Status:
ACTIVE_NOT_RECRUITING
A Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Moderate to Severe Plaque Psoriasis
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). Participants 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
- Participants 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 participant's immune status
- Lab abnormalities indicating significant renal, hepatic or bone marrow dysfunction
- History of any immune-mediated or inflammatory medical condition for which participants requires current systemic corticosteroids
- \* Stable doses of inhaled corticosteroids for treatment of asthma are allowed
- Known current malignancy or current evaluation for a potential malignancy or history of malignancy within the past 5 years prior to screening, except for adequately treated basal cell or squamous cell skin carcinoma or carcinoma in situ of the cervix
- Live vaccines within 4 weeks prior to Study Day 1
- Participant has planned surgery during the study period
- Any acute or chronic illness/condition or evidence of an unstable clinical condition that, in the opinion of the Investigator, will substantially increase the risk to the participant if he or she participates in the study
- History of mental illness within the last 5 years, unless receiving a fixed regimen of psychiatric medications for at least 6 months before screening or has not required or been prescribed any psychiatric medication within 12 months before screening
- Evidence of severe depressive symptoms or active suicidal ideation or behavior
Key Trial Info
Start Date :
July 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
840 Patients enrolled
Trial Details
Trial ID
NCT06586112
Start Date
July 25 2024
End Date
December 1 2025
Last Update
December 9 2025
Active Locations (158)
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1
Alliance Dermatology
Phoenix, Arizona, United States, 85032
2
Scottsdale Clinical Trials
Scottsdale, Arizona, United States, 85260
3
Northwest Arkansas Clinical Trials Center (NWACTC), PLLC
Rogers, Arkansas, United States, 72758-8600
4
Exalt Clinical Research
Chula Vista, California, United States, 91910