Systemic exposure and bioavailability of delgocitinib cream in adults with moderate to severe Chronic Hand Eczema
Bibliographic record
Abstract
BACKGROUND: Chronic Hand Eczema (CHE) is a prevalent inflammatory skin condition characterized by pain, pruritus and significant impact on patients' quality of life. Delgocitinib cream, a pan-Janus kinase inhibitor, has shown potential in targeting the key mediators of CHE. To develop a detailed trial drug safety profile, it is vital to assess systemic exposure and bioavailability following repeated drug applications. OBJECTIVES: This analysis aimed to evaluate the systemic exposure and bioavailability of delgocitinib cream 20 mg/g in adults with moderate to severe CHE and compare these parameters with those from oral delgocitinib administration in healthy adults. METHODS: An open-label, single-arm, Phase 1 trial (NCT05486117) was conducted involving 16 adults with moderate to severe CHE. Participants applied delgocitinib cream 20 mg/g twice daily for 1 week. Pharmacokinetic sampling was performed on Day (D)1 and D8. Systemic exposure was compared with data from two Phase 1 trials involving oral delgocitinib in healthy adults (1.5-12 mg, NCT05050279, and 1-100 mg, NBX1-1). RESULTS: ) was 2.5 h*ng/mL on D1 and 3.7 h*ng/mL on D8. No significant accumulation of delgocitinib was observed over time. Systemic exposure with topical application was significantly lower than with oral administration, with a relative bioavailability of 0.6%. Delgocitinib cream was well tolerated, with no reported adverse events during the trial. CONCLUSIONS: Delgocitinib cream shows minimal systemic exposure and is well tolerated in patients with moderate to severe CHE. These findings suggest that no systemic pharmacological effect is expected with the application of delgocitinib cream 20 mg/g to the hands and wrists of patients with moderate to severe CHE. CLINICALTRIALS: gov (or equivalent) listing: NCT05486117, NCT05050279.
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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 | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.001 | 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".