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

Plaque Psoriasis Clinical Trial

— SUMMIT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05357755
• Other study ID #: CR109193
• Secondary ID: 2021-005987-2377
• Status: Completed
• Phase: Phase 2
• Start date: June 13, 2022
• Est. completion date: April 10, 2023

Study information

• Verified date: April 2024
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: April 10, 2023
• Est. primary completion date: March 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• JNJ-77242113
JNJ-77242113 will be administered orally as delayed release tablets.
• Placebo
Matching placebo will be administered orally as delayed release tablets.

Locations

Country	Name	City	State
Canada	Dermatology Research Institute Inc.	Calgary	Alberta
Canada	The Guenther Dermatology Research Centre	London	Ontario
Canada	Lynderm Research Inc.	Markham	Ontario
Canada	DermEdge Research	Mississauga	Ontario
Canada	Toronto Research Centre	Toronto	Ontario
France	CHRU Brest - Hopital Morvan	Brest
France	CHU de Grenoble Hopital Albert Michallon	La Tronche
France	CHU de Nice Hopital de l Archet	Nice
France	Polyclinique de Courlancy	Reims
Germany	Hautarztpraxis	Bramsche
Germany	Universitatsklinikum Carl Gustav Carus Dresden	Dresden
Germany	Privatpraxis Dr. Hilton & Partner	Dusseldorf
Germany	Universitatsklinikum Frankfurt	Frankfurt am Main
Germany	Universitatsklinikum Schleswig Holstein Campus Lubeck	Lübeck
Germany	Universitatsklinikum Munster	Münster
Germany	Universitaetsmedizin Rostock	Rostock
Poland	Specderm Poznanska sp j	Bialystok
Poland	Specjalistyczny gabinet dermatologiczny Aplikacyjno Badawczy Marek Brzewski Pawel Brzewski Spolka Cywilna	Krakow
Poland	Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna	Lodz
Spain	Hosp. Univ. de Cruces	Barakaldo
Spain	Hosp. Univ. San Cecilio	Granada
Spain	Hosp. Virgen Macarena	Sevilla
United States	Arlington Center for Dermatology	Arlington	Texas
United States	ActivMed Practices and Research	Beverly	Massachusetts
United States	Stoll Dermatology	Beverly Hills	California
United States	Windsor Dermatology, PC	East Windsor	New Jersey
United States	The Pennsylvania Centre for Dermatology, LLC	Exton	Pennsylvania
United States	Dermatology Specialists	Louisville	Kentucky
United States	Unity Clinical Research	Oklahoma City	Oklahoma
United States	Epiphany Dermatology of Kansas, LLC	Overland Park	Kansas
United States	ActivMed Practices and Research	Portsmouth	New Hampshire
United States	Health Concepts	Rapid City	South Dakota
United States	Lawrence J Green MD LLC	Rockville	Maryland
United States	Northshore University Healthsystem	Skokie	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Canada,  France,  Germany,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Score at Week 16	Percentage of participants achieving PASI 75 score (greater than or equal to [>=] 75 percentage [%] improvement from baseline in PASI) at Week 16 will be reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: head, trunk, upper, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease.	Week 16
Secondary	Number of Participants with Adverse Events (AEs)	An adverse event is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the intervention.	Up to Week 24
Secondary	Number of Participants with Serious Adverse Events (SAEs)	SAE is an adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.	Up to Week 24
Secondary	Change from Baseline in PASI Total Score at Week 16	Change from baseline in PASI total score at Week 16 will be reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: head, trunk, upper, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease.	Baseline and Week 16
Secondary	Percentage of Participants Achieving PASI 90 Score at Week 16	Percentage of participants achieving PASI 90 score (>=90% improvement from baseline in PASI) at Week 16 will be reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: head, trunk, upper, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease.	Week 16
Secondary	Percentage of Participants Achieving PASI 100 Score at Week 16	Percentage of participants achieving PASI 100 score (100% improvement from baseline in PASI) at Week 16 will be reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: head, trunk, upper, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease.	Week 16
Secondary	Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16	Percentage of participants achieving an IGA score of cleared (0) or minimal (1) at Week 16 will be reported. The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).	Week 16
Secondary	Percentage of Participants Achieving an IGA Score of Cleared (0) at Week 16	Percentage of participants achieving an IGA score of cleared (0) at Week 16 will be reported. The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).	Week 16
Secondary	Change from Baseline in Body Surface Area (BSA) at Week 16	Change from baseline in BSA at Week 16 will be reported. BSA is a commonly used measure of extent of skin disease. It is defined as the percentage of surface area of the body involved with the condition being assessed (that is, plaque psoriasis).	Baseline and Week 16