Clinical trial NCT05357755: A Study of JNJ-77242113 for the Treatment of Moderate-to-Severe Plaque Psoriasis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Plaque Psoriasis
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2022-05-03
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Score at Week 16
timeFrame: Week 16
Secondary outcomes:
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to Week 24
measure: Number of Participants with Serious Adverse Events (SAEs)
timeFrame: Up to Week 24
measure: Change from Baseline in PASI Total Score at Week 16
timeFrame: Baseline and Week 16
measure: Percentage of Participants Achieving PASI 90 Score at Week 16
timeFrame: Week 16
measure: Percentage of Participants Achieving PASI 100 Score at Week 16
timeFrame: Week 16
measure: Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16
timeFrame: Week 16
measure: Percentage of Participants Achieving an IGA Score of Cleared (0) at Week 16
timeFrame: Week 16
measure: Change from Baseline in Body Surface Area (BSA) at Week 16
timeFrame: Baseline and Week 16
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Stoll Dermatology
state: California
city: Skokie
country: United States
facility: Northshore University Healthsystem
state: Illinois
city: Overland Park
country: United States
facility: Epiphany Dermatology of Kansas, LLC
state: Kansas
city: Louisville
country: United States
facility: Dermatology Specialists
state: Kentucky
city: Rockville
country: United States
facility: Lawrence J Green MD LLC
state: Maryland
city: Beverly
country: United States
facility: ActivMed Practices and Research
state: Massachusetts
city: Portsmouth
country: United States
facility: ActivMed Practices and Research
state: New Hampshire
city: East Windsor
country: United States
facility: Windsor Dermatology, PC
state: New Jersey
city: Oklahoma City
country: United States
facility: Unity Clinical Research
state: Oklahoma
city: Exton
country: United States
facility: The Pennsylvania Centre for Dermatology, LLC
state: Pennsylvania
city: Rapid City
country: United States
facility: Health Concepts
state: South Dakota
city: Arlington
country: United States
facility: Arlington Center for Dermatology
state: Texas
city: Calgary
country: Canada
facility: Dermatology Research Institute Inc
state: Alberta
city: London
country: Canada
facility: The Guenther Dermatology Research Centre
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research Inc.
state: Ontario
city: Mississauga
country: Canada
facility: DermEdge Research
state: Ontario
city: Toronto
country: Canada
facility: Toronto Research Centre
state: Ontario
city: Brest
country: France
facility: CHRU Brest - Hopital Morvan
city: La Tronche
country: France
facility: CHU de Grenoble Hopital Albert Michallon
city: Nice
country: France
facility: CHU de Nice Hopital de l Archet
city: Reims
country: France
facility: Polyclinique de Courlancy
city: Bramsche
country: Germany
facility: Hautarztpraxis
city: Dresden
country: Germany
facility: Universitatsklinikum Carl Gustav Carus Dresden
city: Dusseldorf
country: Germany
facility: Privatpraxis Dr. Hilton & Partner
city: Frankfurt am Main
country: Germany
facility: Universitatsklinikum Frankfurt
city: Lübeck
country: Germany
facility: Universitatsklinikum Schleswig Holstein Campus Lubeck
city: Münster
country: Germany
facility: Universitatsklinikum Munster
city: Rostock
country: Germany
facility: Universitaetsmedizin Rostock
city: Bialystok
country: Poland
facility: Specderm Poznanska sp j
city: Krakow
country: Poland
facility: Specjalistyczny gabinet dermatologiczny Aplikacyjno Badawczy Marek Brzewski Pawel Brzewski Spolka Cywilna
city: Lodz
country: Poland
facility: Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna
city: Barakaldo
country: Spain
facility: Hosp. Univ. de Cruces
city: Granada
country: Spain
facility: Hosp. Univ. San Cecilio
city: Sevilla
country: Spain
facility: Hosp. Virgen Macarena
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: