieving at least a 90 percent improvement from baseline in the PASI score. |
| JNJ-77242113 and Ustekinumab Group: Percentage of Participants Achieving PASI 100 Response at Week 16 | Week 16 | PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In this 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 (none) to 4 (severe) and extent of involvement on a scale of 0 (indicates no involvement) to 6 (90% to 100% involvement). The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 100 response represents participants achieving at least a 100 percent improvement from baseline in the PASI score. |
Countries
Argentina, Australia, Austria, Belgium, Canada, Denmark, Germany, Hungary, Poland, Portugal, Spain, United Kingdom, United States
Outcome results
None listed