Tildrakizumab Shows Efficacy for Nail Psoriasis in Phase 3b Trial

A newly presented phase 3b trial of tildrakizumab-asmn (Ilumya) for moderate-to-severe plaque psoriasis of the nails demonstrated significant efficacy in clearing nail lesions, according to data presented at the 2025 American Academy of Dermatology (AAD) Annual Meeting in Orlando.1

The findings highlight the potential of Ilumya, an interleukin-23 inhibitor developed by Sun Pharma, to address a notoriously difficult-to-treat manifestation of psoriasis.

In the randomized, double-blind, placebo-controlled study, 99 adults with moderate-to-severe plaque psoriasis and concurrent nail involvement received either Ilumya or placebo. At Week 28, patients receiving Ilumya achieved significantly higher rates of ≥75% improvement in the modified Nail Psoriasis Severity Index (mNAPSI 75) compared with the placebo group (25.5% vs 4.5%; P=0.003). In total, 29.4% of patients who received Ilumya achieved clear or nearly clear nails (ViSENPsO score of 0 or 1), compared with 4.2% of those in the placebo group (P=0.0008).1

"Nail psoriasis is understood as a difficult to treat population, and many current therapies fall short of providing lasting relief or are slow to produce results," said Paul Yamauchi, MD, lead investigator of the study in a Sun Pharma news release. "While other IL-23 inhibitors do not have a dedicated study to evaluate efficacy in nail psoriasis, these trial results clearly demonstrate the promise for Ilumya to ease discomfort and improve patient outcomes."1

Safety findings were consistent with the known profile for Ilumya. Upper respiratory infections, injection-site reactions, and diarrhea were the most common adverse events. No serious adverse events were reported in the treatment arm.

Nail psoriasis occurs in up to 50% of individuals with plaque psoriasis and can disproportionately affect quality of life due to pain, functional impairment, and cosmetic concerns. The relative inaccessibility of nail units, along with the slow growth rate of nails, has posed longstanding hurdles to effective treatment.1

"Psoriasis affecting the nails can have a profound impact on a patient's daily life, causing both physical discomfort and emotional distress. Although highly prevalent in people with plaque psoriasis, nail psoriasis has been challenging to treat," said Marek Honczarenko, M.D., PhD, Senior Vice President, Head of Development for Sun Pharma, North America, in the news release. "As a company dedicated to developing innovative therapies which help improve quality of life for patients, these data, along with our existing data in scalp psoriasis, reinforces the benefits of ILUMYA in difficult to treat populations."1

Tildrakizumab is a humanized IgG1/k monoclonal antibody that selectively binds to the p19 subunit of IL-23, inhibiting its interaction with the IL-23 receptor and downregulating proinflammatory cytokine release. In the United States, Ilumya is approved for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Reference

1.ILUMYA (tildrakizumab-asmn) found effective for treatment of moderate-to-severe plaque psoriasis affecting nails in study presented at 2025 AAD conference [news release]. PR Newswire. March 7, 2025. Accessed March 7, 2025. https://prnmedia.prnewswire.com/news-releases/ilumya-tildrakizumab-asmn-found-effective-for-treatment-of-moderate-to-severe-plaque-psoriasis-affecting-nails-in-study-presented-at-2025-aad-conference-302395300.html