VISIBLE: Study of Guselkumab in Skin of Color Participants With Moderate-to-severe Plaque and/or Scalp Psoriasis
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Cohort A: Moderate-to-severe Plaque Psoriasis Participants will receive either guselkumab subcutaneously (SC) or placebo SC. Placebo participants will then crossover to receive guselkumab SC. |
Drug: Guselkumab
Participants will receive guselkumab as subcutaneous injection.
Other Names:
Drug: Placebo
Participants will receive placebo as subcutaneous injection.
|
| Experimental: Cohort B: Moderate-to-severe Scalp Psoriasis Participants will receive either guselkumab SC or placebo SC. Placebo participants will then crossover to receive guselkumab SC. |
Drug: Guselkumab
Participants will receive guselkumab as subcutaneous injection.
Other Names:
Drug: Placebo
Participants will receive placebo as subcutaneous injection.
|
Outcome Measures
Primary Outcome Measures
- Cohort A: Percentage of Participants who Achieve Psoriasis Area and Severity Index (PASI) 90 Response at Week 16 [Week 16]
A PASI 90 response is defined as greater than or equal to (>=) 90 percent (%) improvement in PASI score from baseline. 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: head, trunk, upper, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease.
- Cohort A: Percentage of Participants who Achieve an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16 [Week 16]
Percentage of participants with IGA score of 0 (cleared) or 1 (minimal) will be reported. The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
- Cohort B: Percentage of Participants who Achieve Psoriasis Scalp Severity Index (PSSI) 90 Response at Week 16 [Week 16]
A PSSI 90 response is defined as >=90% reduction in PSSI score from baseline. The PSSI measures the extent of psoriasis involvement and the severity of erythema, infiltration, and desquamation of the scalp. Involved scalp area is measured on a scale from 0 (0% of scalp involved) to 6 (90-100% of scalp involved), clinical symptoms are each rated from 0 (absent) to 4 (severest possible). Involvement and severity of psoriasis for the PSSI is scored by physicians using a scale from 0 to 72, where 0=no psoriasis, and higher scores indicating more severe disease.
- Cohort B: Percentage of Participants who Achieve Scalp-specific Investigator Global Assessment (ss-IGA) Score of Absence of Disease (0) or Very Mild Disease (1) at Week 16 [Week 16]
Percentage of participants with ss-IGA score 0 (absence of disease) or 1 (very mild disease) will be reported. The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. The lesions are assessed in terms of the clinical signs of redness, thickness, and scaliness which are scored as: absence of disease (0), very mild disease (1), mild disease (2), moderate disease (3), and severe disease (4).
Secondary Outcome Measures
- Cohort A: Percentage of Participants who Achieve IGA Score of Cleared (0) at Week 16 [Week 16]
Percentage of participants with IGA score 0 (cleared) will be reported. The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
- Cohort A: Percentage of Participants who Achieve PASI 100 Response at Week 16 [Week 16]
A PASI 100 response is defined as 100% improvement in PASI score from baseline. 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: head, trunk, upper, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease.
- Cohort A: Change from Baseline in PASI Score at Week 16 [Baseline and 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: head, trunk, upper, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The individual scores are multiplied by a weighted factor for each body region; the sum of these scores gives the total PASI score. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease.
- Cohort A: Change from Baseline in Body Surface Area (BSA) at Week 16 [Baseline and Week 16]
Change from baseline in BSA 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).
- Cohort A: Time to >=90% Reduction in PASI Score [Up to Week 16]
Time to >=90% reduction in PASI score will be reported which is defined as time to achieve >=90% improvement in PASI. 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: head, trunk, upper, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease.
- Cohorts A and B: Change from Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16 [Baseline and Week 16]
Change from baseline in DLQI score at Week 16 will be reported. The DLQI is a dermatology specific quality of life instrument designed to assess the impact of dermatologic disease on a participant's quality of life (QoL). It is a 10 item patient-reported outcome(s) (PRO) questionnaire that, in addition to evaluating overall QoL, can be used to assess 6 different aspects that may affect QoL: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. The DLQI produces a numeric score that can range from 0 to 30. A higher score indicates more severe disease.
- Cohort A: Percentage of Participants who Achieve >= 4-point Reduction (Improvement) from Baseline in the Psoriasis Symptom and Sign Diary (PSSD) Itch Score at Week 16, Among Participants with Baseline PSSD Itch >= 4 at Baseline [Week 16]
Percentage of participants who achieve >=4-point reduction (improvement) from baseline in PSSD itch score at Week 16 among participants with baseline PSSD itch >=4 at baseline will be reported. The PSSD includes PRO questionnaires designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefits. The participants are asked to answer the questions thinking about either the last 24 hours (24-hour recall version) or the last 7 days (7 days recall version). Both versions include 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 subscores will be derived, each ranging from 0-100: the psoriasis symptom score and the psoriasis sign score. A higher score indicates more severe disease.
- Cohorts A and B: Percentage of Participants who Achieve a PSSD Symptom Score of 0 at Week 16, Among Randomized Participants with Baseline PSSD Symptom Score >=1 [Week 16]
Percentage of participants who achieve a PSSD symptom score of 0 at Week 16 among randomized participants with baseline PSSD symptom score >=1 will be reported. The PSSD includes PRO questionnaires designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefits. The participants are asked to answer the questions thinking about either the last 24 hours (24-hour recall version) or the last 7 days (7 days recall version). Both versions include 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 subscores will be derived, each ranging from 0-100: the psoriasis symptom score and the psoriasis sign score. A higher score indicates more severe disease.
- Cohorts A and B: Change from Baseline in PSSD Symptom Score at Week 16 [Baseline and Week 16]
Change from baseline in PSSD symptom score at Week 16 will be reported. The PSSD includes PRO questionnaires designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefits. The participants are asked to answer the questions thinking about either the last 24 hours (24-hour recall version) or the last 7 days (7 days recall version). Both versions include 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 subscores will be derived, each ranging from 0-100: the psoriasis symptom score and the psoriasis sign score. A higher score indicates more severe disease.
- Cohort B: Percentage of Participants who Achieve ss-IGA Score of Absence of Disease (0) at Week 16 [Week 16]
Percentage of participants with ss-IGA score 0 (absence of disease) will be reported. The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. The lesions are assessed in terms of the clinical signs of redness, thickness, and scaliness which are scored as: absence of disease (0), very mild disease (1), mild disease (2), moderate disease (3), and severe disease (4).
- Cohort B: Change from Baseline in Scalp Surface Area (SSA) at Week 16 [Baseline and Week 16]
Change from baseline in SSA at Week 16 will be reported. The SSA is a measurement of involved skin on the scalp. The overall SSA affected by psoriasis will be estimated based on the participant's thumb.
- Cohort B: Percentage of Participants who Achieve PSSI 100 Response at Week 16 [Week 16]
A PSSI 100 response is defined as 100% reduction in PSSI score from baseline. The PSSI measures the extent of psoriasis involvement and the severity of erythema, infiltration, and desquamation of the scalp. Involved scalp area is measured on a scale from 0 (0% of scalp involved) to 6 (90-100% of scalp involved), clinical symptoms are each rated from 0 (absent) to 4 (severest possible). Involvement and severity of psoriasis for the PSSI is scored by physicians using a scale from 0 to 72, where 0=no psoriasis, and higher scores indicating more severe disease.
- Cohort B: Change from Baseline in PSSI Score at Week 16 [Baseline and Week 16]
Change from baseline in PSSI score at Week 16 will be reported. The PSSI measures the extent of psoriasis involvement and the severity of erythema, infiltration, and desquamation of the scalp. Involved scalp area is measured on a scale from 0 (0% of scalp involved) to 6 (90-100% of scalp involved), clinical symptoms are each rated from 0 (absent) to 4 (severest possible).The PSSI total score is a composite score derived from the sum of the scores for erythema, induration and desquamation multiplied by the score for the extent of scalp area involved (percent of scalp involved). Involvement and severity of psoriasis for the PSSI is scored by physicians using a scale from 0 to 72, where 0=no psoriasis, and higher scores indicating more severe disease.
- Cohort B: Time to >=90% Reduction in PSSI Score [Up to Week 16]
Time to >=90% reduction in PSSI score will be reported which is defined as time to achieve >=90% improvement in PSSI. The PSSI measures the extent of psoriasis involvement and the severity of erythema, infiltration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored by physicians using a scale from 0 to 72, where 0=no psoriasis, and higher scores indicating more severe disease.
- Cohort B: Percentage of Participants with >= 4 Point Reduction (Improvement) from Baseline in the Scalp Itch NRS Score at Week 16, Among Participants with Baseline Scalp Itch >=4 at Baseline [Week 16]
Percentage of participants with >=4 point reduction (improvement) from baseline in scalp itch NRS score, among participants with scalp itch >=4 at baseline will be reported. The scalp itch NRS is 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 participants will be asked to assess scalp itch and select a number on a scale of 0-10, where "0" represents no scalp itch, and "10" represents the worst imaginable scalp itch.
- Cohorts A and B: Number of Participants with Adverse Events (AEs) [Up to Week 116]
An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
- Cohorts A and B: Number of Participants with Serious Adverse Events (SAEs) [Up to Week 116]
SAE is an adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Have a diagnosis of plaque psoriasis (with or without psoriatic arthritis [PsA]) for at least 6 months before the first administration of study drug
-
Self-identify as non-white or non-caucasian
-
Be a candidate for phototherapy or systemic treatment for psoriasis
-
Have an involved body surface area (BSA) greater than or equal to (>=) 10 percent (%), psoriasis area and severity index (PASI) >=12, investigator global assessment (IGA)
=3 at screening and at baseline (Cohort A), or have a scalp surface area >=30%, psoriasis scalp severity index (PSSI) >=12, scalp specific investigator global assessment (ss-IGA) >=3, and one plaque outside of the scalp at screening and at baseline (Cohort B)
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Agree not to receive a live virus or live bacterial vaccination during the study, or within 12 weeks after the last administration of study intervention
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Agree not to receive a Bacillus Calmette-Guérin (BCG) vaccination during the study, and within 12 weeks after the last administration of study intervention
Exclusion Criteria:
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Has a nonplaque form of psoriasis (example: erythrodermic, guttate, or pustular)
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Has received ustekinumab, ixekizumab, secukinumab, or brodalumab within 12 weeks of first dose of study drug
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Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
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Participant has known allergies, hypersensitivity, or intolerance to guselkumab or its excipients
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Has or has had a serious infection (example: sepsis, pneumonia or pyelonephritis), or has been hospitalized or received intravenous antibiotics for an infection during the 2 months before screening
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Skin Wellness Dermatology | Birmingham | Alabama | United States | 35209 |
| 2 | The Regents of the University of California | San Francisco | California | United States | 94118 |
| 3 | FXM Clinical Research Ft. Lauderdale | Fort Lauderdale | Florida | United States | 33308 |
| 4 | FXM Clinical Research Miramar, LLC | Miami | Florida | United States | 33175 |
| 5 | FXM Clinical Research Miramar, LLC | Miramar | Florida | United States | 33027 |
| 6 | Water's Edge Dermatology Inc | Palm Beach Gardens | Florida | United States | 33410 |
| 7 | Marietta Dermatology Clinical Research | Marietta | Georgia | United States | 30060 |
| 8 | Boston University Medical Center | Boston | Massachusetts | United States | 02218 |
| 9 | Dermatology Consulting Services, PLLC | High Point | North Carolina | United States | 27262 |
| 10 | University Hospitals Cleveland Medical Center | Cleveland | Ohio | United States | 44106 |
| 11 | Oregon Medical Research Center | Portland | Oregon | United States | 97223 |
| 12 | Austin Institute for Clinical Research | Pflugerville | Texas | United States | 78660 |
Sponsors and Collaborators
- Janssen Research & Development, LLC
Investigators
- Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CR109163
- CNTO1959PSO3018