Plaque Psoriasis
Conditions
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 psoriasis? * How safe is ESK-001 in people with moderate to severe plaque psoriasis? The study includes 2 comparators: a placebo control (a 'dummy' tablet that does not contain the medicine ESK-001 but looks just like it) and an active control (apremilast, which is a medicine approved to treat psoriasis). People taking part in this study must be men or women aged at least 18 years and have had plaque psoriasis for at least 6 months, currently moderate to severe. Participants will: * take drug every day for 24 weeks. * visit the clinic for checkups and tests. * fill out questionnaires about their psoriasis, itch severity, and change in quality of life. * be assessed for health issues and side effects, physical examinations, vital signs, heart electrical activity measurements, and psychological health. * provide blood and urine samples.
Interventions
Sponsors
Alumis Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To determine whether ESK-001 reduces the severity of psoriasis by 75% (using the PASI) or by at least 2 points (using sPGA score) compared to placebo | 16 weeks | Proportion of patients achieving ≥75% reduction in PASI score. Proportion of patients achieving a score of 0 or 1 on sPGA. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To compare the Psoriasis Area and Severity Index (PASI-75) between ESK-001 and apremilast | 24 weeks | Proportion of patients achieving of ≥75% reduction in PASI |
| To compare the Static Physician's Global Assessment (sPGA-0/1) between ESK-001 and apremilast | 24 weeks | Proportion of patients achieving a score of 0 or 1 on sPGA |
| To compare the affected body surface area (%BSA) between ESK-001 and placebo or apremilast | 24 weeks | Change from baseline in %BSA |
| To compare the scalp specific Physician's Global Assessment (ssPGA) between ESK-001 and placebo or apremilast | 24 weeks | Proportion of patients achieving a score of 0 or 1 on ssPGA |
| To compare the Psoriasis Area and Severity Index (PASI-90 and PASI-100) between ESK-001 and placebo or apremilast | 24 weeks | Proportion of patients achieving of ≥90% or 100% reduction in PASI |
| To compare the Dermatology Life Quality Index (DLQI) between ESK-001 and placebo or apremilast | 24 weeks | Proportion of patients achieving a score of 0 or 1 |
| To compare the Pruritus numeric rating scale (NRS) between ESK-001 and placebo | 24 weeks | Change from baseline in Pruritus NRS (scale is from 0 (no pain) to 10 (severe pain)). |
| Proportion of patients with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) | 24 weeks | Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) |
| To characterize the pharmacokinetics of ESK-001 | 24 weeks | Maximum \[Cmax\] and minimum \[Cmin\] plasma concentration |
| To compare the Psoriasis Symptoms and Signs Diary (PSSD) between ESK-001 and placebo or apremilast | 24 weeks | Proportion of patients achieving a score of 0 |
Countries
Austria, Canada, Estonia, France, Germany, Hungary, Israel, Latvia, Poland, Puerto Rico, Spain, United States
Outcome results
None listed