Clinical trial NCT06586112: A Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Moderate to Severe Plaque Psoriasis
Official title: A Multicenter, Randomized, Double-Blind, Placebo and Active Comparator Controlled Phase 3 Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Moderate to Severe Plaque Psoriasis (ONWARD1)
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). Participants 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. Participants 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 participant'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 participants requires current systemic corticosteroids

    \* Stable doses of inhaled corticosteroids for treatment of asthma are allowed
14. Known current malignancy or current evaluation for a potential malignancy or history of malignancy within the past 5 years prior to screening, except for adequately treated basal cell or squamous cell skin carcinoma or carcinoma in situ of the cervix
15. Live vaccines within 4 weeks prior to Study Day 1
16. Participant has planned surgery during the study period
17. Any acute or chronic illness/condition or evidence of an unstable clinical condition that, in the opinion of the Investigator, will substantially increase the risk to the participant if he or she participates in the study
18. History of mental illness within the last 5 years, unless receiving a fixed regimen of psychiatric medications for at least 6 months before screening or has not required or been prescribed any psychiatric medication within 12 months before screening
19. Evidence of severe depressive symptoms or active suicidal ideation or behavior

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 participants 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: Phoenix
country: United States
facility: Alliance Dermatology
state: Arizona
city: Scottsdale
country: United States
facility: Scottsdale Clinical Trials
state: Arizona
city: Rogers
country: United States
facility: Northwest Arkansas Clinical Trials Center (NWACTC), PLLC
state: Arkansas
city: Chula Vista
country: United States
facility: Exalt Clinical Research
state: California
city: Encinitas
country: United States
facility: California Dermatology & Clinical Research Institute
state: California
city: Fountain Valley
country: United States
facility: First OC Dermatology Research Inc
state: California
city: Huntington Beach
country: United States
facility: Marvel Clinical Research, LLC
state: California
city: Lafayette
country: United States
facility: Sunwise Clinical Research, LLC
state: California
city: Los Angeles
country: United States
facility: Wallace Medical Group Inc
state: California
city: Northridge
country: United States
facility: Northridge Clinical Trials - Elite Clinical Network
state: California
city: Pasadena
country: United States
facility: Pasadena Clinical Trials
state: California
city: San Diego
country: United States
facility: Therapeutics Clinical Research
state: California
city: Sherman Oaks
country: United States
facility: Unison Clinical Trials/ Shahram Jacobs MD
state: California
city: Sylmar
country: United States
facility: Olive View - UCLA Education & Research Institute
state: California
city: Thousand Oaks
country: United States
facility: California Dermatology Institute - Thousand Oaks
state: California
city: Boca Raton
country: United States
facility: Clearlyderm Dermatology - West Boca Raton
state: Florida
city: Coral Gables
country: United States
facility: Driven Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Maitland
country: United States
facility: Accel Research Sites - Maitland
state: Florida
city: Margate
country: United States
facility: Glick Skin Institute - Margate
state: Florida
city: Miami Lakes
country: United States
facility: San Marcus Research Clinic, Inc - Miami
state: Florida
city: Miami Lakes
country: United States
facility: Savin Medical Group LLC
state: Florida
city: North Miami Beach
country: United States
facility: Oceanic Research Group
state: Florida
city: Sweetwater
country: United States
facility: LENUS Research
state: Florida
city: Tampa
country: United States
facility: Caban Skin Institute
state: Florida
city: Tampa
country: United States
facility: ForCare Medical Center
state: Florida
city: Macon
country: United States
facility: Skin Care Physicians of Georgia - Warner Robins
state: Georgia
city: Meridian
country: United States
facility: Velocity Clinical Research, Boise
state: Idaho
city: Chicago
country: United States
facility: MetroMed Clinical Trials
state: Illinois
city: Rolling Meadows
country: United States
facility: Arlington Dermatology
state: Illinois
city: Skokie
country: United States
facility: NorthShore Medical Group - Dermatology - Skokie
state: Illinois
city: West Dundee
country: United States
facility: Dundee Dermatology
state: Illinois
city: Columbus
country: United States
facility: Dawes Fretzin Clinical Research Group
state: Indiana
city: South Bend
country: United States
facility: The South Bend Clinic
state: Indiana
city: Bowling Green
country: United States
facility: Equity Medical - Bowling Green
state: Kentucky
city: Baton Rouge
country: United States
facility: Velocity Clinical Research at The Dermatology Clinic, Baton Rouge
state: Louisiana
city: New Orleans
country: United States
facility: Tulane University School of Medicine
state: Louisiana
city: Brighton
country: United States
facility: MetroBoston Clinical Partners
state: Massachusetts
city: Bay City
country: United States
facility: Great Lakes Research Group Inc.
