What side effects are associated with this type of intervention?

Common treatments for plaque psoriasis that are similar to Tildrakizumab include other IL-23 inhibitors like Guselkumab and IL-17 inhibitors such as Secukinumab and Ixekizumab. Known side effects of these treatments can include upper respiratory infections, injection site reactions, and headaches. Additionally, IL-17 inhibitors have been associated with an increased risk of inflammatory bowel disease. Long-term safety data suggest that these treatments are generally well-tolerated, but monitoring for infections and other adverse effects is recommended.

What prior FDA approvals exist?

Several drugs targeting the IL-23 pathway have been approved by the FDA for the treatment of moderate-to-severe plaque psoriasis. These include Tildrakizumab, which specifically inhibits IL-23 to reduce inflammation and immune response. Other similar biologics include Ustekinumab, which targets both IL-12 and IL-23, and Guselkumab, which also specifically targets IL-23. These treatments have shown efficacy in reducing the symptoms of plaque psoriasis by modulating the immune system's response.

What other types of research exist?

Promising alternatives to Tildrakizumab for plaque psoriasis include: 1) Ixekizumab (targets IL-17A), 2) Secukinumab (targets IL-17A), 3) Brodalumab (targets IL-17 receptor A), 4) Guselkumab (targets IL-23), and 5) Bimekizumab (targets both IL-17A and IL-17F). These agents have shown significant efficacy and safety in clinical trials and are viable options for treatment in 2024.

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Monoclonal Antibodies

Tildrakizumab for Nail Psoriasis

Phase 3

Recruiting

Research Sponsored by Sun Pharma Global FZE

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects with a chronic moderate to severe plaque-type psoriasis for at least 6 months (as determined by subject interview and confirmation of diagnosis through physical examination by Investigator).

Body Surface Area (BSA) involvement of ≥10%.

Must not have

Subjects who have predominantly non-plaque forms of psoriasis, specifically erythrodermic psoriasis, predominantly pustular psoriasis, medication-induced, or medication-exacerbated psoriasis, or new-onset guttate psoriasis.

Subjects with ongoing inflammatory skin diseases other than psoriasis or any other disease affecting the fingernails, which may potentially confound the evaluation of study treatment.

Timeline

Screening 1 day

Treatment Varies

Follow Up week 52

Awards & highlights

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not specified here, drugs like Tildrakizumab may cause side effects such as injection site reactions, upper respiratory infections, headache and fatigue. The exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had severe plaque psoriasis for at least 6 months.

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

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I have had severe plaque psoriasis for at least 6 months.

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My nail psoriasis is moderate to severe, with a high mNAPSI score.

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I have severe psoriasis with a significant area of my body affected.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I do not have skin or nail diseases that could affect the study, except for psoriasis.

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I have never used tildrakizumab or similar drugs for psoriasis.

Timeline

Screening ~ 1 day1 visit

Treatment ~ Varies

Follow Up ~ week 52

Screening ~ 1 day

Treatment ~ Varies

Follow Up ~week 52

This trial's timeline: 1 day for screening, Varies for treatment, and week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The proportion of subjects who achieve at least a 75% improvement from baseline in totalmNAPSI at Week 28.

Secondary study objectives

The proportion of subjects with a score of "0 - normal" or "1 - minimal nail psoriasis" and at least a 2-point decrease from baseline at Week 28 as measured by the ViSENPsO.

The proportion of subjects with at least 3 point decrease from baseline, in Nail Pain NRS score in subjects with baseline nail pain NRS score of >3

Other study objectives

The percentage of subjects with Major Adverse Cardiovascular Events.

The percentage of subjects with incidence, seriousness, and severity of all adverse events.

The percentage of subjects with injection site reactions (eg. pain, erythema, edema etc)

+5 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm AExperimental Treatment1 Intervention

Group II: Arm BPlacebo Group2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tildrakizumab

2020

Completed Phase 4

~600

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Plaque Psoriasis treatments often target specific cytokines to modulate the immune system and reduce inflammation. Tildrakizumab, for example, inhibits IL-23, a cytokine involved in the inflammatory process, thereby reducing the immune response and inflammation. Other treatments, such as secukinumab and ixekizumab, target IL-17, while TNF-alpha inhibitors like adalimumab and etanercept block TNF-alpha. These treatments are crucial for Plaque Psoriasis patients as they help control the chronic inflammation and immune dysregulation that characterize the disease, leading to improved skin symptoms and overall quality of life.

Efficacy of tildrakizumab by patient demographic and disease characteristics across a phase 2b and 2 phase 3 trials in patients with moderate-to-severe chronic plaque psoriasis.