A Study of JNJ-77242113 in Participants with Moderate-to-severe Plaque Psoriasis

JRCT ID: jRCT2011210074

Registered date:17/03/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: plaque psoriasis
• Date of first enrollment: 29/06/2022
• Target sample size: 240
• Countries of recruitment: Canada,Japan,Czechia,Japan,Germany,Japan,Spain,Japan,France,Japan,United Kingdom Of Great Britain,Japan,Korea,Japan,Poland,Japan,Taiwan,Japan,United States Of America,Japan
• Study type: Interventional

Intervention(s)

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 and Placebo,Group 3: JNJ-77242113Dose 3 QD and Placebo,Group 4: JNJ-77242113Dose 1 Twice Daily (BID)and Placebo,Group 5: JNJ-77242113Dose 3 BID and Placebo,Group 6: Placebo

Outcome(s)

• Primary Outcome: -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 Outcome

-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-administered PRO instrument that includes 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 to 10 numerical rating scales for severity. Two subscores 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.
-Change from Baseline in PSSD Signs Score at Week 16:From baseline to Week 16:Change from baseline in PSSD signs score at Week 16 will be reported.
-Percentage of Participants Achieving PSSD Symptoms Score=0 at Week 16 in Participants with a Baseline Symptoms Score >=1:Week 16:Percentage of participants achieving PSSD symptoms score=0 at Week 16 in participants with a baseline symptoms score >=1 will be reported.
-Percentage of Participants Achieving PSSD Sign Score=0 at Week 16 in Participants with a Baseline Sign Score >=1:Week 16:Percentage of participants achieving PSSD sign score=0 at Week 16 in participants with a baseline sign score >=1 will be reported.
-Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) of 0 or 1 at Week 16 in Participants with Baseline DLQI Score >1:Week 16:The DLQI is a dermatology-specific health-related quality of life (HRQoL) instrument designed to assess the impact of the disease on a participant's HRQoL. It is a 10 item questionnaire that assesses HRQoL over the past 7 days and in addition to evaluating overall HRQoL, 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.
-Change from Baseline in Patient-reported Outcomes Measurement Information System (PROMIS-29) Domain Score at Week 16:From baseline to Week 16:Change from baseline in PROMIS-29 domain scores at week 16 will be reported. The PROMIS-29 is a 29-item generic HRQoL instrument assessing 7 PROMIS domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles and activities) with 4 questions for each domain. These questions are ranked on a 5-point Likert scale. There is also a numerical rating scale that ranges from 0 (No pain) to 10 (Worst pain imaginable) for pain intensity. The raw domain scores are converted to standardized T-scores with a mean of 50 and a standard deviation of 10. Higher scores on anxiety, depression, fatigue, sleep disturbance, and pain interference indicate more severe symptoms. Higher scores on physical function and social participation indicate better health outcomes.
-Percentage of Participants Who Achieve >= 5-Point Improvement from Baseline in PROMIS-29 Domain Score at Week 16:Week 16:Percentage of participants who achieve >=5-point improvement from baseline in PROMIS-29 domain score at Week 16 will be reported.
-Number of Participants with Adverse Events (AEs):Up to 24 weeks:An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
-Number of Participants with Serious Adverse Events (SAEs):Up to 24 weeks:SAE is an adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Nakano Masayoshi
• Secondary ID(s): NCT05223868