Clinical trial NCT05223868: A Study of JNJ-77242113 in Participants With Moderate-to-severe Plaque Psoriasis
Official title: A Phase 2b Multicenter, Randomized, Placebo Controlled, Dose-ranging Study to Evaluate the Efficacy and Safety 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: 2022-02-04
Enrollment: 255
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Th purpose of the study is to evaluate the dose response of JNJ-77242113 in efficacy at Week 16 in participants with moderate-to-severe plaque psoriasis.

Detailed description: The populations of people living with moderate to severe psoriasis is approximately 3.5 billion which 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 (PsA) and this study evaluates JNJ-77242113 as options of advanced therapies in moderate to severe plaque psoriasis. 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 treatment period, and a 4-week safety follow-up period. Safety will be assessed by adverse events (AEs), clinical safety laboratory assessments, electrocardiograms (ECGs), vital signs and physical examinations.

Eligibility criteria: Inclusion Criteria:

* Participant has a diagnosis of plaque psoriasis, with or without psoriatic arthritis (PsA), for at least 6 months prior to the first administration of study intervention
* Participant be a candidate for phototherapy or systemic treatment for plaque psoriasis
* Participant has a total body surface area (BSA) greater than or equal to (\>=)10 percent (%) at screening and baseline
* Participant has a total Psoriasis area and severity index (PASI) \>=12 at screening and baseline
* Participant has a total Investigator global assessment (IGA) \>=3 at screening and baseline

