A Study of JNJ-77242113 for the Treatment of Moderate-to-Severe Plaque Psoriasis (SUMMIT)

A Phase 2a Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of an Oral Tablet Formulation of JNJ-77242113 for the Treatment of Moderate-to-Severe Plaque Psoriasis

The purpose of the study is to evaluate the efficacy of an oral tablet formulation of JNJ-77242113 compared with placebo in participants with moderate-to-severe plaque psoriasis.

Study Overview

• Status: Completed
• Conditions: Plaque Psoriasis
• Intervention / Treatment: Drug: JNJ-77242113; Drug: Placebo

Detailed Description

The population of people living with moderate to severe psoriasis is approximately 3.5 billion who are mostly managed with topical and conventional therapies. JNJ-77242113, investigational drug, targets the immune responses in the body and skin which impacts diseases, such as psoriasis and psoriatic arthritis and this study evaluates JNJ-77242113 as options of advanced therapies in moderate to severe plaque psoriasis. The hypothesis of this study is that an oral tablet formulation of JNJ-77242113 will result in superior efficacy compared with placebo as determined by the percentage of participants achieving Psoriasis Area and Severity Index (PASI) 75 (greater than or equal to [>=] 75 percentage [%] improvement in PASI) (PASI 75) response at Week 16. The total duration of this study is up to 24 weeks which includes a screening period of less than or equal to (<=) 4 weeks, a 16-week placebo- controlled treatment period, and a follow-up visit approximately 4 weeks after the last administration of study intervention. Safety assessments include adverse events (AEs) monitoring, clinical safety laboratory assessments, electrocardiograms (ECGs), vital signs, physical examinations, concomitant medication monitoring, pregnancy testing, Columbia Suicide Severity Rating Scale (C-SSRS) and tuberculosis evaluations.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2J 7E1
      • Dermatology Research Institute Inc
  • Ontario
    • London, Ontario, Canada, N6A 3H7
      • The Guenther Dermatology Research Centre
    • Markham, Ontario, Canada, L3P 1X2
      • Lynderm Research Inc.
    • Mississauga, Ontario, Canada, L4Y 4C5
      • DermEdge Research
    • Toronto, Ontario, Canada, M3H 5Y8
      • Toronto Research Centre
• France
  • Brest, France, 29200
    • CHRU Brest - Hopital Morvan
  • La Tronche, France, 38700
    • CHU de Grenoble Hopital Albert Michallon
  • Nice, France, 06200
    • CHU de Nice Hopital de l Archet
  • Reims, France, 51100
    • Polyclinique de Courlancy
• Germany
  • Bramsche, Germany, 49565
    • Hautarztpraxis
  • Dresden, Germany, 01307
    • Universitatsklinikum Carl Gustav Carus Dresden
  • Düsseldorf, Germany, 40212
    • Privatpraxis Dr. Hilton & Partner
  • Frankfurt am Main, Germany, 60590
    • Universitatsklinikum Frankfurt
  • Lübeck, Germany, 23538
    • Universitatsklinikum Schleswig Holstein Campus Lubeck
  • Münster, Germany, 48149
    • Universitatsklinikum Munster
  • Rostock, Germany, 18057
    • Universitaetsmedizin Rostock
• Poland
  • Bialystok, Poland, 15 375
    • Specderm Poznanska sp j
  • Krakow, Poland, 30 002
    • Specjalistyczny gabinet dermatologiczny Aplikacyjno Badawczy Marek Brzewski Pawel Brzewski Spolka Cywilna
  • Lodz, Poland, 90-338
    • Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna
• Spain
  • Barakaldo, Spain, 48902
    • Hosp. Univ. de Cruces
  • Granada, Spain, 18016
    • Hosp. Univ. San Cecilio
  • Seville, Spain, 41009
    • Hosp. Virgen Macarena
• United States
  • California
    • Beverly Hills, California, United States, 90212
      • Stoll Dermatology
  • Illinois
    • Skokie, Illinois, United States, 60077
      • Northshore University Healthsystem
  • Kansas
    • Overland Park, Kansas, United States, 66210
      • Epiphany Dermatology of Kansas, LLC
  • Kentucky
    • Louisville, Kentucky, United States, 40241
      • Dermatology Specialists
  • Maryland
    • Rockville, Maryland, United States, 20850
      • Lawrence J Green MD LLC
  • Massachusetts
    • Beverly, Massachusetts, United States, 01915
      • ActivMed Practices and Research
  • New Hampshire
    • Portsmouth, New Hampshire, United States, 03801
      • ActivMed Practices and Research
  • New Jersey
    • East Windsor, New Jersey, United States, 08520
      • Windsor Dermatology, PC
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73118
      • Unity Clinical Research
  • Pennsylvania
    • Exton, Pennsylvania, United States, 19341
      • The Pennsylvania Centre for Dermatology, LLC
  • South Dakota
    • Rapid City, South Dakota, United States, 57702
      • Health Concepts
  • Texas
    • Arlington, Texas, United States, 76011
      • Arlington Center for Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participant has a diagnosis of plaque psoriasis, with or without psoriatic arthritis, for at least 26 weeks prior to the first administration of study intervention
• Participant has a total Body Surface Area (BSA) greater than or equal to (>=) 10 percentage (%) at screening and baseline
• Participant has a total Psoriasis Area and Severity Index (PASI) >= 12 at screening and baseline
• Participant has a total Investigator's Global Assessment (IGA) >= 3 at screening and baseline
• Participant be a candidate for phototherapy or systemic treatment for plaque psoriasis

Exclusion Criteria:

• Participant has a nonplaque form of psoriasis (for example, erythrodermic, guttate, or pustular)
• Participant has current drug-induced psoriasis (for example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
• Participant have previously received any other therapeutic agent directly targeted to interleukin 23 (including but not limited to guselkumab, tildrakizumab, or risankizumab)
• Participant has received any therapeutic agent directly targeted to interleukin 17 (IL-17), interleukin 17 receptor (IL-17R) or interleukin 12/23 (IL-12/23) (including but not limited to secukinumab, ixekizumab, brodalumab, or ustekinumab) or has received biological therapy targeting tumor necrosis factor (TNF) (including, but not limited to adalimumab, infliximab, or etanercept) within 12 weeks or 5 half-lives, whichever is longer, of the first administration of study intervention
• Participant has received proton pump inhibitors (including but not limited to omeprazole, esomeprazole, lansoprazole, rabeprazole, pantoprazole, dexlansoprazole, or zegerid) within 1 week of first administration of study intervention

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: JNJ-77242113 Dose 1; Participants will receive JNJ-77242113 Dose 1 as delayed release tablets orally once daily from Week 0 through Week 16.	Drug: JNJ-77242113; JNJ-77242113 will be administered orally as delayed release tablets.; Other Names: PN-21235,; PN-235
Experimental: Group 2: JNJ-77242113 Dose 2; Participants will receive JNJ-77242113 Dose 2 as delayed release tablets orally once daily from Week 0 through Week 16.	Drug: JNJ-77242113; JNJ-77242113 will be administered orally as delayed release tablets.; Other Names: PN-21235,; PN-235
Placebo Comparator: Group 3: Placebo; Participants will receive oral dose of matching placebo once daily from Week 0 through Week 16.	Drug: Placebo; Matching placebo will be administered orally as delayed release tablets.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentages of Participants Who Achieved at Least 75 Percent (%) Improvement From Baseline in Psoriasis Area and Severity Index (PASI 75) Score at Week 16	Percentage of participants who achieved PASI-75 score (greater than or equal to [>=] 75% improvement from baseline in PASI) at Week 16 were reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.	Baseline (Week 0), Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in PASI Total Score at Week 16	Change from baseline in PASI total score at Week 16 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.	Baseline (Week 0), Week 16
Percentages of Participants Who Achieved at Least 90% Improvement From Baseline in PASI (PASI 90) Score at Week 16	Percentage of participants who achieved PASI-90 score (>=90% improvement from baseline in PASI) at Week 16 were reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.	Baseline (Week 0), Week 16
Percentages of Participants Who Achieved 100% Improvement From Baseline in PASI (PASI 100) Score at Week 16	Percentages of participants who achieved PASI 100- score (100% improvement from baseline in PASI) at Week 16 were reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.	Baseline (Week 0), Week 16
Percentage of Participants Who Achieved an Investigator Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16	The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 point scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 millimeters (mm); 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, greater than (>)1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicated more severe disease.	Week 16
Percentages of Participants Who Achieved an IGA Score of Cleared (0) at Week 16	The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 point scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 millimeters (mm); 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, greater than (>)1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicated more severe disease.	Week 16
Percent Change From Baseline in Psoriasis-Affected Body Surface Area (BSA) at Week 16	Percent change from baseline in psoriasis-affected BSA at Week 16 was reported. BSA was commonly used measure of severity of skin disease. It was defined as the percentage of surface area of the body involved with the condition being assessed, (that is, plaque psoriasis). BSA was assessed using handprint method where the surface area of the participant's hand including the palm and all 5 digits was used as a guide to estimate 1% BSA. The baseline measurement was defined as the closest measurement taken prior to or at the time of the first study intervention administration date.	Baseline (Week 0), Week 16
Number of Participants With 1 or More Treatment-emergent Adverse Events (TEAEs)	An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAE was defined as any adverse event that occurred at or after the initial administration of study intervention. Data included all TEAEs (both serious and non-serious).	From Week 0 through Week 20
Number of Participants With Serious TEAEs	An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. A serious adverse event (SAE) is any untoward medical occurrence at any dose that: results in death, is life threatening, require inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or results in congenital anomaly/birth defect. TEAE was defined as any adverse event that occurs at or after the initial administration of study intervention.	From Week 0 through Week 20

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2022
• Primary Completion (Actual): March 23, 2023
• Study Completion (Actual): April 10, 2023

Study Registration Dates

• First Submitted: April 27, 2022
• First Submitted That Met QC Criteria: April 27, 2022
• First Posted (Actual): May 3, 2022

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: May 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Psoriasis
• Other Study ID Numbers: CR109193; 2021-005987-23 (EudraCT Number); 77242113PSO2003 (Other Identifier: Janssen Research & Development, LLC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No