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ESK-001 for Psoriasis (ONWARD1 Trial)

Verified 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
Have you been diagnosed with Plaque Psoriasis?
Be older than 18 years old
Must not have
Have you been diagnosed with Inflammatory Bowel Disease?
Have you been hospitalized for cardiovascular disease in the last 3 months?
Timeline
Screening 28 days
Treatment 6 days
Follow Up 28 days
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 in treating plaque psoriasis compared to a placebo (dummy pill) and Apremilast (an approved treatment). Participants will be monitored through clinic visits, questionnaires, health checks, heart activity tests, and by providing blood/urine samples.
What are the potential side effects?
Possible side effects of ESK-001 may include reactions similar to those experienced with other psoriasis treatments such as digestive issues, headaches, fatigue. The exact side effects will be studied during the trial.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Timeline

Screening ~ 28 days
Treatment ~ 6 days
Follow Up ~28 days
This trial's timeline: 28 days for screening, 6 days for treatment, and 28 days 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

Logistics

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

Alumis IncLead Sponsor
7 Previous Clinical Trials
1,720 Total Patients Enrolled
~560 spots leftby May 2026
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