A Study in Patients With Moderate to Severe Plaque Psoriasis to Evaluate the Efficacy and Safety of ESK-001

Launched by ALUMIS INC · Sep 7, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called ESK-001 to see if it can help people with moderate to severe plaque psoriasis, a skin condition that causes red, scaly patches. The trial aims to find out if ESK-001 can make these skin symptoms better and how safe it is for patients. Participants will take ESK-001 every day for 24 weeks and will have regular checkups at the clinic. They will answer questions about their psoriasis and its effects on their lives, undergo health assessments, and provide blood and urine samples.

To be eligible for the trial, participants must be at least 18 years old, have had plaque psoriasis for at least 6 months, and have a significant amount of skin affected by the condition. Certain health conditions and recent treatments could disqualify someone from joining. If you decide to participate, you will be helping researchers learn more about a potential new treatment for psoriasis, and you may also receive care and attention for your condition throughout the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Males or females, age ≥18 years
• • 2. Diagnosis of plaque psoriasis for ≥6 months
• • 3. Plaques covering ≥10% of BSA
• • 4. PASI ≥12
• • 5. sPGA ≥3
• • 6. Women of childbearing potential (WOCBP) and males who are sexually active with WOCBP must agree to adhere to highly effective methods of contraception
• Exclusion Criteria:
• • 1. Nonplaque psoriasis or other inflammatory skin conditions
• • 2. Immune-mediated conditions commonly associated with psoriasis (eg inflammatory bowel disease). Patients with psoriatic arthritis may participate
• • 3. Pregnant, lactating, or planning to get pregnant during the study
• 4. 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
• • 5. Lack of clinical response to a TYK2, IL-12, or IL-23 targeted psoriasis treatment
• • 6. Patients with QTcF \>450 msec (males) or \>470 msec (females) at Screening
• • 7. Unstable cardiovascular disease, defined as a recent clinical deterioration or a cardiac hospitalization within the last 3 months
• • 8. Evidence of recent or recurrent herpes zoster or herpes simplex viral infection
• • 9. Evidence of active infection or positive test result for hepatitis B, hepatitis C, HIV or TB
• • 10. History of serious bacterial, fungal, or viral infections that led to hospitalization, or any recent serious infection requiring antibiotic treatment
• • 11. Any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the patient's immune status
• • 12. Lab abnormalities indicating significant renal, hepatic or bone marrow dysfunction
• • 13. History of any immune-mediated or inflammatory medical condition for which patient requires current systemic corticosteroids