Tildrakizumab for Nail Psoriasis

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

99 Participants Needed

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.

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.

What data supports the effectiveness of the drug Tildrakizumab for nail psoriasis?

Research shows that Tildrakizumab, originally used for plaque psoriasis, significantly improved nail psoriasis in patients, with a 90% improvement in nail condition after 20 weeks and marked improvement in treatment-resistant cases over 6 to 12 months. ^{1 2 3 4 5}

Is Tildrakizumab safe for humans?

Tildrakizumab has been tested in several clinical trials for chronic plaque psoriasis, and no related side effects have been observed in the reported cases of nail psoriasis. It is generally considered safe for use in humans based on available data. ^{2 3 4 6 7}

How does the drug Tildrakizumab differ from other treatments for nail psoriasis?

Tildrakizumab is unique because it targets the p19 subunit of interleukin-23, a protein involved in inflammation, and has shown fast improvement in nail psoriasis, which is typically hard to treat. It is administered as an injection and has been effective even in cases resistant to other treatments. ^{1 2 3 5 7}

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

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Nail Psoriasis Improvement During Tildrakizumab Therapy: A Real-Life Experience. [2022]

2. Australia pubmed.ncbi.nlm.nih.gov

Successful management of treatment resistant nail psoriasis with tildrakizumab. [2022]

3. Austria pubmed.ncbi.nlm.nih.gov

Effectiveness and Safety After a Switch to Tildrakizumab: A Real World Multicenter Italian Study in Psoriasis. [2023]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Tildrakizumab: First Global Approval. [2020]

5. England 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. [2019]

6. England 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). [2023]

7. England pubmed.ncbi.nlm.nih.gov

Tildrakizumab for treatment of moderate to severe psoriasis: an expert opinion of efficacy, safety, and use in special populations. [2022]