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

NCT06586112 | Completed Phase 3 FDA Drug

• 1 other identifier: ESK-001-016
• Study Type: interventional
• Target: 912
• Locations: 10 countries
• Sites: 156

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.

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• 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

  Proportion of participants achieving ≥75% reduction in PASI score. Proportion of participants achieving a score of 0 or 1 on sPGA.

  16 weeks

Secondary Outcomes (10)

• To compare the Psoriasis Area and Severity Index (PASI-90 and PASI-100) between ESK-001 and placebo or apremilast

  24 weeks

• To compare the Psoriasis Area and Severity Index (PASI-75) between ESK-001 and apremilast

  24 weeks

• To compare the Static Physician's Global Assessment (sPGA-0/1) between ESK-001 and apremilast

  24 weeks

• To compare the affected body surface area (%BSA) between ESK-001 and placebo or apremilast

  24 weeks

• To compare the scalp specific Physician's Global Assessment (ssPGA) between ESK-001 and placebo or apremilast.

  24 weeks

Study Arms (3)

ESK-001

EXPERIMENTAL

ESK-001 administered as an oral tablet

Drug: Envudeucitinib

Placebo

PLACEBO COMPARATOR

Matching oral placebo

Drug: Placebo

Apremilast

ACTIVE COMPARATOR

Apremilast administered as an oral capsule

Drug: Apremilast

Interventions

Apremilast DRUG

Apremilast

Apremilast

Placebo DRUG

Placebo

Placebo

Envudeucitinib DRUG

ESK-001

ESK-001

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Nonplaque psoriasis or other inflammatory skin conditions
• immune-mediated conditions commonly associated with psoriasis (eg inflammatory bowel disease). Participants 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
• Participants 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

Sponsors & Collaborators

• Alumis Inc: lead

Study Sites (156)

