LITFULO improves facial and total body repigmentation in Phase III vitiligo trials

Pfizer has reported positive Phase III results for LITFULO, also known as ritlecitinib, as a once daily oral treatment for people with nonsegmental vitiligo.

Findings from the TRANQUILLO 2 and TRANQUILLO studies showed that LITFULO significantly improved both facial and total body repigmentation compared with placebo.

The results were presented in a late breaking oral session at the 35th European Academy of Dermatology and Venereology Annual Congress in Vienna.

Pfizer said the two studies form the largest Phase III clinical development programme conducted to date for an oral systemic treatment in nonsegmental vitiligo.

TRANQUILLO 2 evaluated LITFULO at a dose of 100 mg, while TRANQUILLO assessed the 50 mg dose.

At week 52, both regimens produced significant improvements in facial and total body repigmentation compared with placebo.

Improvements continued to increase over time after becoming apparent from week 24.

Patient reported outcomes also supported the clinical findings, with participants describing reductions in the perceived severity of facial and overall vitiligo.

LITFULO treatment was additionally associated with greater disease stabilisation compared with placebo.

Pfizer plans to submit the Phase III findings to regulatory authorities worldwide, including the U.S. Food and Drug Administration and European Medicines Agency.

Michael Vincent, MD, PhD, Chief Inflammation and Immunology Officer at Pfizer, said LITFULO targets signalling pathways involved in the immune response that attacks pigment producing cells in the skin.

The treatment selectively targets Janus kinase 3, known as JAK3, and members of the TEC family of kinases.

Vincent said this mechanism is designed to address an underlying driver of nonsegmental vitiligo rather than focusing solely on its visible manifestations.

He added that both Phase III studies demonstrated increasing improvements in facial and total body repigmentation over time, alongside improvements in patients’ assessments of their disease.

Iltefat Hamzavi, MD, Senior Staff Physician in the Department of Dermatology at Henry Ford Health and Hamzavi Dermatology Specialists, said nonsegmental vitiligo can have effects extending beyond visible changes to the skin.

He noted that the chronic autoimmune disease may progress unpredictably and can affect highly visible areas of the body, while treatment options have historically remained limited.

Hamzavi said the Phase III findings support the potential for LITFULO to establish a systemic treatment approach that targets biological processes underlying the disease while improving repigmentation and disease stability.

Nonsegmental vitiligo is a chronic autoimmune condition in which immune activity damages pigment producing cells, leading to areas of skin depigmentation.

Pfizer said the TRANQUILLO programme will support its planned regulatory filings as it seeks to expand the potential use of LITFULO into nonsegmental vitiligo.

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Related Topics and Keywords

autoimmune disease, clinical trials, dermatology, JAK3, litfulo, nonsegmental vitiligo, Pfizer, pharma news, ritlecitinib, skin health, TRANQUILLO, Vitiligo