Targeted Oral Peptide Icotrokinra for Psoriasis Involving High-Impact Sites
Bibliographic record
Abstract
BACKGROUND: Plaque psoriasis involving high-impact sites is difficult to treat. Icotrokinra, a targeted oral peptide that selectively binds interleukin-23 receptors, is a new treatment being investigated for this condition. METHODS: This phase 3, double-blind, placebo-controlled trial randomly assigned participants 12 years of age and over with plaque psoriasis {with a body surface area ≥1%; an Investigator's Global Assessment (IGA) score ≥2 [clear (0), minimal (1), mild (2), moderate (3), and severe (4)] for overall skin; and at least moderate psoriasis involving the scalp, genitalia, and/or hands and feet} to receive either icotrokinra 200 mg daily or placebo in a 2:1 ratio. The primary end point at week 16 was the proportion of participants achieving an overall IGA score of 0 or 1 and an improvement of 2 points or more from baseline (IGA score of 0 or 1), reported as the between-group difference adjusted for high-impact site involvement, geographic region, and body surface area category using Mantel-Haenszel weights. Absent/clear or minimal/almost clear scalp, genital, and/or hand and foot psoriasis at 16 weeks were secondary end points. Adverse events were recorded. RESULTS: The trial randomly assigned 311 participants (icotrokinra, n=208; placebo, n=103) with scalp (n=252: icotrokinra, n=167; placebo, n=85), genital (n=140: icotrokinra, n=98; placebo, n=42), and/or hand and foot (n=71: icotrokinra, n=48; placebo, n=23) psoriasis. The proportions of participants achieving an IGA score of 0 or 1 in the icotrokinra and placebo groups were 56.7% and 5.8%, respectively [adjusted difference, 51.1 percentage points; 95% confidence interval (CI), 42.1 to 58.8; P<0.001]. The proportions of icotrokinra-treated and placebo-treated participants achieving absence/clear or minimal/almost clear high-impact site psoriasis were as follows: scalp, 65.9% and 10.6% (difference, 55.5 percentage points; 95% CI, 44.8 to 64.4; P<0.001); genitalia, 76.5% and 21.4% (difference, 55.4 percentage points; 95% CI, 39.1 to 68.0; P<0.001); and hand and foot, 41.7% and 26.1% (difference, 16.7 percentage points; 95% CI, -6.2 to 36.8; P=0.144). Adverse events occurred among 50% and 42% of participants in the icotrokinra and placebo groups, respectively. CONCLUSIONS: At 16 weeks, significantly higher proportions of participants 12 years of age and over with at least moderate psoriasis involving high-impact sites treated with icotrokinra versus placebo achieved clearance or minimal psoriasis in their skin overall and in the scalp and genital areas, but not in their hands and feet. No safety signals were identified. (Funded by Johnson & Johnson; ClinicalTrials.gov number, NCT06095102.).
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.004 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".