A study of JNJ-77242113 for the treatment of participants with plaque psoriasis involving special areas (scalp, genital, and/or palms of hands and the soles of the feet)

Approved 20/10/2023, North West – Liverpool Central Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)207 104 8118; liverpoolcentral.rec@hra.nhs.uk), ref: 23/NW/0268

Percentage of participants achieving an Investigator's Global Assessment (IGA) Score of 0 or 1 and Greater Than or Equal to (>=) 2 Grade Improvement from Baseline at Week 16. The IGA documents the investigator's assessment of the participant's 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).

1. Percentage of participants achieving Scalp-specific Investigator Global Assessment (ss-IGA) Score of 0 or 1 at Week 16. The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. The lesions are assessed in terms of the clinical signs of redness, thickness, and scaliness which are scored as: absence of disease (0), very mild disease (1), mild disease (2), moderate disease (3), and severe disease (4).
2. Percentage of participants achieving Psoriasis Scalp Severity Index (PSSI) 90 at Week 16. The PSSI is a scalp-specific modification of the PASI based on the extent of involvement and the severity of erythema, infiltration, and desquamation. Involvement and severity of psoriasis on the PSSI is scored by physicians on a scale from 0 to 72, where 0 = no psoriasis and higher scores indicate more severe disease.
3. Percentage of participants achieving a Static Physician’s Global Assessment of Genitalia (sPGA-G) Score of 0 or 1 at Week 16. The sPGA-G is a 6-point scale to assess the severity of genital psoriasis at a given time point. The sPGA-G evaluates erythema, plaque elevation, and scale of genital psoriatic lesions. The severity of genital psoriasis is assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), and very severe (5).
4. Percentage of participants achieving a Physician’s Global Assessment of Hands and Feet (hf-PGA) Score of 0 or 1 at Week 16. The hf-PGA assesses the severity of hand and foot psoriasis using a 5-point scale to score the plaques on the hands and feet as: clear (0), almost clear (1), mild (2), moderate (3), and severe (4).
5. Percentage of participants achieving Psoriasis Symptom and Sign Diary (PSSD) Symptoms Score of 0 at Week 16. The PSSD includes a 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 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.
6. Percentage of participants achieving >=4 point improvement from baseline in PSSD itch score at Week 16. The PSSD includes a 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 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.
7. Percentage of participants achieving Genital Psoriasis Sexual Frequency Questionnaire (GenPs-SFQ) Item 2 score of 0 or 1 at Week 16. The GenPs-SFQ is a 2-item participant-reported instrument used to assess the impact of genital psoriasis on the frequency of sexual activity in the last 7 days. Item 1 assesses the overall frequency of sexual activity in the last 7 days (none/zero, once, or 2 or more times), and item 2 assesses how frequently genital psoriasis symptoms have limited the frequency of sexual activity in the last 7 days (never [0], rarely [1], sometimes [2], often [3], or always [4]).
8. Percentage of participants achieving >=4-point improvement from baseline in Scalp Itch Numeric Rating Scale (NRS) Score at Week 16. The Scalp Itch NRS is a single-item instrument that evaluates the severity of scalp itch in adult and adolescent populations over the past 24 hours. The instrument uses an NRS score ranging from 0 (no scalp itch) to 10 (worst scalp itch imaginable).
9. Percentage of participants achieving >=4-point Improvement from Baseline in Genital Psoriasis Symptoms Scale (GPSS) Genital Itch NRS Score at Week 16. The GPSS is a participant-administered assessment of 8 symptoms: itch, pain, discomfort, stinging, burning, redness, scaling, and cracking. Each respondent is asked to answer the questions based on the psoriasis symptoms in his or her genital area. The overall severity for each individual genital psoriasis symptom is indicated by selecting the number from an NRS of 0 to 10 that best describes the worst level of each symptom in the genital area in the past 24 hours, ranging from 0 (no severity) to 10 (worst imaginable severity).
10. Number of participants with adverse events (AEs) up to week 165. 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.
11. Number of participants with serious adverse events (SAEs) up to week 165. An SAE is any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, or is medically important.
12. Percentage of participants achieving Psoriasis Area and Severity Index (PASI) 90 Response at Week 16. 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.
13. Percentage of participants achieving PASI 75 Response at Week 16. 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.
14. Change from baseline in PASI Total Score at Week 16. 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: head, trunk, upper, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease.
