Tildrakizumab for Nail Psoriasis

Recruiting in Palo Alto (17 mi)

+42 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Sun Pharma Global FZE

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?This trial is testing Tildrakizumab, a medication that helps reduce inflammation, in patients with moderate to severe nail psoriasis. These patients often do not respond well to standard treatments. Tildrakizumab works by blocking a protein that causes inflammation, helping to calm the immune system and reduce symptoms. Tildrakizumab has been shown to be effective in improving skin manifestations as well as enhancing quality of life outcomes in patients with psoriasis.

Eligibility Criteria

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

+7 more

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.

+2 more

Participant Groups

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.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm AExperimental Treatment1 Intervention

Group II: Arm BPlacebo Group2 Interventions

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

🇪🇺 Approved in European Union as Ilumya for: