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ESK-001 for Psoriasis (ONWARD2 Trial)

Phase 3
Recruiting
Research Sponsored by Alumis Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of plaque psoriasis for ≥6 months
Plaques covering ≥10% of BSA
Must not have
Lab abnormalities indicating significant renal, hepatic or bone marrow dysfunction
Any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the patient's immune status
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights
Pivotal Trial

Summary

This trial aims to see if ESK-001 is effective in treating moderate to severe plaque psoriasis and how safe it is for patients. Participants will take ESK-001 daily for 24 weeks

Who is the study for?
Adults aged 18+ with moderate to severe plaque psoriasis for at least 6 months can join this study. They'll take a daily drug for half a year, visit the clinic regularly, and report on their skin condition, itchiness, and life quality changes.
What is being tested?
The trial is testing ESK-001's effectiveness against psoriasis compared to a placebo (dummy pill) and Apremilast (an approved treatment). Participants will be randomly assigned to one of these treatments for 24 weeks.
What are the potential side effects?
Possible side effects include reactions similar to those seen in other psoriasis treatments: skin irritation, gastrointestinal issues, headaches, potential impact on mood or heart function as monitored through tests.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with plaque psoriasis for at least 6 months.
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Over 10% of my body is covered in plaques.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My kidney, liver, or bone marrow is not functioning properly.
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I have a condition that weakens my immune system.
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I am currently taking systemic corticosteroids for an immune or inflammatory condition.
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I do not have plaque psoriasis or other skin inflammation.
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My psoriasis did not improve with specific treatments.
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I have not had any recent major heart problems or hospital visits for my heart in the last 3 months.
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I have had recent herpes outbreaks.
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I have been hospitalized for a serious infection or recently needed antibiotics for one.
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I do not have an active infection or positive tests for hepatitis B, C, HIV, or TB.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks 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 determine whether ESK-001 reduces the severity of psoriasis by 75% (using the PASI) or by at least 2 points (using sPGA score) compared to placebo
Secondary study objectives
Proportion of patients with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
To characterize the pharmacokinetics of ESK-001
To compare the Dermatology Life Quality Index (DLQI) between ESK-001 and placebo or apremilast
+7 more

Side effects data

From 2023 Phase 2 trial • 228 Patients • NCT05600036
8%
Nasopharyngitis
8%
Headache
8%
Upper respiratory tract infection
5%
Cough
5%
Acne
5%
Pyrexia
5%
Dermatitis acneiform
3%
COVID-19
100%
80%
60%
40%
20%
0%
Study treatment Arm
ESK-001 40mg BID
ESK-001 40mg QD
ESK-001 20mg BID
ESK-001 10mg QD
ESK-001 20mg QD
Placebo

Awards & Highlights

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

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: ESK-001Experimental Treatment1 Intervention
ESK-001 administered as an oral tablet
Group II: ApremilastActive Control1 Intervention
Apremilast administered as an oral capsule
Group III: PlaceboPlacebo Group1 Intervention
Matching oral placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ESK-001
2022
Completed Phase 2
~250

Find a Location

Who is running the clinical trial?

Alumis IncLead Sponsor
7 Previous Clinical Trials
1,720 Total Patients Enrolled
~560 spots leftby May 2026
Unbiased ResultsWe believe in providing patients with all the options.
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