Phase 2b Dose-ranging Trial to Evaluate Delgocitinib Cream 1, 3, 8, and 20 mg/g Compared to Delgocitinib Cream Vehicle Over a 16-week Treatment Period in Adult Subjects With Chronic Hand Eczema

Summary

The purpose of this research trial was to test different strengths of a new trial medication, delgocitinib cream 1, 3, 8, and 20 mg/g, and to investigate how treatment with delgocitinib cream affects chronic hand eczema. This was judged by a range of assessments that rate the severity and extent of chronic hand eczema and its symptoms, as well as general health status and quality of life.

Timeline

Start

2018-11-28

Primary completion

2020-03-06

Completion

2020-04-20

Outcome

Met primary endpoint

registry analysis (superiority test); Delgocitinib Cream 8 mg/g vs Delgocitinib Cream Vehicle; p <0.001; Risk Difference (RD) 28.22 (95% CI 13.8 to 42.64) NCT03683719 ↗

registry analysis (superiority test); Delgocitinib Cream 20 mg/g vs Delgocitinib Cream Vehicle; p <0.001; Risk Difference (RD) 29.61 (95% CI 14.56 to 44.67) NCT03683719 ↗

Publications

• Buhl T, Bauer A, Ehst BD, Thyssen JP, Hahn-Pedersen J, Hagen BF, Apol ED, Agner T. Health-Related Quality of Life in Chronic Hand Eczema in a Phase 2b Trial of Delgocitinib Cream. Dermatol Ther (Heidelb). 2025 May;15(5):1181-1193. doi: 10.1007/s13555-025-01384-4. Epub 2025 Apr 5.
• Weisshaar E, Yuksel YT, Agner T, Larsen LS, Grant L, Arbuckle R, Jones AM, Fromy P, Balita-Crisostomo CL, Mathiasen NN, Thoning H, Apfelbacher C. Development and Validation of a Patient-Reported Outcome Measure of the Impact of Chronic Hand Eczema on Health-Related Quality of Life: the Hand Eczema Impact Scale (HEIS). Dermatol Ther (Heidelb). 2024 Nov;14(11):3047-3070. doi: 10.1007/s13555-024-01267-0. Epub 2024 Oct 21.
• Molin S, Larsen LS, Joensson P, Oesterdal ML, Arbuckle R, Grant L, Skingley G, Schuttelaar MLA. Development and Psychometric Validation of a Patient-Reported Outcome Measure to Assess the Signs and Symptoms of Chronic Hand Eczema: The Hand Eczema Symptom Diary (HESD). Dermatol Ther (Heidelb). 2024 Mar;14(3):643-669. doi: 10.1007/s13555-024-01114-2. Epub 2024 Mar 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Delgocitinib	Small molecule	1 unknown	Topical
Subject	Delgocitinib	Small molecule	3 unknown	Topical
Subject	Delgocitinib	Small molecule	8 unknown	Topical
Subject	Delgocitinib	Small molecule	20 unknown	Topical

Indications

No indication recorded.