A Study in Patients With Moderate to Severe Plaque Psoriasis to Evaluate the Efficacy and Safety of ESK-001
- 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
- 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
-
Lack of clinical response to a TYK2, IL-12, or IL-23 targeted psoriasis treatment
-
Patients 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 patient's immune status
-
Lab abnormalities indicating significant renal, hepatic or bone marrow dysfunction
-
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)
Orvostudomanyi Kutato es Fejleszto Kft
🇭🇺Debrecen, Hungary
Allergo Derm Bakos Kft
🇭🇺Szolnok, Hungary
Medmare Bt
🇭🇺Veszprém, Hungary
Uno Medical Trials Kft
🇭🇺Budapest, Hungary
Klinik Hietzing
🇦🇹Vienna, Austria
Beacon Dermatology
🇨🇦Calgary, Alberta, Canada
Alberta DermaSurgery
🇨🇦Edmonton, Alberta, Canada
CaRe Clinic Red Deer
🇨🇦Red Deer, Alberta, Canada
CCA Medical Research Corp
🇨🇦Ajax, Ontario, Canada
SKiN Health
🇨🇦Cobourg, Ontario, Canada
Innomedica
🇪🇪Tallinn, Harjumaa, Estonia
Hopital Prive d Antony
🇫🇷Antony, Ile de France, France
CHU de Rouen
🇫🇷Rouen, Normandy, France
DermaMed Research Kf
🇭🇺Bekes, Oroshaza, Hungary
Semmelweis Egyetem
🇭🇺Budapest, Hungary
Rabin Medical Center
🇮🇱Petah tikva, Israel
Sheba Tel HaShomer Medical Centre
🇮🇱Ramat Gan, Israel
Semigallia Ltd
🇱🇻Kuldiga, Kuldigas, Latvia
Riga 1st Hospital
🇱🇻Riga, Latvia
Med Art Clinic
🇱🇻Riga, Latvia
Veselibas Centrs 4
🇱🇻Riga, Latvia
SIA Veseliba un estetika
🇱🇻Riga, Latvia
Veselibas Centrs 4 Filiale Dermatologijas Klinika
🇱🇻Riga, Latvia
Smite Aija Medical Practice in Dermatology Venereology
🇱🇻Talsi, Latvia
FutureMeds Lodz
🇵🇱Lodz, Lodzkie, Poland
Dermoklinika
🇵🇱Łódź, Lodzkie, Poland
Specderm
🇵🇱Białystok, Podlaskie, Poland
Pratia Gdynia
🇵🇱Gdynia, Pomorskie, Poland
MTZ Clinical Research Sp z o o
🇵🇱Warsaw, Poland
Klinika Ambroziak Dermatologia Kliniczna
🇵🇱Warszawa, Poland
dermMedica
🇵🇱Wroclaw, Poland
Centro Reumatologico de Caguas
🇵🇷Caguas, Puerto Rico
Clinical Research Puerto Rico
🇵🇷Ponce, Puerto Rico
GCM Medical Group PSC Hato Rey Site
🇵🇷San Juan, Puerto Rico
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Hospital Universitarion de La Princesa
🇪🇸Madrid, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
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
UC San Diego
🇺🇸San Diego, California, United States
Southern California Clinical Research
🇺🇸Santa Ana, California, United States
Clinical Science Institute Dermatology Institute
🇺🇸Santa Monica, California, United States
FXM Clinical Research Ft. Lauderdale LLC
🇺🇸Fort Lauderdale, Florida, United States
Direct Helpers Research Center (DHRC)
🇺🇸Hialeah, Florida, United States
Green Leaf Clinical Trials
🇺🇸Jacksonville, Florida, United States
AppleMed Research Group under WCG
🇺🇸Miami, Florida, United States
FAX Pharma Clinical Research Inc
🇺🇸Miami, Florida, United States
FXM Clinical Research - Miami LLC
🇺🇸Miami, Florida, United States
Las Mercedes Medical Research
🇺🇸Miami, Florida, United States
FXM Clinical Research Miramar LLC
🇺🇸Miramar, Florida, United States
Renstar Medical Research
🇺🇸Ocala, Florida, United States
DS Research of Southern Indiana
🇺🇸Clarksville, Indiana, United States
The Indiana Clinical Trials Center
🇺🇸Plainfield, Indiana, United States
DS Research of Kentucky
🇺🇸Louisville, Kentucky, United States
Michigan Center for Research Company
🇺🇸Clarkston, Michigan, United States
Henry Ford Medical Center - Farmington Road
🇺🇸Detroit, Michigan, United States
Revival Research Institute
🇺🇸Troy, Michigan, United States
Grekin Skin Institute
🇺🇸Warren, Michigan, United States
Associated Skin Care Specialists - Minnesota Clinical Study Center
🇺🇸New Brighton, Minnesota, United States
Schlessinger MD
🇺🇸Omaha, Nebraska, United States
Las Vegas Clinical Trials
🇺🇸Las Vegas, Nevada, United States
NYC Health and Hospitals Elmhurst
🇺🇸Elmhurst, New York, United States
Pioneer Clinical Research NY
🇺🇸New York, New York, United States
Cameron Dermatology
🇺🇸New York, New York, United States
DermResearchCenter of New York
🇺🇸Stony Brook, New York, United States
Asheville Clinical Trials
🇺🇸Asheville, North Carolina, United States
WDC Cosmetic and Research
🇺🇸Wilmington, North Carolina, United States
Optima Research Boardman
🇺🇸Boardman, Ohio, United States
Synexus Clinical Research US Inc - Cincinnati
🇺🇸Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Clinical Partners LLC
🇺🇸Johnston, Rhode Island, United States
Arlington Research Center
🇺🇸Arlington, Texas, United States
Modern Research Associates PLLC
🇺🇸Dallas, Texas, United States
SMS Clinical Research
🇺🇸Mesquite, Texas, United States
Progressive Clinical Research - San Antonio
🇺🇸San Antonio, Texas, United States
Center for Clinical Studies (CCS) - Webster/Clear Lake Location
🇺🇸Webster, Texas, United States
Jordan Valley Dermatology
🇺🇸South Jordan, Utah, United States
VIDA Dermatology/VIDA Clinical Research
🇨🇦Edmonton, Alberta, Canada
Skincare Studio
🇨🇦Saint John's, Newfoundland and Labrador, Canada
SimcoDerm Medical and Surgical Dermatology Center
🇨🇦Barrie, Ontario, Canada
Kingsway Clinical Research
🇨🇦Etobicoke, Ontario, Canada
Guelph Dermatology Research
🇨🇦Guelph, Ontario, Canada
Mediprobe Research
🇨🇦London, Ontario, Canada
Clear Skin Dermatology
🇨🇦Newmarket, Ontario, Canada
North Bay Dermatology Centre
🇨🇦North Bay, Ontario, Canada
Rejuvination Dermatology Oakville
🇨🇦Oakville, Ontario, Canada
Toronto Research Centre
🇨🇦Toronto, Ontario, Canada
XLR8 Medical Research
🇨🇦Windsor, Ontario, Canada
Innovaderm
🇨🇦Montreal, Quebec, Canada
SkinSense Medical Research
🇨🇦Saskatoon, Saskatchewan, Canada
Tartu University Hospital
🇪🇪Tartu, Tartumaa, Estonia
Center for Clinical and Basic Research AS
🇪🇪Tallinn, Estonia
