Positive Results Reported From Delgocitinib CHE Trial in China
Positive results were announced for the primary endpoint from the double-blind treatment period of the DELTA China phase 3 clinical trial with Anzupgo® (delgocitinib) 20mg/g cream, a topical pan-Janus kinase (JAK) inhibitor, for the potential treatment of Chinese adults and adolescents (aged 12 and above) with moderate to severe chronic hand eczema (CHE) for whom topical corticosteroids are inadequate or inappropriate, according to a press release from LEO Pharma.
The phase 3 trial consists of a 16-week randomized, double-blind, vehicle-controlled, treatment period, followed by an open-label treatment period of 36 weeks, according to the release, with a total of 362 subjects having been recruited and randomized in a 2:1 ratio to receive either delgocitinib or cream vehicle.
The results announced today cover the double-blind treatment period of the DELTA China trial from Week 0 to Week 16 of treatment and are an important milestone in the Chinese market as there are currently no approved treatment options specifically indicated for moderate to severe CHE in China, the company said in the release. The primary endpoint for DELTA China was the investigator’s global assessment for chronic hand eczema score (IGA-CHE TS) at Week 16, which was met with a statistically significant improvement in CHE severity after 16 weeks of treatment with delgocitinib compared to cream vehicle.
Furthermore, the 16-week safety profile was consistent with previous pivotal trials, and the pharmacokinetics (PK) data supported low systemic exposure.
The open-label treatment period of the DELTA China trial runs from Week 16 to Week 52 and is still ongoing. The results from this stage of the trial will be released at a later date, the company said.
The primary objective of the study was to evaluate the efficacy of twice-daily applications of delgocitinib compared with cream vehicle in the treatment of Chinese subjects with moderate to severe CHE for whom topical corticosteroids are inadequate or inappropriate.
“Following the results from DELTA China, including the consistent safety profile and pharmacokinetics data, we will continue our work to investigate delgocitinib cream as a potential treatment option for patients living with moderate to severe CHE, as there are currently no approved treatments specifically for CHE available here in China,” Byron Yin, general manager for LEO Pharma in China, said in the press release. “LEO Pharma has a unique heritage for innovative topicals, and I look forward to seeing the full data set, which I hope will set us up for further advances and ultimately help us to introduce this new treatment option in China.”
The DELTA China trial was structured in line with the DELTA 1 and 2 phase 3 trials investigating CHE in Europe and Canada, which both met all primary and secondary endpoints.
“DELTA China demonstrates LEO Pharma’s truly global approach when it comes to addressing the unmet needs of patients living with moderate to severe CHE worldwide,” Kreesten Meldgaard Madsen, Chief Development Officer, LEO Pharma, said in the release. “Skin conditions are not specific to borders and nor is our commitment to research. The results from this phase 3 trial in the Chinese population builds upon our expanding collection of scientific data for treating moderate to severe CHE globally. Our work will continue to advance the standard of care for this debilitating condition.”
Currently, delgocitinib is approved for adults in the European Union, United Kingdom, Switzerland, and the United Arab Emirates for the treatment of moderate-to-severe CHE for whom topical corticosteroids are inadequate or inappropriate, and is under investigation in other markets, including the United States.
Detailed results from DELTA China are planned to be submitted for scientific presentation and publication at a later date.
For more information on the DELTA China trial (NCT06004050) go to clinicaltrials.gov.