A Study of JNJ-77242113 for the Treatment of Participants With Generalized Pustular Psoriasis or Erythrodermic Psoriasis

Generalized Pustular Psoriasis Clinical Trial

Official title:

A Phase 3, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Participants With Generalized Pustular Psoriasis or Erythrodermic Psoriasis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06295692
• Other study ID #: 77242113PSO3005
• Secondary ID: 77242113PSO3005
• Status: Recruiting
• Phase: Phase 3
• Start date: February 9, 2024
• Est. completion date: December 23, 2027

Study information

• Verified date: April 2024
• Source: Janssen Pharmaceutical K.K.
• Contact: Study Contact
• Phone: 844-434-4210
• Email: Participate-In-This-Study[@]its.jnj.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate how effective JNJ-77242113 is in participants with generalized pustular psoriasis (GPP) or erythrodermic psoriasis (EP).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: December 23, 2027
• Est. primary completion date: February 19, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• The study participant has a diagnosis of generalized pustular psoriasis (GPP) or erythrodermic psoriasis (EP) at screening. For GPP, a diagnosis must be classified based on the criteria for diagnosis of GPP by the Japanese Dermatological Association (JDA); for EP, has a history of plaque-type psoriasis. In addition, has an involved body surface area (BSA) of lesion greater than or equal to (>=) 80 percent (%) at baseline
• Candidate for phototherapy or systemic treatment for psoriasis (either naive or history of previous treatment)
• A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test (beta-human chorionic gonadotropin [beta-hCG]) at screening and have a negative urine pregnancy test at Week 0 prior to administration of study intervention
• A male participant must agree not to plan to father a child while enrolled in this study or within 90 days after the last dose of study intervention
• A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 90 days after receiving the last dose of study intervention

Exclusion Criteria:

• The study participant has a total score of JDA severity index for GPP >=14 at baseline if participants have a diagnosis of GPP
• The study participant has a differential diagnosis of the erythroderma (for example, erythroderma caused by lymphoma or drug eruption) other than EP
• The study participant has a history of or current diagnosis or signs or symptoms of severe, progressive, or uncontrolled liver, renal; cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
• The study participant has a history of amyloidosis
• Known allergies, hypersensitivity, or intolerance to JNJ-77242113 or its excipients
• The study participant who doesn't meet the criteria of prior/current concomitant therapy and/or history/conditions of infections

Related Conditions & MeSH terms

• Erythrodermic Psoriasis
• Generalized Pustular Psoriasis
• Psoriasis

Intervention

Drug:
• JNJ-77242113
JNJ-77242113 tablet will be administered orally.

Locations

Country	Name	City	State
Japan	JR Sapporo Hospital	Hokkaido
Japan	Ichinomiya Municipal Hospital	Ichinomiya
Japan	Teikyo University Hospital	Itabashi Ku
Japan	Hospital of the University of Occupational and Environmental Health	Kitakyushu-shi
Japan	Kumamoto University Hospital	Kumamoto
Japan	Nagoya City University Hospital	Nagoya
Japan	Public Interest Incorporated Foundation Nipoon Life Saiseikai Nippon Life Hospital	Osaka
Japan	Tohoku University Hospital	Sendai
Japan	Dokkyo Medical University Hospital	Shimotsuga Gun
Japan	Tokyo Medical University Hospital	Shinjuku
Japan	Fujita Health University Hospital	Toyoake
Japan	Mie University Hospital	Tsu

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Pharmaceutical K.K.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Generalized Pustular Psoriasis (GPP) who Experience Treatment Success Based on Clinical Global Impression (CGI) Scale According to Japanese Dermatological Association (JDA) Total Score at Week 16	GPP treatment success is defined as at least "minimally improved" rating according to total JDA score for GPP at Week 16. The CGI score is defined as 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = Worsened.	Week 16
Primary	Percentage of Participants With Erythrodermic Psoriasis (EP) who Experience Treatment Success Based on CGI Scale at Week 16	EP treatment success is defined as at least 'Minimally Improved' rating in CGI scale for EP at Week 16. The CGI score is defined as 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = Worsened.	Week 16
Secondary	Percentage of Participants With GPP who Experience Treatment Success Based on CGI Scale According to JDA Total Score Over Time	GPP treatment success is defined as at least "minimally improved" rating according to total JDA score for GPP. The CGI score is defined as 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = Worsened.	Up to Week 156
Secondary	Percentage of Participants With EP who Experience Treatment Success Based on CGI Scale Over Time	EP treatment success is defined as at least 'Minimally Improved' rating in CGI scale for EP. The CGI score is defined as 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = Worsened.	Up to Week 156
Secondary	Change From Baseline in Total Score of JDA Severity Index for GPP	The JDA Severity Index (JDA-SI) includes assessment of skin symptoms (area of erythema, area of erythema with pustules, and area of edema) and systemic symptoms/laboratory findings (fever, white blood cell count, C-reactive protein [CRP], serum albumin). The total score ranges from 0 to 17 with higher score indicating more severe disease .	Baseline up to Week 156
Secondary	Change From Baseline in Severity Classification of JDA Severity Index for GPP	Change from baseline in severity classification (mild, moderate and severe) of JDA severity index for GPP will be reported. The JDA-SI includes assessment of skin symptoms (area of erythema, area of erythema with pustules, and area of edema) and systemic symptoms/laboratory findings (fever, white blood cell count, CRP, serum albumin). The total score ranges from 0 to 17 and classifies disease severity as mild (0-6), moderate (7-10), or severe (11-17). Higher score indicate more severe disease.	Baseline up to Week 156
Secondary	Change From Baseline in Body Surface Area (BSA) for EP	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.	Baseline up to Week 156
Secondary	Percentage of Participants who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1)	The IGA is 5-point scale assessing the severity of psoriasis, with scores cleared (0), minimal (1), mild (2), moderate (3), or severe (4).	Up to Week 156
Secondary	Percentage of Participants who Achieve an IGA Score of Cleared (0)	The IGA is 5-point scale assessing the severity of psoriasis, with scores cleared (0), minimal (1), mild (2), moderate (3), or severe (4).	Up to Week 156
Secondary	Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI)	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 .	Baseline up to Week 156
Secondary	Change From Baseline in Dermatology Life Quality Index (DLQI) Score	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.	Baseline up to Week 156
Secondary	Percentage of Participants who Achieve a DLQI Score of 0 or 1	The DLQI is a dermatology specific 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.	Up to Week 156
Secondary	Change From Baseline in EuroQol-5 Dimension 5-Level (EQ-5D-5L)	The EQ-5D-5L is a standardized 2-part instrument used to measure health outcomes, primarily designed for self-completion by respondents. It consists of the EQ-5D-5L descriptive system and the EQ Visual Analogue Scale (EQ-VAS). The EQ-5D-5L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each of the 5 dimensions is divided into 5 levels of perceived problems (level 1 = no problem, level 2 = slight problems, level 3 = moderate problems, level 4 = severe problems, level 5 = extreme problems. The EQ-5D also includes a visual analog scale (EQ-VAS) that has endpoints labeled "best imaginable health state" and "worst imaginable health state" anchored at 100 and 0, respectively. The participant selects an answer for each of the 5 dimensions considering the response that best matches his or her health "today."	Baseline up to Week 156
Secondary	Percentage of Participants With Adverse Events (AEs) and Serious AEs	Percentage of participants with AEs and Serious AEs (SAEs) will be reported. An AE was any untoward medical occurrence in a clinical investigation where participants administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. A SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or resulted in congenital anomaly/birth defect.	Up to 160 weeks