Phase 3
N=338
Study of Guselkumab Versus Placebo for the Treatment of Low Body Surface Area Moderate Plaque Psoriasis
Moderate Plaque Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT06039189 ↗Enrolled (actual)
338
Serious AEs
3.4%
Results posted
May 2026
Primary outcome: Primary: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16 — 12.4; 74.2 Percentage of participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Guselkumab (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Janssen Research & Development, LLC
- Primary completion
- Apr 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16 |
12.4; 74.2 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Body Surface Area (BSA) at Week 16 |
-5.6; -80.5 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Psoriasis Area Severity Index (PASI) Total Score at Week 16 |
-13.6; -82.6 | <0.001 sig |
| SECONDARY Percentage of Participants Who Achieved IGA Score of Cleared (0) at Week 16 |
3.5; 40.4 | <0.001 sig |
| SECONDARY Percentage of Participants Who Achieved PASI 90 Response at Week 16 |
6.2; 52.9 | <0.001 sig |
| SECONDARY Percentage of Participants Who Achieved PASI 100 Response at Week 16 |
2.7; 32.4 | <0.001 sig |
| SECONDARY Percentage of Participants Who Achieved Scalp Specific (ss)-IGA Score of Absence of Disease (0) or Very Mild Disease (1) at Week 16 Among Randomized Participants With Ss-IGA Score >=3 at Baseline |
14.5; 75.0 | <0.001 sig |
| SECONDARY Percentage of Participants Who Achieved Static Physician's Global Assessment of Genitalia (sPGA-G) Score of 0 or 1 at Week 16 Among Randomized Participants With sPGA-G Score >=3 at Baseline |
37.5; 78.0 | <0.001 sig |
| SECONDARY Percentage of Participants Who Achieved Intertriginous IGA (i-IGA) Score of Clear (0) or Minimal (1) at Week 16 Among Randomized Participants With an i-IGA Score >=3 at Baseline |
28.8; 86.5 | <0.001 sig |
| SECONDARY Percentage of Participants Who Achieved Facial IGA (f-IGA) Score of Clear (0) or Minimal (1) at Week 16 Among Randomized Participants With f-IGA Score >=3 at Baseline |
28.6; 87.8 | <0.001 sig |
| SECONDARY Change From Baseline in Psoriasis Symptom and Sign Diary (PSSD) Total Symptom Score at Week 16 |
0.37; -36.08 | <0.001 sig |
| SECONDARY Percentage of Participants Who Achieved >=4-Point Improvement From Baseline in PSSD Itch Score at Week 16 Among Participants With a PSSD Itch Score >=4 at Baseline |
12.5; 62.7 | <0.001 sig |
| SECONDARY Percentage of Participants Who Achieved PSSD Individual Symptom Scale Score=0 at Week 16 Among Participants With a PSSD Symptom Score >0 at Baseline |
2.7; 21.9 | <0.001 sig |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
45; 56; 138 | — |
| SECONDARY Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) |
1; 2; 12 | — |
Summary
The purpose of this study is to evaluate the efficacy of guselkumab compared to an inactive drug in participants with low body surface area moderate plaque psoriasis and special site involvement.
Eligibility Criteria
Inclusion Criteria
- All participants must have a diagnosis of plaque psoriasis (with or without psoriatic arthritis) for at least 6 months before first administration of study intervention
- All participants must meet the following disease severity criteria at screening and at baseline: (a) Overall Investigator's Global Assessment (IGA) 3 (moderate) plaque psoriasis; (b) Body Surface Area (BSA) 2-15 percent (%) with at least 1 plaque outside of special sites; (c) Involvement of at least 1 special site with at least moderate severity. Qualifying sites include scalp with scalp-specific IGA greater than or equal to (>=) 3, face with facial psoriasis IGA >=3, intertriginous with intertriginous psoriasis IGA >=3, or genital with static physician global assessment of genitalia (sPGA-G) >=3
- All participants be inadequately controlled with or intolerant of at least 1 prior topical therapy (including, but not limited to, corticosteroids, retinoids, vitamin D, or vitamin D/steroid and retinoid/steroid combinations, tacrolimus, pimecrolimus, anthralin/dithranol, coal tar preparations, tapinarof, roflumilast, etcetera) for the treatment of psoriasis at both screening
- All participants be a candidate for phototherapy or systemic treatment for psoriasis
Exclusion Criteria
- Has a nonplaque form of psoriasis (example, erythrodermic, guttate, or pustular) at screening or randomization
- Has current drug-induced psoriasis (for example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
- For participants with palmoplantar involvement, confounding diagnoses, including, but not limited, to palmoplantar pustulosis, eczematous dermatitis, contact/irritant dermatitis, acquired keratoderma, etcetera, should be confirmed and excluded
- Participants will not be eligible if they have ever received prior biologic (or biosimilars of) for the treatment of psoriasis, psoriatic arthritis (PsA), or any other indications that could impact the assessment of psoriasis. Prior biologics (or biosimilars of) may include, but not limited to, tumor necrosis factor (TNF)-inhibitors (for example: adalimumab, etanercept, infliximab, or certolizumab or biosimilars), interleukin (IL)-17 inhibitors (for example: secukinumab, ixekizumab, brodalumab, or bimekizumab), and IL-12/23 inhibitors (for example: ustekinumab), or IL-23 inhibitor (for example: guselkumab, risankizumab or tildrakizumab)
- Has a history of chronic or recurrent infectious disease, including, but not limited to, chronic renal infection, chronic chest infection (for example, bronchiectasis), recurrent urinary tract infection (recurrent pyelonephritis or chronic non-remitting cystitis), fungal infection (mucocutaneous candidiasis), or open, draining, or infected skin wounds or ulcers
Data sourced from ClinicalTrials.gov (NCT06039189). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.