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A Study of JNJ-77242113 in Participants With Moderate-to-severe Plaque Psoriasis (FRONTIER 1)

Primary Purpose

Plaque Psoriasis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
JNJ-77242113
Placebo
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plaque Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical Dermatology Specialists
  • Pacific Skin Institute
  • Renstar Medical Research
  • Forcare Clinical Research, Inc.
  • Atlanta Dermatology, Vein & Research Center
  • Arlington Dermatology
  • Dawes Fretzin Clinical Research Group, LLC
  • Indiana Clinical Trial Center
  • DermAssociates, PC
  • Hamzavi Dermatology
  • Vivida Dermatology
  • Windsor Dermatology, PC
  • Oregon Dermatology and Research Center
  • University of Pittsburgh Department of Dermatology
  • Modern Research Associates
  • Center for Clinical Studies
  • Austin Institute for Clinical Research
  • Center for Clinical Studies
  • Virginia Clinical Research
  • Dermatology Associates
  • Premier Clinical Research
  • Dermatrials Research
  • K. Papp Clinical Research
  • XLR8 Medical Research
  • Innovaderm Research
  • Centre Hospitalier Le Mans
  • Hopital Charles Nicolle
  • HIA Sainte Anne
  • Fachklinik Bad Bentheim
  • Charite - Universitatsmedizin Berlin (CCM)
  • Rothhaar Studien GmbH
  • ISA - Interdisciplinary Study Association GmbH
  • Niesmann & Othlinghaus GbR
  • Rosenpark Research GmbH
  • Universitatsklinikum Frankfurt
  • Derma-Study-Center Friedrichshafen GmbH
  • MensingDerma research GmbH
  • Universitätsklinikum Heidelberg
  • Universitatsklinikum Schleswig-Holstein - Kiel
  • Universitätsklinikum Leipzig AÖR
  • Dermatologische Gemeinschaftspraxis
  • Hautarztpraxis
  • Yamanashi Prefectural Central Hospital
  • Miyata Dermatology Clinic
  • Takagi Dermatology Clinic
  • Kume Clinic
  • Sapporo Skin Clinic
  • Shizuoka Prefectural General Hospital
  • Shirasaki Dermatology Clinic
  • Kumamoto Kenhoku Hospital
  • Toyama Prefectural Central Hospital
  • Nomura Dermatology Clinic
  • Pusan National University Hospital
  • Seoul National University Bundang Hospital
  • Seoul National University Hospital
  • Konkuk University Medical Center
  • KyungHee University Hospital
  • Nzoz Zdrowie Osteo-Medic
  • Dermed Centrum Medyczne Sp. z o.o
  • DermoDent Centrum Medyczne Aldona Czajkowska Rafał Czajkowski s.c.
  • Klinika Ambroziak Estederm Sp. z o.o
  • Wromedica
  • Hosp. Univ. Germans Trias I Pujol
  • Hosp. Univ. 12 de Octubre
  • Hosp. Provincial de Pontevedra
  • Hosp. Univ. I Politecni La Fe
  • Hosp. de Manises
  • Chang Gung Memorial Hospital
  • National Cheng Kung University Hospital
  • National Taiwan University Hospital
  • Chang-Gung Memorial Hospital, LinKou Branch
  • Castle Hill Hospital
  • Russell's Hall Hospital
  • Guy's and St Thomas' NHS Foundation Trust
  • University Hospital Southampton NHS Foundation Trust
  • Mid Yorkshire Hospital NHS Trust- Pinderfields Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Group 1: JNJ-77242113 Dose 1 Once Daily (QD) and Placebo

Group 2: JNJ-77242113 Dose 2 QD and Placebo

Group 3: JNJ-77242113 Dose 3 QD and Placebo

Group 4: JNJ-77242113 Dose 1 Twice Daily (BID) and Placebo

Group 5: JNJ-77242113 Dose 3 BID and Placebo

Group 6: Placebo

Arm Description

Participants will receive JNJ-77242113 Dose 1 QD and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens.

Participants will receive JNJ-77242113 Dose 2 QD and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens.

Participants will receive JNJ-77242113 Dose 3 QD and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens.

Participants will receive JNJ-77242113 Dose 1 BID and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens.

Participants will receive JNJ-77242113 Dose 3 BID and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens.

Participants will receive placebo BID from Week 0 through Week 16.

Outcomes

Primary Outcome Measures

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: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed and scored separately for erythema, induration, and scaling, which are each rated on a scale of 0 to 4 and extent of involvement on a scale of 0 to 6. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease.

Secondary Outcome Measures

Change from Baseline in PASI Total Score at Week 16
Change from baseline in PASI total score at Week 16 will be reported.
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.
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.
Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16
Percentage of participants who achieve 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).
Percentage of Participants Achieving an IGA Score of Cleared (0) at Week 16
Percentage of participants who achieve an IGA score of cleared (0) at Week 16 will be reported.
Change from Baseline in Body Surface Area (BSA) at Week 16
Change from baseline in BSA at Week 16 will be reported. Body Surface Area is a commonly used measure of severity 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).
Change from Baseline in Psoriasis Symptoms and Signs Diary (PSSD) Symptoms Scores at Week 16
Change from baseline in PSSD symptoms scores at Week 16 will be reported. The PSSD includes patient-reported outcome (PRO) questionnaire designed to measure the severity of psoriasis symptoms and signs over the previous 7 days for the assessment of treatment benefit. The PSSD is a self-administered PRO instrument that includes 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 to 10 numerical rating scales for severity. Two subscores will be derived each ranging from 0 to 100: the psoriasis symptom score and the psoriasis sign score. A higher score indicates more severe disease.
Change from Baseline in PSSD Signs Score at Week 16
Change from baseline in PSSD signs score at Week 16 will be reported.
Percentage of Participants Achieving PSSD Symptoms Score=0 at Week 16 in Participants with a Baseline Symptoms Score >=1
Percentage of participants achieving PSSD symptoms score=0 at Week 16 in participants with a baseline symptoms score >=1 will be reported.
Percentage of Participants Achieving PSSD Sign Score=0 at Week 16 in Participants with a Baseline Sign Score >=1
Percentage of participants achieving PSSD sign score=0 at Week 16 in participants with a baseline sign score >=1 will be reported.
Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) of 0 or 1 at Week 16 in Participants with Baseline DLQI Score >1
The DLQI is a dermatology-specific health-related quality of life (HRQoL) instrument designed to assess the impact of the disease on a participant's HRQoL. It is a 10-item questionnaire that assesses HRQoL over the past 7 days and in addition to evaluating overall HRQoL, can be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. The total score ranges from 0 to 30 with a higher score indicating greater impact on HRQoL.
Change from Baseline in Patient-reported Outcomes Measurement Information System (PROMIS-29) Domain Score at Week 16
Change from baseline in PROMIS-29 domain scores at week 16 will be reported. The PROMIS-29 is a 29-item generic HRQoL instrument assessing 7 PROMIS domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles and activities) with 4 questions for each domain. These questions are ranked on a 5-point Likert scale. There is also a numerical rating scale that ranges from 0 (No pain) to 10 (Worst pain imaginable) for pain intensity. The raw domain scores are converted to standardized T-scores with a mean of 50 and a standard deviation of 10. Higher scores on anxiety, depression, fatigue, sleep disturbance, and pain interference indicate more severe symptoms. Higher scores on physical function and social participation indicate better health outcomes.
Percentage of Participants Who Achieve >= 5-Point Improvement from Baseline in PROMIS-29 Domain Score at Week 16
Percentage of participants who achieve >=5-point improvement from baseline in PROMIS-29 domain score at Week 16 will be reported.
Number of Participants with Adverse Events (AEs)
An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
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.

Full Information

First Posted
January 24, 2022
Last Updated
January 17, 2023
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05223868
Brief Title
A Study of JNJ-77242113 in Participants With Moderate-to-severe Plaque Psoriasis
Acronym
FRONTIER 1
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
February 3, 2022 (Actual)
Primary Completion Date
December 15, 2022 (Actual)
Study Completion Date
December 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
255 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1: JNJ-77242113 Dose 1 Once Daily (QD) and Placebo
Arm Type
Experimental
Arm Description
Participants will receive JNJ-77242113 Dose 1 QD and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens.
Arm Title
Group 2: JNJ-77242113 Dose 2 QD and Placebo
Arm Type
Experimental
Arm Description
Participants will receive JNJ-77242113 Dose 2 QD and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens.
Arm Title
Group 3: JNJ-77242113 Dose 3 QD and Placebo
Arm Type
Experimental
Arm Description
Participants will receive JNJ-77242113 Dose 3 QD and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens.
Arm Title
Group 4: JNJ-77242113 Dose 1 Twice Daily (BID) and Placebo
Arm Type
Experimental
Arm Description
Participants will receive JNJ-77242113 Dose 1 BID and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens.
Arm Title
Group 5: JNJ-77242113 Dose 3 BID and Placebo
Arm Type
Experimental
Arm Description
Participants will receive JNJ-77242113 Dose 3 BID and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens.
Arm Title
Group 6: Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo BID from Week 0 through Week 16.
Intervention Type
Drug
Intervention Name(s)
JNJ-77242113
Intervention Description
JNJ-77242113 tablet will be administered orally.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablet will be administered orally.
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Score at Week 16
Description
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: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed and scored separately for erythema, induration, and scaling, which are each rated on a scale of 0 to 4 and extent of involvement on a scale of 0 to 6. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease.
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
Change from Baseline in PASI Total Score at Week 16
Description
Change from baseline in PASI total score at Week 16 will be reported.
Time Frame
From baseline to Week 16
Title
Percentage of Participants Achieving PASI 90 Score at Week 16
Description
Percentage of participants achieving PASI 90 score (>=90% improvement from baseline in PASI) at Week 16 will be reported.
Time Frame
Week 16
Title
Percentage of Participants Achieving PASI 100 Score at Week 16
Description
Percentage of participants achieving PASI 100 score (100% improvement from baseline in PASI) at Week 16 will be reported.
Time Frame
Week 16
Title
Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16
Description
Percentage of participants who achieve 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).
Time Frame
Week 16
Title
Percentage of Participants Achieving an IGA Score of Cleared (0) at Week 16
Description
Percentage of participants who achieve an IGA score of cleared (0) at Week 16 will be reported.
Time Frame
Week 16
Title
Change from Baseline in Body Surface Area (BSA) at Week 16
Description
Change from baseline in BSA at Week 16 will be reported. Body Surface Area is a commonly used measure of severity 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).
Time Frame
From baseline to Week 16
Title
Change from Baseline in Psoriasis Symptoms and Signs Diary (PSSD) Symptoms Scores at Week 16
Description
Change from baseline in PSSD symptoms scores at Week 16 will be reported. The PSSD includes patient-reported outcome (PRO) questionnaire designed to measure the severity of psoriasis symptoms and signs over the previous 7 days for the assessment of treatment benefit. The PSSD is a self-administered PRO instrument that includes 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 to 10 numerical rating scales for severity. Two subscores will be derived each ranging from 0 to 100: the psoriasis symptom score and the psoriasis sign score. A higher score indicates more severe disease.
Time Frame
From baseline to Week 16
Title
Change from Baseline in PSSD Signs Score at Week 16
Description
Change from baseline in PSSD signs score at Week 16 will be reported.
Time Frame
From baseline to Week 16
Title
Percentage of Participants Achieving PSSD Symptoms Score=0 at Week 16 in Participants with a Baseline Symptoms Score >=1
Description
Percentage of participants achieving PSSD symptoms score=0 at Week 16 in participants with a baseline symptoms score >=1 will be reported.
