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| ID | Type | Description | Link |
|---|---|---|---|
| 77242113PSO3005 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to evaluate how effective JNJ-77242113 is in participants with generalized pustular psoriasis (GPP) or erythrodermic psoriasis (EP).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JNJ-77242113- Participants With Generalized Pustular Psoriasis (GPP) or Erythrodermic Psoriasis (EP) | Experimental | Participants with GPP or EP will receive JNJ-77242113 tablet orally. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-77242113 | Drug | JNJ-77242113 tablet will be administered orally. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Generalized Pustular Psoriasis (GPP) Who Experienced Treatment Success at Week 16 | Percentage of participants with GPP who experienced treatment success at Week 16 was reported. Treatment success for GPP was defined as at least "minimally improved" rating in Clinical Global Impression (CGI) scale for GPP based on Japanese Dermatological Association (JDA) total score. JDA severity index includes skin symptoms (area of erythema with pustules, total area of erythema, and area of edema; each scored 0-3) and systemic/laboratory findings (fever, white blood cell count, C-reactive protein, and serum albumin; each scored 0-2). JDA total score was sum of 2 assessments ranging from 0 (best) to 17 (worst). CGI ratings were defined as: 1=Very much improved (greater than or equal to [>=]3-point reduction in JDA total score), 2=Much improved (1-2-point reduction), 3=Minimally improved (no change in JDA total score, but >=20 percent (%) reduction in area of erythema with pustules or meaningful improvement in >=1 other parameter), 4=No change, 5=Worsened. Higher score = worsening. | Week 16 |
| Percentage of Participants With Erythrodermic Psoriasis (EP) Who Experience Treatment Success at Week 16 | Percentage of participants with EP who experienced treatment success at Week 16 was reported. Treatment success for EP was defined as at least "minimally improved" rating in CGI scale for EP. The CGI scale is a clinician-rated 5-point scale with the following categories: 1 = Very much improved, 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Worsened. Higher score indicated worsening. | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With GPP Who Experienced Treatment Success Over Time Based on CGI Scale According to JDA Total Score | From baseline (Week 0) to Week 156 | |
| Percentage of Participants With EP Who Experienced Treatment Success Over Time Based on CGI Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Pharmaceutical K.K., Japan Clinical Trial | Janssen Pharmaceutical K.K. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| JR Sapporo Hospital | Hokkaido | 060-0033 | Japan | |||
| Ichinomiya Municipal Hospital |
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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The results presented are based on the primary completion date (14 Jan 2025). Remaining results will be reported within a year of study completion.
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| ID | Title | Description |
|---|---|---|
| FG000 | GPP: JNJ-77242113 200 mg QD | Participants with generalized pustular psoriasis (GPP) received JNJ-77242113 200 milligrams (mg) tablet orally once daily (QD) from Week 0 up to Week 24. |
| FG001 | EP: JNJ-77242113 200 mg QD |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 29, 2023 | Jan 12, 2026 |
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| From Baseline (Week 0) to Week 156 |
| Change From Baseline in the Total Score of the Japanese Dermatological Association (JDA) Severity Index for GPP Over Time | From baseline (Week 0) up to Week 156 |
| Change From Baseline in Severity Classification of JDA Severity Index for GPP Over Time | From baseline (Week 0) up to Week 156 |
| Change From Baseline in the Body Surface Area (BSA) of Involvement of Lesion for EP Over Time | From baseline (Week 0) up to Week 156 |
| Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) Over Time | Baseline (Week 0) up to Week 156 |
| Percentage of Participants Who Achieved an IGA Score of Cleared (0) Over Time | Baseline (Week 0) up to Week 156 |
| Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Over Time | From baseline (Week 0) up to Week 156 |
| Change From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time | From baseline (Week 0) up to Week 156 |
| Percentage of Participants Who Achieved DLQI Score of 0 or 1 Over Time | Baseline (Week 0) up to Week 156 |
| Change From Baseline in EuroQol-5 Dimension 5-Level (EQ-5D-5L) Over Time: Domain Scores | From baseline (week 0) up to Week 156 |
| Change From Baseline in EQ-5D-5L Over Time: Visual Analog Scale (VAS) Scores | From baseline (Week 0) up to Week 156 |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Baseline (Week 0) up to 160 weeks |
| Ichinomiya |
| 491-8558 |
| Japan |
| Teikyo University Hospital | Itabashi Ku | 173 8606 | Japan |
| Hospital of the University of Occupational and Environmental Health | Kitakyushu-shi | 807-8556 | Japan |
| Kumamoto University Hospital | Kumamoto | 860-8556 | Japan |
| Nagoya City University Hospital | Nagoya | 467 8602 | Japan |
| Public Interest Incorporated Foundation Nipoon Life Saiseikai Nippon Life Hospital | Osaka | 550 0006 | Japan |
| Tohoku University Hospital | Sendai | 980 8574 | Japan |
| Dokkyo Medical University Hospital | Shimotsuga Gun | 321 0293 | Japan |
| Tokyo Medical University Hospital | Shinjuku | 160 0023 | Japan |
| Fujita Health University Hospital | Toyoake | 470-1192 | Japan |
| Mie University Hospital | Tsu | 514 8507 | Japan |
Participants with erythrodermic psoriasis (EP) received JNJ-77242113 200 mg tablet orally QD from Week 0 up to Week 24.
