What side effects are associated with this type of intervention?

Common treatments for plaque psoriasis, such as biologic agents (e.g., TNF-alpha inhibitors like infliximab and adalimumab), methotrexate, and cyclosporine, have various side effects. Biologic agents can cause infections, injection site reactions, and potential cardiovascular events. Methotrexate may lead to liver toxicity, bone marrow suppression, and gastrointestinal issues. Cyclosporine is associated with nephrotoxicity, hypertension, and increased risk of infections. Patients should discuss these potential side effects with their healthcare provider to make informed treatment decisions.

What prior FDA approvals exist?

The FDA has approved several biologic agents for the treatment of plaque psoriasis, including TNF-alpha inhibitors like etanercept and adalimumab, and IL-12/23 inhibitors such as ustekinumab. These treatments have shown efficacy in reducing the severity of psoriasis by targeting specific pathways in the immune system. Additionally, systemic treatments like methotrexate and cyclosporine have been used to manage severe cases. The ESK-001 trial likely involves a systemic or biologic agent, given its context in plaque psoriasis treatment.

What other types of research exist?

Promising novel alternatives to ESK-001 for plaque psoriasis include: 1) Risankizumab, an anti-IL-23p19 biologic, which has shown efficacy in phase III trials. 2) Ponesimod, an oral selective modulator of sphingosine 1-phosphate receptor 1, which demonstrated significant PASI score reduction in phase II trials. 3) Certolizumab pegol, an anti-TNF-α agent, which has shown efficacy in both biologic-naïve and previously treated patients over a 52-week period.

← Back to Search

Biologic Response Modifier

ESK-001 for Plaque Psoriasis

Phase 2

Waitlist Available

Research Sponsored by Alumis Inc

Eligibility Criteria Checklist

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

Must have

Men and Women must use highly effective methods of contraception for the entirety of the study

Be older than 18 years old

Must not have

Received a prohibited concomitant medication

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 3 years

Awards & highlights

Summary

This trial involves patients with plaque psoriasis who have already participated in a previous study of ESK-001. They will continue to receive ESK-001 to see if it helps reduce their symptoms. The study will last for an extended period.

Who is the study for?

This trial is for men and women with plaque psoriasis who have finished a previous study involving ESK-001. Participants must commit to using effective contraception throughout the study. Pregnant individuals or those on certain other medications cannot join.

What is being tested?

The trial is testing the long-term safety and effectiveness of a medication called ESK-001 in treating plaque psoriasis. It's an open-label extension, meaning everyone knows they're getting ESK-001, and it involves multiple centers.

What are the potential side effects?

While specific side effects are not listed here, typical ones for psoriasis treatments may include skin irritation, headaches, fatigue, nausea, and potential risks associated with long-term use which will be monitored.

Eligibility Criteria

Inclusion Criteria

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

Select...

I will use effective birth control during the study.

Exclusion Criteria

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

Select...

I have not taken any medication that is not allowed in the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 3 years

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

Treatment Details

Study Objectives

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

Primary study objectives

To assess the safety and tolerability of long-term ESK-001 treatment

Secondary study objectives

To assess the change in quality of life (QoL) with long-term ESK-001 administration

To assess the long-term efficacy of ESK-001

To assess the pharmacokinetics (PK) of ESK-001 (ctrough)

Side effects data

From 2023 Phase 2 trial • 228 Patients • NCT05600036

Upper respiratory tract infection

Nasopharyngitis

Diabetes mellitus

Dermatitis acneiform

Lower limb fracture

Diarrhea

100%

80%

60%

40%

20%

Study treatment Arm

ESK-001 10mg QD

ESK-001 20mg QD

ESK-001 40mg QD

ESK-001 20mg BID

ESK-001 40mg BID

Placebo

Trial Design

2Treatment groups

Experimental Treatment

Group I: ESK-001 Dose Level 2Experimental Treatment1 Intervention

ESK-001 administered as an oral tablet

Group II: ESK-001 Dose Level 1Experimental Treatment1 Intervention

ESK-001 administered as an oral tablet

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ESK-001

2022

Completed Phase 2

~250

0 / 2Eligibility 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 primarily target the immune system to reduce inflammation and slow down the overproduction of skin cells. Biologics, such as TNF-alpha inhibitors (e.g., etanercept) and IL-12/23 inhibitors (e.g., ustekinumab), work by blocking specific proteins involved in the inflammatory process. Systemic drugs like methotrexate and cyclosporine suppress the overall immune response. Topical therapies, including corticosteroids and vitamin D analogs, act locally to reduce inflammation and cell turnover. Understanding these mechanisms helps patients and doctors choose the most effective treatment based on the severity and specific characteristics of the disease, potentially improving outcomes and quality of life.

Oral Supplementation and Systemic Drugs for Skin Aging: A Narrative Review.Recommendations for managing a suboptimal response to biologics for moderate-to-severe psoriasis: A Belgian perspective.Treatment of psoriasis. Part 1. Topical therapy and phototherapy.