Status:
ACTIVE_NOT_RECRUITING
A Study in Patients With Moderate to Severe Plaque Psoriasis to Evaluate the Efficacy and Safety of ESK-001
Lead Sponsor:
Alumis Inc
Conditions:
Plaque Psoriasis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The goal of this clinical trial is to learn if ESK-001 works to treat moderate to severe plaque psoriasis. The main questions it aims to answer are: * Does ESK-001 reduce the severity of people's pso...
Eligibility Criteria
Inclusion
- Males or females, age ≥18 years
- Diagnosis of plaque psoriasis for ≥6 months
- Plaques covering ≥10% of BSA
- PASI ≥12
- sPGA ≥3
- Women of childbearing potential (WOCBP) and males who are sexually active with WOCBP must agree to adhere to highly effective methods of contraception
Exclusion
- Nonplaque psoriasis or other inflammatory skin conditions
- Immune-mediated conditions commonly associated with psoriasis (eg inflammatory bowel disease). Patients with psoriatic arthritis may participate
- Pregnant, lactating, or planning to get pregnant during the study
- Use of drugs prior to Study Day 1 that treat or may affect psoriasis:
- Topical within 2 weeks
- Phototherapy or any systemic treatments within 4 weeks
- Any biologic agent targeted to IL-12 or IL-23 within 6 months, oral IL-12 or IL-23 or TNFα inhibitor within 2 months, or IL-17 within 4 months
- Systemic immunosuppressants or immunomodulatory drugs within 4 weeks
- Modulators of B cells within 6 months, or T cells within 3 months
- JAK inhibitors or TYK2 inhibitors within 4 weeks
- PDE4 inhibitor within 2 months
- Any investigational agent, within 30 days or 5 half-lives or is currently enrolled in an investigational study
- Lack of clinical response to a TYK2, IL-12, or IL-23 targeted psoriasis treatment
- Patients with QTcF \>450 msec (males) or \>470 msec (females) at Screening
- Unstable cardiovascular disease, defined as a recent clinical deterioration or a cardiac hospitalization within the last 3 months
- Evidence of recent or recurrent herpes zoster or herpes simplex viral infection
- Evidence of active infection or positive test result for hepatitis B, hepatitis C, HIV or TB
- History of serious bacterial, fungal, or viral infections that led to hospitalization, or any recent serious infection requiring antibiotic treatment
- Any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the patient's immune status
- Lab abnormalities indicating significant renal, hepatic or bone marrow dysfunction
- History of any immune-mediated or inflammatory medical condition for which patient requires current systemic corticosteroids
Key Trial Info
Start Date :
August 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
840 Patients enrolled
Trial Details
Trial ID
NCT06588738
Start Date
August 20 2024
End Date
December 1 2025
Last Update
December 9 2025
Active Locations (125)
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1
Total Skin and Beauty Dermatology Center, PC
Birmingham, Alabama, United States, 35203
2
Chandler Clinical Trials
Chandler, Arizona, United States, 85224
3
Noble Clinical Research
Tucson, Arizona, United States, 85704
4
Zenith Research Inc.
Beverly Hills, California, United States, 90211-1705