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | GPP: JNJ-77242113 200 mg QD | Participants with generalized pustular psoriasis (GPP) received JNJ-77242113 200 milligrams (mg) tablet orally once daily (QD) from Week 0 up to Week 24. |
| BG001 | EP: JNJ-77242113 200 mg QD | Participants with erythrodermic psoriasis (EP) received JNJ-77242113 200 mg tablet orally QD from Week 0 up to Week 24. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Generalized Pustular Psoriasis (GPP) Who Experienced Treatment Success at Week 16 | Percentage of participants with GPP who experienced treatment success at Week 16 was reported. Treatment success for GPP was defined as at least "minimally improved" rating in Clinical Global Impression (CGI) scale for GPP based on Japanese Dermatological Association (JDA) total score. JDA severity index includes skin symptoms (area of erythema with pustules, total area of erythema, and area of edema; each scored 0-3) and systemic/laboratory findings (fever, white blood cell count, C-reactive protein, and serum albumin; each scored 0-2). JDA total score was sum of 2 assessments ranging from 0 (best) to 17 (worst). CGI ratings were defined as: 1=Very much improved (greater than or equal to [>=]3-point reduction in JDA total score), 2=Much improved (1-2-point reduction), 3=Minimally improved (no change in JDA total score, but >=20 percent (%) reduction in area of erythema with pustules or meaningful improvement in >=1 other parameter), 4=No change, 5=Worsened. Higher score = worsening. | Full analysis set (FAS) included all enrolled participants who received at least 1 dose of JNJ-77242113. This outcome measure was planned to be analyzed for specified arm only. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 16 |
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| Primary | Percentage of Participants With Erythrodermic Psoriasis (EP) Who Experience Treatment Success at Week 16 | Percentage of participants with EP who experienced treatment success at Week 16 was reported. Treatment success for EP was defined as at least "minimally improved" rating in CGI scale for EP. The CGI scale is a clinician-rated 5-point scale with the following categories: 1 = Very much improved, 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Worsened. Higher score indicated worsening. | FAS included all enrolled participants who received at least 1 dose of JNJ-77242113. This outcome measure was planned to be analyzed for specified arm only. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 16 |
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| Secondary | Percentage of Participants With GPP Who Experienced Treatment Success Over Time Based on CGI Scale According to JDA Total Score | Not Posted | Oct 2028 | From baseline (Week 0) to Week 156 | Participants | |||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With EP Who Experienced Treatment Success Over Time Based on CGI Scale | Not Posted | Oct 2028 | From Baseline (Week 0) to Week 156 | Participants | |||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Total Score of the Japanese Dermatological Association (JDA) Severity Index for GPP Over Time | Not Posted | Oct 2028 | From baseline (Week 0) up to Week 156 | Participants | |||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Severity Classification of JDA Severity Index for GPP Over Time | Not Posted | Oct 2028 | From baseline (Week 0) up to Week 156 | Participants | |||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Body Surface Area (BSA) of Involvement of Lesion for EP Over Time | Not Posted | Oct 2028 | From baseline (Week 0) up to Week 156 | Participants | |||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) Over Time | Not Posted | Oct 2028 | Baseline (Week 0) up to Week 156 | Participants | |||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved an IGA Score of Cleared (0) Over Time | Not Posted | Oct 2028 | Baseline (Week 0) up to Week 156 | Participants | |||||||||||||||||||||||||||||||
| Secondary | Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Over Time | Not Posted | Oct 2028 | From baseline (Week 0) up to Week 156 | Participants | |||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time | Not Posted | Oct 2028 | From baseline (Week 0) up to Week 156 | Participants | |||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved DLQI Score of 0 or 1 Over Time | Not Posted | Oct 2028 | Baseline (Week 0) up to Week 156 | Participants | |||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in EuroQol-5 Dimension 5-Level (EQ-5D-5L) Over Time: Domain Scores | Not Posted | Oct 2028 | From baseline (week 0) up to Week 156 | Participants | |||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in EQ-5D-5L Over Time: Visual Analog Scale (VAS) Scores | Not Posted | Oct 2028 | From baseline (Week 0) up to Week 156 | Participants | |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Not Posted | Oct 2028 | Baseline (Week 0) up to 160 weeks | Participants |
From Week 0 up to Week 24
Safety analysis set included all enrolled participants who received at least 1 dose of JNJ-77242113.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GPP: JNJ-77242113 200 mg QD | Participants with generalized pustular psoriasis (GPP) received JNJ-77242113 200 milligrams (mg) tablet orally once daily (QD) from Week 0 up to Week 24. | 0 | 9 | 2 | 9 | 6 | 9 |