15. Change from baseline in BSA at Week 16. BSA is a commonly used measure of extent 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).
16. Percent change from baseline in Modified Nail Psoriasis Areas and Severity Index (mNAPSI) Score at Week 16. The mNAPSI is an index used for assessing and grading the severity of nail psoriasis. Each of the participant’s ten fingernails are evaluated on 7 features. The first three features are each scored from 0 to 3 in severity and are (1) onycholysis and oil-drop dyschromia, (2) pitting, and (3) nail plate crumbling. The next four features are each scored 0 –absent or 1 –present, and are (1) leukonychia, (2) splinter hemorrhages, (3) nail bed hyperkeratosis, and (4) red spots in the lunula. The score ranges from 0-13 per nail, and 0-130 for all fingernails.
17. Percentage of participants achieving Fingernail Physician’s Global Assessment (f-PGA) Score of 0 or 1 at Week 16. The f-PGA is used to evaluate the current status of a participant’s fingernail psoriasis on a scale of 0 to 4 similar (clear [0], minimal [1], mild [2], moderate [3], or severe [4]). A higher score indicated severe disease.
18. Percentage of participants achieving an IGA Score of 0 at Week 16. The IGA documents the investigator's assessment of the participant's 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).
19. Percentage of participants achieving PSSD Symptom Score of 0 at Week 8. The PSSD includes a 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 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.
20. Change from baseline in PSSD Symptom Score at Week 16. The PSSD includes a 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 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.
21. Percentage of participants achieving >=4-point improvement from baseline in PSSD Itch Score at Week 4. The PSSD includes a 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 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.
22. Change from baseline in PSSD sign score at Week 16. The PSSD includes a 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 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.
23. Percentage of participants achieving PSSD Sign Score of 0 at Week 16. The PSSD includes a 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 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.
24. Percentage of participants achieving a Dermatology Life Quality Index (DLQI) Score of 0 or 1 at 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 week 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.
25. Percentage of participants achieving Children’s Dermatology Life Quality Index (CDLQI) score of 0 or 1 at Week 16. The CDLQI is a dermatology-specific quality of life (QoL) instrument designed to assess the impact of the disease on a child's QoL. The CDLQI, a 10-item questionnaire has 4-item response options and a recall period of 1 week. The CDLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0; the higher the score, the greater the impairment in QoL.
26. Change from baseline in Domain Scores of the Patient-reported Outcomes Measurement Information System-29 (PROMIS-29) Score at Week 16. 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.
27. Change from baseline in Domain Scores of the Patient-reported Outcomes Measurement Information System-25 (PROMIS-25) Score at Week 16. The PROMIS-25 will be utilized in the adolescent population and is a 25-item generic HRQoL survey. Six PROMIS domains (physical function mobility, anxiety, depressive symptoms, fatigue, peer relationships, pain interference) are each assessed with 4 questions. There is also one 11-point rating scale for pain intensity. The instrument is designed for use in ages 8-17 years of age and can be self-administered.
28. Change from baseline in Palmoplantar Quality of Life Instrument (ppQLI) Score at Week 16. The ppQLI assesses the impact on patient quality of life due to palmoplantar psoriasis over the past month in adult and adolescent populations. Fifteen items evaluate hand functionality, pain, and social impact due to psoriasis. Fourteen items evaluate foot functionality, pain, and physical limitations due to psoriasis. All items use verbal rating scales ranging from 1 to 5. The ppQLI yields a score for hands, ranging from 15 to 80, and a score for feet, ranging from 14 to 70.
29. Change from baseline in Genital Psoriasis Symptoms Scale (GPSS) Total Score at Week 16. The GPSS is a participant-administered assessment of 8 symptoms: itch, pain, discomfort, stinging, burning, redness, scaling, and cracking. Each respondent is asked to answer the questions based on the psoriasis symptoms in his or her genital area. The overall severity for each individual genital psoriasis symptom is indicated by selecting the number from an NRS of 0 to 10 that best describes the worst level of each symptom in the genital area in the past 24 hours, ranging from 0 (no severity) to 10 (worst imaginable severity).