What side effects are associated with this type of intervention?

Common treatments for plaque psoriasis include biologics, phototherapy, and oral medications. Biologics like TNF-alpha inhibitors (e.g., infliximab, adalimumab) can reduce cardiovascular risk but may cause infections and injection site reactions. IL-12/23 inhibitors (e.g., ustekinumab) are generally well-tolerated but have raised concerns about cardiovascular risks, which were not confirmed in meta-analyses. Phototherapy, particularly UVB, can cause erythema, skin dryness, pruritus, and an increased risk of skin cancer with prolonged use. Oral medications like cyclosporine and methotrexate can lead to liver toxicity, renal impairment, and increased risk of infections.

What prior FDA approvals exist?

The FDA has approved several biologic agents for the treatment of plaque psoriasis, focusing on different targets within the immune system. TNF-alpha inhibitors such as adalimumab, etanercept, and infliximab have been widely used and shown to reduce cardiovascular risks in patients. IL-17 inhibitors like secukinumab, ixekizumab, and brodalumab have also been approved, demonstrating efficacy in moderate-to-severe cases. Additionally, IL-12/23 inhibitors such as ustekinumab have been approved, offering another mechanism of action for managing the disease. These treatments have been evaluated for their pharmacokinetics, safety, and long-term efficacy in various clinical trials.

What other types of research exist?

Promising novel alternatives for plaque psoriasis treatment in 2024 include: 1) Brodalumab, an anti-interleukin-17-receptor antibody, which has shown efficacy in moderate-to-severe plaque psoriasis. 2) Ustekinumab, an interleukin-12/23 monoclonal antibody, with long-term efficacy and safety data. 3) Bimekizumab, which has demonstrated effectiveness in multiple comparative trials against other biologics like secukinumab and adalimumab. These treatments offer new options for patients seeking alternatives to traditional PK drugs.

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Monoclonal Antibodies

Tildrakizumab for Pediatric Psoriasis

Q: What is the mechanism of action of this treatment?

Common treatments for Plaque Psoriasis include biologic agents such as IL-23 inhibitors (e.g., tildrakizumab), TNF-alpha inhibitors, and IL-12/23 inhibitors. These biologics work by targeting specific cytokines involved in the inflammatory process, thereby reducing inflammation and the rapid turnover of skin cells. For instance, IL-23 inhibitors block the action of interleukin-23, a cytokine that plays a key role in the inflammatory cascade of psoriasis. This targeted approach is crucial for patients as it offers more effective and sustained relief from symptoms compared to traditional systemic therapies, which can have broader immunosuppressive effects and more side effects.

Phase 2 & 3

Waitlist Available

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

Moderate to severe psoriasis at baseline defined as: at least 10% Body Surface Area (BSA) involvement, PGA score ≥ 3, and PASI score ≥ 12

Subject must be 6 to < 18 years of age, of either sex, of any race/ethnicity, must weigh greater than or equal to 15Kg

Must not have

Subject with presence of any infection or history of recurrent infection requiring treatment with systemic antibiotics within 2 weeks prior to Screening, or severe infection (e.g. pneumonia, cellulitis, bone or joint infections) requiring hospitalization or treatment with IV antibiotics within 8 weeks prior to Screening

Subject has predominantly non-plaque forms of psoriasis specifically erythrodermic psoriasis, predominantly pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new-onset guttate psoriasis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 108

Summary

This trial involves studying how a drug moves through and is processed by the bodies of children. It first examines older children and then younger children. The goal is to understand how the drug is absorbed, distributed, metabolized, and excreted in these age groups.

Who is the study for?

This trial is for children and teens aged 6 to <18 with moderate to severe plaque psoriasis, who haven't responded well to topical treatments or phototherapy. They must weigh at least 15 kg and have a confirmed diagnosis of plaque psoriasis for over six months. Participants should not have recent serious infections, HIV, hepatitis B/C, significant lab abnormalities, or be pregnant.

What is being tested?

The study tests Tildrakizumab's effects on pediatric chronic plaque psoriasis. It starts with an open-label phase to understand how the body processes the drug (pharmacokinetics), followed by a randomized comparison with Etanercept and placebo, then a long-term extension phase for further evaluation.

What are the potential side effects?

Potential side effects may include reactions at the injection site like pain or swelling, increased risk of infections due to immune system suppression, possible liver issues indicated by blood test changes, and allergic reactions that could manifest as rashes or difficulty breathing.

Eligibility Criteria

Inclusion Criteria

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

Select...

My psoriasis is severe, affecting over 10% of my body.

Select...

I am between 6 and 18 years old, weigh at least 15Kg.

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I have passed the screening for tuberculosis.

Exclusion Criteria

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

Select...

I haven't had severe infections or needed antibiotics in the last 2 months.

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 108

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 108

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 108 for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Change in quality of life as measured by Children's Dermatology Life Quality Index (CDLQI)

Percent of subjects with confirmed major adverse cardiovascular events

Percent of subjects with drug- related hypersensitivity reactions

+2 more

Trial Design

5Treatment groups

Experimental Treatment

Active Control

Group I: Part C: LTEExperimental Treatment1 Intervention

Group II: Part B-1 and B-2: Randomized withdrawal and retreatment after relapseExperimental Treatment2 Interventions

Group III: Part B Part 1: Placebo and active comparator controlled studyExperimental Treatment3 Interventions

Group IV: Part B 3: Efficacy and Safety Follow-upActive Control1 Intervention

Group V: Part AActive Control1 Intervention

Part A is a DOSE FINDING COMPONENT: OPEN LABEL PK lead-in and safety component

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Etanercept

2005

Completed Phase 4

~4720

Tildrakizumab

2020

Completed Phase 4

~580

Placebo

1995

Completed Phase 3

~2670

0 / 5Eligibility 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

Common treatments for Plaque Psoriasis include biologic agents such as IL-23 inhibitors (e.g., tildrakizumab), TNF-alpha inhibitors, and IL-12/23 inhibitors. These biologics work by targeting specific cytokines involved in the inflammatory process, thereby reducing inflammation and the rapid turnover of skin cells. For instance, IL-23 inhibitors block the action of interleukin-23, a cytokine that plays a key role in the inflammatory cascade of psoriasis. This targeted approach is crucial for patients as it offers more effective and sustained relief from symptoms compared to traditional systemic therapies, which can have broader immunosuppressive effects and more side effects.

Oral Chinese herbal medicine combined with pharmacotherapy for psoriasis vulgaris: a systematic review.