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.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE3

Target enrollment

19 participants

Primary outcome timeframe

Week 16

Results posted on

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

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

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

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 16

Population: 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

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 16

Population: 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

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 156

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Baseline (Week 0) to Week 156

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From baseline (Week 0) up to Week 156

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From baseline (Week 0) up to Week 156

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From baseline (Week 0) up to Week 156

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (Week 0) up to Week 156

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (Week 0) up to Week 156

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From baseline (Week 0) up to Week 156

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From baseline (Week 0) up to Week 156

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (Week 0) up to Week 156

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From baseline (week 0) up to Week 156

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From baseline (Week 0) up to Week 156

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (Week 0) up to 160 weeks

Outcome measures

Outcome data not reported

Adverse Events

GPP: JNJ-77242113 200 mg QD

Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths

EP: JNJ-77242113 200 mg QD

Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths

Serious adverse events

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

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

Phone: 844-434-4210

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