Tildrakizumab for Nail Psoriasis

No longer recruiting at 42 trial locations

Overseen By Head, Clinical development

Age: 18+

Sex: Any

Travel: May Be Covered

Trial Phase: Phase 3

Sponsor: Sun Pharma Global FZE

Must not be taking: IL-23 inhibitors

Disqualifiers: Non-plaque psoriasis, Fungal infection, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 28 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called Tildrakizumab, a monoclonal antibody, for individuals with moderate to severe nail psoriasis, a condition causing changes and discomfort in the nails. Researchers aim to assess the effectiveness and safety of this treatment compared to a placebo, which contains no active medicine. The trial targets individuals who have had plaque psoriasis for at least six months and experience moderate to severe nail issues that have not improved with standard treatments like creams or light therapy. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to the potential availability of a new treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it mentions that participants should be candidates for systemic therapy, which means their psoriasis is not well-controlled by topical treatments or other therapies.

Is there any evidence suggesting that Tildrakizumab is likely to be safe for humans?

Research has shown that tildrakizumab is generally safe and well-tolerated for treating moderate to severe nail psoriasis. In previous studies, patients using tildrakizumab did not encounter any new safety issues compared to those taking a placebo, indicating that side effects were as expected with no surprises. The FDA has already approved tildrakizumab for other types of psoriasis, further supporting its safety. Most participants in those studies handled the treatment well, with no major side effects reported. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for nail psoriasis?

Researchers are excited about tildrakizumab for nail psoriasis because it offers a new approach compared to current treatments like corticosteroids and topical calcineurin inhibitors. Tildrakizumab is a biologic that specifically targets the interleukin-23 (IL-23) pathway, which plays a key role in the inflammatory process of psoriasis. This targeted action could potentially lead to more effective and sustained relief with fewer side effects. Additionally, as a biologic treatment, it is administered through injections, which might provide convenience and improved adherence compared to daily topical applications.

What evidence suggests that Tildrakizumab might be an effective treatment for nail psoriasis?

Research has shown that tildrakizumab, which participants in this trial may receive, effectively treats moderate to severe nail psoriasis. In one study, 29.4% of patients using tildrakizumab had normal nails or only mild psoriasis, compared to just 4.2% of those who took a placebo. This trial will compare the effectiveness of tildrakizumab to a placebo, highlighting its potential benefits for nail psoriasis. Importantly, the studies found no new safety issues. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for people with moderate to severe nail psoriasis who haven't had enough relief from topical treatments, light therapy, or other systemic therapies. They should have a history of plaque-type psoriasis for at least 6 months and meet specific severity scores (mNAPSI ≥20, s-PGA ≥3, PASI ≥12). Those with allergies to Tildrakizumab ingredients, non-plaque psoriasis types, fungal nail infections or previous use of IL-23/Th-17 inhibitors can't participate.

Inclusion Criteria

ViSENPsO ≥3

Over 10% of my body is affected by my condition.

PASI ≥12

Exclusion Criteria

You are allergic to any of the ingredients in Tildrakizumab or the placebo.

My psoriasis is mostly non-plaque, including erythrodermic, pustular, medication-related, or new guttate types.

I do not have a fungal nail infection.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Tildrakizumab or placebo for the treatment of moderate to severe nail psoriasis

28 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Tildrakizumab

Trial Overview The study tests the effectiveness and safety of Tildrakizumab compared to a placebo in treating nail psoriasis. It's a Phase 3b trial where participants are randomly assigned either the drug or placebo to see if there's an improvement in their condition.

How Is the Trial Designed?

Group I: Arm A Experimental Treatment 1 Intervention

Group II: Arm B Placebo Group 2 Interventions

Tildrakizumab is already approved in European Union, United States for the following indications:

Approved in European Union as Ilumya for:

• Moderate to severe plaque psoriasis

Approved in United States as Ilumya for:

• Moderate to severe plaque psoriasis

Who Is Running the Clinical Trial?

Sun Pharma Global FZE

Lead Sponsor

Trials

34

Recruited

10,200+

Sun Pharmaceutical Industries Limited

Lead Sponsor

Trials

71

Recruited

14,000+

Dilip Shanghvi

Sun Pharmaceutical Industries Limited

Chief Executive Officer since 1993

Majored in Cellular and Molecular Biology at the University of Michigan – Ann Arbor

Dr. Azadar H. Khan

Sun Pharmaceutical Industries Limited

Chief Medical Officer since 2023

MD from a recognized institution

Published Research Related to This Trial

In a study of 51 patients with moderate-to-severe plaque psoriasis who had previously failed biologic treatments, tildrakizumab showed significant effectiveness, with a marked reduction in the Psoriasis Area Severity Index (PASI) score from 19.2 at baseline to 0.6 at 48 weeks (P < 0.001).

