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

NCT06588738 | Completed Phase 3 FDA Drug

• 1 other identifier: ESK-001-017
• Study Type: interventional
• Target: 862
• Locations: 11 countries
• Sites: 120

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 patients achieving ≥75% reduction in PASI score. Proportion of patients 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

Envudeucitinib DRUG

ESK-001

ESK-001

Placebo DRUG

Placebo

Placebo

Apremilast DRUG

Apremilast

Apremilast

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). 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

Sponsors & Collaborators

• Alumis Inc: lead

Study Sites (124)

Total Skin and Beauty Dermatology Center, PC

Birmingham, Alabama, 35203, United States

Location

Chandler Clinical Trials

Chandler, Arizona, 85224, United States

Location

Noble Clinical Research

Tucson, Arizona, 85704, United States

Location

Zenith Research Inc.

Beverly Hills, California, 90211-1705, United States

Location

Raoof MD

Encino, California, 91436, United States

Location

Long Beach Research Institute

Long Beach, California, 90805, United States

Location

Dermatology Research Associates

Los Angeles, California, 90045, United States

Location

Empire Clinical Research - Pomona

Pomona, California, 91767, United States

Location

Integrative Skin Science and Research

Sacramento, California, 95815, United States

Location

UC San Diego

San Diego, California, 92122, United States

Location

Southern California Clinical Research

Santa Ana, California, 92701, United States

Location

Clinical Science Institute Dermatology Institute

Santa Monica, California, 90404, United States

Location

FXM Clinical Research Ft. Lauderdale LLC

Fort Lauderdale, Florida, 33308, United States

Location

Direct Helpers Research Center (DHRC)

Hialeah, Florida, 33012, United States

Location

AppleMed Research Group under WCG

Miami, Florida, 33126, United States

Location

FAX Pharma Clinical Research Inc

Miami, Florida, 33146, United States

Location

FXM Clinical Research - Miami LLC

Miami, Florida, 33175, United States

Location

Las Mercedes Medical Research

Miami, Florida, 33196, United States

Location

FXM Clinical Research Miramar LLC

Miramar, Florida, 33027, United States

Location

Renstar Medical Research

Ocala, Florida, 34470, United States

Location

DS Research of Southern Indiana

Clarksville, Indiana, 47129, United States

Location

The Indiana Clinical Trials Center

Plainfield, Indiana, 46168, United States

Location

DS Research of Kentucky

Louisville, Kentucky, 40241, United States

Location

Michigan Center for Research Company

Clarkston, Michigan, 48346, United States

Location

Henry Ford Medical Center - Farmington Road

Detroit, Michigan, 48202, United States

Location

Revival Research Institute

Troy, Michigan, 48084, United States

Location

Grekin Skin Institute

Warren, Michigan, 48088, United States

Location

Associated Skin Care Specialists - Minnesota Clinical Study Center

New Brighton, Minnesota, 55112, United States

Location

Schlessinger MD

Omaha, Nebraska, 68144, United States

Location

Las Vegas Clinical Trials

Las Vegas, Nevada, 89030, United States

Location

NYC Health and Hospitals Elmhurst

Elmhurst, New York, 11373, United States

Location

Pioneer Clinical Research NY

New York, New York, 10016, United States

Location

Cameron Dermatology

New York, New York, 10023, United States

Location

DermResearchCenter of New York

Stony Brook, New York, 11790, United States

Location

Asheville Clinical Trials

Asheville, North Carolina, 28803, United States

Location

WDC Cosmetic and Research

Wilmington, North Carolina, 28405, United States

Location

Optima Research Boardman

Boardman, Ohio, 44512, United States

Location

Clinical Partners LLC

Johnston, Rhode Island, 02919, United States

Location

Modern Research Associates PLLC

Dallas, Texas, 75231, United States

Location

SMS Clinical Research

Mesquite, Texas, 75149, United States

Location

Progressive Clinical Research - San Antonio

San Antonio, Texas, 78213, United States

Location

Center for Clinical Studies (CCS) - Webster/Clear Lake Location

Webster, Texas, 77598, United States

Location

Jordan Valley Dermatology

South Jordan, Utah, 84095, United States

Location

Klinik Hietzing

Vienna, Vienna, 1220, Austria

Location

Beacon Dermatology

Calgary, Alberta, T3E 0B2, Canada

Location

Alberta DermaSurgery

Edmonton, Alberta, T6G 1C3, Canada

Location

VIDA Dermatology/VIDA Clinical Research

Edmonton, Alberta, T6H 4J8, Canada

Location

CaRe Clinic Red Deer

Red Deer, Alberta, T4P 1K4, Canada

Location

Skincare Studio

St. John's, Newfoundland and Labrador, A1E 1V4, Canada

Location

CCA Medical Research Corp

Ajax, Ontario, L1S 7K8, Canada

Location

SimcoDerm Medical and Surgical Dermatology Center

Barrie, Ontario, L4M 7G1, Canada

Location

SKiN Health

Cobourg, Ontario, K9A 0Z4, Canada

Location

Guelph Dermatology Research

Guelph, Ontario, N1L 0B3, Canada

Location

Mediprobe Research

London, Ontario, N5X 2P1, Canada

Location

Clear Skin Dermatology

Newmarket, Ontario, L3Y 5G8, Canada

Location

North Bay Dermatology Centre

North Bay, Ontario, P1B 3Z7, Canada

Location

Rejuvination Dermatology Oakville

Oakville, Ontario, L6H 6P8, Canada

Location

Toronto Research Centre

Toronto, Ontario, M3H 5Y8, Canada

Location

XLR8 Medical Research

Windsor, Ontario, N8T 1E6, Canada

Location

Innovaderm

Montreal, Quebec, H2X 2V1, Canada

Location

SkinSense Medical Research

Saskatoon, Saskatchewan, S7K 2C1, Canada

Location

Innomedica

Tallinn, Harju, 10117, Estonia

Location

Tartu University Hospital

Tartu, Tartu, 50411, Estonia

Location

Center for Clinical and Basic Research AS

Tallinn, 10128, Estonia

Location

Kliiniliste Uuringute Keskus OU

Tartu, 50106, Estonia

Location

CHU de Rouen

Rouen, Normandy, 76031, France

Location

Centre Azur Nice

Nice, 06000, France

Location

Polyclinique de Courlancy

Reims, 51100, France

Location

Universitatsklinikum Erlangen

Erlangen, Bavaria, 91054, Germany

Location

Rosenpark Research

Darmstadt, Hesse, 64283, Germany

Location

Klinikum Oldenburg

Oldenburg, Lower Saxony, 26133, Germany

Location

Klinische Forschung Schwerin GmbH

Schwerin, Mecklenburg-Vorpommern, 19055, Germany

Location

Hautarztpraxis Dr Niesmann and Dr Othlinghaus

Bochum, North Rhine-Westphalia, 44793, Germany

Location

Universitaetsklinikum Muenster

Münster, North Rhine-Westphalia, 48149, Germany

Location

Dermatologische Praxis Dres Quist

Mainz, Rhinelkand-Palatinate, 55128, Germany

Location

Praxis fur Dermatologie und Venerologie

Dresden, Saxony, 01097, Germany

Location

Klinische Forschung Dresden GmbH

Dresden, Saxony, 1069, Germany

Location

ISA - Interdisciplinary Study Association GmbH

Berlin, State of Berlin, 10789, Germany

Location

MVZ DermaKiel GmbH

Kiel, D-24148, Germany

Location

Haut Ambulatorium Magdeburg

Magdeburg, 39104, Germany

Location

KliFOs Klinische Forschung Osnabruck

Osnabrück, 49074, Germany

Location

Bacs Kiskun County Teaching Hospital

Kecskemét, Bács-Kiskun county, 6000, Hungary

Location

Borgyogyaszati Klinika Debreceni Egyetem Orvos es Egeszsegtudomenyi Centrum

Debrecen, Hajdú-Bihar, 4032, Hungary

Location

DERMA B Kft

Debrecen, Hajdú-Bihar Megye, 4031, Hungary

Location

DermaMed Research Kf

Békés, Oroshaza, 5900, Hungary

Location

Uno Medical Trials Kft

Budapest, 1152, Hungary

Location

Orvostudomanyi Kutato es Fejleszto Kft

Debrecen, 4027, Hungary

Location

Allergo Derm Bakos Kft

Szolnok, 5000, Hungary

Location

Medmare Bt

Veszprém, 8200, Hungary

Location

Sheba Tel HaShomer Medical Centre

Ramat Gan, 526200, Israel

Location

Semigallia Ltd

Kuldīga, Kuldigas, LV3301, Latvia

Location

Smite Aija Medical Practice in Dermatology Venereology

Talsi, Talsi, LV3201, Latvia

Location

Riga 1st Hospital

Riga, LV1001, Latvia

Location

Med Art Clinic

Riga, LV1003, Latvia

Location

Veselibas Centrs 4

Riga, LV1003, Latvia

Location

SIA Veseliba un estetika

Riga, LV1009, Latvia

Location

Veselibas Centrs 4 Filiale Dermatologijas Klinika

Riga, LV1013, Latvia

Location

FutureMeds Krakow

Krakow, Lesser Poland Voivodeship, 31-501, Poland

Location

Luxderm

Lublin, Lublin Voivodeship, 20-573, Poland

Location

Centrum Medyczne dr Rajzer Spolka Zoo

Krakow, Malopolska, 30-438, Poland

Location

RCMed Oddział Sochaczew

Sochaczew, Masovian Voivodeship, 96-500, Poland

Location

Clinical Best Solutions

Warsaw, Masovian Voivodeship, 00-710, Poland

Location

Centrum Medyczne Evimed

Warsaw, Masovian Voivodeship, 02-625, Poland

Location

Klinika Dermatologii Uniwersytecki Szpital Kliniczny im F Chopina

Rzeszów, Podkarpackie Voivodeship, 50-368, Poland

Location

Specderm

Bialystok, Podlaskie Voivodeship, 15-375, Poland

Location

Pratia Gdynia

Gdynia, Pomeranian Voivodeship, 81-338, Poland

Location

Pratia Katowice

Katowice, Silesian Voivodeship, 40-018, Poland

Location

Research Solutions

Katowice, Silesian Voivodeship, 40-748, Poland

Location

Care Clinic Katowice

Katowice, 40-568, Poland

Location

Zanamed Medical Clinic Sp z o o

Lublin, 20-601, Poland

Location

MTZ Clinical Research Sp z o o

Warsaw, 02-172, Poland

Location

Klinika Ambroziak Dermatologia Kliniczna

Warsaw, 02-953, Poland

Location

dermMedica

Wroclaw, 51-503, Poland

Location

Dermoklinika

Lodz, Łódź Voivodeship, 90-436, Poland

Location

FutureMeds Lodz

Lodz, Łódź Voivodeship, 91-363, Poland

Location

GCM Medical Group PSC Hato Rey Site

San Juan, PR, 00917, Puerto Rico

Location

Centro Reumatologico de Caguas

Caguas, Puerto Rico, 00725, Puerto Rico

Location

Ponce Medical School Foundation Inc

Ponce, Puerto Rico, 00716, Puerto Rico

Location

Clinical Research Puerto Rico

Ponce, Puerto Rico, 00909, Puerto Rico

Location

Hospital Clínico Universitario de Santiago de Compostela

Santiago de Compostela, A Coruña, 15706, Spain

Location

University General Hospital Dr Balmis

Alicante, Alicante, 3010, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, 8041, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, Madrid, 28041, Spain

Location

Hospital de Manises

Manises, 46940, Spain

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: September 7, 2024
• First Posted: September 19, 2024
• Study Start: August 20, 2024
• Primary Completion: September 23, 2025
• Study Completion: December 18, 2025
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

ES (5); FR (3); AU (1); HU (8); PL (18); PR (4); DE (13); US (43); LA (7); CA (17); IL (1)