Clinical trial NCT05364554: A Long-term Extension Study of JNJ-77242113 in Participants With Moderate-to-Severe Plaque Psoriasis
Official title: A Phase 2b Multicenter, Long-Term Extension, 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: 2022-05-06
Enrollment: 227
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate long-term clinical response of JNJ-77242113 treatment 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 this study evaluates JNJ-77242113 as options of advanced therapies in moderate to severe plaque psoriasis. This is a long-term extension study of JNJ-77242113 in eligible participants who have completed the Week 16 visit of the originating Study 77242113PSO2001. The total duration of this study will be up to 40 weeks which will include a 36-week treatment period, and a 4-week safety follow-up period after the last study intervention administration. Safety will be assessed by adverse events (AEs), clinical safety laboratory assessments, electrocardiograms (ECGs), vital signs and physical examinations.

Eligibility criteria: Inclusion Criteria:

* Must have completed the Week 16 visit in Protocol 77242113PSO2001
* In the opinion of the investigator, may benefit from inclusion in this long term extension (LTE) study
* Must agree to avoid prolonged sun exposure and avoid use of tanning booths or other ultraviolet light sources during the study
* Must agree to discontinue all topical therapies that could affect psoriasis or the psoriasis area severity index (PASI) or investigator's global assessment (IGA) evaluation, other than nonmedicated emollient and salicylic acid shampoos, prior to first administration of study intervention
* Agree not to receive a live virus or live bacterial vaccination during the study, or within 4 weeks after the last administration of study intervention

Exclusion Criteria:

* Was permanently discontinued from study intervention in Protocol 77242113PSO2001 for any reason
* Has received any biologic therapy or experimental therapy since completion of the originating study, 77242113PSO2001
* Has received any live virus or bacterial vaccination within 12 weeks before the first administration of study intervention
* Has received the bacille Calmette-Guerin (BCG) vaccine within 12 months of the first administration of study intervention
* Currently has hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or has other clinically active liver disease, or tests positive for HBsAg or anti-HCV

Primary outcomes:
measure: Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Score at Week 36
timeFrame: Week 36
Secondary outcomes:
measure: Percentage of Participants Achieving PASI 90 Score at Week 36
timeFrame: Week 36
measure: Percentage of Participants Achieving PASI 100 Score at Week 36
timeFrame: Week 36
measure: Change From Baseline in PASI Total Score at Week 36
timeFrame: Baseline and Week 36
measure: Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 36
timeFrame: Week 36
measure: Change from Baseline in Psoriasis Symptoms and Signs Diary (PSSD) Symptoms Scores at Week 36
timeFrame: Baseline and Week 36
measure: Change from Baseline in PSSD Signs Score at Week 36
timeFrame: Baseline and Week 36
measure: Percentage of Participants Achieving PSSD Symptoms Score=0 at Week 36 Among Participants With a Baseline (in the Originating Study) Symptoms Score >=1
timeFrame: Week 36
measure: Percentage of Participants Achieving PSSD Signs Score=0 at Week 36 Among Participants With a Baseline (in the Originating Study) Signs Score >=1
timeFrame: Week 36
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to Week 40
measure: Number of Participants with Serious Adverse Events (SAEs)
timeFrame: Up to Week 40
Other outcomes:
Locations:
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: Rolling Meadows
country: United States
facility: Arlington Dermatology
state: Illinois
city: Plainfield
country: United States
facility: Indiana Clinical Trial Center
state: Indiana
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: Webster
country: United States
facility: Center for Clinical Studies
state: Texas
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 Inc.
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: ISA - Interdisciplinary Study Association GmbH
city: Berlin
country: Germany
facility: CRS Clinical Research Services Berlin 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: Mahlow
country: Germany
facility: Gemeinschaftspraxis Scholz/Sebastian/Schilling
city: Witten
country: Germany
facility: Hautarztpraxis
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: 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: Warszawa
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: 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: London
country: United Kingdom
facility: Guys and St Thomas NHS Foundation Trust
city: Southampton
country: United Kingdom
facility: University Hospital Southampton NHS Foundation Trust
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: