Trial Outcomes & Findings for A Study of JNJ-77242113 for the Treatment of Participants With Generalized Pustular Psoriasis or Erythrodermic Psoriasis (NCT NCT06295692)
NCT ID: NCT06295692
Last Updated: 2026-05-08
Results Overview
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.
ACTIVE_NOT_RECRUITING
PHASE3
19 participants
Week 16
2026-05-08
Participant Flow
The results presented are based on the primary completion date (14 Jan 2025). Remaining results will be reported within a year of study completion.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
10
|
|
Overall Study
COMPLETED
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
8
|
9
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Ongoing
|
8
|
9
|
Baseline Characteristics
A Study of JNJ-77242113 for the Treatment of Participants With Generalized Pustular Psoriasis or Erythrodermic Psoriasis
Baseline characteristics by cohort
| Measure |
GPP: JNJ-77242113 200 mg QD
n=9 Participants
Participants with generalized pustular psoriasis (GPP) received JNJ-77242113 200 milligrams (mg) tablet orally once daily (QD) from Week 0 up to Week 24.
|
EP: JNJ-77242113 200 mg QD
n=10 Participants
Participants with erythrodermic psoriasis (EP) received JNJ-77242113 200 mg tablet orally QD from Week 0 up to Week 24.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60 Years
STANDARD_DEVIATION 11.91 • n=41 Participants
|
56.8 Years
STANDARD_DEVIATION 14.01 • n=40 Participants
|
58.3 Years
STANDARD_DEVIATION 12.8 • n=81 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=41 Participants
|
1 Participants
n=40 Participants
|
6 Participants
n=81 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=41 Participants
|
9 Participants
n=40 Participants
|
13 Participants
n=81 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=41 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=81 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=41 Participants
|
10 Participants
n=40 Participants
|
19 Participants
n=81 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=81 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=81 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=41 Participants
|
10 Participants
n=40 Participants
|
19 Participants
n=81 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=81 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=41 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=81 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=41 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=81 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=81 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=81 Participants
|
|
Region of Enrollment
Japan
|
9 Participants
n=41 Participants
|
10 Participants
n=40 Participants
|
19 Participants
n=81 Participants
|
PRIMARY outcome
Timeframe: Week 16Population: 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.
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.
Outcome measures
| Measure |
GPP: JNJ-77242113 200 mg QD
n=9 Participants
Participants with generalized pustular psoriasis (GPP) received JNJ-77242113 200 milligrams (mg) tablet orally once daily (QD) from Week 0 up to Week 24.
|
|---|---|
|
Percentage of Participants With Generalized Pustular Psoriasis (GPP) Who Experienced Treatment Success at Week 16
|
88.9 Percentage of participants
Interval 51.8 to 99.7
|
PRIMARY outcome
Timeframe: Week 16Population: 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.
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.
Outcome measures
| Measure |
GPP: JNJ-77242113 200 mg QD
n=10 Participants
Participants with generalized pustular psoriasis (GPP) received JNJ-77242113 200 milligrams (mg) tablet orally once daily (QD) from Week 0 up to Week 24.
|
|---|---|
|
Percentage of Participants With Erythrodermic Psoriasis (EP) Who Experience Treatment Success at Week 16
|
100.0 Percentage of participants
Interval 69.2 to 100.0
|
SECONDARY outcome
Timeframe: From baseline (Week 0) to Week 156Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Baseline (Week 0) to Week 156Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From baseline (Week 0) up to Week 156Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From baseline (Week 0) up to Week 156Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From baseline (Week 0) up to Week 156Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Week 0) up to Week 156Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Week 0) up to Week 156Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From baseline (Week 0) up to Week 156Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From baseline (Week 0) up to Week 156Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Week 0) up to Week 156Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From baseline (week 0) up to Week 156Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From baseline (Week 0) up to Week 156Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Week 0) up to 160 weeksOutcome measures
Outcome data not reported
Adverse Events
GPP: JNJ-77242113 200 mg QD
EP: JNJ-77242113 200 mg QD
Serious adverse events
| Measure |
GPP: JNJ-77242113 200 mg QD
n=9 participants at risk
Participants with generalized pustular psoriasis (GPP) received JNJ-77242113 200 milligrams (mg) tablet orally once daily (QD) from Week 0 up to Week 24.
