Incyte has reported positive top-line data from Phase III TRuE-V1 and TRuE-V2 clinical trials of ruxolitinib cream to treat vitiligo in adolescents and adults.
A chronic autoimmune disease, vitiligo causes skin depigmentation due to the loss of pigment-generating cells called melanocytes. The disease is linked to excessive activity of the Janus kinase (JAK) signalling pathway.
Ruxolitinib is a selective inhibitor of JAK1/JAK2 and its cream formulation is meant for topical use.
The TRuE-V1 and TRuE-V2 trials under the TRuE-V programme evaluated the safety and efficacy of ruxolitinib cream in a total of about 300 patients aged 12 years and above with non-segmental vitiligo.
The trials’ primary endpoint is the proportion of participants with facial vitiligo area severity index score 75 (F-VASI75), which is determined as at least a 75% improvement in the score from baseline to week 24.
Key secondary endpoints are the percentage change in facial BSA (F-BSA) from baseline to week 24, F-VASI50, F-VASI90 and T-VASI50 at week 24, along with F-VASI90, T-VASI50 and T-VASI75 at week 52 and a Vitiligo Noticeability Scale (VNS) score of four or five at week 24.
VNS four indicates that vitiligo is a lot less noticeable, while five is for no longer noticeable.
The frequency, duration and severity of adverse events with ruxolitinib cream are also assessed in the trials.
Top-line data showed that both trials met their primary endpoint and key secondary endpoints, including outcomes reported by the participants.
The overall efficacy and safety profile of the cream was observed to be consistent with prior Phase II results, without any new safety signals.
Incyte added that the long-term efficacy and safety parts of the trials will continue as per protocol.
Incyte Inflammation & Autoimmunity group vice-president Jim Lee said: “These positive results, the first Phase III data to demonstrate significant improvements in facial and total body repigmentation, confirm the potential of ruxolitinib cream to be a meaningful treatment option for individuals living with and seeking treatment for their vitiligo.”
Based on these Phase III data, the company intends to file marketing applications in the second half of this year for ruxolitinib cream to treat vitiligo in this patient population in the US and Europe.
In this March, Incyte said that its Phase III DEVENT study of ruxolitinib failed to meet its primary endpoint for treating patients on mechanical ventilation with Covid-19 associated Acute Respiratory Distress Syndrome (ARDS).