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Positive topline results were announced from a second phase 3 study evaluating delgocitinib cream in adult patients with moderate to severe chronic hand eczema.
The phase 3 DELTA 2 study (ClinicalTrials.gov Identifier: NCT04872101) compared delgocitinib cream, a topical pan-Janus kinase (JAK) inhibitor, to vehicle in patients with moderate to severe chronic hand eczema. The primary endpoint was the Investigator’s Global Assessment for chronic hand eczema (IGA-CHE) treatment success at week 16. Treatment success was defined as an IGA-CHE score of 0 (clear) or 1 (almost clear) with at least a 2-step improvement from baseline.
Compared with vehicle cream, treatment with delgocitinib cream was associated with a statistically significant improvement in chronic hand eczema at week 16. Additionally, a significantly larger proportion of patients treated with delgocitinib cream had early symptom relief compared with those treated with vehicle cream.
Detailed results from DELTA-2 will be submitted for scientific presentation and publication at a later date. Findings from DELTA-2 confirm the positive results previously reported from the DELTA-1 trial.
“It is incredibly exciting to see the level of consistency that our DELTA 2 results show in line with the positive DELTA-1 results announced late last year”, said Jörg Möller, Executive Vice President, Global Research & Development, LEO Pharma. “These results bring us one step closer towards establishing delgocitinib as a best-in-class innovative topical treatment for patients affected by this hard-to-treat disease.”
Reference
LEO Pharma announces positive phase 3 topline results from DELTA 2 trial with delgocitinib cream in adults with moderate to severe chronic hand eczema (CHE), confirming the positive results of the recent DELTA 1 Trial. News release. LEO Pharma. Accessed February 13, 2023. https://www.businesswire.com/news/home/20230209005440/en/LEO-Pharma-Announces-Positive-Phase-3-Topline-Results-From-DELTA-2-Trial-With-Delgocitinib-Cream-in-Adults-With-Moderate-to-Severe-Chronic-Hand-Eczema-CHE-Confirming-the-Positive-Results-of-the-Recent-DELTA-1-Trial.