|
EP: JNJ-77242113 200 mg QD
n=10 participants at risk
Participants with erythrodermic psoriasis (EP) received JNJ-77242113 200 mg tablet orally QD from Week 0 up to Week 24.
|
|---|---|---|
|
Blood and lymphatic system disorders
Acquired Haemophilia
|
11.1%
1/9 • From Week 0 up to Week 24
Safety analysis set included all enrolled participants who received at least 1 dose of JNJ-77242113.
|
0.00%
0/10 • From Week 0 up to Week 24
Safety analysis set included all enrolled participants who received at least 1 dose of JNJ-77242113.
|
|
Eye disorders
Cataract
|
11.1%
1/9 • From Week 0 up to Week 24
Safety analysis set included all enrolled participants who received at least 1 dose of JNJ-77242113.
|
0.00%
0/10 • From Week 0 up to Week 24
Safety analysis set included all enrolled participants who received at least 1 dose of JNJ-77242113.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/9 • From Week 0 up to Week 24
Safety analysis set included all enrolled participants who received at least 1 dose of JNJ-77242113.
|
10.0%
1/10 • From Week 0 up to Week 24
Safety analysis set included all enrolled participants who received at least 1 dose of JNJ-77242113.
|
Other adverse events
| Measure |
GPP: JNJ-77242113 200 mg QD
n=9 participants at risk
Participants with generalized pustular psoriasis (GPP) received JNJ-77242113 200 milligrams (mg) tablet orally once daily (QD) from Week 0 up to Week 24.
|
EP: JNJ-77242113 200 mg QD
n=10 participants at risk
Participants with erythrodermic psoriasis (EP) received JNJ-77242113 200 mg tablet orally QD from Week 0 up to Week 24.
|
|---|---|---|
|
Infections and infestations
Cystitis
|
11.1%
1/9 • From Week 0 up to Week 24
Safety analysis set included all enrolled participants who received at least 1 dose of JNJ-77242113.
|
0.00%
0/10 • From Week 0 up to Week 24
Safety analysis set included all enrolled participants who received at least 1 dose of JNJ-77242113.
|
|
Gastrointestinal disorders
Constipation
|
11.1%
1/9 • From Week 0 up to Week 24
Safety analysis set included all enrolled participants who received at least 1 dose of JNJ-77242113.
|
0.00%
0/10 • From Week 0 up to Week 24
Safety analysis set included all enrolled participants who received at least 1 dose of JNJ-77242113.
|
|
Hepatobiliary disorders
Hepatic Function Abnormal
|
11.1%
1/9 • From Week 0 up to Week 24
Safety analysis set included all enrolled participants who received at least 1 dose of JNJ-77242113.
|
0.00%
0/10 • From Week 0 up to Week 24
Safety analysis set included all enrolled participants who received at least 1 dose of JNJ-77242113.
|
|
Infections and infestations
Covid-19
|
0.00%
0/9 • From Week 0 up to Week 24
Safety analysis set included all enrolled participants who received at least 1 dose of JNJ-77242113.
|
10.0%
1/10 • From Week 0 up to Week 24
Safety analysis set included all enrolled participants who received at least 1 dose of JNJ-77242113.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/9 • From Week 0 up to Week 24
Safety analysis set included all enrolled participants who received at least 1 dose of JNJ-77242113.
|
10.0%
1/10 • From Week 0 up to Week 24
Safety analysis set included all enrolled participants who received at least 1 dose of JNJ-77242113.
|
|
Eye disorders
Keratitis
|
11.1%
1/9 • From Week 0 up to Week 24
Safety analysis set included all enrolled participants who received at least 1 dose of JNJ-77242113.
|
0.00%
0/10 • From Week 0 up to Week 24
Safety analysis set included all enrolled participants who received at least 1 dose of JNJ-77242113.
|
|
Gastrointestinal disorders
Angular Cheilitis
|
11.1%
1/9 • From Week 0 up to Week 24
Safety analysis set included all enrolled participants who received at least 1 dose of JNJ-77242113.
|
0.00%
0/10 • From Week 0 up to Week 24
Safety analysis set included all enrolled participants who received at least 1 dose of JNJ-77242113.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/9 • From Week 0 up to Week 24
Safety analysis set included all enrolled participants who received at least 1 dose of JNJ-77242113.