Kliiniliste Uuringute Keskus OU
🇪🇪Tartu, Estonia
Centre Hospitalier Le Mans
🇫🇷Le Mans, Sarthe département, France
Centre Azur Nice
🇫🇷Nice, France
Polyclinique de Courlancy
🇫🇷Reims, France
Hopitaux Drome Nord
🇫🇷Romans-sur-Isère, France
Universitatsklinikum Erlangen
🇩🇪Erlangen, Bavaria, Germany
Ludwig Maximilians Universitaet Muenchen Klinik und Poliklinik fuer Dermatologie und Allergologie
🇩🇪Munich, Bavaria, Germany
Rosenpark Research
🇩🇪Darmstadt, Hesse, Germany
Elbe Klinikum Buxtehude
🇩🇪Buxtehude, Lower Saxony, Germany
Klinische Forschung Schwerin GmbH
🇩🇪Schwerin, Mecklenburg-Vorpommern, Germany
Klinikum Oldenburg
🇩🇪Oldenburg, Niedersachsen, Germany
Hautarztpraxis Dr Niesmann and Dr Othlinghaus
🇩🇪Bochum, NRW, Germany
MVZ Dermatologisches Zentrum Bonn GmbH
🇩🇪Bonn, NRW, Germany
Universitaetsklinikum Muenster
🇩🇪Münster, NRW, Germany
Dermatologische Praxis Dres Quist
🇩🇪Mainz, Rhinelkand-Palatinate, Germany
Praxis fur Dermatologie und Venerologie
🇩🇪Dresden, Saxony, Germany
Klinische Forschung Dresden GmbH
🇩🇪Dresden, Saxony, Germany
Universitatsklinikum Schleswig Holstein
🇩🇪Luebeck, Schleswig Holstein, Germany
ISA - Interdisciplinary Study Association GmbH
🇩🇪Berlin, Germany
Dr med Thomas Wildfeuer and Kolleg Innen
🇩🇪Berlin, Germany
MVZ DermaKiel GmbH
🇩🇪Kiel, Germany
Studienzentrum Dr med Beate Schwarz
🇩🇪Langenau, Germany
Haut Ambulatorium Magdeburg
🇩🇪Magdeburg, Germany
KliFOs Klinische Forschung Osnabruck
🇩🇪Osnabruck, Germany
Harzklinikum Dorothea Christiane Erxleben
🇩🇪Quedlinburg, Germany
Bacs Kiskun County Teaching Hospital
🇭🇺Kecskemét, Bacs-Kiskun, Hungary
Borgyogyaszati Klinika Debreceni Egyetem Orvos es Egeszsegtudomenyi Centrum
🇭🇺Debrecen, Hajdu-Bihar, Hungary
DERMA B Kft
🇭🇺Debrecen, Hajdú-Bihar megye, Hungary
Centrum Medyczne dr Rajzer Spolka Zoo
🇵🇱Kraków, Malopolska, Poland
FutureMeds Krakow
🇵🇱Krakow, Malopolskie, Poland
Clinical Best Solutions
🇵🇱Warsaw, Masovian, Poland
Centrum Medyczne Evimed
🇵🇱Warszawa, Masovian, Poland
RCMed Oddział Sochaczew
🇵🇱Sochaczew, Mazowieckie, Poland
Klinika Dermatologii Uniwersytecki Szpital Kliniczny im F Chopina
🇵🇱Rzeszow, Podkarpackie, Poland
Pratia Katowice
🇵🇱Katowice, Silesia, Poland
Research Solutions
🇵🇱Katowice, Slaskie, Poland
Care Clinic Katowice
🇵🇱Katowice, Poland
Luxderm
🇵🇱Lublin, Poland
Zanamed Medical Clinic Sp z o o
🇵🇱Lublin, Poland
Ponce Medical School Foundation Inc
🇵🇷Ponce, Puerto Rico
Hospital Clínico Universitario de Santiago de Compostela
🇪🇸Santiago de Compostela, A Coruña, Spain
Hospital Germans Trias i Pujol
🇪🇸Barcelona, Badalona, Spain
Consorcio Hospital General Universitario de Valencia
🇪🇸Valencia, Valencian Community, Spain
University General Hospital Dr Balmis
🇪🇸Alicante, Spain
Hospital del Mar
🇪🇸Barcelona, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hospital de Manises
🇪🇸Manises, Spain
Hospital Universitario Virgen Macarena
🇪🇸Sevilla, Spain