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ESK-001 Dose Level 1 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 weeks
Awards & highlights
Summary
This trial tests ESK-001, a new medication, on patients with moderate to severe plaque psoriasis. It aims to see if ESK-001 can help reduce inflammation and slow down skin cell growth. The study lasts for several months.
Eligible Conditions
- Plaque Psoriasis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 14 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
To Compare the Psoriasis Area and Severity Index (PASI-75) Between Doses of ESK-001 and Placebo
Secondary study objectives
To Assess the Response Rate in Static Physician's Global Assessment (sPGA) Score
To Assess the Safety and Tolerability of ESK-001 Dose in Moderate to Severe Psoriasis Patients
To Characterize the Pharmacokinetics (PK) of ESK-001
Side effects data
From 2023 Phase 2 trial • 228 Patients • NCT056000368%
Headache
8%
Nasopharyngitis
8%
Upper respiratory tract infection
5%
Dermatitis acneiform
5%
Pyrexia
5%
Acne
5%
Cough
3%
COVID-19
100%
80%
60%
40%
20%
0%
Study treatment Arm
ESK-001 40mg BID
ESK-001 20mg BID
ESK-001 10mg QD
ESK-001 20mg QD
ESK-001 40mg QD
Placebo
Trial Design
6Treatment groups
Experimental Treatment
Placebo Group
Group I: ESK-001 Dose Level 5Experimental Treatment1 Intervention
ESK-001 administered as an oral tablet
Group II: ESK-001 Dose Level 4Experimental Treatment1 Intervention
ESK-001 administered as an oral tablet
Group III: ESK-001 Dose Level 3Experimental Treatment1 Intervention
ESK-001 administered as an oral tablet
Group IV: ESK-001 Dose Level 2Experimental Treatment1 Intervention
ESK-001 administered as an oral tablet
Group V: ESK-001 Dose Level 1Experimental Treatment1 Intervention
ESK-001 administered as an oral tablet
Group VI: PlaceboPlacebo Group1 Intervention
Placebo 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
Find a Location
Who is running the clinical trial?
Alumis IncLead Sponsor
7 Previous Clinical Trials
2,332 Total Patients Enrolled
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