Clinical trial NCT06588738: A Study in Patients With Moderate to Severe Plaque Psoriasis to Evaluate the Efficacy and Safety of ESK-001
Official title: A Multicenter, Randomized, Double-Blind, Placebo and Active Comparator Controlled Phase 3 Study in Patients With Moderate to Severe Plaque Psoriasis to Evaluate the Efficacy and Safety of ESK-001 (ONWARD2)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Plaque Psoriasis
Lead sponsor: Alumis Inc
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 840
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 16 weeks
Secondary outcomes:
measure: To compare the Psoriasis Area and Severity Index (PASI-90 and PASI-100) between ESK-001 and placebo or apremilast
timeFrame: 24 weeks
measure: To compare the Psoriasis Area and Severity Index (PASI-75) between ESK-001 and apremilast
timeFrame: 24 weeks
measure: To compare the Static Physician's Global Assessment (sPGA-0/1) between ESK-001 and apremilast
timeFrame: 24 weeks
measure: To compare the affected body surface area (%BSA) between ESK-001 and placebo or apremilast
timeFrame: 24 weeks
measure: To compare the scalp specific Physician's Global Assessment (ssPGA) between ESK-001 and placebo or apremilast
timeFrame: 24 weeks
measure: To compare the Psoriasis Symptoms and Signs Diary (PSSD) between ESK-001 and placebo or apremilast
timeFrame: 24 weeks
measure: To compare the Dermatology Life Quality Index (DLQI) between ESK-001 and placebo or apremilast
timeFrame: 24 weeks
measure: To compare the Pruritus numeric rating scale (NRS) between ESK-001 and placebo
timeFrame: 24 weeks
measure: Proportion of patients with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
timeFrame: 24 weeks
measure: To characterize the pharmacokinetics of ESK-001
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Total Skin and Beauty Dermatology Center, PC
state: Alabama
city: Chandler
country: United States
facility: Chandler Clinical Trials
state: Arizona
city: Phoenix
country: United States
facility: Medical Dermatology Specialists
state: Arizona
city: Tucson
country: United States
facility: Noble Clinical Research
state: Arizona
city: Beverly Hills
country: United States
facility: Zenith Research Inc.
state: California
city: Encino
country: United States
facility: Raoof MD
state: California
city: Long Beach
country: United States
facility: Long Beach Research Institute
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Pomona
country: United States
facility: Empire Clinical Research - Pomona
state: California
city: Sacramento
country: United States
facility: Integrative Skin Science and Research
state: California
city: San Diego
country: United States
facility: UC San Diego
state: California
city: Santa Ana
country: United States
facility: Southern California Clinical Research
state: California
city: Santa Monica
country: United States
facility: Clinical Science Institute Dermatology Institute
state: California
city: Fort Lauderdale
country: United States
facility: FXM Clinical Research Ft. Lauderdale LLC
state: Florida
city: Hialeah
country: United States
facility: Direct Helpers Research Center (DHRC)
state: Florida
city: Jacksonville
country: United States
facility: Green Leaf Clinical Trials
state: Florida
city: Miami
country: United States
facility: AppleMed Research Group under WCG
state: Florida
city: Miami
country: United States
facility: FAX Pharma Clinical Research Inc
state: Florida
city: Miami
country: United States
facility: FXM Clinical Research - Miami LLC
state: Florida
city: Miami
country: United States
facility: Las Mercedes Medical Research
state: Florida
city: Miramar
country: United States
facility: FXM Clinical Research Miramar LLC
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Clarksville
country: United States
facility: DS Research of Southern Indiana
state: Indiana
city: Plainfield
country: United States
facility: The Indiana Clinical Trials Center
state: Indiana
city: Louisville
country: United States
facility: DS Research of Kentucky
state: Kentucky
city: Clarkston
country: United States
facility: Michigan Center for Research Company
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Medical Center - Farmington Road
state: Michigan
city: Troy
country: United States
facility: Revival Research Institute
state: Michigan
city: Warren
country: United States
facility: Grekin Skin Institute
state: Michigan
city: New Brighton
country: United States
facility: Associated Skin Care Specialists - Minnesota Clinical Study Center
state: Minnesota
city: Omaha
country: United States
facility: Schlessinger MD
state: Nebraska
city: Las Vegas
country: United States
facility: Las Vegas Clinical Trials
state: Nevada
city: Elmhurst
country: United States
facility: NYC Health and Hospitals Elmhurst
state: New York
city: New York
country: United States
facility: Pioneer Clinical Research NY
state: New York
city: New York
country: United States
facility: Cameron Dermatology
state: New York
city: Stony Brook
country: United States
facility: DermResearchCenter of New York
state: New York
city: Asheville
country: United States
facility: Asheville Clinical Trials
state: North Carolina
city: Wilmington
country: United States
facility: WDC Cosmetic and Research
state: North Carolina
city: Boardman
country: United States
facility: Optima Research Boardman
state: Ohio
city: Cincinnati
country: United States
facility: Synexus Clinical Research US Inc - Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Johnston
country: United States
facility: Clinical Partners LLC
state: Rhode Island
city: Arlington
country: United States
facility: Arlington Research Center
state: Texas
city: Dallas
country: United States
facility: Modern Research Associates PLLC
state: Texas
city: Mesquite
country: United States
facility: SMS Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research - San Antonio
state: Texas
city: Webster
country: United States
facility: Center for Clinical Studies (CCS) - Webster/Clear Lake Location
state: Texas
city: South Jordan
country: United States
facility: Jordan Valley Dermatology
state: Utah
city: Vienna
country: Austria
facility: Klinik Hietzing
city: Calgary
country: Canada
facility: Beacon Dermatology
state: Alberta
city: Edmonton
country: Canada
facility: Alberta DermaSurgery
state: Alberta
city: Edmonton
country: Canada
facility: VIDA Dermatology/VIDA Clinical Research
state: Alberta
city: Red Deer
country: Canada
facility: CaRe Clinic Red Deer
state: Alberta
city: Saint John's
country: Canada
facility: Skincare Studio
state: Newfoundland and Labrador
city: Ajax
country: Canada
facility: CCA Medical Research Corp
state: Ontario
city: Barrie
country: Canada
facility: SimcoDerm Medical and Surgical Dermatology Center
state: Ontario
city: Cobourg
country: Canada
facility: SKiN Health
state: Ontario
city: Etobicoke
country: Canada
facility: Kingsway Clinical Research
state: Ontario
city: Guelph
country: Canada
facility: Guelph Dermatology Research
state: Ontario
city: London
country: Canada
facility: Mediprobe Research
state: Ontario
city: Newmarket
country: Canada
facility: Clear Skin Dermatology
state: Ontario
city: North Bay
country: Canada
facility: North Bay Dermatology Centre
state: Ontario
city: Oakville
country: Canada
facility: Rejuvination Dermatology Oakville
state: Ontario
city: Toronto
country: Canada
facility: Toronto Research Centre
state: Ontario
city: Windsor
country: Canada
facility: XLR8 Medical Research
state: Ontario
city: Montreal
country: Canada
facility: Innovaderm
state: Quebec
city: Saskatoon
country: Canada
facility: SkinSense Medical Research
state: Saskatchewan
city: Tallinn
country: Estonia
facility: Innomedica
state: Harjumaa
city: Tartu
country: Estonia
facility: Tartu University Hospital
state: Tartumaa
city: Tallinn
country: Estonia
facility: Center for Clinical and Basic Research AS
city: Tartu
country: Estonia
facility: Kliiniliste Uuringute Keskus OU
city: Antony
country: France
facility: Hopital Prive d Antony
state: Ile de France
city: Rouen
country: France
facility: CHU de Rouen
state: Normandy
city: Le Mans
country: France
facility: Centre Hospitalier Le Mans
state: Sarthe département
city: Nice
country: France
facility: Centre Azur Nice
city: Reims
country: France
facility: Polyclinique de Courlancy
city: Romans-sur-Isère
country: France
facility: Hopitaux Drome Nord
city: Erlangen
country: Germany
facility: Universitatsklinikum Erlangen
state: Bavaria
city: Munich
country: Germany
facility: Ludwig Maximilians Universitaet Muenchen Klinik und Poliklinik fuer Dermatologie und Allergologie
state: Bavaria
city: Darmstadt
country: Germany
facility: Rosenpark Research
state: Hesse
city: Buxtehude
country: Germany
facility: Elbe Klinikum Buxtehude
state: Lower Saxony
city: Schwerin
country: Germany
facility: Klinische Forschung Schwerin GmbH
state: Mecklenburg-Vorpommern
city: Oldenburg
country: Germany
facility: Klinikum Oldenburg
state: Niedersachsen
city: Bochum
country: Germany
facility: Hautarztpraxis Dr Niesmann and Dr Othlinghaus
state: NRW
city: Bonn
country: Germany
facility: MVZ Dermatologisches Zentrum Bonn GmbH
state: NRW
city: Münster
country: Germany
facility: Universitaetsklinikum Muenster
state: NRW
city: Mainz
