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

Launched by ALUMIS INC · Sep 3, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called ESK-001 to see if it can help treat people with moderate to severe plaque psoriasis, a skin condition that causes red, scaly patches. The researchers want to find out if ESK-001 can make these psoriasis symptoms better and how safe it is for patients. The study includes two groups: one group will receive ESK-001, while another group will either get a placebo (a fake pill) or an already approved medication called apremilast.

To participate in the trial, individuals must be at least 18 years old and have been diagnosed with plaque psoriasis for at least six months, with skin plaques covering a significant area. Participants will take the medication daily for 24 weeks and will have regular check-ups at the clinic to monitor their health, report on their symptoms, and provide samples for testing. It's important for potential participants to know that certain health conditions or treatments can make them ineligible, so it's best to discuss their situation with a healthcare provider to see if they qualify.

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). Participants 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. Participants 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 participant'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 participants requires current systemic corticosteroids
• • \* Stable doses of inhaled corticosteroids for treatment of asthma are allowed
• • 14. 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
• • 15. Live vaccines within 4 weeks prior to Study Day 1
• • 16. Participant has planned surgery during the study period
• • 17. 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
• • 18. 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
• • 19. Evidence of severe depressive symptoms or active suicidal ideation or behavior