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Active, not recruitingNCT06295692Updated Sep 28, 2026Results posted

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

A Phase 3 interventional study of JNJ-77242113 in Generalized Pustular Psoriasis and Erythrodermic Psoriasis, sponsored by Janssen Pharmaceutical K.K.. Active, not recruiting at 12 sites in Japan. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-09-28.

Sponsored by Janssen Pharmaceutical K.K. (part of Johnson & Johnson) · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
19
Allocation
Not applicable
Ages
12 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Generalized Pustular Psoriasis
  • Erythrodermic Psoriasis

Browse trials for

03

In context

Psoriasis

2,028 studies on the registry are indexed under Psoriasis; 275 are open to participants now.

This study's enrollment of 19 is below the median of 75 across 1,565 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

Janssen Pharmaceutical K.K. is the lead sponsor of 126 studies on the registry; none are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 7 (50%) have results posted.

Browse Janssen Pharmaceutical K.K. studies →All Johnson & Johnson studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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

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, , or intolerance to JNJ-77242113 or its
  • The study participant who doesn't meet the criteria of prior/current concomitant therapy and/or history/conditions of infections
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
19 participants (actual)

Study arms

  • Experimental
    JNJ-77242113- Participants With Generalized Pustular Psoriasis (GPP) or Erythrodermic Psoriasis (EP)

    Participants with GPP or EP will receive JNJ-77242113 tablet orally.

    Drug: JNJ-77242113

Interventions

  • DrugJNJ-77242113

    JNJ-77242113 tablet will be administered orally.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Week 16

  2. 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.

    Time frame: Week 16

Secondary outcomes

  1. Percentage of Participants With GPP Who Experienced Treatment Success Over Time Based on CGI Scale According to JDA Total Score

    Time frame: From baseline (Week 0) to Week 156

  2. Percentage of Participants With EP Who Experienced Treatment Success Over Time Based on CGI Scale

    Time frame: From Baseline (Week 0) to Week 156

  3. Change From Baseline in the Total Score of the Japanese Dermatological Association (JDA) Severity Index for GPP Over Time

    Time frame: From baseline (Week 0) up to Week 156

  4. Change From Baseline in Severity Classification of JDA Severity Index for GPP Over Time

    Time frame: From baseline (Week 0) up to Week 156

  5. Change From Baseline in the Body Surface Area (BSA) of Involvement of Lesion for EP Over Time

    Time frame: From baseline (Week 0) up to Week 156

  6. Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) Over Time

    Time frame: Baseline (Week 0) up to Week 156

  7. Percentage of Participants Who Achieved an IGA Score of Cleared (0) Over Time

    Time frame: Baseline (Week 0) up to Week 156

  8. Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Over Time

    Time frame: From baseline (Week 0) up to Week 156

  9. Change From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time

    Time frame: From baseline (Week 0) up to Week 156

  10. Percentage of Participants Who Achieved DLQI Score of 0 or 1 Over Time

    Time frame: Baseline (Week 0) up to Week 156

  11. Change From Baseline in EuroQol-5 Dimension 5-Level (EQ-5D-5L) Over Time: Domain Scores

    Time frame: From baseline (week 0) up to Week 156

  12. Change From Baseline in EQ-5D-5L Over Time: Visual Analog Scale (VAS) Scores

    Time frame: From baseline (Week 0) up to Week 156

  13. Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

    Time frame: Baseline (Week 0) up to 160 weeks

07

Results

Posted Jan 28, 2026

Participant flow

Participant flow — Overall Study
MilestoneGPP: JNJ-77242113 200 mg QDEP: JNJ-77242113 200 mg QD
Started910
Completed11
Not completed89
Withdrew: Ongoing89

Outcome measures

PrimaryPercentage 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.

Time frame:
Week 16
Reported as:
Number · Percentage of participants
Percentage of Participants With Generalized Pustular Psoriasis (GPP) Who Experienced Treatment Success at Week 16
Percentage of participantsGPP: JNJ-77242113 200 mg QD
Percentage of Participants With Generalized Pustular Psoriasis (GPP) Who Experienced Treatment Success at Week 1688.9 (51.8 to 99.7)
PrimaryPercentage 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.

Time frame:
Week 16
Reported as:
Number · Percentage of participants
Percentage of Participants With Erythrodermic Psoriasis (EP) Who Experience Treatment Success at Week 16
Percentage of participantsEP: JNJ-77242113 200 mg QD
Percentage of Participants With Erythrodermic Psoriasis (EP) Who Experience Treatment Success at Week 16100.0 (69.2 to 100.0)
SecondaryPercentage of Participants With GPP Who Experienced Treatment Success Over Time Based on CGI Scale According to JDA Total Score
Time frame:
From baseline (Week 0) to Week 156

Results for this outcome have not been posted.

SecondaryPercentage of Participants With EP Who Experienced Treatment Success Over Time Based on CGI Scale
Time frame:
From Baseline (Week 0) to Week 156

Results for this outcome have not been posted.

SecondaryChange From Baseline in the Total Score of the Japanese Dermatological Association (JDA) Severity Index for GPP Over Time
Time frame:
From baseline (Week 0) up to Week 156

Results for this outcome have not been posted.

SecondaryChange From Baseline in Severity Classification of JDA Severity Index for GPP Over Time
Time frame:
From baseline (Week 0) up to Week 156

Results for this outcome have not been posted.

SecondaryChange From Baseline in the Body Surface Area (BSA) of Involvement of Lesion for EP Over Time
Time frame:
From baseline (Week 0) up to Week 156

Results for this outcome have not been posted.

SecondaryPercentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) Over Time
Time frame:
Baseline (Week 0) up to Week 156

Results for this outcome have not been posted.

SecondaryPercentage of Participants Who Achieved an IGA Score of Cleared (0) Over Time
Time frame:
Baseline (Week 0) up to Week 156

Results for this outcome have not been posted.

SecondaryPercent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Over Time
Time frame:
From baseline (Week 0) up to Week 156

Results for this outcome have not been posted.

SecondaryChange From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time
Time frame:
From baseline (Week 0) up to Week 156

Results for this outcome have not been posted.

SecondaryPercentage of Participants Who Achieved DLQI Score of 0 or 1 Over Time
Time frame:
Baseline (Week 0) up to Week 156

Results for this outcome have not been posted.

SecondaryChange From Baseline in EuroQol-5 Dimension 5-Level (EQ-5D-5L) Over Time: Domain Scores
Time frame:
From baseline (week 0) up to Week 156

Results for this outcome have not been posted.

SecondaryChange From Baseline in EQ-5D-5L Over Time: Visual Analog Scale (VAS) Scores
Time frame:
From baseline (Week 0) up to Week 156

Results for this outcome have not been posted.

SecondaryNumber of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Time frame:
Baseline (Week 0) up to 160 weeks

Results for this outcome have not been posted.

Adverse events

Collected over From Week 0 up to Week 24. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
GPP: JNJ-77242113 200 mg QD0/9 (0%)2/9 (22.2%)6/9 (66.7%)
EP: JNJ-77242113 200 mg QD0/10 (0%)1/10 (10%)8/10 (80%)
Most frequent serious events
Most frequent serious events
EventGPP: JNJ-77242113 200 mg QDEP: JNJ-77242113 200 mg QD
Acquired HaemophiliaBlood and lymphatic system disorders1/90/10
CataractEye disorders1/90/10
PruritusSkin and subcutaneous tissue disorders0/91/10
Most frequent other events
Showing 10 of 33
Most frequent other events
EventGPP: JNJ-77242113 200 mg QDEP: JNJ-77242113 200 mg QD
NasopharyngitisInfections and infestations1/92/10
KeratitisEye disorders1/90/10
Angular CheilitisGastrointestinal disorders1/90/10
ConstipationGastrointestinal disorders1/90/10
Hepatic Function AbnormalHepatobiliary disorders1/90/10
CystitisInfections and infestations1/90/10
InfluenzaInfections and infestations1/91/10
Oral CandidiasisInfections and infestations1/90/10
Suspected Covid-19Infections and infestations1/90/10
Upper Respiratory Tract InfectionInfections and infestations1/90/10

Baseline characteristics

Age, Continuous
Age, Continuous(Years)GPP: JNJ-77242113 200 mg QDEP: JNJ-77242113 200 mg QDTotal
Mean60 ± 11.9156.8 ± 14.0158.3 ± 12.8
Sex: Female, Male
Sex: Female, Male(Participants)GPP: JNJ-77242113 200 mg QDEP: JNJ-77242113 200 mg QDTotal
Female516
Male4913
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)GPP: JNJ-77242113 200 mg QDEP: JNJ-77242113 200 mg QDTotal
Hispanic or Latino000
Not Hispanic or Latino91019
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)GPP: JNJ-77242113 200 mg QDEP: JNJ-77242113 200 mg QDTotal
American Indian or Alaska Native000
Asian91019
Native Hawaiian or Other Pacific Islander000
Black or African American000
White000
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(Participants)GPP: JNJ-77242113 200 mg QDEP: JNJ-77242113 200 mg QDTotal
Japan91019
08

Study locations

12 sites
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — 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

Data sharing details ↗ · www.janssen.com

10

Updates

1 registry update since Sep 25, 2026
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
1 update, last Sep 28, 2026
Show all 1 update
  1. Sep 28, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

11

Registry details

Key details

Study ID
NCT06295692
Lead sponsor
Janssen Pharmaceutical K.K.
Responsible party
Sponsor
First posted
Mar 6, 2024
Start date
Feb 9, 2024
Primary completion
Jan 14, 2025
Completion
Oct 14, 2027 (estimated)
Results posted
Jan 28, 2026
Last update
Sep 28, 2026

Study contacts

Janssen Pharmaceutical K.K., Japan Clinical Trial
study director · Janssen Pharmaceutical K.K.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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