Clinical trial NCT06295692: A Study of JNJ-77242113 for the Treatment of Participants With Generalized Pustular Psoriasis or Erythrodermic Psoriasis
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Generalized Pustular Psoriasis
Erythrodermic Psoriasis
Lead sponsor: Janssen Pharmaceutical K.K.
Sponsor class: INDUSTRY
First posted: 2024-03-06
Enrollment: 19
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Week 16
measure: Percentage of Participants With Erythrodermic Psoriasis (EP) who Experience Treatment Success Based on CGI Scale at Week 16
timeFrame: Week 16
Secondary outcomes:
measure: Percentage of Participants With GPP who Experience Treatment Success Based on CGI Scale According to JDA Total Score Over Time
timeFrame: Up to Week 156
measure: Percentage of Participants With EP who Experience Treatment Success Based on CGI Scale Over Time
timeFrame: Up to Week 156
measure: Change From Baseline in Total Score of JDA Severity Index for GPP
timeFrame: Baseline up to Week 156
measure: Change From Baseline in Severity Classification of JDA Severity Index for GPP
timeFrame: Baseline up to Week 156
measure: Change From Baseline in Body Surface Area (BSA) for EP
timeFrame: Baseline up to Week 156
measure: Percentage of Participants who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1)
timeFrame: Up to Week 156
measure: Percentage of Participants who Achieve an IGA Score of Cleared (0)
timeFrame: Up to Week 156
measure: Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI)
timeFrame: Baseline up to Week 156
measure: Change From Baseline in Dermatology Life Quality Index (DLQI) Score
timeFrame: Baseline up to Week 156
measure: Percentage of Participants who Achieve a DLQI Score of 0 or 1
timeFrame: Up to Week 156
measure: Change From Baseline in EuroQol-5 Dimension 5-Level (EQ-5D-5L)
timeFrame: Baseline up to Week 156
measure: Percentage of Participants With Adverse Events (AEs) and Serious AEs
timeFrame: Up to 160 weeks
Other outcomes:
Locations:
city: Hokkaido
country: Japan
facility: JR Sapporo Hospital
city: Ichinomiya
country: Japan
facility: Ichinomiya Municipal Hospital
city: Itabashi Ku
country: Japan
facility: Teikyo University Hospital
city: Kitakyushu-shi
country: Japan
facility: Hospital of the University of Occupational and Enviromental Health
city: Kumamoto
country: Japan
facility: Kumamoto University Hospital
city: Nagoya
country: Japan
facility: Nagoya City University Hospital
city: Osaka
country: Japan
facility: Public Interest Incorporated Foundation Nipoon Life Saiseikai Nippon Life Hospital
city: Sendai
country: Japan
facility: Tohoku University Hospital
city: Shimotsuga Gun
country: Japan
facility: Dokkyo Medical University Hospital
city: Shinjuku
country: Japan
facility: Tokyo Medical University Hospital
city: Toyoake
country: Japan
facility: Fujita Health University Hospital
city: Tsu
country: Japan
facility: Mie University Hospital
Study officials:
affiliation: Janssen Pharmaceutical K.K.
name: Janssen Pharmaceutical K.K., Japan Clinical Trial
role: STUDY_DIRECTOR
References: