Back to resultsStudy of Guselkumab Versus Placebo for the Treatment of Low Body Surface Area Moderate Plaque Psoriasis (SPECTREM)
Primary Purpose
Moderate Plaque Psoriasis
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Guselkumab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Moderate Plaque Psoriasis
Eligibility Criteria
Inclusion Criteria: All participants must have a diagnosis of plaque psoriasis (with or without psoriatic arthritis) for at least 6 months before first administration of study intervention All participants must meet the following disease severity criteria at screening and at baseline: (a) Overall Investigator's Global Assessment (IGA) 3 (moderate) plaque psoriasis; (b) Body Surface Area (BSA) 2-15 percent (%) with at least 1 plaque outside of special sites; (c) Involvement of at least 1 special site with at least moderate severity. Qualifying sites include scalp with scalp-specific IGA greater than or equal to (>=) 3, face with facial psoriasis IGA >=3, intertriginous with intertriginous psoriasis IGA >=3, or genital with static physician global assessment of genitalia (sPGA-G) >=3 All participants be inadequately controlled with or intolerant of at least 1 prior topical therapy (including, but not limited to, corticosteroids, retinoids, vitamin D, or vitamin D/steroid and retinoid/steroid combinations, tacrolimus, pimecrolimus, anthralin/dithranol, coal tar preparations, tapinarof, roflumilast, etcetera) for the treatment of psoriasis at both screening All participants be a candidate for phototherapy or systemic treatment for psoriasis Exclusion Criteria: Has a nonplaque form of psoriasis (example, erythrodermic, guttate, or pustular) at screening or randomization 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) For participants with palmoplantar involvement, confounding diagnoses, including, but not limited, to palmoplantar pustulosis, eczematous dermatitis, contact/irritant dermatitis, acquired keratoderma, etcetera, should be confirmed and excluded Participants will not be eligible if they have ever received prior biologic (or biosimilars of) for the treatment of psoriasis, psoriatic arthritis (PsA), or any other indications that could impact the assessment of psoriasis. Prior biologics (or biosimilars of) may include, but not limited to, tumor necrosis factor (TNF)-inhibitors (for example: adalimumab, etanercept, infliximab, or certolizumab or biosimilars), interleukin (IL)-17 inhibitors (for example: secukinumab, ixekizumab, brodalumab, or bimekizumab), and IL-12/23 inhibitors (for example: ustekinumab), or IL-23 inhibitor (for example: guselkumab, risankizumab or tildrakizumab) Has a history of chronic or recurrent infectious disease, including, but not limited to, chronic renal infection, chronic chest infection (for example, bronchiectasis), recurrent urinary tract infection (recurrent pyelonephritis or chronic non-remitting cystitis), fungal infection (mucocutaneous candidiasis), or open, draining, or infected skin wounds or ulcers
Sites / Locations
- Total Skin & Beauty Dermatology CenterRecruiting
- Cahaba Research IncRecruiting
- Miami VA Healthcare SystemRecruiting
- Metro Boston Clinical PartnersRecruiting
- Darst DermatologyRecruiting
- Piedmont Plastic Surgery and Dermatology - DenverRecruiting
- Apex Dermatology Mayfield HeightsRecruiting
- Center for Clinical StudiesRecruiting
- Suzanne Bruce and Associates - The Center for Skin ResearchRecruiting
- Texas Dermatology and Laser SpecialistsRecruiting
- Progressive Clinical ResearchRecruiting
- Dr. Chih-ho Hong MedicalRecruiting
- CCA Medical Research CorporationRecruiting
- Dermatrials ResearchRecruiting
- Toronto Research CentreRecruiting
- Manna ResearchRecruiting
- SimcoDerm Medical and Surgical Dermatology CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Group 1: Guselkumab
Group 2: Placebo
Arm Description
Participants will receive guselkumab by subcutaneous injection with placebo as needed to maintain the blind.
Participants will receive placebo by subcutaneous injection then receive guselkumab by subcutaneous injection.
Outcomes
Primary Outcome Measures
Percentage of Participants who Achieve 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 participant's psoriasis. 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).
Secondary Outcome Measures
Change From Baseline in Body Surface Area (BSA) Affected With Psoriasis at Week 16
Change from baseline in BSA affected with psoriasis at Week 16 will be reported. The BSA is a measurement of involved skin over the whole body. The overall BSA affected by psoriasis is estimated based on the participant's handprint (defined as the entire palmar surface of the hand including fingers).