country: Germany
facility: Dermatologische Praxis Dres Quist
state: Rhinelkand-Palatinate
city: Dresden
country: Germany
facility: Praxis fur Dermatologie und Venerologie
state: Saxony
city: Dresden
country: Germany
facility: Klinische Forschung Dresden GmbH
state: Saxony
city: Luebeck
country: Germany
facility: Universitatsklinikum Schleswig Holstein
state: Schleswig Holstein
city: Berlin
country: Germany
facility: ISA - Interdisciplinary Study Association GmbH
city: Berlin
country: Germany
facility: Dr med Thomas Wildfeuer and Kolleg Innen
city: Kiel
country: Germany
facility: MVZ DermaKiel GmbH
city: Langenau
country: Germany
facility: Studienzentrum Dr med Beate Schwarz
city: Magdeburg
country: Germany
facility: Haut Ambulatorium Magdeburg
city: Osnabruck
country: Germany
facility: KliFOs Klinische Forschung Osnabruck
city: Quedlinburg
country: Germany
facility: Harzklinikum Dorothea Christiane Erxleben
city: Kecskemét
country: Hungary
facility: Bacs Kiskun County Teaching Hospital
state: Bacs-Kiskun
city: Debrecen
country: Hungary
facility: Borgyogyaszati Klinika Debreceni Egyetem Orvos es Egeszsegtudomenyi Centrum
state: Hajdu-Bihar
city: Debrecen
country: Hungary
facility: DERMA B Kft
state: Hajdú-Bihar megye
city: Bekes
country: Hungary
facility: DermaMed Research Kf
state: Oroshaza
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Budapest
country: Hungary
facility: Uno Medical Trials Kft
city: Debrecen
country: Hungary
facility: Orvostudomanyi Kutato es Fejleszto Kft
city: Szolnok
country: Hungary
facility: Allergo Derm Bakos Kft
city: Veszprém
country: Hungary
facility: Medmare Bt
city: Petah tikva
country: Israel
facility: Rabin Medical Center
city: Ramat Gan
country: Israel
facility: Sheba Tel HaShomer Medical Centre
city: Kuldiga
country: Latvia
facility: Semigallia Ltd
state: Kuldigas
city: Riga
country: Latvia
facility: Riga 1st Hospital
city: Riga
country: Latvia
facility: Med Art Clinic
city: Riga
country: Latvia
facility: Veselibas Centrs 4
city: Riga
country: Latvia
facility: SIA Veseliba un estetika
city: Riga
country: Latvia
facility: Veselibas Centrs 4 Filiale Dermatologijas Klinika
city: Talsi
country: Latvia
facility: Smite Aija Medical Practice in Dermatology Venereology
city: Lodz
country: Poland
facility: FutureMeds Lodz
state: Lodzkie
city: Łódź
country: Poland
facility: Dermoklinika
state: Lodzkie
city: Kraków
country: Poland
facility: Centrum Medyczne dr Rajzer Spolka Zoo
state: Malopolska
city: Krakow
country: Poland
facility: FutureMeds Krakow
state: Malopolskie
city: Warsaw
country: Poland
facility: Clinical Best Solutions
state: Masovian
city: Warszawa
country: Poland
facility: Centrum Medyczne Evimed
state: Masovian
city: Sochaczew
country: Poland
facility: RCMed Oddział Sochaczew
state: Mazowieckie
city: Rzeszow
country: Poland
facility: Klinika Dermatologii Uniwersytecki Szpital Kliniczny im F Chopina
state: Podkarpackie
city: Białystok
country: Poland
facility: Specderm
state: Podlaskie
city: Gdynia
country: Poland
facility: Pratia Gdynia
state: Pomorskie
city: Katowice
country: Poland
facility: Pratia Katowice
state: Silesia
city: Katowice
country: Poland
facility: Research Solutions
state: Slaskie
city: Katowice
country: Poland
facility: Care Clinic Katowice
city: Lublin
country: Poland
facility: Luxderm
city: Lublin
country: Poland
facility: Zanamed Medical Clinic Sp z o o
city: Warsaw
country: Poland
facility: MTZ Clinical Research Sp z o o
city: Warszawa
country: Poland
facility: Klinika Ambroziak Dermatologia Kliniczna
city: Wroclaw
country: Poland
facility: dermMedica
city: Caguas
country: Puerto Rico
facility: Centro Reumatologico de Caguas
city: Ponce
country: Puerto Rico
facility: Ponce Medical School Foundation Inc
city: Ponce
country: Puerto Rico
facility: Clinical Research Puerto Rico
city: San Juan
country: Puerto Rico
facility: GCM Medical Group PSC Hato Rey Site
city: Santiago de Compostela
country: Spain
facility: Hospital Clínico Universitario de Santiago de Compostela
state: A Coruña
city: Barcelona
country: Spain
facility: Hospital Germans Trias i Pujol
state: Badalona
city: Valencia
country: Spain
facility: Consorcio Hospital General Universitario de Valencia
state: Valencian Community
city: Alicante
country: Spain
facility: University General Hospital Dr Balmis
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Madrid
country: Spain
facility: Hospital Universitarion de La Princesa
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Manises
country: Spain
facility: Hospital de Manises
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
Study officials:
References: