Trial reportBritish journal of clinical pharmacology2025
Mild psoriasis as a suitable model for proof-of-mechanism in a phase 1B setting: Results from a double-blind placebo-controlled trial with guselkumab.
Trial report in British journal of clinical pharmacology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
2 citing papers in PubMed.
- Mild psoriasis as a suitable model for proof-of-mechanism in a phase 1B setting: Results from a double-blind placebo-controlled trial with guselkumab.British journal of clinical pharmacology · 2025Trial
- Multi-omics profiling of chronic immune-mediated skin diseases: SKINERGY protocol and strategic evaluation.Journal of the European Academy of Dermatology and Venereology : JEADV · 2026Observational
Corrections and comments
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Authors and funding
12 authors.
Funding
Abstract
aimsEarly clinical development of novel psoriasis therapies is hampered by a decreasing number of moderate-to-severe psoriasis patients eligible for participation in trials since efficacious treatments, such as biologics, have become widely available. The aim of this study was to establish mild psoriasis patients as a suitable alternative trial population since these patients are generally not eligible for these treatments.
methodsA randomized double-blind controlled trial was performed in 20 mild psoriasis patients (psoriasis area and severity index ≤5), randomized 3:1 to guselkumab 100 mg or placebo, and 5 moderate-to-severe psoriasis patients (psoriasis area and severity index ≥10) on guselkumab 100 mg. Clinical scoring was performed over 24 weeks and substantiated with multimodal imaging comprising multispectral imaging, optical coherence tomography and laser speckle contrast imaging.
resultsClinician-reported outcomes demonstrated significant treatment effects compared to placebo in mild patients. Focusing on a target plaque, severity scores significantly decreased during treatment with guselkumab only. Imaging demonstrated significant decreases in erythema, maximal height within-lesion and cutaneous perfusion compared to placebo. Plaques of mild and moderate-to-severe patients did not differ at baseline and showed similar treatment responses.
conclusionClinical scoring and multimodal lesion monitoring enabled the detection of a clear treatment effect of guselkumab in mild psoriasis patients. Although this trial was not powered to demonstrate equivalence between the severity groups, our results indicate that the treatment responses follow the same trend in mild and moderate-to-severe patients with a high degree of similarity. Therefore, mild patients can be considered a suitable study population for early phase proof-of-concept trials.
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