Change From Baseline in Total Psoriasis Area and Severity Index (PASI) Score at Week 16
Change from baseline in PASI 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: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for erythema, induration and scaling, which are each rated on a scale of 0 to 4 that is none to maximum severity. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease.
Percentage of Participants who Achieve an Investigator's Global Assessment (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. The IGA documents the investigator's assessment of the participant's psoriasis. 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 who Achieve a PASI 90 Response at Week 16
Percentage of participants who achieve a PASI 90 response 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 separately for erythema, induration and scaling, which are each rated on a scale of 0 to 4 that is none to maximum severity. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response is defined as greater than or equal to (>=) 90 percent (%) improvement in PASI score from baseline.
Percentage of Participants who Achieve a PASI 100 Response at Week 16
Percentage of participants who achieve a PASI 100 response 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 separately for erythema, induration and scaling, which are each rated on a scale of 0 to 4 that is none to maximum severity. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 100 response is defined as 100% improvement in PASI score from baseline.
Percentage of Participants who Achieve a Scalp-Specific Investigator Global Assessment (ss-IGA) Score of Absence of Disease (0) or Very Mild Disease (1) at Week 16 Among Participants With an ss-IGA Score >=3 at Baseline
Percentage of participants who achieve a ss-IGA score of absence of disease (0) or very mild disease (1) at Week 16 among participants with an ss-IGA score >=3 at baseline will be reported. The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. Scalp lesions are graded for induration, erythema, and scaling. The participant's scalp psoriasis is assessed as absence of disease (0), very mild disease (1), mild disease (2), moderate disease (3), or severe disease (4).
Percentage of Participants who Achieve a Static Physician's Global Assessment of Genitalia (sPGA-G) Score of Clear (0) or Minimal (1) at Week 16 Among Participants With a sPGA-G Score >=3 at Baseline
Percentage of participants who achieve a sPGA-G score of clear (0) or minimal (1) at Week 16 among participants with a sPGA-G score >=3 at baseline will be reported. The sPGA-G is used to evaluate the disease severity of genital psoriasis. Severity of genital psoriasis is determined by a combination of 3 plaque characteristics: erythema, elevation, and scale. The participant's severity of genital psoriasis is assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), and very severe (5).
Percentage of Participants who Achieve an Intertriginous IGA (i-IGA) Score of Clear (0) or Minimal (1) at Week 16 Among Participants With an i-IGA Score >=3 at Baseline
Percentage of participants who achieve an i-IGA score of clear (0) or minimal (1) at Week 16 among participants with an i-IGA score >=3 at baseline will be reported. The IGA used for the full body assessment has been adapted with descriptions of disease features that are more consistent with intertriginous psoriasis presentation. The intertriginous areas affected to be scored include the axillary, sub-mammary, abdominal fold, inguinal, and intergluteal cleft/peri-anal region (distinct from genital/perineum involvement). The participant's intertriginous areas affected are assessed as clear (0), minimal (1), mild (2), moderate (3), and severe (4).
Percentage of Participants who Achieve a Facial IGA (f-IGA) Score of Clear (0) or Minimal (1) at Week 16 Among Participants With an f-IGA Score >=3 at Baseline
Percentage of participants who achieve a f-IGA score of clear (0) or minimal (1) at Week 16 among participants with an f-IGA score >=3 at baseline will be reported. The IGA used for the full body assessment will be adapted for use, but only the face will be scored. The participant's facial psoriasis is assessed as clear (0), minimal (1), mild (2), moderate (3), and severe (4).
Change From Baseline in Psoriasis Symptom and Sign Diary (PSSD) Total Symptom Score at Week 16
Change from baseline in PSSD total symptom score at Week 16 will be reported. The PSSD includes patient-reported outcome (PRO) questionnaire designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. The PSSD is a patient-reported outcome instrument that includes 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Two sub scores are derived each ranging from 0 to 100: the psoriasis symptom score and the psoriasis sign score. A higher score indicates more severe disease.
