Delgocitinib cream, a potential first-in-class topical pan-Janus kinase (JAK) inhibitor for the treatment of adults with moderate-to-severe chronic hand eczema, has shown positive results in a phase 3 trial, its manufacturer Leo Pharma has announced.
The investigational delgocitinib cream inhibits the activation of JAK-STAT signalling, which plays a key role in the pathogenesis of chronic hand eczema.
The DELTA 1 and DELTA 2 randomised, double-blind, vehicle-controlled, multi-centre phase 3
clinical trials sought to evaluate the efficacy of twice-daily applications of delgocitinib cream compared with placebo in the treatment of adults with moderate-to-severe chronic hand eczema.
In these initial trials, 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 two-step improvement from baseline. Additional IGA-CHE scores included 2 (mild), 3 (moderate), and 4 (severe).
Participants of the DELTA 1 and DELTA 2 trials who completed the 16-week, twice-daily treatment regimen of delgocitinib cream or the placebo were offered immediate enrolment onto the DELTA 3 single-arm, open-label extension trial.
This extension evaluated the long-term safety of twice-daily delgocitinib cream treatment applied as needed for up to 36 weeks.
DELTA 3 participants visited the clinic every four weeks to assess the safety and efficacy of the treatment, as well as its effect on patient-reported outcomes until Week 36, with a final follow-up phone call planned on Week 38.
Patients who had received delgocitinib cream in DELTA 1 and DELTA 2 maintained similar levels of symptom relief and treatment success over the additional 36-week treatment regimen.
Those who entered the DELTA 3 trial after receiving the placebo in the previous trials reached similar levels of treatment success as the patients previously treated with delgocitinib cream.
The long-term safety profile remained consistent between all three trials, and delgocitinib cream was generally well tolerated over the 36-week period.
Kreesten Meldgaard Madsen, chief development officer at LEO Pharma, 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.‘
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 chronic hand eczema. Detailed results from DELTA 3 are planned to be submitted for scientific presentation and publication at a later date.
Delgocitinib is not currently approved by any health regulators.