Time Frame
Week 16
Title
Percentage of Participants Achieving PSSD Sign Score=0 at Week 16 in Participants with a Baseline Sign Score >=1
Description
Percentage of participants achieving PSSD sign score=0 at Week 16 in participants with a baseline sign score >=1 will be reported.
Time Frame
Week 16
Title
Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) of 0 or 1 at Week 16 in Participants with Baseline DLQI Score >1
Description
The DLQI is a dermatology-specific health-related quality of life (HRQoL) instrument designed to assess the impact of the disease on a participant's HRQoL. It is a 10-item questionnaire that assesses HRQoL over the past 7 days and in addition to evaluating overall HRQoL, can be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. The total score ranges from 0 to 30 with a higher score indicating greater impact on HRQoL.
Time Frame
Week 16
Title
Change from Baseline in Patient-reported Outcomes Measurement Information System (PROMIS-29) Domain Score at Week 16
Description
Change from baseline in PROMIS-29 domain scores at week 16 will be reported. The PROMIS-29 is a 29-item generic HRQoL instrument assessing 7 PROMIS domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles and activities) with 4 questions for each domain. These questions are ranked on a 5-point Likert scale. There is also a numerical rating scale that ranges from 0 (No pain) to 10 (Worst pain imaginable) for pain intensity. The raw domain scores are converted to standardized T-scores with a mean of 50 and a standard deviation of 10. Higher scores on anxiety, depression, fatigue, sleep disturbance, and pain interference indicate more severe symptoms. Higher scores on physical function and social participation indicate better health outcomes.
Time Frame
From baseline to Week 16
Title
Percentage of Participants Who Achieve >= 5-Point Improvement from Baseline in PROMIS-29 Domain Score at Week 16
Description
Percentage of participants who achieve >=5-point improvement from baseline in PROMIS-29 domain score at Week 16 will be reported.
Time Frame
Week 16
Title
Number of Participants with Adverse Events (AEs)
Description
An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Time Frame
Up to 24 weeks
Title
Number of Participants with Serious Adverse Events (SAEs)
Description
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.
Time Frame
Up to 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Medical Dermatology Specialists
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Pacific Skin Institute
City
Sacramento
State/Province
California
ZIP/Postal Code
95815
Country
United States
Facility Name
Renstar Medical Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34470
Country
United States
Facility Name
Forcare Clinical Research, Inc.
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Atlanta Dermatology, Vein & Research Center
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30022
Country
United States
Facility Name
Arlington Dermatology
City
Rolling Meadows
State/Province
Illinois
ZIP/Postal Code
60008
Country
United States
Facility Name
Dawes Fretzin Clinical Research Group, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
Indiana Clinical Trial Center
City
Plainfield
State/Province
Indiana
ZIP/Postal Code
46168
Country
United States
Facility Name
DermAssociates, PC
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Hamzavi Dermatology
City
Fort Gratiot
State/Province
Michigan
ZIP/Postal Code
48059
Country
United States
Facility Name
Vivida Dermatology
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Windsor Dermatology, PC
City
East Windsor
State/Province
New Jersey
ZIP/Postal Code
08520
Country
United States
Facility Name
Oregon Dermatology and Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
University of Pittsburgh Department of Dermatology
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Modern Research Associates
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Center for Clinical Studies
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Austin Institute for Clinical Research
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Facility Name
Center for Clinical Studies
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
Virginia Clinical Research
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Dermatology Associates
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Premier Clinical Research
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Dermatrials Research
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 1Y2
Country
Canada
Facility Name
K. Papp Clinical Research
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada
Facility Name
XLR8 Medical Research
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 1E6
Country
Canada
Facility Name
Innovaderm Research
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 2V1
Country
Canada
Facility Name
Centre Hospitalier Le Mans
City
Le Mans
ZIP/Postal Code
72037
Country
France
Facility Name
Hopital Charles Nicolle
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
HIA Sainte Anne
City
Toulon
ZIP/Postal Code
83800
Country
France
Facility Name
Fachklinik Bad Bentheim
City
Bad Bentheim
ZIP/Postal Code
48455
Country
Germany
Facility Name
Charite - Universitatsmedizin Berlin (CCM)
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Rothhaar Studien GmbH
City
Berlin
ZIP/Postal Code
10783
Country
Germany
Facility Name
ISA - Interdisciplinary Study Association GmbH
City
Berlin
ZIP/Postal Code
10789
Country
Germany
Facility Name
Niesmann & Othlinghaus GbR
City
Bochum
ZIP/Postal Code
44793
Country
Germany
Facility Name
Rosenpark Research GmbH
City
Darmstadt
ZIP/Postal Code
64283
Country
Germany
Facility Name
Universitatsklinikum Frankfurt
City
Frankfurt am Main
ZIP/Postal Code
60590
Country
Germany
Facility Name
Derma-Study-Center Friedrichshafen GmbH
City
Friedrichshafen
ZIP/Postal Code
88045
Country
Germany
Facility Name
MensingDerma research GmbH
City
Hamburg
ZIP/Postal Code
22391
Country
Germany
Facility Name
Universitätsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Universitatsklinikum Schleswig-Holstein - Kiel
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Universitätsklinikum Leipzig AÖR
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Dermatologische Gemeinschaftspraxis
City
Mahlow
ZIP/Postal Code
15831
Country
Germany
Facility Name
Hautarztpraxis
City
Witten
ZIP/Postal Code
58453
Country
Germany
Facility Name
Yamanashi Prefectural Central Hospital
City
Kofu
ZIP/Postal Code
400-8506
Country
Japan
Facility Name
Miyata Dermatology Clinic
City
Matsudo
ZIP/Postal Code
271-0092
Country
Japan
Facility Name
Takagi Dermatology Clinic
City
Obihiro-shi
ZIP/Postal Code
080-0013
Country
Japan
Facility Name
Kume Clinic
City
Osaka Fu
ZIP/Postal Code
593-8324
Country
Japan
Facility Name
Sapporo Skin Clinic
City
Sapporo
ZIP/Postal Code
060-0063
Country
Japan
Facility Name
Shizuoka Prefectural General Hospital
City
Shizuoka
ZIP/Postal Code
420-8527
Country
Japan
Facility Name
Shirasaki Dermatology Clinic
City
Takaoka
ZIP/Postal Code
933-0871
Country
Japan
Facility Name
Kumamoto Kenhoku Hospital
City
Tamana
ZIP/Postal Code
865-0005
Country
Japan
Facility Name
Toyama Prefectural Central Hospital
City
Toyama
ZIP/Postal Code
930-8550
Country
Japan
Facility Name
Nomura Dermatology Clinic
City
Yokohama
ZIP/Postal Code
221-0825
Country
Japan
Facility Name
Pusan National University Hospital
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Konkuk University Medical Center
City
Seoul
ZIP/Postal Code
05030
Country
Korea, Republic of
Facility Name
KyungHee University Hospital
City
Seoul
ZIP/Postal Code
102-1703
Country
Korea, Republic of
Facility Name
Nzoz Zdrowie Osteo-Medic
City
Bialystok
ZIP/Postal Code
15-351
Country
Poland
Facility Name
Dermed Centrum Medyczne Sp. z o.o
City
Lodz
ZIP/Postal Code
90-265
Country
Poland
Facility Name
DermoDent Centrum Medyczne Aldona Czajkowska Rafał Czajkowski s.c.
City
Osielsko
ZIP/Postal Code
86031
Country
Poland
Facility Name
Klinika Ambroziak Estederm Sp. z o.o
City
Warsaw
ZIP/Postal Code
02-953
Country
Poland
Facility Name
Wromedica
City
Wroclaw
ZIP/Postal Code
51-685
Country
Poland
Facility Name
Hosp. Univ. Germans Trias I Pujol
City
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hosp. Univ. 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hosp. Provincial de Pontevedra
City
Pontevedra
ZIP/Postal Code
36001
Country
Spain
Facility Name
Hosp. Univ. I Politecni La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Hosp. de Manises
City
Valencia
ZIP/Postal Code
46940
Country
Spain
Facility Name
Chang Gung Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
83342
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
70403
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei City
ZIP/Postal Code
10048
Country
Taiwan
Facility Name
Chang-Gung Memorial Hospital, LinKou Branch
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Castle Hill Hospital
City
Cottingham
ZIP/Postal Code
HU16 5JQ
Country
United Kingdom
Facility Name
Russell's Hall Hospital
City
Dudley
ZIP/Postal Code
DY1 2HQ
Country
United Kingdom
Facility Name
Guy's and St Thomas' NHS Foundation Trust
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
University Hospital Southampton NHS Foundation Trust
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Mid Yorkshire Hospital NHS Trust- Pinderfields Hospital
City
Wakefield
ZIP/Postal Code
WF1 4DG
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

A Study of JNJ-77242113 in Participants With Moderate-to-severe Plaque Psoriasis

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