Alliance Dermatology

Phoenix, Arizona, 85032, United States

Location

Scottsdale Clinical Trials

Scottsdale, Arizona, 85260, United States

Location

Northwest Arkansas Clinical Trials Center (NWACTC), PLLC

Rogers, Arkansas, 72758-8600, United States

Location

Exalt Clinical Research

Chula Vista, California, 91910, United States

Location

California Dermatology & Clinical Research Institute

Encinitas, California, 92024-7700, United States

Location

First OC Dermatology Research Inc

Fountain Valley, California, 92708, United States

Location

Marvel Clinical Research, LLC

Huntington Beach, California, 92647, United States

Location

Sunwise Clinical Research, LLC

Lafayette, California, 94549, United States

Location

Wallace Medical Group Inc

Los Angeles, California, 90056, United States

Location

Northridge Clinical Trials - Elite Clinical Network

Northridge, California, 91325, United States

Location

Pasadena Clinical Trials

Pasadena, California, 91101, United States

Location

Therapeutics Clinical Research

San Diego, California, 92123, United States

Location

Unison Clinical Trials/ Shahram Jacobs MD

Sherman Oaks, California, 91403-1814, United States

Location

Olive View - UCLA Education & Research Institute

Sylmar, California, 91342, United States

Location

California Dermatology Institute - Thousand Oaks

Thousand Oaks, California, 91320-2130, United States

Location

Clearlyderm Dermatology - West Boca Raton

Boca Raton, Florida, 33428, United States

Location

Driven Clinical Research

Coral Gables, Florida, 33134, United States

Location

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

Location

Glick Skin Institute - Margate

Margate, Florida, 33063-7011, United States

Location

San Marcus Research Clinic, Inc - Miami

Miami Lakes, Florida, 33014, United States

Location

Savin Medical Group LLC

Miami Lakes, Florida, 33014, United States

Location

Oceanic Research Group

North Miami Beach, Florida, 33169, United States

Location

LENUS Research

Sweetwater, Florida, 33172, United States

Location

Caban Skin Institute

Tampa, Florida, 33607, United States

Location

ForCare Medical Center

Tampa, Florida, 33613-1244, United States

Location

Skin Care Physicians of Georgia - Warner Robins

Macon, Georgia, 31217, United States

Location

MetroMed Clinical Trials

Chicago, Illinois, 60614-3625, United States

Location

Arlington Dermatology

Rolling Meadows, Illinois, 60008, United States

Location

NorthShore Medical Group - Dermatology - Skokie

Skokie, Illinois, 60077-1049, United States

Location

Dundee Dermatology

West Dundee, Illinois, 60118, United States

Location

Dawes Fretzin Clinical Research Group

Columbus, Indiana, 47201, United States

Location

The South Bend Clinic

South Bend, Indiana, 46617, United States

Location

Equity Medical - Bowling Green

Bowling Green, Kentucky, 42104, United States

Location

Velocity Clinical Research at The Dermatology Clinic, Baton Rouge

Baton Rouge, Louisiana, 70808, United States

Location

Tulane University School of Medicine

New Orleans, Louisiana, 70112, United States

Location

MetroBoston Clinical Partners

Brighton, Massachusetts, 02135, United States

Location

Cleaver Dermatology

Kirksville, Missouri, 63501-5362, United States

Location

OptiSkin

New York, New York, 10128-0724, United States

Location

The Ohio State University Wexner Medical Center (OSUWMC) - OSU Dermatology East - Columbus

Gahanna, Ohio, 43230-5317, United States

Location

Dermatologists of Southwestern Ohio, LLC

Mason, Ohio, 45040-4520, United States

Location

Unity Clinical Research (UCR)

Oklahoma City, Oklahoma, 73118, United States

Location

Velocity Clinical Research, Medford

Medford, Oregon, 97504, United States

Location

Oregon Medical Research Center

Portland, Oregon, 97201, United States

Location

Paddington Testing Company Inc.

Philadelphia, Pennsylvania, 19103, United States

Location

UPMC Department of Dermatology

Pittsburgh, Pennsylvania, 15213, United States

Location

Health Concepts

Rapid City, South Dakota, 57702-9208, United States

Location

Discover Dermatology, LLC d/b/a Goodlettsville Dermatology Research

Goodlettsville, Tennessee, 37072-2301, United States

Location

Discover Dermatology, LLC d/b/a Cumberland Skin Center for Clinical Research under Objective Health

Hermitage, Tennessee, 37076, United States

Location

UT Health Houston Department of Dermatology

Bellaire, Texas, 77401, United States

Location

Studies in Dermatology, LLC

Cypress, Texas, 77429, United States

Location

Reveal Research Institute

Frisco, Texas, 75033, United States

Location

Center for Clinical Studies - Texas Medical Center

Houston, Texas, 77004, United States

Location

Austin Institute for Clinical Research - Houston

Houston, Texas, 77056, United States

Location

University of Utah Health Care - Midvalley Health Center

Murray, Utah, 84107, United States

Location

Frontier Dermatology

Mill Creek, Washington, 98012, United States

Location

Premier Specialists

Kogarah, New South Wales, 2217, Australia

Location

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

North Eastern Health Specialists (NEHS)

Campbelltown, South Australia, 5074, Australia

Location

Skin Health Institute Inc.

Carlton, Victoria, 3053, Australia

Location

Sinclair Dermatology

East Melbourne, Victoria, 3002, Australia

Location

Multiprofile Hospital for Active Treatment Dr Tota Venkova

Gabrovo, Gabrovo, 5300, Bulgaria

Location

Clineca

Stara Zagora, Stara Zagora, 6000, Bulgaria

Location

Medikal Center Kordis

Pleven, 5800, Bulgaria

Location

Skin and Venereal Diseases Center EOOD

Sofia, 1404, Bulgaria

Location

Diagnostic Consultative Center Aleksandrovska EOOD

Sofia, 1431, Bulgaria

Location

Rejuvenation Medical Group Edmonton Downtown

Edmonton, Alberta, T5J 3S9, Canada

Location

Enverus Medical Research

Surrey, British Columbia, V3V 0C6, Canada

Location

Dermatrials Research Inc.

Hamilton, Ontario, L8N 1Y2, Canada

Location

Centricity Research

London, Ontario, N6A 2C2, Canada

Location

DermEffects

London, Ontario, N6H 5L5, Canada

Location

Lynderm Research Inc.

Markham, Ontario, L3P 1X3, Canada

Location

DermEdge Research

Mississauga, Ontario, L4Y 4C5, Canada

Location

Institute of Cosmetic & Laser Surgery

Oakville, Ontario, L6J 7W5, Canada

Location

The Centre for Dermatology

Richmond Hill, Ontario, L4B 1A5, Canada

Location

North York Research Inc.

Toronto, Ontario, M2N3A6, Canada

Location

Canadian Dermatology Centre

Toronto, Ontario, M3B 0A7, Canada

Location

Dermatology on Bloor

Toronto, Ontario, M4W 2N4, Canada

Location

Alliance Clinical Trials

Waterloo, Ontario, N2J 1C4, Canada

Location

"Centre de Recherche Dermatologique du Quebec Metropolitain Inc."

Québec, Quebec, G1V 4X7, Canada

Location

Dermatologie Sima Inc.

Verdun, Quebec, H4G 3E7, Canada

Location

Fakultni nemocnice Plzen Dermatovenerologicka klinika

Pilsen, Bory, 301 00, Czechia

Location

Pratia Brno s.r.o.

Brno, Moravia, 60200, Czechia

Location

Dermskin, s.r.o.

Olomouc, Moravia, 77900, Czechia

Location

Kozni ambulance Kutna Hora, s.r.o.

Kutná Hora, 28401, Czechia

Location

DERMAMEDICA, s.r.o.

Náchod, 54701, Czechia

Location

Nemocnice Nový Jičín, A.S.

Nový Jičín, 74101, Czechia

Location

CCR Ostrava, s.r.o.

Ostrava, 70200, Czechia

Location

Vesalion sro

Ostrava, 70200, Czechia

Location

Pratia Pardubice a.s.

Pardubice, 53002, Czechia

Location

Clintrial s.r.o.

Prague, 100 00, Czechia

Location

Fakultni Nemocnice Kralovske Vinohrady FNKV Dermatovenerologicka Klinika

Prague, 10034, Czechia

Location

Sanatorium Profesora Arenbergera

Prague, 110 00, Czechia

Location

Pratia Prague, s.r.o.

Prague, 13000, Czechia

Location

Praglandia

Prague, 15000, Czechia

Location

Dermatologicka ambulance - Svitavy

Svitavy, 568 02, Czechia

Location

MUDr Radka Neumannova

Svitavy, 56802, Czechia

Location

Eberhard Karls Universitaet Tuebingen Universitaets Hautklinik Tuebingen

Tübingen, Baden-Wurttemberg, 72070, Germany

Location

Hautarztpraxis Dr. Mihaescu

Augsburg, Bavaria, 86150, Germany

Location

Hautarztpraxis Mahlow

Mahlow, Brandenburg, 15831, Germany

Location

Universitatsklinikum Frankfurt

Frankfurt am Main, Hesse, 60590, Germany

Location

Fachklinik Bad Bentheim

Bad Bentheim, Lower Saxony, 48455, Germany

Location

Hautarztpraxis an der Hase

Bramsche, Lower Saxony, 49565, Germany

Location

Siteworks

Lohne, Lower Saxony, 49393, Germany

Location

Klinikum Bielefeld

Bielefeld, North Rhine-Westphalia, 33647, Germany

Location

Pro Derma

Dülmen, North Rhine-Westphalia, 48249, Germany

Location

Intramedis CSS

Remscheid, North Rhine-Westphalia, 42897, Germany

Location

Universitatsklinikum Schleswig-Holstein

Kiel, Schleswig-Holstein, 24105, Germany

Location

Fukuoka University Hospital

Fukuoka, Fukuoka-shi, 814-0180, Japan

Location

Asahikawa Medical University Hospital

Asahikawa, Hokkaido, 078-8510, Japan

Location

Nihon University Itabashi Hospital

Tokyo, Itabashi-Ku, 173-8610, Japan

Location

Saruwatari Dermatology Clinic

Kagoshima, Kagoshima-Shi, 890-0046, Japan

Location

Kanto Rosai Hospital

Kanagawa, Kawasaki-shi, 211-8510, Japan

Location

Nagoya City University Hospital

Aichi, Nagoya-shi, 467-8602, Japan

Location

Okayama University Hospital

Okayama, Okayama-shi, 700-8558, Japan

Location

Osaka Metropolitan University Hospital

Osaka, Osaka-shi, 545-8586, Japan

Location

Nippon Life Hospital

Osaka, Osaka-Shi, 550-0006, Japan

Location

National Hospital Organization Sagamihara National Hospital

Kanagawa, Sagamihara, 252-0392, Japan

Location

Dermatology and Ophthalmology Kume Clinic

Osaka, Saka-Shi, 593-8324, Japan

Location

Hokkaido University Hospital

Hokkaido, Sapporo-shi, 060-8648, Japan

Location

Kindai University Hospital

Osaka, Sayama-Shi, 589-8511, Japan

Location

Tokyo Medical University Hospital

Tokyo, Shinjuku-Ku, 160-0023, Japan

Location

Osaka University Hospital

Osaka, Suita-shi, 565-0871, Japan

Location

Medical Corporation Jitai kai Tachikawa Dermatology Clinic

Tokyo, Tachikawa-shi, 190-0023, Japan

Location

Mie University Hospital

Mie, Tsu-shi, 514-8507, Japan

Location

Yamaguchi University Hospital

Yamaguchi, Ube-shi, 755-8505, Japan

Location

Yokohama City University Hospital

Kanagawa, Yokohama-shi, 236-0004, Japan

Location

Centrum Medyczne Pratia Bydgoszcz

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85796, Poland

Location

Specjalistyczny Ośrodek Alergologiczno-Internistyczny "ALL-MED"

Krakow, Lesser Poland Voivodeship, 30-033, Poland

Location

Centrum Medyczne Synexus Wroclaw

Wroclaw, Lower Silesian Voivodeship, 50-381, Poland

Location

WroMedica

Wroclaw, Lower Silesian Voivodeship, 51-685, Poland

Location

Diamond Clinic

Krakow, Malopolska, 31-559, Poland

Location

MICS Medical Center Warsaw

Warsaw, Masovian Voivodeship, 00-874, Poland

Location

FutureMeds Warszawa Centrum

Warsaw, Masovian Voivodeship, 00215, Poland

Location

High Med Przychodnia Specjalistyczna

Warsaw, Masovian Voivodeship, 01-817, Poland

Location

Centrum Medyczne Reuma Park

Warsaw, Masovian Voivodeship, 02-665, Poland

Location

RoyalDerm

Warsaw, Mazowiecke, 02-962, Poland

Location

ClinicMed Daniluk, Nowak Spolka Komandytowa

Bialystok, Podlaskie Voivodeship, 15-879, Poland

Location

AES Gdansk

Gdansk, Pomeranian Voivodeship, 80-382, Poland

Location

Derm Art Institute

Gdynia, Pomeranian Voivodeship, 81-415, Poland

Location

Centrum Medyczne Synexus Gdynia

Gdynia, Pomeranian Voivodeship, 81-537, Poland

Location

Centrum Medyczne Angelius Provita (Angelius Provita Medical Centre)

Katowice, Silesian Voivodeship, 40-611, Poland

Location

Laser Clinic

Szczecin, West Pomeranian Voivodeship, 70-332, Poland

Location

Centrum Badań Klinicznych PI House Sp. Z O.O.

Gdansk, 80-546, Poland

Location

Pratia Małopolskie Centrum Medyczne (MCM) Kraków

Krakow, 30-727, Poland

Location

Rheuma Medicus

Warsaw, 02-118, Poland

Location

Centrum Medyczne Synexus Warszawa

Warsaw, 02-672, Poland

Location

Velocity Clinical Research, Skierniewice

Skierniewice, Łódź Voivodeship, 96-100, Poland

Location

Hospital da Senhora da Oliveira

Guimarães, Braga District, 4835-044, Portugal

Location

Hospital CUF Descobertas

Lisbon, Lisbon District, 1998-018, Portugal

Location

Unidade Local de Saude Santo Antonio Hospital de Santo Antonio

Porto, Porto District, 4099-001, Portugal

Location

Chosun Universtiy Hospital

Gwangju, Dong-gu, 61453, South Korea

Location

Konkuk University Medical Center

Seoul, Gwangjin-gu, 05030, South Korea

Location

Hallym University Sacred Heart Hospital

Anyang-si, Gyeonggi-do, 14068, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

Pusan National University Hospital

Busan, 49241, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Interventions

apremilast

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: September 19, 2024
• Study Start: July 25, 2024
• Primary Completion: September 19, 2025
• Study Completion: November 20, 2025
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

CA (15); KR (6); BU (5); US (55); PL (21); PT (3); DE (11); JP (19); AU (5); CZ (16)