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| ID | Type | Description | Link |
|---|---|---|---|
| CNTO1959PSO3018 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to evaluate the efficacy of guselkumab treatment versus placebo in skin of color participants with predominant moderate-to-severe body psoriasis or predominant moderate-to-severe scalp psoriasis by assessing improvements in the signs and symptoms of psoriasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A: Moderate-to-severe Plaque Psoriasis | Experimental | Participants will receive either guselkumab subcutaneously (SC) or placebo SC. Placebo participants will then crossover to receive guselkumab SC. |
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| Cohort B: Moderate-to-severe Scalp Psoriasis | Experimental | Participants will receive either guselkumab SC or placebo SC. Placebo participants will then crossover to receive guselkumab SC. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guselkumab | Drug | Participants will receive guselkumab as subcutaneous injection. |
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| Measure | Description | Time Frame |
|---|---|---|
| Cohort A: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16 | The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 point scale. Induration: 0 = no evidence of plaque elevation; 1 = minimal plaque elevation, = 0.25 millimeters (mm); 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, greater than (>) 1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Higher score indicated more severe disease. | Week 16 |
| Cohort A: Percentage of Participants Who Achieved Psoriasis Area Severity Index (PASI) 90 Response at Week 16 | Percentage of participants who achieved PASI 90 response (greater than or equal to [>=] 90 percent [%] improvement from baseline in PASI) at Week 16 was reported. PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1=slight, 2=moderate, 3=severe and 4=very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date unless otherwise specified. | Week 16 |
| Cohort B: Percentage of Participants Who Achieved Scalp Specific (ss)-IGA Score of Absence of Disease (0) or Very Mild Disease (1) at Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Cohort A: Percentage of Participants Who Achieved IGA Score of Cleared (0) at Week 16 | The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 point scale. Induration: 0 = no evidence of plaque elevation; 1 = minimal plaque elevation, = 0.25 millimeters (mm); 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, greater than (>) 1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Higher score indicated more severe disease. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Total Skin and Beauty Dermatology Center | Birmingham | Alabama | 35203 | United States | ||
| Cahaba Research Inc |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41770445 | Derived | Alexis A, McMichael A, Vashi N, Bhutani T, Yeung J, Alkousakis T, Rowland K, Choi O, Ma T, Chan D, Lester J, Rodriguez AO, Yadav G, Kindred C, Grimes P, Taylor SC, Desai SR. The Impact of Post-inflammatory Pigment Alteration After Psoriasis: Novel Data from the VISIBLE Study. Dermatol Ther (Heidelb). 2026 Apr;16(4):2031-2045. doi: 10.1007/s13555-026-01688-z. Epub 2026 Mar 2. | |
| 40560559 |
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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
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort A: Placebo Followed by Guselkumab 100 mg | Participants with predominant body moderate-to-severe plaque psoriasis received placebo matching to guselkumab by subcutaneous (SC) injection at Weeks 0, 4, and 12, and then crossed-over to receive guselkumab 100 milligrams (mg) as SC injection at Weeks 16, 20, and then every 8 week (q8w) through Week 100. Participants were then followed up for safety up to 12 weeks (Week 112). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 2, 2022 | May 28, 2026 |
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| Placebo | Drug | Participants will receive placebo as subcutaneous injection. |
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The ss-IGA instrument was used to evaluate the disease severity of scalp psoriasis. The lesions were assessed in terms of the clinical signs of redness, thickness, and scaliness which was scored as: absence of disease = 0, very mild disease = 1, mild disease = 2, moderate disease = 3, and severe disease = 4. A higher score indicated more severe disease. |
| Week 16 |
| Cohort B: Percentage of Participants Who Achieved Psoriasis Scalp Severity Index (PSSI) 90 Response at Week 16 | PSSI 90 response is defined as a percentage of participants who achieved at least 90% improvement from baseline in the PSSI score. PSSI is a physician assessment of severity of erythema, infiltration, and desquamation and extent of psoriasis involvement. Severity of erythema, infiltration, and desquamation each scored on a scale of 0 (none) to 4 (very severe) and the extent of psoriasis involvement scored on a scale from 1 (<10% of scalp involved) to 6 (90 to 100% of scalp involved). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the psoriasis involvement. The PSSI score ranged from 0 (less severity) to 72 (more severity). Higher scores indicated more severe symptoms. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date unless otherwise specified. | Week 16 |
| Week 16 |
| Cohort A: Percentage of Participants Who Achieved PASI 100 Response at Week 16 | Percentage of participants who achieved PASI-100 response (100% improvement from baseline in PASI) at Week 16 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date unless otherwise specified. | Week 16 |
| Cohort A: Percent Change From Baseline in PASI Total Score at Week 16 | Percent change from baseline in PASI total score at Week 16 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date unless otherwise specified. | Baseline (Week 0), Week 16 |
| Cohort A: Percent Change From Baseline in Body Surface Area (BSA) at Week 16 | A BSA was commonly used measure of severity of skin disease. It was defined as the percentage of surface area of the body involved with the condition being assessed, (that is, plaque psoriasis). BSA was assessed using hand print method where the surface area of the participant's hand including the palm and all 5 digits was used as a guide to estimate 1% BSA. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date unless otherwise specified. | Baseline (Week 0), Week 16 |
| Cohort A: Time to Greater Than or Equal to (>=) 90 Percent (%) Reduction in PASI Score | Time to >=90% reduction was defined as the time at which >=90% improvement in PASI from baseline was achieved. PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1=slight, 2=moderate, 3=severe and 4=very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date unless otherwise specified. | From baseline (Week 0) up to Week 16 |
| Cohorts A and B: Change From Baseline in Total Dermatology Life Quality Index (DLQI) Score at Week 16 | Change from baseline in total DLQI score at Week 16 was reported. The DLQI was a dermatology specific health related quality of life (HRQoL) instrument designed to assess the impact of the disease on a participant's HRQoL. It was a 10-item questionnaire that assesses HRQoL over the past week and in addition to evaluating overall HRQoL, could 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. Each question was scored on a 4-point scale of 0 to 3 (0 = not at all, 1 = a little; 2 = a lot; or 3 = very much), where higher score indicated more impact on QoL. The total score was sum of scores from all 10 questions and it ranged from 0 (not at all) to 30 (very much), with a higher score indicating greater impact on HRQoL. Baseline = closest measurement taken prior to or at the time of the first study drug administration date unless otherwise specified. | Baseline (Week 0), Week 16 |
| Cohort A: Percentage of Participants Who Achieved >= 4-point Reduction From Baseline in the Psoriasis Symptom and Sign Diary (PSSD) Itch Score at Week 16 Among Participants With Baseline PSSD Itch Score >=4 | PSSD was a patient reported outcomes (PRO) questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 7 day recall version was used. PSSD was a self-administered PRO instrument that included 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. PSSD itch item score over seven days was averaged into a weekly itch score, ranging from 0 to 10 with higher scores indicating severe disease. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date unless otherwise specified. | Week 16 |
| Cohorts A and B: Change From Baseline in PSSD Symptom Score at Week 16 | Change from baseline in PSSD symptoms scores at Week 16 was reported. PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 7-day recall version was used. PSSD was self-administered PRO instrument that included 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. Items were averaged on the weekly symptom score when at least 3 items (>=50 percentage of 5 items) on these scales are answered. The average value was converted into 0-100 scoring, such that symptom score = average value*10, where, 0= least severe and 100= most severe. Higher score indicated more severe disease. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date unless otherwise specified. | Baseline (Week 0), Week 16 |
| Cohorts A and B: Percentage of Participants Who Achieved PSSD Symptom Score of 0 at Week 16 Among Participants With Baseline PSSD Symptom Score >=1 | PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 7-day recall version was used. PSSD was self-administered PRO instrument that included 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. Items were averaged on the weekly symptom score when at least 3 items (>=50 percentage of 5 items) on these scales are answered. The average value was converted into 0-100 scoring, such that symptom score = average value*10, where, 0= least severe and 100= most severe. Higher score indicated more severe disease. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date unless otherwise specified. | Week 16 |
| Cohort B: Percent Change From Baseline in Psoriasis Scalp Severity Index (PSSI) Score at Week 16 | PSSI is a physician assessment of severity of erythema, infiltration, and desquamation and extent of psoriasis involvement. Severity of erythema, infiltration, and desquamation each scored on a scale of 0 (none) to 4 (very severe) and the extent of psoriasis involvement scored on a scale from 1 (<10% of scalp involved) to 6 (90 to 100% of scalp involved). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the psoriasis involvement. The PSSI score ranged from 0 (less severity) to 72 (more severity). Higher scores indicated more severe symptoms. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date unless otherwise specified. | Baseline (Week 0), Week 16 |
| Cohort B: Percent Change From Baseline in Scalp Surface Area (SSA) at Week 16 | Scalp Surface Area (SSA) is defined as the extent of scalp skin affected by psoriasis, expressed as a percentage of the total scalp surface area. The adult SSA was 520-705 centimeter^2 (cm^2), which mean 1% SSA is 5.2 - 7.1 cm^2. The thumbprint has an average surface area of 5.5 cm^2 +/- 1.3 cm^2. The thumb (in particular, the thumb projection) was used as a tool for accurate measurement of 1% SSA. The overall SSA affected by psoriasis was thus be estimated based on the participant's thumb. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date unless otherwise specified. | Baseline (Week 0), Week 16 |
| Cohort B: Percentage of Participants Who Achieved Scalp Specific (ss)-IGA Score of Absence of Disease (0) at Week 16 | The ss-IGA instrument was used to evaluate the disease severity of scalp psoriasis. The lesions were assessed in terms of the clinical signs of redness, thickness, and scaliness which was scored as: absence of disease = 0, very mild disease = 1, mild disease = 2, moderate disease = 3, and severe disease = 4. A higher score indicated more severe disease. | Week 16 |
| Cohort B: Percentage of Participants Who Achieved PSSI 100 Response at Week 16 | PSSI 100 response is defined as a percentage of participants who achieved 100% improvement from baseline in the PSSI score. PSSI is a physician assessment of severity of erythema, infiltration, and desquamation and extent of psoriasis involvement. Severity of erythema, infiltration, and desquamation each scored on a scale of 0 (none) to 4 (very severe) and the extent of psoriasis involvement scored on a scale from 1 (<10% of scalp involved) to 6 (90 to 100% of scalp involved). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the psoriasis involvement. The PSSI score ranged from 0 (less severity) to 72 (more severity). Higher scores indicated more severe symptoms. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date unless otherwise specified. | Week 16 |
| Cohort B: Time to >=90% Reduction in PSSI Score | Time to >=90% reduction was defined as the time at which >=90% improvement in PSSI from baseline was achieved. PSSI is a physician assessment of severity of erythema, infiltration, and desquamation and extent of psoriasis involvement. Severity of erythema, infiltration, and desquamation each scored on a scale of 0 (none) to 4 (very severe) and the extent of psoriasis involvement scored on a scale from 1 (<10% of scalp involved) to 6 (90 to 100% of scalp involved). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the psoriasis involvement. The PSSI score ranged from 0 (less severity) to 72 (more severity). Higher scores indicated more severe symptoms. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date unless otherwise specified. | From Baseline (Week 0) up to Week 16 |
| Cohort B: Percentage of Participants Who Achieved >=4-point Reduction From Baseline in the Scalp Itch Numeric Rating Scale (NRS) Score at Week 16 Among Participants With Baseline Scalp Itch Score >=4 | The scalp itch NRS was a single-item scale that asks participants to rate the severity of their scalp itching due to psoriasis by considering their worst level of itching over the past 24 hours. The 11-point scalp itch NRS ranged from 0 (no scalp itch) to 10 (worst scalp itch imaginable). Higher scores indicated more severe scalp itch. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date unless otherwise specified. | Week 16 |
| Cohorts A and B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAE was defined as any AE that occurred after the start of initial study agent administration and those AEs that were presented at baseline but worsened in severity after the start of initial study agent administration. | Cohorts A and B: Placebo: From Week 0 to Week 16; Cohorts A and B: Placebo Followed by Guselkumab 100 mg: From Week 16 to Week 112; Cohorts A and B: Guselkumab 100 mg: From Week 0 to Week 112 |
| Cohorts A and B: Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) | An AE was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Serious adverse event (SAE) was any untoward medical occurrence at any dose that: resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or resulted in congenital anomaly/birth defect. TEAE was defined as any AE that occurred after the start of initial study agent administration and those AEs that were presented at baseline but worsened in severity after the start of initial study agent administration. | Cohorts A and B: Placebo: From Week 0 to Week 16; Cohorts A and B: Placebo Followed by Guselkumab 100 mg: From Week 16 to Week 112; Cohorts A and B: Guselkumab 100 mg: From Week 0 to Week 112 |
| Birmingham |
| Alabama |
| 35244 |
| United States |
| Stoll Dermatology | Beverly Hills | California | 90212 | United States |
| California Dermatology & Clinical Research Institute | Encinitas | California | 92024 | United States |
| First OC Dermatology | Fountain Valley | California | 92708 | United States |
| Center for Dermatology Clinical Research | Fremont | California | 94538 | United States |
| Community Regional Medical Center | Fresno | California | 93701 | United States |
| Paul Wallace MD | Ladera Heights | California | 90056 | United States |
| The Grimes Center for Medical and Aesthetic Dermatology | Los Angeles | California | 90036 | United States |
| Care Access Research 1 | Newport Beach | California | 92660 | United States |
| MedDerm Associates | San Diego | California | 92103 | United States |
| Synergy Clinical Research | San Francisco | California | 94132 | United States |
| Southern California Dermatology | Santa Ana | California | 92701 | United States |
| Clinical Science Institute | Santa Monica | California | 90404 | United States |
| University of Connecticut Health Center | Farmington | Connecticut | 06030 | United States |
| Center for Dermatology and Dermatologic Surgery | Washington D.C. | District of Columbia | 20037 | United States |
| Skin Care Research | Boca Raton | Florida | 33486 | United States |
| Driven Research LLC | Coral Gables | Florida | 33134 | United States |
| Florida Academic Dermatology Centers | Coral Gables | Florida | 33134 | United States |
| Hollywood Dermatology and Cosmetic Surgery | Hollywood | Florida | 33021 | United States |
| International Dermatology Research, Inc. | Miami | Florida | 33144 | United States |
| Tory P Sullivan M D PA | North Miami Beach | Florida | 33162 | United States |
| Park Avenue Dermatology | Orange Park | Florida | 32073 | United States |
| Riverchase Dermatology and Cosmetic Surgery | Pembroke Pines | Florida | 33028 | United States |
| GCP Research | St. Petersburg | Florida | 33705 | United States |
| Forcare Clinical Research Inc | Tampa | Florida | 33613 | United States |
| Hamilton Dermatology Atlanta Dermatology, Vein & Research Center, LLC | Alpharetta | Georgia | 30022-1160 | United States |
| Advanced Medical Research | Atlanta | Georgia | 30328 | United States |
| Skin Care Physicians of Georgia | Macon | Georgia | 31217 | United States |
| University Dermatology and Vein Clinic | Darien | Illinois | 60561 | United States |
| Northshore University Healthsystem | Skokie | Illinois | 60077 | United States |
| Dundee Dermatology | West Dundee | Illinois | 60118 | United States |
| Dawes Fretzin Clinical Research Group | Indianapolis | Indiana | 46256 | United States |
| Indiana Clinical Trial Center | Plainfield | Indiana | 46168 | United States |
| Epiphany Dermatology of Kansas, LLC | Overland Park | Kansas | 66210 | United States |
| Ds Research | Louisville | Kentucky | 40241 | United States |
| Callender Center for Clinical Research | Glenn Dale | Maryland | 20769 | United States |
| Care Access Research | Marriottsville | Maryland | 21104 | United States |
| DermAssociates, PC | Rockville | Maryland | 20850 | United States |
| Lawrence J Green MD LLC | Rockville | Maryland | 20850 | United States |
| Allcutis Research | Beverly | Massachusetts | 01915 | United States |
| Metro Boston Clinical Partners | Brighton | Massachusetts | 02135 | United States |
| David Fivenson MD, Dermatology | Ann Arbor | Michigan | 48103 | United States |
| St Joseph Dermatology and Vein Clinic | Saint Joseph | Michigan | 49085 | United States |
| Somerset Skin Centre | Troy | Michigan | 48084 | United States |
| Henry Ford Medical Center | West Bloomfield | Michigan | 48322 | United States |
| Twin Cities Dermatology Center | Minneapolis | Minnesota | 55416 | United States |
| Skin Specialists | Omaha | Nebraska | 68144 | United States |
| Psoriasis Treatment Center of Central New Jersey | East Windsor | New Jersey | 08520 | United States |
| Hudson Dermatology & Skin Cancer Center | Hoboken | New Jersey | 07030 | United States |
| Schweiger Dermatology Group | Verona | New Jersey | 07044 | United States |
| Forest Hills Dermatology Group PLLC | Forest Hills | New York | 11375 | United States |
| MDCS Dermatology | New York | New York | 10065 | United States |
| Sadick Research Group | New York | New York | 10075 | United States |
| Markowitz Medical OptiSkin | New York | New York | 10128 | United States |
| Accellacare Research of Cary | Cary | North Carolina | 27511 | United States |
| Darst Dermatology | Charlotte | North Carolina | 28277 | United States |
| Dermatology Specialists | Charlotte | North Carolina | 28277 | United States |
| Accellacare of Raleigh | Raleigh | North Carolina | 27612 | United States |
| PMG Research of Rocky Mount, LLC | Rocky Mount | North Carolina | 27804 | United States |
| PMG Research of Wilmington, LLC | Wilmington | North Carolina | 28401 | United States |
| Wake Forest Health Sciences | Winston-Salem | North Carolina | 27104 | United States |
| Advanced Dermatology and Skin Cancer Center | Boardman | Ohio | 44512 | United States |
| Wright State Physicians Health Center | Dayton | Ohio | 45324 | United States |
| Apex Dermatology Mayfield Heights | Mayfield Heights | Ohio | 44124 | United States |
| Central Sooner Research | Norman | Oklahoma | 73071 | United States |
| Schweiger Dermatology Group 1 | Exton | Pennsylvania | 19341 | United States |
| Temple University School of Medicine | Philadelphia | Pennsylvania | 19140 | United States |
| University of Pittsburgh Medical Center (UPMC) | Pittsburgh | Pennsylvania | 15213 | United States |
| Dermatology and Laser Center of Charleston | Charleston | South Carolina | 29407 | United States |
| Palmetto Clinical Trial Services, LLC | Fountain Inn | South Carolina | 29644 | United States |
| Arlington Center for Dermatology | Arlington | Texas | 76011 | United States |
| Dermatology Treatment & Research Center, PA | Dallas | Texas | 75230 | United States |
| Modern Research Associates PLLC | Dallas | Texas | 75231 | United States |
| Center for Clinical Studies | Houston | Texas | 77004 | United States |
| Suzanne Bruce and Associates - The Center for Skin Research | Houston | Texas | 77056-4132 | United States |
| Austin Institute for Clinical Research | Pflugerville | Texas | 78660 | United States |
| Progressive Clinical Research | San Antonio | Texas | 78213 | United States |
| Texas Dermatology and Laser Specialists | San Antonio | Texas | 78218 | United States |
| Dermatology Research Institute Inc | Calgary | Alberta | T2J 7E1 | Canada |
| Beacon Dermatology | Calgary | Alberta | T3E 0B2 | Canada |
| Alberta DermaSurgery Centre | Edmonton | Alberta | T6G 2C1 | Canada |
| Dr. Chih ho Hong Medical | Surrey | British Columbia | V3R 6A7 | Canada |
| Dr. Lorne E. Albrecht | Surrey | British Columbia | V3V 0C6 | Canada |
| CCA Medical Research Corporation | Ajax | Ontario | L1S7K8 | Canada |
| Dr Dusan Sajic Medicine Professional Corporation | Guelph | Ontario | N1L 0B7 | Canada |
| Lynderm Research Inc. | Markham | Ontario | L3P 1X2 | Canada |
| North York Research Inc | North York | Ontario | M2M 4J5 | Canada |
| JRB Research Inc | Ottawa | Ontario | K1K 4L2 | Canada |
| Nectar Research Group Inc | Richmond Hill | Ontario | L4B 1A5 | Canada |
| Canadian Dermatology Center | Toronto | Ontario | M3B 0A7 | Canada |
| Toronto Research Centre | Toronto | Ontario | M3H 5Y8 | Canada |
| FACET Dermatology | Toronto | Ontario | M4E 2Y9 | Canada |
| Research Toronto | Toronto | Ontario | M4W 2N4 | Canada |
| Derived |
| Alexis A, McMichael A, Soung J, Choi O, Alkousakis T, Alonso-Llamazares J, Shahriari M, Rodriguez AO, Bhutani T, Chan D, Rowland K, Sauder M, Hong HC, Yadav G, Yeung J, Jeyarajah J, Ma T, Gao LL, Park-Wyllie L, Green L, Lee M, Vashi N, Kindred C, Grimes P, Taylor SC, Desai SR; VISIBLE Trial Investigators. Guselkumab for Moderate to Severe Psoriasis Across All Skin Tones: Cohort A of the VISIBLE Randomized Clinical Trial. JAMA Dermatol. 2025 Sep 1;161(9):901-911. doi: 10.1001/jamadermatol.2025.1836. |
| 40560554 | Derived | McMichael A, Shahriari M, Stein Gold L, Alkousakis T, Choi O, Bhutani T, Rodriguez AO, Tyring SK, Chan D, Rowland K, Albrecht L, Lynde C, Yadav G, Yeung J, Park-Wyllie L, Ma T, Jeyarajah J, Gao LL, Smith S, Moore AY, Vashi N, Kindred C, Grimes P, Desai SR, Taylor SC, Alexis A; VISIBLE Trial Investigators. Guselkumab for Moderate to Severe Scalp Psoriasis Across All Skin Tones: Cohort B of the VISIBLE Randomized Clinical Trial. JAMA Dermatol. 2025 Sep 1;161(9):912-922. doi: 10.1001/jamadermatol.2025.1849. |
| 39661358 | Derived | Alexis A, McMichael A, Vashi N, Bhutani T, Rodriguez AO, Yeung J, Choi O, Chan D, Alkousakis T, Bronner DN, Park-Wyllie L, Gao LL, Grimes P, Shahriari M, Yadav G, Kindred C, Taylor SC, Desai SR. Improving Diversity in a Novel Psoriasis Study: VISIBLE as a Framework for Clinical Trial Quality Improvement. JAMA Dermatol. 2025 Mar 1;161(3):256-264. doi: 10.1001/jamadermatol.2024.5103. |
| FG001 | Cohort A: Guselkumab 100 mg | Participants with predominant body moderate-to-severe plaque psoriasis received guselkumab 100 mg by SC injection at Weeks 0, 4 and then q8w through Week 100. Participants also received placebo at Week 16 to maintain the blind. Participants were then followed up for safety up to 12 weeks (Week 112). |
| FG002 | Cohort B: Placebo Followed by Guselkumab 100 mg | Participants with predominant moderate-to-severe scalp psoriasis received placebo matching to guselkumab by SC injection at Weeks 0, 4, and 12, and then crossed-over to receive guselkumab 100 mg as SC injection at Weeks 16, 20, and then q8w through Week 100. Participants were then followed up for safety up to 12 weeks (Week 112). |
| FG003 | Cohort B: Guselkumab 100 mg | Participants with predominant moderate-to-severe scalp psoriasis received guselkumab 100 mg by SC injection at Weeks 0, 4 and then q8w through Week 100. Participants also received placebo at Week 16 to maintain the blind. Participants were then followed up for safety up to 12 weeks (Week 112). |
| Participants Who Crossed Over to Guselkumab |
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| COMPLETED |
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| NOT COMPLETED |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort A: Placebo Followed by Guselkumab 100 mg | Participants with predominant body moderate-to-severe plaque psoriasis received placebo matching to guselkumab by subcutaneous (SC) injection at Weeks 0, 4, and 12, and then crossed-over to receive guselkumab 100 milligrams (mg) as SC injection at Weeks 16, 20, and then every 8 week (q8w) through Week 100. Participants were then followed up for safety up to 12 weeks (Week 112). |
| BG001 | Cohort A: Guselkumab 100 mg | Participants with predominant body moderate-to-severe plaque psoriasis received guselkumab 100 mg by SC injection at Weeks 0, 4 and then q8w through Week 100. Participants also received placebo at Week 16 to maintain the blind. Participants were then followed up for safety up to 12 weeks (Week 112). |
| BG002 | Cohort B: Placebo Followed by Guselkumab 100 mg | Participants with predominant moderate-to-severe scalp psoriasis received placebo matching to guselkumab by SC injection at Weeks 0, 4, and 12, and then crossed-over to receive guselkumab 100 mg as SC injection at Weeks 16, 20, and then q8w through Week 100. Participants were then followed up for safety up to 12 weeks (Week 112). |
| BG003 | Cohort B: Guselkumab 100 mg | Participants with predominant moderate-to-severe scalp psoriasis received guselkumab 100 mg by SC injection at Weeks 0, 4 and then q8w through Week 100. Participants also received placebo at Week 16 to maintain the blind. Participants were then followed up for safety up to 12 weeks (Week 112). |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Cohort A: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16 | The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 point scale. Induration: 0 = no evidence of plaque elevation; 1 = minimal plaque elevation, = 0.25 millimeters (mm); 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, greater than (>) 1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Higher score indicated more severe disease. | Efficacy analysis set-Cohort A included all participants who were randomized in Cohort A. This outcome measure was planned to be analyzed for cohort A only. | Posted | Number | Percentage of participants | Week 16 |
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| Primary | Cohort A: Percentage of Participants Who Achieved Psoriasis Area Severity Index (PASI) 90 Response at Week 16 | Percentage of participants who achieved PASI 90 response (greater than or equal to [>=] 90 percent [%] improvement from baseline in PASI) at Week 16 was reported. PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1=slight, 2=moderate, 3=severe and 4=very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date unless otherwise specified. | Efficacy analysis set-Cohort A included all participants who were randomized in Cohort A. This outcome measure was planned to be analyzed for cohort A only. | Posted | Number | Percentage of participants | Week 16 |
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| Primary | Cohort B: Percentage of Participants Who Achieved Scalp Specific (ss)-IGA Score of Absence of Disease (0) or Very Mild Disease (1) at Week 16 | The ss-IGA instrument was used to evaluate the disease severity of scalp psoriasis. The lesions were assessed in terms of the clinical signs of redness, thickness, and scaliness which was scored as: absence of disease = 0, very mild disease = 1, mild disease = 2, moderate disease = 3, and severe disease = 4. A higher score indicated more severe disease. | Efficacy analysis set-Cohort B included all participants who were correctly randomized in Cohort B (that is, excluding the participants who were randomized incorrectly in Cohort B). This outcome measure was planned to be analyzed for cohort B only. | Posted | Number | Percentage of participants | Week 16 |
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| Primary | Cohort B: Percentage of Participants Who Achieved Psoriasis Scalp Severity Index (PSSI) 90 Response at Week 16 | PSSI 90 response is defined as a percentage of participants who achieved at least 90% improvement from baseline in the PSSI score. PSSI is a physician assessment of severity of erythema, infiltration, and desquamation and extent of psoriasis involvement. Severity of erythema, infiltration, and desquamation each scored on a scale of 0 (none) to 4 (very severe) and the extent of psoriasis involvement scored on a scale from 1 (<10% of scalp involved) to 6 (90 to 100% of scalp involved). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the psoriasis involvement. The PSSI score ranged from 0 (less severity) to 72 (more severity). Higher scores indicated more severe symptoms. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date unless otherwise specified. | Efficacy analysis set-Cohort B included all participants who were correctly randomized in Cohort B (that is, excluding the participants who were randomized incorrectly in Cohort B). This outcome measure was planned to be analyzed for cohort B only. | Posted | Number | Percentage of participants | Week 16 |
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| Secondary | Cohort A: Percentage of Participants Who Achieved IGA Score of Cleared (0) at Week 16 | The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 point scale. Induration: 0 = no evidence of plaque elevation; 1 = minimal plaque elevation, = 0.25 millimeters (mm); 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, greater than (>) 1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Higher score indicated more severe disease. | Efficacy analysis set-Cohort A included all participants who were randomized in Cohort A. This outcome measure was planned to be analyzed for cohort A only. | Posted | Number | Percentage of participants | Week 16 |
