AzTrials
AzTrials

Generalized Pustular PsoriasisPhase 3NCT06295692

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

A Phase 3 study testing JNJ-77242113 in people with Generalized Pustular Psoriasis and Erythrodermic Psoriasis, run by Janssen Pharmaceutical K.K. at 12 sites in Japan.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 12 years and older
What is being tested?
JNJ-77242113
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
12 sitesJapan
Study dates
9 Feb 2024to 14 Oct 2027
Phase
Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

Japan12 sites

  • JR Sapporo Hospital

    Hokkaido, 060-0033

  • Ichinomiya Municipal Hospital

    Ichinomiya, 491-8558

  • Teikyo University Hospital

    Itabashi Ku, 173 8606

  • Hospital of the University of Occupational and Environmental Health

    Kitakyushu-shi, 807-8556

  • Kumamoto University Hospital

    Kumamoto, 860-8556

  • Nagoya City University Hospital

    Nagoya, 467 8602

  • Public Interest Incorporated Foundation Nipoon Life Saiseikai Nippon Life Hospital

    Osaka, 550 0006

  • Tohoku University Hospital

    Sendai, 980 8574

  • Dokkyo Medical University Hospital

    Shimotsuga Gun, 321 0293

  • Tokyo Medical University Hospital

    Shinjuku, 160 0023

  • Fujita Health University Hospital

    Toyoake, 470-1192

  • Mie University Hospital

    Tsu, 514 8507

Other trials in Japan

About this study

Official title: 77242113PSO3005: 77242113PSO3005 Ph III Trial Local Study (N=20) {EP/GPP}

The purpose of this study is to evaluate how effective JNJ-77242113 is in participants with generalized pustular psoriasis (GPP) or erythrodermic psoriasis (EP).

Being tested
JNJ-77242113
Medical subject headings
Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JNJ-77242113Drug

    JNJ-77242113 tablet will be administered orally.

Study groups in NCT06295692
Study groupRoleWhat they receive
JNJ-77242113- Participants With Generalized Pustular Psoriasis (GPP) or Erythrodermic Psoriasis (EP)ExperimentalParticipants with GPP or EP will receive JNJ-77242113 tablet orally.
Receives: Drug: JNJ-77242113

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: Week 16

Secondary outcomes (13)

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

    Measured: From baseline (Week 0) to Week 156

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

    Measured: 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

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

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

    Measured: 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

    Measured: 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

    Measured: Baseline (Week 0) up to Week 156

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

    Measured: Baseline (Week 0) up to Week 156

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

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

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

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

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

    Measured: Baseline (Week 0) up to Week 156

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

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

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

    Measured: 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)

    Measured: Baseline (Week 0) up to 160 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2024
  2. Study start9 Feb 2024
  3. Primary completion14 Jan 2025
  4. Study completion14 Oct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06295692
Sponsor's protocol ID
77242113PSO3005
Other IDs
77242113PSO3005
Status last verified
Sep 2026
First submitted
29 Feb 2024
Last updated
28 Sep 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
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

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in