Ritlecitinib Meets Co-Primary End Points in Phase 3 Nonsegmental Vitiligo Trials

Pfizer recently announced positive topline results from 2 phase 3 trials evaluating ritlecitinib (Litfulo) in patients with nonsegmental vitiligo (NSV). Both the TRANQUILLO and TRANQUILLO 2 studies met their co-primary end points, with the 50 mg and 100 mg once-daily doses producing significant, clinically meaningful improvement in facial and total body repigmentation versus placebo at week 52. Based on these results, Pfizer intends to submit global regulatory filings for ritlecitinib as a potential oral systemic therapy for NSV in adults.¹

Ritlecitinib is already approved for severe alopecia areata in adults and adolescents 12 years and older, and the NSV program marks the largest phase 3 evaluation of an oral systemic therapy in NSV to date.^1,2 Its dual inhibition of Janus kinase 3 (JAK3) and TEC family kinases distinguishes ritlecitinib's mechanism within the vitiligo treatment landscape. Pfizer positions the data as a step toward a new oral systemic option for adults with NSV, a population for whom disease burden often warrants more than localized treatment alone.¹

TRANQUILLO (NCT05583526) and TRANQUILLO 2 (NCT06072183) form the pivotal core of the phase 3 TRANQUILLO clinical program, which also includes TRANQUILLO LTE (NCT06163326), a long-term extension trial for patients who completed the parent TRANQUILLO study. TRANQUILLO enrolled 607 adults and adolescents 12 years and older on ritlecitinib 50 mg once daily, while TRANQUILLO 2 enrolled 1567 adults on 50 mg or 100 mg once daily, with 50 mg comparisons in TRANQUILLO 2 considered exploratory and descriptive. Across both trials, investigators evaluated 2174 patients with active or stable NSV and a broad range of disease severity at 271 sites worldwide.¹

In the US, co-primary end points were the proportion of patients achieving at least 75% improvement in Facial Vitiligo Area Scoring Index (F-VASI75) and at least 50% improvement in Total Vitiligo Area Scoring Index (T-VASI50) at week 52. Outside the US, F-VASI75 at week 52 served as the primary end point, with T-VASI50 at week 52 as a key secondary end point. Significantly more patients treated with ritlecitinib achieved F-VASI75 and T-VASI50 vs placebo across both studies, though Pfizer's release did not report exact response rates or P values for these comparisons.¹

"In these trials, Litfulo (ritlecitinib) demonstrated significant improvements in both facial and total body repigmentation, with the findings reinforcing the potential of Litfulo to help support a new treatment paradigm with systemic therapies for patients for whom disease burden warrants more than localized treatment alone,” said Iltefat Hamzavi, MD, a dermatologist and senior staff physician in the department of dermatology at Henry Ford Health and Hamzavi Dermatology Specialists, in the news release.¹

Ritlecitinib Safety Profile and Secondary End Point Data in NSV

Additional findings from TRANQUILLO and TRANQUILLO 2, including secondary end point data beyond the co-primary measures, are expected at a future medical meeting rather than in the topline release. The safety profile of ritlecitinib in NSV was consistent with its established profile in alopecia areata, and Pfizer reported no new safety signals across the 2 trials. The proportion of patients experiencing treatment-emergent adverse events (TEAEs) was similar across all treatment groups, though the release did not specify TEAE rates by arm or name adverse events of special interest.¹

See previous phase 2 data here

Pfizer characterized the NSV program as building on its dermatology experience with ritlecitinib in severe alopecia areata, including the drug's established efficacy and well-characterized safety profile in alopecia areata. The company has not disclosed a submission timeline for the NSV filings beyond stating an intent to pursue them globally.¹

Ritlecitinib carries FDA approval for severe alopecia areata in adults and adolescents 12 years and older in the US, along with approvals in the European Union, Canada, Japan, China, and the United Kingdom. Pfizer also plans to initiate a pivotal study of ritlecitinib for moderate alopecia areata in 2026, expanding the drug's evidence base across immune-mediated dermatologic conditions.¹

References

1. Pfizer announces positive topline phase 3 results for LITFULO in patients with nonsegmental vitiligo. News release. Pfizer. July 30, 2026. Accessed July 30, 2026. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-announces-positive-topline-phase-3-results-litfulo
2. FDA approves Pfizer’s LITFULO Ritlecitinib) for adults and adolescents with severe alopecia areata. News release: Pfizer June 23, 2023. Accessed July 30, 2026. https://www.pfizer.com/news/press-release/press-release-detail/fda-approves-pfizers-litfulotm-ritlecitinib-adults-and

Frequently Asked Questions

What is ritlecitinib being studied for in vitiligo?
Ritlecitinib is being evaluated in phase 3 trials as a potential oral systemic therapy for nonsegmental vitiligo in adults, with 2 studies showing significant facial and total body repigmentation versus placebo at week 52.

How does ritlecitinib work?
Ritlecitinib inhibits Janus kinase 3 (JAK3) and TEC family kinases, immune signaling pathways thought to drive the melanocyte destruction underlying nonsegmental vitiligo.

What did the TRANQUILLO trials show?
Across TRANQUILLO and TRANQUILLO 2, significantly more patients treated with ritlecitinib achieved F-VASI75 and T-VASI50 at week 52 versus placebo, meeting co-primary end points in both studies.