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| Secondary | Cohort A: Percentage of Participants Who Achieved PASI 100 Response at Week 16 | Percentage of participants who achieved PASI-100 response (100% improvement from baseline in PASI) at Week 16 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date unless otherwise specified. | Efficacy analysis set-Cohort A included all participants who were randomized in Cohort A. This outcome measure was planned to be analyzed for cohort A only. | Posted | Number | Percentage of participants | Week 16 |
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| Secondary | Cohort A: Percent Change From Baseline in PASI Total Score at Week 16 | Percent change from baseline in PASI total score at Week 16 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date unless otherwise specified. | Efficacy analysis set-Cohort A included all participants who were randomized in Cohort A. This outcome measure was planned to be analyzed for cohort A only. | Posted | Least Squares Mean | 95% Confidence Interval | Percent change | Baseline (Week 0), Week 16 |
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| Secondary | Cohort A: Percent Change From Baseline in Body Surface Area (BSA) at Week 16 | A BSA was commonly used measure of severity of skin disease. It was defined as the percentage of surface area of the body involved with the condition being assessed, (that is, plaque psoriasis). BSA was assessed using hand print method where the surface area of the participant's hand including the palm and all 5 digits was used as a guide to estimate 1% BSA. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date unless otherwise specified. | Efficacy analysis set-Cohort A included all participants who were randomized in Cohort A. This outcome measure was planned to be analyzed for cohort A only. | Posted | Least Squares Mean | 95% Confidence Interval | Percent change | Baseline (Week 0), Week 16 |
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| Secondary | Cohort A: Time to Greater Than or Equal to (>=) 90 Percent (%) Reduction in PASI Score | Time to >=90% reduction was defined as the time at which >=90% improvement in PASI from baseline was achieved. PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1=slight, 2=moderate, 3=severe and 4=very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date unless otherwise specified. | Efficacy analysis set-Cohort A included all participants who were randomized in Cohort A. This outcome measure was planned to be analyzed for cohort A only. | Posted | Median | Inter-Quartile Range | Weeks | From baseline (Week 0) up to Week 16 |
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| Secondary | Cohorts A and B: Change From Baseline in Total Dermatology Life Quality Index (DLQI) Score at Week 16 | Change from baseline in total DLQI score at Week 16 was reported. The DLQI was a dermatology specific health related quality of life (HRQoL) instrument designed to assess the impact of the disease on a participant's HRQoL. It was a 10-item questionnaire that assesses HRQoL over the past week and in addition to evaluating overall HRQoL, could 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. Each question was scored on a 4-point scale of 0 to 3 (0 = not at all, 1 = a little; 2 = a lot; or 3 = very much), where higher score indicated more impact on QoL. The total score was sum of scores from all 10 questions and it ranged from 0 (not at all) to 30 (very much), with a higher score indicating greater impact on HRQoL. Baseline = closest measurement taken prior to or at the time of the first study drug administration date unless otherwise specified. | Cohort A: efficacy analysis set-Cohort A included all participants who were randomized in Cohort A. Cohort B: efficacy analysis set-Cohort B included all participants who were correctly randomized in Cohort B (that is, excluding the participants who were randomized incorrectly in Cohort B). | Posted | Least Squares Mean | 95% Confidence Interval | Units on a Scale | Baseline (Week 0), Week 16 |
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| Secondary | Cohort A: Percentage of Participants Who Achieved >= 4-point Reduction From Baseline in the Psoriasis Symptom and Sign Diary (PSSD) Itch Score at Week 16 Among Participants With Baseline PSSD Itch Score >=4 | PSSD was a patient reported outcomes (PRO) questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 7 day recall version was used. PSSD was a self-administered PRO instrument that included 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. PSSD itch item score over seven days was averaged into a weekly itch score, ranging from 0 to 10 with higher scores indicating severe disease. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date unless otherwise specified. | Analysis population included all participants with a baseline PSSD itch score >=4. This outcome measure was planned to be analyzed for cohort A only. | Posted | Number | Percentage of participants | Week 16 |
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| Secondary | Cohorts A and B: Change From Baseline in PSSD Symptom Score at Week 16 | Change from baseline in PSSD symptoms scores at Week 16 was reported. PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 7-day recall version was used. PSSD was self-administered PRO instrument that included 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. Items were averaged on the weekly symptom score when at least 3 items (>=50 percentage of 5 items) on these scales are answered. The average value was converted into 0-100 scoring, such that symptom score = average value*10, where, 0= least severe and 100= most severe. Higher score indicated more severe disease. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date unless otherwise specified. | Cohort A: efficacy analysis set-Cohort A included all participants who were randomized in Cohort A. Cohort B: efficacy analysis set-Cohort B included all participants who were correctly randomized in Cohort B (that is, excluding the participants who were randomized incorrectly in Cohort B). | Posted | Least Squares Mean | 95% Confidence Interval | Units on a scale | Baseline (Week 0), Week 16 |
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| Secondary | Cohorts A and B: Percentage of Participants Who Achieved PSSD Symptom Score of 0 at Week 16 Among Participants With Baseline PSSD Symptom Score >=1 | PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 7-day recall version was used. PSSD was self-administered PRO instrument that included 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. Items were averaged on the weekly symptom score when at least 3 items (>=50 percentage of 5 items) on these scales are answered. The average value was converted into 0-100 scoring, such that symptom score = average value*10, where, 0= least severe and 100= most severe. Higher score indicated more severe disease. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date unless otherwise specified. | Analysis population included participants with a baseline PSSD symptom score >=1. | Posted | Number | Percentage of participants | Week 16 |
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| Secondary | Cohort B: Percent Change From Baseline in Psoriasis Scalp Severity Index (PSSI) Score at Week 16 | PSSI is a physician assessment of severity of erythema, infiltration, and desquamation and extent of psoriasis involvement. Severity of erythema, infiltration, and desquamation each scored on a scale of 0 (none) to 4 (very severe) and the extent of psoriasis involvement scored on a scale from 1 (<10% of scalp involved) to 6 (90 to 100% of scalp involved). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the psoriasis involvement. The PSSI score ranged from 0 (less severity) to 72 (more severity). Higher scores indicated more severe symptoms. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date unless otherwise specified. | Efficacy analysis set-Cohort B included all participants who were correctly randomized in Cohort B (that is, excluding the participants who were randomized incorrectly in Cohort B). This outcome measure was planned to be analyzed for cohort B only. | Posted | Least Squares Mean | 95% Confidence Interval | Percent change | Baseline (Week 0), Week 16 |
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| Secondary | Cohort B: Percent Change From Baseline in Scalp Surface Area (SSA) at Week 16 | Scalp Surface Area (SSA) is defined as the extent of scalp skin affected by psoriasis, expressed as a percentage of the total scalp surface area. The adult SSA was 520-705 centimeter^2 (cm^2), which mean 1% SSA is 5.2 - 7.1 cm^2. The thumbprint has an average surface area of 5.5 cm^2 +/- 1.3 cm^2. The thumb (in particular, the thumb projection) was used as a tool for accurate measurement of 1% SSA. The overall SSA affected by psoriasis was thus be estimated based on the participant's thumb. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date unless otherwise specified. | Efficacy analysis set-Cohort B included all participants who were correctly randomized in Cohort B (that is, excluding the participants who were randomized incorrectly in Cohort B). This outcome measure was planned to be analyzed for cohort B only. | Posted | Least Squares Mean | 95% Confidence Interval | Percent change | Baseline (Week 0), Week 16 |
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| Secondary | Cohort B: Percentage of Participants Who Achieved Scalp Specific (ss)-IGA Score of Absence of Disease (0) at Week 16 | The ss-IGA instrument was used to evaluate the disease severity of scalp psoriasis. The lesions were assessed in terms of the clinical signs of redness, thickness, and scaliness which was scored as: absence of disease = 0, very mild disease = 1, mild disease = 2, moderate disease = 3, and severe disease = 4. A higher score indicated more severe disease. | Efficacy analysis set-Cohort B included all participants who were correctly randomized in Cohort B (that is, excluding the participants who were randomized incorrectly in Cohort B). This outcome measure was planned to be analyzed for cohort B only. | Posted | Number | Percentage of participants | Week 16 |
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| Secondary | Cohort B: Percentage of Participants Who Achieved PSSI 100 Response at Week 16 | PSSI 100 response is defined as a percentage of participants who achieved 100% improvement from baseline in the PSSI score. PSSI is a physician assessment of severity of erythema, infiltration, and desquamation and extent of psoriasis involvement. Severity of erythema, infiltration, and desquamation each scored on a scale of 0 (none) to 4 (very severe) and the extent of psoriasis involvement scored on a scale from 1 (<10% of scalp involved) to 6 (90 to 100% of scalp involved). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the psoriasis involvement. The PSSI score ranged from 0 (less severity) to 72 (more severity). Higher scores indicated more severe symptoms. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date unless otherwise specified. | Efficacy analysis set-Cohort B included all participants who were correctly randomized in Cohort B (that is, excluding the participants who were randomized incorrectly in Cohort B). This outcome measure was planned to be analyzed for cohort B only. | Posted | Number | Percentage of participants | Week 16 |
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| Secondary | Cohort B: Time to >=90% Reduction in PSSI Score | Time to >=90% reduction was defined as the time at which >=90% improvement in PSSI from baseline was achieved. PSSI is a physician assessment of severity of erythema, infiltration, and desquamation and extent of psoriasis involvement. Severity of erythema, infiltration, and desquamation each scored on a scale of 0 (none) to 4 (very severe) and the extent of psoriasis involvement scored on a scale from 1 (<10% of scalp involved) to 6 (90 to 100% of scalp involved). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the psoriasis involvement. The PSSI score ranged from 0 (less severity) to 72 (more severity). Higher scores indicated more severe symptoms. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date unless otherwise specified. | Efficacy analysis set-Cohort B included all participants who were correctly randomized in Cohort B (that is, excluding the participants who were randomized incorrectly in Cohort B). This outcome measure was planned to be analyzed for cohort B only. | Posted | Median | Inter-Quartile Range | Weeks | From Baseline (Week 0) up to Week 16 |
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| Secondary | Cohort B: Percentage of Participants Who Achieved >=4-point Reduction From Baseline in the Scalp Itch Numeric Rating Scale (NRS) Score at Week 16 Among Participants With Baseline Scalp Itch Score >=4 | The scalp itch NRS was a single-item scale that asks participants to rate the severity of their scalp itching due to psoriasis by considering their worst level of itching over the past 24 hours. The 11-point scalp itch NRS ranged from 0 (no scalp itch) to 10 (worst scalp itch imaginable). Higher scores indicated more severe scalp itch. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date unless otherwise specified. | Analysis population included participants with a baseline scalp itch score >=4. This outcome measure was planned to be analyzed for cohort B only. | Posted | Number | Percentage of participants | Week 16 |
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| Secondary | Cohorts A and B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAE was defined as any AE that occurred after the start of initial study agent administration and those AEs that were presented at baseline but worsened in severity after the start of initial study agent administration. | The safety analysis set included all participants who received at least 1 (partial or complete) dose of study agent (the treated population). Per plan, data for adverse events was collected and analyzed per intervention. | Posted | Count of Participants | Participants | Cohorts A and B: Placebo: From Week 0 to Week 16; Cohorts A and B: Placebo Followed by Guselkumab 100 mg: From Week 16 to Week 112; Cohorts A and B: Guselkumab 100 mg: From Week 0 to Week 112 |
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| Secondary | Cohorts A and B: Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) | An AE was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Serious adverse event (SAE) was any untoward medical occurrence at any dose that: resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or resulted in congenital anomaly/birth defect. TEAE was defined as any AE that occurred after the start of initial study agent administration and those AEs that were presented at baseline but worsened in severity after the start of initial study agent administration. | The safety analysis set included all participants who received at least 1 (partial or complete) dose of study agent (the treated population). Per plan, data for adverse events was collected and analyzed per intervention. | Posted | Count of Participants | Participants | Cohorts A and B: Placebo: From Week 0 to Week 16; Cohorts A and B: Placebo Followed by Guselkumab 100 mg: From Week 16 to Week 112; Cohorts A and B: Guselkumab 100 mg: From Week 0 to Week 112 |
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Cohorts A and B: Placebo: From Week 0 to Week 16, Cohorts A and B: Placebo Followed by Guselkumab 100 mg: From Week 16 to Week 112, Cohorts A and B: Guselkumab 100 mg: From Week 0 to Week 112
The safety analysis set included all participants who received at least 1 (partial or complete) dose of study agent (the treated population). Per plan, data for adverse events was collected and analyzed per intervention.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort A: Placebo | Participants with predominant body moderate-to-severe plaque psoriasis received placebo matching to guselkumab by subcutaneous (SC) injection at Weeks 0, 4, and 12. | 0 | 26 | 0 | 26 | 5 | 26 |
| EG001 | Cohort A: Placebo Followed by Guselkumab 100 mg | Participants with predominant body moderate-to-severe plaque psoriasis who were randomized to receive placebo crossed-over to receive guselkumab 100 mg as SC injection at Weeks 16, 20, and then every 8 week (q8w) through Week 100. Participants were then followed up for safety up to 12 weeks (Week 112). | 0 | 25 | 1 | 25 | 8 | 25 |
| EG002 | Cohort A: Guselkumab 100 mg | Participants with predominant body moderate-to-severe plaque psoriasis received guselkumab 100 mg by SC injection at Weeks 0, 4 and then q8w through Week 100. Participants also received placebo at Week 16 to maintain the blind. Participants were then followed up for safety up to 12 weeks (Week 112). | 0 | 77 | 3 | 77 | 36 | 77 |
| EG003 | Cohort B: Placebo | Participants with predominant moderate-to-severe scalp psoriasis received placebo matching to guselkumab by SC injection at Weeks 0, 4, and 12. | 0 | 27 | 1 | 27 | 2 | 27 |
| EG004 | Cohort B: Placebo Followed by Guselkumab 100 mg | Participants with predominant moderate-to-severe scalp psoriasis who were randomized to receive placebo crossed-over to receive guselkumab 100 mg as SC injection at Weeks 16, 20, and then every 8 week (q8w) through Week 100. Participants were then followed up for safety up to 12 weeks (Week 112). | 0 | 24 | 0 | 24 | 8 | 24 |
| EG005 | Cohort B: Guselkumab 100 mg | Participants with predominant moderate-to-severe scalp psoriasis received guselkumab 100 mg by SC injection at Weeks 0, 4 and then q8w through Week 100. Participants also received placebo at Week 16 to maintain the blind. Participants were then followed up for safety up to 12 weeks (Week 112). | 0 | 81 | 3 | 81 | 43 | 81 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina Pectoris | Cardiac disorders | MedDRA Version 27.1 | Non-systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | MedDRA Version 27.1 | Non-systematic Assessment |
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| Perforation Bile Duct | Hepatobiliary disorders | MedDRA Version 27.1 | Non-systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
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| Gallbladder Abscess | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
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| Pyelonephritis | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
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| Viral Rash | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Food Poisoning | Gastrointestinal disorders | MedDRA Version 27.1 | Non-systematic Assessment |
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| Covid-19 | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
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| Tooth Abscess | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
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| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
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| Aspartate Aminotransferase Increased | Investigations | MedDRA Version 27.1 | Non-systematic Assessment |
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| Type 2 Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA Version 27.1 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 27.1 | Non-systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 27.1 | Non-systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA Version 27.1 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.1 | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 27.1 | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA Version 27.1 | Non-systematic Assessment |
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If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| ASSOCIATE DIRECTOR CLINICAL SCIENTIST | Janssen Research and Development, LLC | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 23, 2023 | May 28, 2026 | SAP_001.pdf |
| ID | Term |
|---|---|
| C000588857 | guselkumab |
Not provided
Not provided
Not provided
| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Black or African American |
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| Native Hawaiian or Other Pacific Islander |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Other |
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| UNITED STATES |
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| OG001 | Cohort A: Guselkumab 100 mg | Participants with predominant body moderate-to-severe plaque psoriasis received guselkumab 100 mg by SC injection at Weeks 0, 4 and then q8w through Week 100. Participants also received placebo at Week 16 to maintain the blind. Participants were then followed up for safety up to 12 weeks (Week 112). |
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| OG001 | Cohort B: Guselkumab 100 mg | Participants with predominant moderate-to-severe scalp psoriasis received guselkumab 100 mg by SC injection at Weeks 0, 4 and then q8w through Week 100. Participants also received placebo at Week 16 to maintain the blind. Participants were then followed up for safety up to 12 weeks (Week 112). |
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| OG001 | Cohort A: Guselkumab 100 mg | Participants with predominant body moderate-to-severe plaque psoriasis received guselkumab 100 mg by SC injection at Weeks 0, 4 and then q8w through Week 100. Participants also received placebo at Week 16 to maintain the blind. Participants were then followed up for safety up to 12 weeks (Week 112). |
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| OG001 | Cohort A: Guselkumab 100 mg | Participants with predominant body moderate-to-severe plaque psoriasis received guselkumab 100 mg by SC injection at Weeks 0, 4 and then q8w through Week 100. Participants also received placebo at Week 16 to maintain the blind. Participants were then followed up for safety up to 12 weeks (Week 112). |
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| OG001 | Cohort A: Guselkumab 100 mg | Participants with predominant body moderate-to-severe plaque psoriasis received guselkumab 100 mg by SC injection at Weeks 0, 4 and then q8w through Week 100. Participants also received placebo at Week 16 to maintain the blind. Participants were then followed up for safety up to 12 weeks (Week 112). |
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| OG001 | Cohort A: Guselkumab 100 mg | Participants with predominant body moderate-to-severe plaque psoriasis received guselkumab 100 mg by SC injection at Weeks 0, 4 and then q8w through Week 100. Participants also received placebo at Week 16 to maintain the blind. Participants were then followed up for safety up to 12 weeks (Week 112). |
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| OG001 | Cohort A: Guselkumab 100 mg | Participants with predominant body moderate-to-severe plaque psoriasis received guselkumab 100 mg by SC injection at Weeks 0, 4 and then q8w through Week 100. Participants also received placebo at Week 16 to maintain the blind. Participants were then followed up for safety up to 12 weeks (Week 112). |
| OG002 | Cohort B: Placebo Followed by Guselkumab 100 mg | Participants with predominant moderate-to-severe scalp psoriasis received placebo matching to guselkumab by SC injection at Weeks 0, 4, and 12, and then crossed-over to receive guselkumab 100 mg as SC injection at Weeks 16, 20, and then q8w through Week 100. Participants were then followed up for safety up to 12 weeks (Week 112). |
| OG003 | Cohort B: Guselkumab 100 mg | Participants with predominant moderate-to-severe scalp psoriasis received guselkumab 100 mg by SC injection at Weeks 0, 4 and then q8w through Week 100. Participants also received placebo at Week 16 to maintain the blind. Participants were then followed up for safety up to 12 weeks (Week 112). |
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| OG001 | Cohort A: Guselkumab 100 mg | Participants with predominant body moderate-to-severe plaque psoriasis received guselkumab 100 mg by SC injection at Weeks 0, 4 and then q8w through Week 100. Participants also received placebo at Week 16 to maintain the blind. Participants were then followed up for safety up to 12 weeks (Week 112). |
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| OG001 | Cohort A: Guselkumab 100 mg | Participants with predominant body moderate-to-severe plaque psoriasis received guselkumab 100 mg by SC injection at Weeks 0, 4 and then q8w through Week 100. Participants also received placebo at Week 16 to maintain the blind. Participants were then followed up for safety up to 12 weeks (Week 112). |
| OG002 | Cohort B: Placebo Followed by Guselkumab 100 mg | Participants with predominant moderate-to-severe scalp psoriasis received placebo matching to guselkumab by SC injection at Weeks 0, 4, and 12, and then crossed-over to receive guselkumab 100 mg as SC injection at Weeks 16, 20, and then q8w through Week 100. Participants were then followed up for safety up to 12 weeks (Week 112). |
| OG003 | Cohort B: Guselkumab 100 mg | Participants with predominant moderate-to-severe scalp psoriasis received guselkumab 100 mg by SC injection at Weeks 0, 4 and then q8w through Week 100. Participants also received placebo at Week 16 to maintain the blind. Participants were then followed up for safety up to 12 weeks (Week 112). |
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| OG001 | Cohort A: Guselkumab 100 mg | Participants with predominant body moderate-to-severe plaque psoriasis received guselkumab 100 mg by SC injection at Weeks 0, 4 and then q8w through Week 100. Participants also received placebo at Week 16 to maintain the blind. Participants were then followed up for safety up to 12 weeks (Week 112). |
| OG002 | Cohort B: Placebo Followed by Guselkumab 100 mg | Participants with predominant moderate-to-severe scalp psoriasis received placebo matching to guselkumab by SC injection at Weeks 0, 4, and 12, and then crossed-over to receive guselkumab 100 mg as SC injection at Weeks 16, 20, and then q8w through Week 100. Participants were then followed up for safety up to 12 weeks (Week 112). |
| OG003 | Cohort B: Guselkumab 100 mg | Participants with predominant moderate-to-severe scalp psoriasis received guselkumab 100 mg by SC injection at Weeks 0, 4 and then q8w through Week 100. Participants also received placebo at Week 16 to maintain the blind. Participants were then followed up for safety up to 12 weeks (Week 112). |
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| OG001 | Cohort B: Guselkumab 100 mg | Participants with predominant moderate-to-severe scalp psoriasis received guselkumab 100 mg by SC injection at Weeks 0, 4 and then q8w through Week 100. Participants also received placebo at Week 16 to maintain the blind. Participants were then followed up for safety up to 12 weeks (Week 112). |
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Participants with predominant moderate-to-severe scalp psoriasis received guselkumab 100 mg by SC injection at Weeks 0, 4 and then q8w through Week 100. Participants also received placebo at Week 16 to maintain the blind. Participants were then followed up for safety up to 12 weeks (Week 112). |
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| OG001 | Cohort B: Guselkumab 100 mg | Participants with predominant moderate-to-severe scalp psoriasis received guselkumab 100 mg by SC injection at Weeks 0, 4 and then q8w through Week 100. Participants also received placebo at Week 16 to maintain the blind. Participants were then followed up for safety up to 12 weeks (Week 112). |
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|
| OG001 | Cohort B: Guselkumab 100 mg | Participants with predominant moderate-to-severe scalp psoriasis received guselkumab 100 mg by SC injection at Weeks 0, 4 and then q8w through Week 100. Participants also received placebo at Week 16 to maintain the blind. Participants were then followed up for safety up to 12 weeks (Week 112). |
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| OG002 | Cohort A: Guselkumab 100 mg | Participants with predominant body moderate-to-severe plaque psoriasis received guselkumab 100 mg by SC injection at Weeks 0, 4 and then q8w through Week 100. Participants also received placebo at Week 16 to maintain the blind. Participants were then followed up for safety up to 12 weeks (Week 112). |
| OG003 | Cohort B: Placebo | Participants with predominant moderate-to-severe scalp psoriasis received placebo matching to guselkumab by SC injection at Weeks 0, 4, and 12. |
| OG004 | Cohort B: Placebo Followed by Guselkumab 100 mg | Participants with predominant moderate-to-severe scalp psoriasis who were randomized to receive placebo crossed-over to receive guselkumab 100 mg as SC injection at Weeks 16, 20, and then every 8 week (q8w) through Week 100. Participants were then followed up for safety up to 12 weeks (Week 112). |
| OG005 | Cohort B: Guselkumab 100 mg | Participants with predominant moderate-to-severe scalp psoriasis received guselkumab 100 mg by SC injection at Weeks 0, 4 and then q8w through Week 100. Participants also received placebo at Week 16 to maintain the blind. Participants were then followed up for safety up to 12 weeks (Week 112). |
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Participants with predominant body moderate-to-severe plaque psoriasis who were randomized to receive placebo crossed-over to receive guselkumab 100 mg as SC injection at Weeks 16, 20, and then every 8 week (q8w) through Week 100. Participants were then followed up for safety up to 12 weeks (Week 112). |
| OG002 | Cohort A: Guselkumab 100 mg | Participants with predominant body moderate-to-severe plaque psoriasis received guselkumab 100 mg by SC injection at Weeks 0, 4 and then q8w through Week 100. Participants also received placebo at Week 16 to maintain the blind. Participants were then followed up for safety up to 12 weeks (Week 112). |
| OG003 | Cohort B: Placebo | Participants with predominant moderate-to-severe scalp psoriasis received placebo matching to guselkumab by SC injection at Weeks 0, 4, and 12. |
| OG004 | Cohort B: Placebo Followed by Guselkumab 100 mg | Participants with predominant moderate-to-severe scalp psoriasis who were randomized to receive placebo crossed-over to receive guselkumab 100 mg as SC injection at Weeks 16, 20, and then every 8 week (q8w) through Week 100. Participants were then followed up for safety up to 12 weeks (Week 112). |
| OG005 | Cohort B: Guselkumab 100 mg | Participants with predominant moderate-to-severe scalp psoriasis received guselkumab 100 mg by SC injection at Weeks 0, 4 and then q8w through Week 100. Participants also received placebo at Week 16 to maintain the blind. Participants were then followed up for safety up to 12 weeks (Week 112). |
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