|
10.0%
1/10 • From Week 0 up to Week 24
Safety analysis set included all enrolled participants who received at least 1 dose of JNJ-77242113.
|
|
Infections and infestations
Influenza
|
11.1%
1/9 • From Week 0 up to Week 24
Safety analysis set included all enrolled participants who received at least 1 dose of JNJ-77242113.
|
10.0%
1/10 • From Week 0 up to Week 24
Safety analysis set included all enrolled participants who received at least 1 dose of JNJ-77242113.
|
|
Infections and infestations
Nasopharyngitis
|
11.1%
1/9 • From Week 0 up to Week 24
Safety analysis set included all enrolled participants who received at least 1 dose of JNJ-77242113.
|
20.0%
2/10 • From Week 0 up to Week 24
Safety analysis set included all enrolled participants who received at least 1 dose of JNJ-77242113.
|
|
Infections and infestations
Oral Candidiasis
|
11.1%
1/9 • From Week 0 up to Week 24
Safety analysis set included all enrolled participants who received at least 1 dose of JNJ-77242113.
|
0.00%
0/10 • From Week 0 up to Week 24
Safety analysis set included all enrolled participants who received at least 1 dose of JNJ-77242113.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/9 • From Week 0 up to Week 24
Safety analysis set included all enrolled participants who received at least 1 dose of JNJ-77242113.
|
10.0%
1/10 • From Week 0 up to Week 24
Safety analysis set included all enrolled participants who received at least 1 dose of JNJ-77242113.
|
|
Infections and infestations
Suspected Covid-19
|
11.1%
1/9 • From Week 0 up to Week 24
Safety analysis set included all enrolled participants who received at least 1 dose of JNJ-77242113.
|
0.00%
0/10 • From Week 0 up to Week 24
Safety analysis set included all enrolled participants who received at least 1 dose of JNJ-77242113.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
11.1%
1/9 • From Week 0 up to Week 24
Safety analysis set included all enrolled participants who received at least 1 dose of JNJ-77242113.
|
0.00%
0/10 • From Week 0 up to Week 24
Safety analysis set included all enrolled participants who received at least 1 dose of JNJ-77242113.
|
|
Infections and infestations
Urinary Tract Infection
|
11.1%
1/9 • From Week 0 up to Week 24
Safety analysis set included all enrolled participants who received at least 1 dose of JNJ-77242113.
|
0.00%
0/10 • From Week 0 up to Week 24
Safety analysis set included all enrolled participants who received at least 1 dose of JNJ-77242113.
|
|
Injury, poisoning and procedural complications
Chillblains
|
11.1%
1/9 • From Week 0 up to Week 24
Safety analysis set included all enrolled participants who received at least 1 dose of JNJ-77242113.
|
0.00%
0/10 • From Week 0 up to Week 24
Safety analysis set included all enrolled participants who received at least 1 dose of JNJ-77242113.
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
11.1%
1/9 • From Week 0 up to Week 24
Safety analysis set included all enrolled participants who received at least 1 dose of JNJ-77242113.
|
0.00%
0/10 • From Week 0 up to Week 24
Safety analysis set included all enrolled participants who received at least 1 dose of JNJ-77242113.
|
|
Investigations
Blood Lactate Dehydrogenase Increased
|
0.00%
0/9 • From Week 0 up to Week 24
Safety analysis set included all enrolled participants who received at least 1 dose of JNJ-77242113.
|
10.0%
1/10 • From Week 0 up to Week 24
Safety analysis set included all enrolled participants who received at least 1 dose of JNJ-77242113.
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
11.1%
1/9 • From Week 0 up to Week 24
Safety analysis set included all enrolled participants who received at least 1 dose of JNJ-77242113.
|
0.00%
0/10 • From Week 0 up to Week 24
Safety analysis set included all enrolled participants who received at least 1 dose of JNJ-77242113.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
11.1%
1/9 • From Week 0 up to Week 24
Safety analysis set included all enrolled participants who received at least 1 dose of JNJ-77242113.
|
0.00%
0/10 • From Week 0 up to Week 24
Safety analysis set included all enrolled participants who received at least 1 dose of JNJ-77242113.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.1%
1/9 • From Week 0 up to Week 24
Safety analysis set included all enrolled participants who received at least 1 dose of JNJ-77242113.
