Ruxolitinib meets primary and secondary endpoints in phase 3 TRuE-V clinical trial program.
Less than 2 months after receiving FDA approval as an atopic dermatitis treatment, ruxolitinib cream (Opzelura; Incyte) is one step closer to expanding the armamentarium to combat vitiligo.
The 24-week data from the phase 3 TRuE-V clinical trial program which includes TRuE-V1 (NCT04052425) and TRuE-V2 (NCT04057573) investigated the Janus kinase (JAK) inhibitor as a treatment for patients 12 years and older with nonsegmental vitiligo.
Findings from the week 24 analysis showed treatment with 1.5% ruxolitinib cream twice daily (BID) resulted in greater improvement to vehicle for the primary and all key secondary endpoints in both the TRuE-V1 and TRuE-V2 studies, according to a company press release.1
Results, which were consistent across both studies, showed:
“We are pleased to share the full 24-week results from our pivotal phase 3 TRuE-V program, which resulted in significant improvements in facial and total body repigmentation in vitiligo patients treated with ruxolitinib cream,” said Jim Lee, MD, PhD, group vice president, inflammation and autoimmunity, Incyte, in Wilmington, Delaware. “These positive results reinforce the potential for ruxolitinib cream as a meaningful treatment option for people suffering from vitiligo, and we look forward to working with regulators to bring the first approved medical treatment that directly addresses repigmentation to patients in the U.S. and Europe.”
The overall safety profile of ruxolitinib cream in vitiligo was consistent with previous study data, according to the release. The patients in the ruxolitinib cream treatment arm did not report clinically significant application site reactions and treatment-emergent adverse events (TEAEs) were consistent with previous studies, with no serious TEAEs reported.
“The skin depigmentation associated with vitiligo can have a profound impact on a person’s life and patients are in need of additional treatment options,” said David Rosmarin, MD, vice chair of research and education in the Dermatology Department at Tufts Medical Center, in Boston, Massachusetts. “I am extremely encouraged about the potential of ruxolitinib cream, as evidenced by the clinically meaningful improvements in repigmentation shown in the pivotal trials, and the potential benefits it may bring for my patients.”
Incyte expects to submit a marketing application for ruxolitinib cream for the treatment of patients 12 years and older with vitiligo to the FDA. The European Medicines Agency (EMA) has given ruxolitinib cream a European Marketing Authorization Application (MAA).
In September 2021, ruxolitinib cream was approved by the FDA for the short-term and non-continuous treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.
Data like this and more are being presented at the 2021 Fall Clinical Dermatology Conference for Pas & NPs this weekend, November 12 to 14.
Incyte announces full results from phase 3 true-v program evaluating ruxolitinib cream (Opzelura) in patients with vitiligo. Incyte. Press release. Published October 2, 2021. Accessed November 11, 2021. https://investor.incyte.com/press-releases/press-releases/2021/Incyte-Announces-Full-Results-From-Phase-3-TRuE-V-Program-Evaluating-Ruxolitinib-Cream-Opzelura-in-Patients-With-Vitiligo/default.aspx