A Study in Patients With Moderate to Severe Plaque Psoriasis to Evaluate the Efficacy and Safety of ESK-001
- Conditions
- Plaque Psoriasis
- Interventions
- Registration Number
- NCT06588738
- Lead Sponsor
- Alumis Inc
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 840
- 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
-
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
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Lack of clinical response to a TYK2, IL-12, or IL-23 targeted psoriasis treatment
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Patients with QTcF >450 msec (males) or >470 msec (females) at Screening
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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
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Evidence of active infection or positive test result for hepatitis B, hepatitis C, HIV or TB
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History of serious bacterial, fungal, or viral infections that led to hospitalization, or any recent serious infection requiring antibiotic treatment
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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
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History of any immune-mediated or inflammatory medical condition for which patient requires current systemic corticosteroids
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ESK-001 ESK-001 ESK-001 administered as an oral tablet Placebo Placebo Matching oral placebo Apremilast Apremilast Apremilast administered as an oral capsule
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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 Symptoms and Signs Diary (PSSD) between ESK-001 and placebo or apremilast 24 weeks Proportion of patients achieving a score of 0
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
Trial Locations
- Locations (148)
Total Skin and Beauty Dermatology Center, PC
🇺🇸Birmingham, Alabama, United States
Chandler Clinical Trials
🇺🇸Chandler, Arizona, United States
Medical Dermatology Specialists
🇺🇸Phoenix, Arizona, United States
Noble Clinical Research
🇺🇸Tucson, Arizona, United States
Zenith Research Inc.
🇺🇸Beverly Hills, California, United States
Raoof MD
🇺🇸Encino, California, United States
Long Beach Research Institute
🇺🇸Long Beach, California, United States
Dermatology Research Associates
🇺🇸Los Angeles, California, United States
Empire Clinical Research - Pomona
🇺🇸Pomona, California, United States
Integrative Skin Science and Research
🇺🇸Sacramento, California, United States
Scroll for more (138 remaining)Total Skin and Beauty Dermatology Center, PC🇺🇸Birmingham, Alabama, United States