| EG001 | EP: JNJ-77242113 200 mg QD | Participants with erythrodermic psoriasis (EP) received JNJ-77242113 200 mg tablet orally QD from Week 0 up to Week 24. | 0 | 10 | 1 | 10 | 8 | 10 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acquired Haemophilia | Blood and lymphatic system disorders | MedDRA Version 27.0 | Non-systematic Assessment |
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| Cataract | Eye disorders | MedDRA Version 27.0 | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 27.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eosinophilia | Blood and lymphatic system disorders | MedDRA Version 27.0 | Non-systematic Assessment |
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| Keratitis | Eye disorders | MedDRA Version 27.0 | Non-systematic Assessment |
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| Angular Cheilitis | Gastrointestinal disorders | MedDRA Version 27.0 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA Version 27.0 | Non-systematic Assessment |
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| Hepatic Function Abnormal | Hepatobiliary disorders | MedDRA Version 27.0 | Non-systematic Assessment |
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| Covid-19 | Infections and infestations | MedDRA Version 27.0 | Non-systematic Assessment |
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| Cystitis | Infections and infestations | MedDRA Version 27.0 | Non-systematic Assessment |
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| Hordeolum | Infections and infestations | MedDRA Version 27.0 | Non-systematic Assessment |
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| Influenza | Infections and infestations | MedDRA Version 27.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA Version 27.0 | Non-systematic Assessment |
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| Oral Candidiasis | Infections and infestations | MedDRA Version 27.0 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA Version 27.0 | Non-systematic Assessment |
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| Suspected Covid-19 | Infections and infestations | MedDRA Version 27.0 | Non-systematic Assessment |
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| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 27.0 | Non-systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | MedDRA Version 27.0 | Non-systematic Assessment |
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| Chillblains | Injury, poisoning and procedural complications | MedDRA Version 27.0 | Non-systematic Assessment |
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| Rib Fracture | Injury, poisoning and procedural complications | MedDRA Version 27.0 | Non-systematic Assessment |
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| Blood Lactate Dehydrogenase Increased | Investigations | MedDRA Version 27.0 | Non-systematic Assessment |
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| Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA Version 27.0 | Non-systematic Assessment |
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| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA Version 27.0 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 27.0 | Non-systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 27.0 | Non-systematic Assessment |
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| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 27.0 | Non-systematic Assessment |
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| Carotid Arteriosclerosis | Nervous system disorders | MedDRA Version 27.0 | Non-systematic Assessment |
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| Dizziness Postural | Nervous system disorders | MedDRA Version 27.0 | Non-systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA Version 27.0 | Non-systematic Assessment |
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| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.0 | Non-systematic Assessment |
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| Eczema Asteatotic | Skin and subcutaneous tissue disorders | MedDRA Version 27.0 | Non-systematic Assessment |
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| Erythrodermic Psoriasis | Skin and subcutaneous tissue disorders | MedDRA Version 27.0 | Non-systematic Assessment |
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| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA Version 27.0 | Non-systematic Assessment |
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| Mechanical Urticaria | Skin and subcutaneous tissue disorders | MedDRA Version 27.0 | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 27.0 | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA Version 27.0 | Non-systematic Assessment |
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If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Head Dermatology | Janssen Research and Development, LLC | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 4, 2025 | Jan 12, 2026 | SAP_001.pdf |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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