The treatment also led to substantial improvements in Body Surface Area (BSA) and Dermatology Life Quality Index (DLQI) scores, indicating enhanced quality of life for patients, with significant results observed at both 12 and 48 weeks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and Safety After a Switch to Tildrakizumab: A Real World Multicenter Italian Study in Psoriasis. Di Brizzi, EV., Buononato, D., Benvenuto, P., et al.[2023]

In a 52-week study involving 237 adults with moderate-to-severe plaque psoriasis, tildrakizumab demonstrated high efficacy, with 90.91% of patients achieving at least a 75% reduction in psoriasis severity (PASI 75) and 58.68% achieving complete skin clearance (PASI 100) by Week 52.

The safety profile of tildrakizumab was favorable, with no significant adverse events reported, and no patients had to discontinue treatment due to side effects, indicating it is a well-tolerated option for psoriasis management in real-life settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-life effectiveness of tildrakizumab in chronic plaque psoriasis: A 52-week multicentre retrospective study-IL PSO (Italian landscape psoriasis). Narcisi, A., Valenti, M., Gargiulo, L., et al.[2023]

In two phase 3 trials involving 1862 patients, tildrakizumab (200 mg and 100 mg) demonstrated significant efficacy in treating moderate-to-severe chronic plaque psoriasis, achieving PASI 75 responses in 62-66% of patients compared to only 6% in the placebo group.

Tildrakizumab was well tolerated, with serious adverse events being low and similar across all treatment groups, indicating a favorable safety profile for this new treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tildrakizumab versus placebo or etanercept for chronic plaque psoriasis (reSURFACE 1 and reSURFACE 2): results from two randomised controlled, phase 3 trials. Reich, K., Papp, KA., Blauvelt, A., et al.[2019]

Tildrakizumab is a monoclonal antibody that specifically targets interleukin-23 p19, which plays a key role in the inflammatory process of chronic plaque psoriasis.

The drug received FDA approval based on positive outcomes from the phase III reSURFACE clinical trial program, demonstrating its efficacy for adults with moderate-to-severe chronic plaque psoriasis who require systemic therapy or phototherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tildrakizumab: First Global Approval. Markham, A.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12219165/

52-week Interim Data of the Phase IV Positive Study The results of the study showed that within 16 weeks of treatment, tildrakizumab quickly improved the psychological well-being of the people ...

2. prnewswire.com 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

ILUMYA® (tildrakizumab-asmn) Found Effective for ... 29.4% of patients treated with ILUMYA achieved normal nails or nails with minimal psoriasis (ViSENPsO® score of 0 or 1), compared to 4.2% in the ...

3. jaad.org jaad.org/article/S0190-9622(25)01482-3/fulltext

62370 Efficacy and safety of tildrakizumab in patients with ... Conclusions: Tildrakizumab was efficacious vs placebo for the treatment of moderate-to-severe psoriasis affecting the nails, with no new safety signals.

4. ajmc.com ajmc.com/view/tildrakizumab-for-nail-psoriasis-key-findings-from-aad-2025

Tildrakizumab for Nail Psoriasis: Key Findings From AAD ... A panelist discusses how new data from the 2025 American Academy of Dermatology Annual Meeting (AAD 2025) demonstrates tildrakizumab's efficacy ...

5. hcplive.com hcplive.com/view/new-findings-tildrakizumab-nail-psoriasis-with-paul-yamauchi-md-phd

New Findings on Tildrakizumab for Nail Psoriasis, with ... Additionally, he highlighted that 29.4% of those treated with tildrakizumab were shown to have attained normal nails or nails that had minimal ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03897075

NCT03897075 | Efficacy and Safety Study of Tildrakizumab ... ... Results Type in the Results Data ... Phase 3b study to Assess the Efficacy and Safety of Tildrakizumab in the Treatment of Moderate to Severe Nail Psoriasis.

7. thedermdigest.com thedermdigest.com/tildrakizumab-ilumya-sun-pharma-improves-moderate-to-severe-nail-pso/

Tildrakizumab (Ilumya, Sun Pharma) Improves Moderate- ... Tildrakizumab-asmn (Ilumya, Sun Pharmaceutical Industries, Inc.) improves moderate-to-severe nail psoriasis, according to new research.