|
0.00%
0/10 • From Week 0 up to Week 24
Safety analysis set included all enrolled participants who received at least 1 dose of JNJ-77242113.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
11.1%
1/9 • From Week 0 up to Week 24
Safety analysis set included all enrolled participants who received at least 1 dose of JNJ-77242113.
|
0.00%
0/10 • From Week 0 up to Week 24
Safety analysis set included all enrolled participants who received at least 1 dose of JNJ-77242113.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
11.1%
1/9 • From Week 0 up to Week 24
Safety analysis set included all enrolled participants who received at least 1 dose of JNJ-77242113.
|
10.0%
1/10 • From Week 0 up to Week 24
Safety analysis set included all enrolled participants who received at least 1 dose of JNJ-77242113.
|
|
Nervous system disorders
Carotid Arteriosclerosis
|
0.00%
0/9 • From Week 0 up to Week 24
Safety analysis set included all enrolled participants who received at least 1 dose of JNJ-77242113.
|
10.0%
1/10 • From Week 0 up to Week 24
Safety analysis set included all enrolled participants who received at least 1 dose of JNJ-77242113.
|
|
Nervous system disorders
Dizziness Postural
|
0.00%
0/9 • From Week 0 up to Week 24
Safety analysis set included all enrolled participants who received at least 1 dose of JNJ-77242113.
|
10.0%
1/10 • From Week 0 up to Week 24
Safety analysis set included all enrolled participants who received at least 1 dose of JNJ-77242113.
|
|
Psychiatric disorders
Depression
|
0.00%
0/9 • From Week 0 up to Week 24
Safety analysis set included all enrolled participants who received at least 1 dose of JNJ-77242113.
|
10.0%
1/10 • From Week 0 up to Week 24
Safety analysis set included all enrolled participants who received at least 1 dose of JNJ-77242113.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
11.1%
1/9 • From Week 0 up to Week 24
Safety analysis set included all enrolled participants who received at least 1 dose of JNJ-77242113.
|
0.00%
0/10 • From Week 0 up to Week 24
Safety analysis set included all enrolled participants who received at least 1 dose of JNJ-77242113.
|
|
Skin and subcutaneous tissue disorders
Eczema Asteatotic
|
0.00%
0/9 • From Week 0 up to Week 24
Safety analysis set included all enrolled participants who received at least 1 dose of JNJ-77242113.
|
10.0%
1/10 • From Week 0 up to Week 24
Safety analysis set included all enrolled participants who received at least 1 dose of JNJ-77242113.
|
|
Skin and subcutaneous tissue disorders
Erythrodermic Psoriasis
|
0.00%
0/9 • From Week 0 up to Week 24
Safety analysis set included all enrolled participants who received at least 1 dose of JNJ-77242113.
|
10.0%
1/10 • From Week 0 up to Week 24
Safety analysis set included all enrolled participants who received at least 1 dose of JNJ-77242113.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/9 • From Week 0 up to Week 24
Safety analysis set included all enrolled participants who received at least 1 dose of JNJ-77242113.
|
10.0%
1/10 • From Week 0 up to Week 24
Safety analysis set included all enrolled participants who received at least 1 dose of JNJ-77242113.
|
|
Skin and subcutaneous tissue disorders
Mechanical Urticaria
|
11.1%
1/9 • From Week 0 up to Week 24
Safety analysis set included all enrolled participants who received at least 1 dose of JNJ-77242113.
|
0.00%
0/10 • From Week 0 up to Week 24
Safety analysis set included all enrolled participants who received at least 1 dose of JNJ-77242113.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.1%
1/9 • From Week 0 up to Week 24
Safety analysis set included all enrolled participants who received at least 1 dose of JNJ-77242113.
|
10.0%
1/10 • From Week 0 up to Week 24
Safety analysis set included all enrolled participants who received at least 1 dose of JNJ-77242113.
|
|
Vascular disorders
Hypertension
|
11.1%
1/9 • From Week 0 up to Week 24
Safety analysis set included all enrolled participants who received at least 1 dose of JNJ-77242113.
|
0.00%
0/10 • From Week 0 up to Week 24
Safety analysis set included all enrolled participants who received at least 1 dose of JNJ-77242113.
|
Additional Information
Global Medical Head Dermatology
Janssen Research and Development, LLC
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER