Danish pharmaceutical company Leo Pharma has reported positive data from the Phase III DELTA 3 clinical trial of delgocitinib cream to treat adult patients with moderate to severe chronic hand eczema (CHE).
The single-arm, open-label extension trial analysed the long-term safety of twice-daily application of the cream for up to 36 weeks.
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According to the findings, the long-term safety profile of the treatment was in line with data from the previous DELTA 1 and 2 trials.
In addition, delgocitinib cream was found to be well-tolerated over the trial duration of 36 weeks.
Subjects who were enrolled in the DELTA 3 trial after taking part in DELTA 1 and 2 showed similar symptom relief levels and success of the therapy.
Delgocitinib is an investigational topical pan-Janus kinase (JAK) inhibitor that inhibits the activation of JAK-STAT signaling, which plays a key role in the pathogenesis of CHE.
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By GlobalDataLEO Pharma chief development officer Kreesten Meldgaard Madsen said: “It is encouraging to see the level of consistency that these long-term results show, in line with the previous positive results from the pivotal DELTA 1 and 2 trials.
“This condition can have a negative impact on patient quality of life, physical functioning and ability to work, and there are currently no topical treatments specifically approved for moderate to severe chronic hand eczema.
“We will continue our work to investigate delgocitinib cream as a potential topical treatment for patients affected by this hard-to-treat disease.”
CHE is defined as an eczema of the hands that persists for longer than three months or relapses twice or more in a year.
Earlier this year, LEO Pharma reported positive data from the DELTA 2 trial of delgocitinib cream for moderate to severe CHE.
Patients treated with delgocitinib cream showed statistically significant improvement in CHE after 16 weeks, while the treatment was also found to be well-tolerated.