Percentage of Participants who Achieve >=4 Point Reduction (Improvement) in PSSD Itch Score From Baseline at Week 16 Among Participants With a PSSD Itch Score >=4 at Baseline
Percentage of participants who achieve >=4 point reduction (improvement) in PSSD itch score from baseline at Week 16 among participants with a PSSD itch score >=4 at baseline will be reported. The PSSD includes PRO questionnaire designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit The PSSD is a patient-reported outcome instrument that includes 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Two sub scores are derived each ranging from 0 to 100: the psoriasis symptom score and the psoriasis sign score. A higher score indicates more severe disease.
Percentage of Participants With PSSD Individual Symptom Scale Score of 0 at Week 16 Among Participants With PSSD >0 at Baseline
Percentage of participants with PSSD individual symptom score of 0 at Week 16 among participants with PSSD >0 at baseline will be reported. The PSSD includes PRO questionnaire designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. The PSSD is a patient-reported outcome instrument that includes 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Two sub scores are derived each ranging from 0 to 100: the psoriasis symptom score and the psoriasis sign score. A higher score indicates more severe disease.
Number of Participants With Adverse Events (AEs)
Number of participants with AEs will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Number of Participants With Serious Adverse Events (SAEs)
Number of participants with SAEs will be reported. A SAE is any untoward medical occurrence that may results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.
Full Information
NCT ID
NCT06039189
First Posted
September 9, 2023
Last Updated
October 9, 2023
Sponsor
Janssen Research & Development, LLC
1. Study Identification
Unique Protocol Identification Number
NCT06039189
Brief Title
Study of Guselkumab Versus Placebo for the Treatment of Low Body Surface Area Moderate Plaque Psoriasis
Acronym
SPECTREM
Official Title
A Phase 3b, Multicenter, Randomized, Double-blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Guselkumab Versus Placebo for the Treatment of Low Body Surface Area (BSA) Moderate Plaque Psoriasis With Special Site Involvement
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 6, 2023 (Actual)
Primary Completion Date
April 28, 2025 (Anticipated)
Study Completion Date
May 26, 2025 (Anticipated)
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
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy of guselkumab compared to an inactive drug in participants with low body surface area moderate plaque psoriasis and special site involvement.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate Plaque Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1: Guselkumab
Arm Type
Experimental
Arm Description
Participants will receive guselkumab by subcutaneous injection with placebo as needed to maintain the blind.
Arm Title
Group 2: Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo by subcutaneous injection then receive guselkumab by subcutaneous injection.
Intervention Type
Drug
Intervention Name(s)
Guselkumab
Other Intervention Name(s)
CNTO1959, Tremfya
Intervention Description
Guselkumab will be administered as subcutaneous injection.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo will be administered as subcutaneous injection.
Primary Outcome Measure Information:
Title
Percentage of Participants who Achieve 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 participant's psoriasis. 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
Secondary Outcome Measure Information:
Title
Change From Baseline in Body Surface Area (BSA) Affected With Psoriasis at Week 16
Description
Change from baseline in BSA affected with psoriasis at Week 16 will be reported. The BSA is a measurement of involved skin over the whole body. The overall BSA affected by psoriasis is estimated based on the participant's handprint (defined as the entire palmar surface of the hand including fingers).
Time Frame
Baseline, Week 16
Title
Change From Baseline in Total Psoriasis Area and Severity Index (PASI) Score at Week 16
Description
Change from baseline in PASI 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: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for erythema, induration and scaling, which are each rated on a scale of 0 to 4 that is none to maximum severity. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease.
Time Frame
Baseline, Week 16
Title
Percentage of Participants who Achieve an Investigator's Global Assessment (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. The IGA documents the investigator's assessment of the participant's psoriasis. 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 who Achieve a PASI 90 Response at Week 16
Description
Percentage of participants who achieve a PASI 90 response 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 separately for erythema, induration and scaling, which are each rated on a scale of 0 to 4 that is none to maximum severity. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response is defined as greater than or equal to (>=) 90 percent (%) improvement in PASI score from baseline.
Time Frame
Week 16
Title
Percentage of Participants who Achieve a PASI 100 Response at Week 16
Description
Percentage of participants who achieve a PASI 100 response 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 separately for erythema, induration and scaling, which are each rated on a scale of 0 to 4 that is none to maximum severity. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 100 response is defined as 100% improvement in PASI score from baseline.
Time Frame
Week 16
Title
Percentage of Participants who Achieve a Scalp-Specific Investigator Global Assessment (ss-IGA) Score of Absence of Disease (0) or Very Mild Disease (1) at Week 16 Among Participants With an ss-IGA Score >=3 at Baseline
Description
Percentage of participants who achieve a ss-IGA score of absence of disease (0) or very mild disease (1) at Week 16 among participants with an ss-IGA score >=3 at baseline will be reported. The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. Scalp lesions are graded for induration, erythema, and scaling. The participant's scalp psoriasis is assessed as absence of disease (0), very mild disease (1), mild disease (2), moderate disease (3), or severe disease (4).
Time Frame
Week 16
Title
Percentage of Participants who Achieve a Static Physician's Global Assessment of Genitalia (sPGA-G) Score of Clear (0) or Minimal (1) at Week 16 Among Participants With a sPGA-G Score >=3 at Baseline
Description
Percentage of participants who achieve a sPGA-G score of clear (0) or minimal (1) at Week 16 among participants with a sPGA-G score >=3 at baseline will be reported. The sPGA-G is used to evaluate the disease severity of genital psoriasis. Severity of genital psoriasis is determined by a combination of 3 plaque characteristics: erythema, elevation, and scale. The participant's severity of genital psoriasis is assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), and very severe (5).
Time Frame
Week 16
Title
Percentage of Participants who Achieve an Intertriginous IGA (i-IGA) Score of Clear (0) or Minimal (1) at Week 16 Among Participants With an i-IGA Score >=3 at Baseline
Description
Percentage of participants who achieve an i-IGA score of clear (0) or minimal (1) at Week 16 among participants with an i-IGA score >=3 at baseline will be reported. The IGA used for the full body assessment has been adapted with descriptions of disease features that are more consistent with intertriginous psoriasis presentation. The intertriginous areas affected to be scored include the axillary, sub-mammary, abdominal fold, inguinal, and intergluteal cleft/peri-anal region (distinct from genital/perineum involvement). The participant's intertriginous areas affected are assessed as clear (0), minimal (1), mild (2), moderate (3), and severe (4).
Time Frame
Week 16
Title
Percentage of Participants who Achieve a Facial IGA (f-IGA) Score of Clear (0) or Minimal (1) at Week 16 Among Participants With an f-IGA Score >=3 at Baseline
Description
Percentage of participants who achieve a f-IGA score of clear (0) or minimal (1) at Week 16 among participants with an f-IGA score >=3 at baseline will be reported. The IGA used for the full body assessment will be adapted for use, but only the face will be scored. The participant's facial psoriasis is assessed as clear (0), minimal (1), mild (2), moderate (3), and severe (4).
Time Frame
Week 16
Title
Change From Baseline in Psoriasis Symptom and Sign Diary (PSSD) Total Symptom Score at Week 16
Description
Change from baseline in PSSD total symptom score at Week 16 will be reported. The PSSD includes patient-reported outcome (PRO) questionnaire designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. The PSSD is a patient-reported outcome instrument that includes 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Two sub scores are 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
Baseline, Week 16
Title
Percentage of Participants who Achieve >=4 Point Reduction (Improvement) in PSSD Itch Score From Baseline at Week 16 Among Participants With a PSSD Itch Score >=4 at Baseline
Description
Percentage of participants who achieve >=4 point reduction (improvement) in PSSD itch score from baseline at Week 16 among participants with a PSSD itch score >=4 at baseline will be reported. The PSSD includes PRO questionnaire designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit The PSSD is a patient-reported outcome instrument that includes 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Two sub scores are 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
Week 16
Title
Percentage of Participants With PSSD Individual Symptom Scale Score of 0 at Week 16 Among Participants With PSSD >0 at Baseline
Description
Percentage of participants with PSSD individual symptom score of 0 at Week 16 among participants with PSSD >0 at baseline will be reported. The PSSD includes PRO questionnaire designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. The PSSD is a patient-reported outcome instrument that includes 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Two sub scores are 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
Week 16
Title
Number of Participants With Adverse Events (AEs)
Description
Number of participants with AEs will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Time Frame
Up to Week 56
Title
Number of Participants With Serious Adverse Events (SAEs)
Description
Number of participants with SAEs will be reported. A SAE is any untoward medical occurrence that may results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.
Time Frame
Up to Week 56
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All participants must have a diagnosis of plaque psoriasis (with or without psoriatic arthritis) for at least 6 months before first administration of study intervention
All participants must meet the following disease severity criteria at screening and at baseline: (a) Overall Investigator's Global Assessment (IGA) 3 (moderate) plaque psoriasis; (b) Body Surface Area (BSA) 2-15 percent (%) with at least 1 plaque outside of special sites; (c) Involvement of at least 1 special site with at least moderate severity. Qualifying sites include scalp with scalp-specific IGA greater than or equal to (>=) 3, face with facial psoriasis IGA >=3, intertriginous with intertriginous psoriasis IGA >=3, or genital with static physician global assessment of genitalia (sPGA-G) >=3
All participants be inadequately controlled with or intolerant of at least 1 prior topical therapy (including, but not limited to, corticosteroids, retinoids, vitamin D, or vitamin D/steroid and retinoid/steroid combinations, tacrolimus, pimecrolimus, anthralin/dithranol, coal tar preparations, tapinarof, roflumilast, etcetera) for the treatment of psoriasis at both screening
All participants be a candidate for phototherapy or systemic treatment for psoriasis
Exclusion Criteria:
Has a nonplaque form of psoriasis (example, erythrodermic, guttate, or pustular) at screening or randomization
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)
For participants with palmoplantar involvement, confounding diagnoses, including, but not limited, to palmoplantar pustulosis, eczematous dermatitis, contact/irritant dermatitis, acquired keratoderma, etcetera, should be confirmed and excluded
Participants will not be eligible if they have ever received prior biologic (or biosimilars of) for the treatment of psoriasis, psoriatic arthritis (PsA), or any other indications that could impact the assessment of psoriasis. Prior biologics (or biosimilars of) may include, but not limited to, tumor necrosis factor (TNF)-inhibitors (for example: adalimumab, etanercept, infliximab, or certolizumab or biosimilars), interleukin (IL)-17 inhibitors (for example: secukinumab, ixekizumab, brodalumab, or bimekizumab), and IL-12/23 inhibitors (for example: ustekinumab), or IL-23 inhibitor (for example: guselkumab, risankizumab or tildrakizumab)
Has a history of chronic or recurrent infectious disease, including, but not limited to, chronic renal infection, chronic chest infection (for example, bronchiectasis), recurrent urinary tract infection (recurrent pyelonephritis or chronic non-remitting cystitis), fungal infection (mucocutaneous candidiasis), or open, draining, or infected skin wounds or ulcers
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Contact
Phone
844-434-4210
Email
Participate-In-This-Study@its.jnj.com
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
Total Skin & Beauty Dermatology Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Individual Site Status
Recruiting
Facility Name
Cahaba Research Inc
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35244
Country
United States
Individual Site Status
Recruiting
Facility Name
Miami VA Healthcare System
City
Miami
State/Province
Florida
ZIP/Postal Code
33124
Country
United States
Individual Site Status
Recruiting
Facility Name
Metro Boston Clinical Partners
City
Brighton
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Individual Site Status
Recruiting
Facility Name
Darst Dermatology
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Individual Site Status
Recruiting
Facility Name
Piedmont Plastic Surgery and Dermatology - Denver
City
Denver
State/Province
North Carolina
ZIP/Postal Code
28037
Country
United States
Individual Site Status
Recruiting
Facility Name
Apex Dermatology Mayfield Heights
City
Mayfield Heights
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
Individual Site Status
Recruiting
Facility Name
Center for Clinical Studies
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Individual Site Status
Recruiting
Facility Name
Suzanne Bruce and Associates - The Center for Skin Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77056-4132
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Dermatology and Laser Specialists
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78218
Country
United States
Individual Site Status
Recruiting
Facility Name
Progressive Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Name
Dr. Chih-ho Hong Medical
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3R 6A7
Country
Canada
Individual Site Status
Recruiting
Facility Name
CCA Medical Research Corporation
City
Ajax
State/Province
Ontario
ZIP/Postal Code
L1S7K8
Country
Canada
Individual Site Status
Recruiting
Facility Name
Dermatrials Research
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 1Y2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Toronto Research Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3H5Y8
Country
Canada
Individual Site Status
Recruiting
Facility Name
Manna Research
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4C 1L1
Country
Canada
Individual Site Status
Recruiting
Facility Name
SimcoDerm Medical and Surgical Dermatology Centre
City
Ontario
ZIP/Postal Code
L4M 7G1
Country
Canada
Individual Site Status
Recruiting
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
Study of Guselkumab Versus Placebo for the Treatment of Low Body Surface Area Moderate Plaque Psoriasis
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