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 receptor (IL-23R) (including but not limited to guselkumab, tildrakizumab, or risankizumab)
* Participant has received any therapeutic agent directly targeted to interleukin 17 receptor (IL-17) or interleukin 12/23 receptor (IL-12/23) (including but not limited to secukinumab, ixekizumab, brodalumab, or ustekinumab) or has received anti-tumor necrosis factor \[TNF\]-alpha biologic therapy (including, but not limited to adalimumab) within 12 weeks or 5 half-lives, whichever is longer, of the first administration of study intervention
* Participant has received agents that deplete B cells (including, but not limited to, rituximab, or alemtuzumab) within 26 weeks of the 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: Change from Baseline in PASI Total Score at Week 16
timeFrame: From baseline to 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: From baseline to Week 16
measure: Change from Baseline in Psoriasis Symptoms and Signs Diary (PSSD) Symptoms Scores at Week 16
timeFrame: From baseline to Week 16
measure: Change from Baseline in PSSD Signs Score at Week 16
timeFrame: From baseline to Week 16
measure: Percentage of Participants Achieving PSSD Symptoms Score=0 at Week 16 in Participants with a Baseline Symptoms Score >=1
timeFrame: Week 16
measure: Percentage of Participants Achieving PSSD Sign Score=0 at Week 16 in Participants with a Baseline Sign Score >=1
timeFrame: Week 16
measure: Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) of 0 or 1 at Week 16 in Participants with Baseline DLQI Score >1
timeFrame: Week 16
measure: Change from Baseline in Patient-reported Outcomes Measurement Information System (PROMIS-29) Domain Score at Week 16
timeFrame: From baseline to Week 16
measure: Percentage of Participants Who Achieve >= 5-Point Improvement from Baseline in PROMIS-29 Domain Score at Week 16
timeFrame: Week 16
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to 24 weeks
measure: Number of Participants with Serious Adverse Events (SAEs)
timeFrame: Up to 24 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Medical Dermatology Specialists
state: Arizona
city: Sacramento
country: United States
facility: Pacific Skin Institute
state: California
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Tampa
country: United States
facility: Forcare Clinical Research Inc
state: Florida
city: Alpharetta
country: United States
facility: Atlanta Dermatology, Vein & Research Center
state: Georgia
city: Rolling Meadows
country: United States
facility: Arlington Dermatology
state: Illinois
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group LLC
state: Indiana
city: Plainfield
country: United States
facility: Indiana Clinical Trial Center
state: Indiana
city: Rockville
country: United States
facility: DermAssociates, PC
state: Maryland
city: Fort Gratiot
country: United States
facility: Hamzavi Dermatology
state: Michigan
city: Las Vegas
country: United States
facility: Vivida Dermatology
state: Nevada
city: East Windsor
country: United States
facility: Windsor Dermatology, PC
state: New Jersey
city: Portland
country: United States
facility: Oregon Dermatology and Research Center
state: Oregon
city: Pittsburgh
country: United States
facility: University of Pittsburgh Department of Dermatology
state: Pennsylvania
city: Dallas
country: United States
facility: Modern Research Associates
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies
state: Texas
city: Pflugerville
country: United States
facility: Austin Institute for Clinical Research
state: Texas
city: Webster
country: United States
facility: Center for Clinical Studies
state: Texas
city: Norfolk
country: United States
facility: Virginia Clinical Research
state: Virginia
city: Seattle
country: United States
facility: Dermatology Associates
state: Washington
city: Spokane
country: United States
facility: Premier Clinical Research
state: Washington
city: Hamilton
country: Canada
facility: Dermatrials Research
state: Ontario
city: Waterloo
country: Canada
facility: Alliance Clinical Trials
state: Ontario
city: Windsor
country: Canada
facility: XLR8 Medical Research
state: Ontario
city: Montreal
country: Canada
facility: Innovaderm Research
state: Quebec
city: Le Mans
country: France
facility: Centre Hospitalier Le Mans
city: Rouen
country: France
facility: Hopital Charles Nicolle
city: Toulon
country: France
facility: HIA Sainte Anne
city: Bad Bentheim
country: Germany
facility: Fachklinik Bad Bentheim
city: Berlin
country: Germany
facility: Charite - Universitaetsmedizin Berlin (CCM)
city: Berlin
country: Germany
facility: Rothhaar Studien GmbH
city: Berlin
country: Germany
facility: ISA - Interdisciplinary Study Association GmbH
city: Bochum
country: Germany
facility: Niesmann & Othlinghaus GbR
city: Darmstadt
country: Germany
facility: Rosenpark Research GmbH
city: Frankfurt am Main
country: Germany
facility: Universitatsklinikum Frankfurt
city: Friedrichshafen
country: Germany
facility: Derma-Study-Center Friedrichshafen GmbH
city: Hamburg
country: Germany
facility: MensingDerma research GmbH
city: Heidelberg
country: Germany
facility: Universitaetsklinikum Heidelberg
city: Kiel
country: Germany
facility: Universitatsklinikum Schleswig Holstein Kiel
city: Leipzig
country: Germany
facility: Universitatsklinikum Leipzig AOR
city: Mahlow
country: Germany
facility: Dermatologische Gemeinschaftspraxis
city: Witten
country: Germany
facility: Hautarztpraxis
city: Kofu
country: Japan
facility: Yamanashi Prefectural Central Hospital
city: Matsudo
country: Japan
facility: Miyata Dermatology Clinic
city: Obihiro-shi
country: Japan
facility: Takagi Dermatological Clinic
city: Sakai City
country: Japan
facility: Kume Clinic
city: Sapporo
country: Japan
facility: Sapporo Skin Clinic
city: Shizuoka
country: Japan
facility: Shizuoka General Hospital
city: Takaoka
country: Japan
facility: Shirasaki Dermatology Clinic
city: Tamana
country: Japan
facility: Kumamoto Kenhoku Hospital
city: Toyama
country: Japan
facility: Toyama Prefectural Central Hospital
city: Yokohama
country: Japan
facility: Nomura Dermatology Clinic
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
city: Seoul
country: Korea, Republic of
facility: KyungHee University Hospital
city: Bialystok
country: Poland
facility: Nzoz Zdrowie Osteo-Medic
city: Lodz
country: Poland
facility: Dermed Centrum Medyczne Sp z o o
city: Osielsko
country: Poland
facility: Dermodent Centrum Medyczne Aldona Czajkowska Rafal Czajkowski S C
city: Warsaw
country: Poland
facility: Klinika Ambroziak Estederm Sp. z o.o
city: Wroclaw
country: Poland
facility: Wro Medica
city: Barcelona
country: Spain
facility: Hosp. Univ. Germans Trias I Pujol
city: Madrid
country: Spain
facility: Hosp. Univ. 12 de Octubre
city: Pontevedra
country: Spain
facility: Hosp. Provincial de Pontevedra
city: Valencia
country: Spain
facility: Hosp. Univ. I Politecni La Fe
city: Valencia
country: Spain
facility: Hosp. de Manises
city: Kaohsiung
country: Taiwan
facility: Chang Gung Memorial Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
city: Taoyuan
country: Taiwan
facility: Chang-Gung Memorial Hospital, LinKou Branch
city: Cottingham
country: United Kingdom
facility: Castle Hill Hospital
city: Dudley
country: United Kingdom
facility: Russell's Hall Hospital
city: London
country: United Kingdom
facility: Guys and St Thomas NHS Foundation Trust
city: Southampton
country: United Kingdom
facility: University Hospital Southampton NHS Foundation Trust
city: Wakefield
country: United Kingdom
facility: Mid Yorkshire Hospital NHS Trust- Pinderfields Hospital
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: