NCT05272150: VISIBLE

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

Completed Phase 3 Last updated 12 September 2025

What this trial tests

Phase 3 trial testing Guselkumab in Plaque Psoriasis in 213 participants. Completed in 30 May 2025.

Timeline

13 July 2022

Primary endpoint
30 May 2025

30 May 2025

Quick facts

Lead sponsor	Janssen Research & Development, LLC
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	213
Start date	13 July 2022
Primary completion	30 May 2025
Estimated completion	30 May 2025
Sites	94 locations across Canada, United States

Drugs / interventions tested

• Guselkumab (GUSELKUMAB) — full drug profile →
• Placebo

Conditions studied

• Plaque Psoriasis — all drugs for Plaque Psoriasis →
• Scalp Psoriasis — all drugs for Scalp Psoriasis →

Sponsor

Janssen Research & Development, LLC — full company profile →

Who can join

18 and older, any sex, with Plaque Psoriasis or Scalp Psoriasis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Improving Diversity in a Novel Psoriasis Study: VISIBLE as a Framework for Clinical Trial Quality Improvement.
   Alexis A, McMichael A, Vashi N, Bhutani T, et al · · 2025 · cited 8× · PMID 39661358 · DOI 10.1001/jamadermatol.2024.5103
2. Psoriasis in People With Skin of Color: An Evidence-Based Update.
   Gkini MA, Nakamura M, Alexis AF, Londoño-Garcia A, et al · · 2025 · cited 7× · PMID 39887710 · DOI 10.1111/ijd.17651
3. Guselkumab for Moderate to Severe Scalp Psoriasis Across All Skin Tones: Cohort B of the VISIBLE Randomized Clinical Trial.
   McMichael A, Shahriari M, Stein Gold L, Alkousakis T, et al · · 2025 · cited 4× · PMID 40560554 · DOI 10.1001/jamadermatol.2025.1849
4. Guselkumab for Moderate to Severe Psoriasis Across All Skin Tones: Cohort A of the VISIBLE Randomized Clinical Trial.
   Alexis A, McMichael A, Soung J, Choi O, et al · · 2025 · cited 2× · PMID 40560559 · DOI 10.1001/jamadermatol.2025.1836
5. Optimizing the management of psoriasis in patients with skin of color: A Canadian Delphi consensus.
   Yadav G, Miller-Monthrope Y, Rao J, Adam DN, et al · · 2025 · cited 1× · PMID 39898016 · DOI 10.1016/j.jdin.2024.09.015
6. Psoriasis in skin of color: clinical presentation, diagnostic challenges, and therapeutic considerations.
   Costa A, Romiti R. · · 2026 · PMID 42150334 · DOI 10.1016/j.abd.2026.501365
7. The Impact of Post-inflammatory Pigment Alteration After Psoriasis: Novel Data from the VISIBLE Study.
   Alexis A, McMichael A, Vashi N, Bhutani T, et al · · 2026 · PMID 41770445 · DOI 10.1007/s13555-026-01688-z
8. IL-23 Inhibitors in Psoriasis: What Have We Learnt so Far?
   Megna M, D'Agostino M, Feo F, Ventura V, et al · · 2026 · PMID 41709961 · DOI 10.2147/jir.s540848