In an exploratory, randomised phase 2 study (NCT05332366), 30 women with FFA were randomised 1:1 to delgocitinib cream 20 mg/g twice daily or a matching vehicle over 12 weeks1. The primary endpoint was defined as change from baseline to week 12 in IFN-γ, CXCL9, and CXCL10. At baseline, the study cohort had a mean age of 64.4 years, the Lichen Planopilaris Activity Index (LPPAI) was 2.79, and FFASS 12.14.
RNA sequencing and Th1 biomarker assessment detected numeric reductions in IFN-γ, CXCL10, and a statistically significant decrease in CXCL9 (P<0.05). Prof. Maryanne Senna (Harvard Medical School, MA, USA) said that this suggested an attenuation of key inflammatory scalp biomarkers in FFA by delgocitinib cream. “Transcriptomic analysis showed that delgocitinib lesions had a 4% improvement towards non-lesional scalp skin compared with the vehicle-treated patients who actually had 33% worsening of their transcriptomic profile,” she added. At week 12, the FFASS decrease was significantly superior to the vehicle (P=0.023) and LPPAI showed numerically greater changes on delgocitinib.
In an open-label extension phase until week 24, all participants continued on the study drug. An exploratory analysis found hair regrowth to some extent for all participants on delgocitinib at week 24. An average of 6.9 new hairs was observed in trichoscopy of 1 cm2 scalp of the participants treated with delgocitinib at week 12, in contrast to a loss of 11.1 hairs in the vehicle group.
The safety assessment deemed delgocitinib cream in FAA well tolerated with only 1 treatment-related adverse event (i.e. moderate hand dermatitis) in the vehicle group. “If we could recapitulate this data in larger clinical trials, this could be potentially a promising therapeutic option for this patient population,” Prof. Senna concluded.
Medical writing support was provided by Karin Drooff MPH