Study of Guselkumab in Skin of Color Participants With Moderate-to-severe Plaque and/or Scalp Psoriasis

Lead sponsor

Janssen Research & Development, LLC is the lead sponsor of 912 studies on the registry; 76 are open to participants now.

Of its 278 completed or terminated interventional studies of FDA-regulated products, 131 (47%) have results posted.

Study arms

• 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 · Drug: Placebo

• 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 · Drug: Placebo

Interventions

• DrugGuselkumab

  Participants will receive guselkumab as subcutaneous injection.

  Also known as: CNTO1959, Tremfya

• DrugPlacebo

  Participants will receive placebo as subcutaneous injection.

Primary outcomes

1. 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.

   Time frame: Week 16

2. 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.

   Time frame: Week 16

3. 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.

   Time frame: Week 16

4. 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.

   Time frame: Week 16

Secondary outcomes

1. 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.

   Time frame: Week 16

2. 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.

   Time frame: Week 16

3. 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.

   Time frame: Baseline (Week 0), Week 16

4. 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.

   Time frame: Baseline (Week 0), Week 16

5. 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.

   Time frame: From baseline (Week 0) up to Week 16

6. 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.

   Time frame: Baseline (Week 0), Week 16

7. 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.

   Time frame: Week 16

8. 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.

   Time frame: Baseline (Week 0), Week 16

9. 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.

   Time frame: Week 16

10. 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.

    Time frame: Baseline (Week 0), Week 16

11. 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.

    Time frame: Baseline (Week 0), Week 16

12. 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.

    Time frame: Week 16

13. 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.

    Time frame: Week 16

14. 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.

    Time frame: From Baseline (Week 0) up to Week 16

15. 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.

    Time frame: Week 16

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.

    Time frame: 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

17. 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.

    Time frame: 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

Baseline characteristics

Publications

• 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. PubMed 41770445 ↗
• 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. PubMed 40560559 ↗
• 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. PubMed 40560554 ↗
• 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. PubMed 39661358 ↗

Study documents

• Study protocol · Nov 2, 2022
• Statistical analysis plan · Jun 23, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — 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