LEO Pharma announced positive results of the DELTA 2 trial, the second of two pivotal phase 3 clinical trials evaluating delgocitinib cream, an investigational topical pan-Janus kinase (JAK)-inhibitor for the potential treatment of adults with moderate to severe chronic hand eczema (CHE).

The trial met its primary endpoint with a statistically significant improvement in CHE after 16 weeks of treatment with delgocitinib cream compared to cream vehicle, and the treatment was well tolerated, according to LEO Pharma. All or most of the signs and symptoms of CHE were cleared early in the treatment period for a significantly larger proportion of patients treated with delgocitinib cream compared to subjects treated with cream vehicle. DELTA 2 is the second phase 3 trial to achieve its primary and all key secondary endpoints, confirming the positive results of 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,” Jörg Möller, executive vice president, global research & development, LEO Pharma, said in a company news release. "CHE is a condition that we know can have a hugely negative impact on patient quality of life, physical functioning, and ability to work. 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."

Subjects who completed 16 weeks of treatment in trials DELTA 1 or DELTA 2 were offered to roll-over to the DELTA 3 extension trial to evaluate the long-term effects of delgocitinib cream.[2]

Further analyses of the data set will be conducted to determine the full potential of delgocitinib cream in the treatment of adults with moderate to severe CHE. Detailed results from DELTA 2 are to be submitted for scientific presentation and publication at a later date.

For more information on the DELTA 2 trial (NCT04872101) go to clinicaltrials.gov.

About the DELTA Trials

The primary objective for the randomized, double-blind, vehicle-controlled, multicenter phase 3 clinical trials (DELTA 1 and DELTA 2) is to evaluate the efficacy of twice-daily applications of delgocitinib cream compared with cream vehicle in the treatment of adults with moderate-to-severe CHE.[3,4]

The primary endpoint of the trials is the Investigator’s Global Assessment (IGA) for CHE treatment success (IGA-CHE TS) at week 16. Treatment success is defined as an IGA-CHE score of 0 (clear) or 1 (almost clear, with little or no disease left) with at least a two-step improvement from baseline. Additional IGA-CHE scores include 2 (mild), 3 (moderate), and 4 (severe).

Key secondary endpoints at week 16 include reduction of itch and pain scores of 4 or more points measured by the Hand Eczema Symptom Diary (HESD) from baseline to week 16 as well as at least a 75% improvement from baseline and at least a 90% improvement from baseline on the Hand Eczema Severity Index (HECSI) at week 16. The number of treatment-emergent adverse events from baseline to week 16 defines the key safety endpoint of the trials.

Subjects who completed 16 weeks of treatment with delgocitinib cream or cream vehicle twice daily in trials DELTA 1 or DELTA 2 were offered to roll-over to the DELTA 3 extension trial. The purpose of this extension trial is to evaluate the long-term effects of delgocitinib.[2]

References

1 A Elsner P, Agner T. J Eur Acad Dermatol Venereol. 2020;34(Suppl. 1):13–21
2 ClinicalTrials.Gov:https://clinicaltrials.gov/ct2/show/NCT04949841 (Accessed Jan 2023).
3 ClinicalTrials.Gov:https://clinicaltrials.gov/ct2/show/NCT04871711 (Accessed Jan 2023).
4 ClinicalTrials.Gov:https://clinicaltrials.gov/ct2/show/NCT04872101 (Accessed Jan 2023).