state: Michigan
city: Kirksville
country: United States
facility: Cleaver Dermatology
state: Missouri
city: New York
country: United States
facility: OptiSkin
state: New York
city: Durham
country: United States
facility: Duke University School of Medicine
state: North Carolina
city: Winston-Salem
country: United States
facility: The Skin Surgery Center for Clinical Research
state: North Carolina
city: Gahanna
country: United States
facility: The Ohio State University Wexner Medical Center (OSUWMC) - OSU Dermatology East - Columbus
state: Ohio
city: Mason
country: United States
facility: Dermatologists of Southwestern Ohio, LLC
state: Ohio
city: Oklahoma City
country: United States
facility: Unity Clinical Research (UCR)
state: Oklahoma
city: Medford
country: United States
facility: Velocity Clinical Research, Medford
state: Oregon
city: Portland
country: United States
facility: Oregon Medical Research Center
state: Oregon
city: Philadelphia
country: United States
facility: Paddington Testing Company Inc.
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Department of Dermatology
state: Pennsylvania
city: Charleston
country: United States
facility: Clinical Research Center of the Carolinas
state: South Carolina
city: North Charleston
country: United States
facility: Coastal Carolina Research Center (CCRC) - North Charleston
state: South Carolina
city: Rapid City
country: United States
facility: Health Concepts
state: South Dakota
city: Goodlettsville
country: United States
facility: Discover Dermatology, LLC d/b/a Goodlettsville Dermatology Research
state: Tennessee
city: Hermitage
country: United States
facility: Discover Dermatology, LLC d/b/a Cumberland Skin Center for Clinical Research under Objective Health
state: Tennessee
city: Bellaire
country: United States
facility: UT Health Houston Department of Dermatology
state: Texas
city: Cypress
country: United States
facility: Studies in Dermatology, LLC
state: Texas
city: Frisco
country: United States
facility: Reveal Research Institute
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies - Texas Medical Center
state: Texas
city: Houston
country: United States
facility: Heights Dermatology & Aesthetic Center
state: Texas
city: Houston
country: United States
facility: Austin Institute for Clinical Research - Houston
state: Texas
city: Sugar Land
country: United States
facility: Stride Clinical Research LLC
state: Texas
city: Murray
country: United States
facility: University of Utah Health Care - Midvalley Health Center
state: Utah
city: Mill Creek
country: United States
facility: Frontier Dermatology
state: Washington
city: Kogarah
country: Australia
facility: Premier Specialists
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Woolloongabba
country: Australia
facility: Veracity Clinical Research
state: Queensland
city: Campbelltown
country: Australia
facility: North Eastern Health Specialists (NEHS)
state: South Australia
city: Carlton
country: Australia
facility: Skin Health Institute Inc.
state: Victoria
city: East Melbourne
country: Australia
facility: Sinclair Dermatology
state: Victoria
city: Liège
country: Belgium
facility: C H U de Liege
state: Liege
city: Gabrovo
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Dr Tota Venkova
city: Pleven
country: Bulgaria
facility: Medikal Center Kordis
city: Sofia
country: Bulgaria
facility: Skin and Venereal Diseases Center EOOD
city: Sofia
country: Bulgaria
facility: Diagnostic Consultative Center Aleksandrovska EOOD
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment Alexandrovska
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna ISUL EAD
city: Stara Zagora
country: Bulgaria
facility: Clineca
city: Edmonton
country: Canada
facility: Rejuvenation Medical Group Edmonton Downtown
state: Alberta
city: Surrey
country: Canada
facility: Enverus Medical Research
state: British Columbia
city: Hamilton
country: Canada
facility: Dermatrials Research Inc.
state: Ontario
city: London
country: Canada
facility: Centricity Research
state: Ontario
city: London
country: Canada
facility: DermEffects
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research Inc.
state: Ontario
city: Mississauga
country: Canada
facility: DermEdge Research
state: Ontario
city: Oakville
country: Canada
facility: Institute of Cosmetic & Laser Surgery
state: Ontario
city: Richmond Hill
country: Canada
facility: The Centre for Dermatology
state: Ontario
city: Toronto
country: Canada
facility: North York Research Inc.
state: Ontario
city: Toronto
country: Canada
facility: Canadian Dermatology Centre
state: Ontario
city: Toronto
country: Canada
facility: Dermatology on Bloor
state: Ontario
city: Waterloo
country: Canada
facility: Alliance Clinical Trials
state: Ontario
city: Québec
country: Canada
facility: "Centre de Recherche Dermatologique du Quebec Metropolitain Inc."
state: Quebec
city: Verdun
country: Canada
facility: Dermatologie Sima Inc.
state: Quebec
city: Plzen
country: Czechia
facility: Fakultni nemocnice Plzen Dermatovenerologicka klinika
state: Bory
city: Brno
country: Czechia
facility: Pratia Brno s.r.o.
state: Moravia
city: Olomouc
country: Czechia
facility: Dermskin, s.r.o.
state: Moravia
city: Kutna Hora
country: Czechia
facility: Kozni ambulance Kutna Hora, s.r.o.
city: Nachod
country: Czechia
facility: DERMAMEDICA, s.r.o.
city: Nový Jičín
country: Czechia
facility: Nemocnice Nový Jičín, A.S.
city: Ostrava
country: Czechia
facility: CCR Ostrava, s.r.o.
city: Ostrava
country: Czechia
facility: Vesalion sro
city: Pardubice
country: Czechia
facility: Pratia Pardubice a.s.
city: Prague
country: Czechia
facility: Clintrial s.r.o.
city: Prague
country: Czechia
facility: Fakultni Nemocnice Kralovske Vinohrady FNKV Dermatovenerologicka Klinika
city: Prague
country: Czechia
facility: Sanatorium Profesora Arenbergera
city: Prague
country: Czechia
facility: Pratia Prague, s.r.o.
city: Prague
country: Czechia
facility: Praglandia
city: Svitavy
country: Czechia
facility: Dermatologicka ambulance - Svitavy
city: Svitavy
country: Czechia
facility: MUDr Radka Neumannova
city: Tuebingen
country: Germany
facility: Eberhard Karls Universitaet Tuebingen Universitaets Hautklinik Tuebingen
state: Baden-Württemberg
city: Augsburg
country: Germany
facility: Hautarztpraxis Dr. Mihaescu
state: Bayern
city: Berlin
country: Germany
facility: emovis GmbH
state: Brandenburg
city: Mahlow
country: Germany
facility: Hautarztpraxis Mahlow
state: Brandenburg
city: Darmstadt
country: Germany
facility: Klinikum Darmstadt GmbH - Hautklinik
state: Hessen
city: Frankfurt
country: Germany
facility: Universitatsklinikum Frankfurt
state: Hessen
city: Bad Bentheim
country: Germany
facility: Fachklinik Bad Bentheim
state: Lower Saxony
city: Bramsche
country: Germany
facility: Hautarztpraxis an der Hase
state: Lower Saxony
city: Lohne
country: Germany
facility: Siteworks
state: Lower Saxony
city: Cologne
country: Germany
facility: Universitätsklinikum Köln
state: North Rhine-Westphalia
city: Bielefeld
country: Germany
facility: Klinikum Bielefeld
state: NRW
city: Bonn
country: Germany
facility: Universitatsklinikum Bonn
state: NRW
city: Dülmen
country: Germany
facility: Pro Derma
state: NRW
city: Remscheid
country: Germany
facility: Intramedis CSS
state: NRW
city: Mainz
country: Germany
facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz Clinical Research Center CRC
state: Rhineland-Palatinate
city: Dresden
country: Germany
facility: Universitatsklinikum Carl Gustav Carus an der Technischen Universitat Dresden
state: Saxonia
city: Kiel
country: Germany
facility: Universitatsklinikum Schleswig-Holstein
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: Charite Universitaetsmedizin Berlin Campus Virchow Klinikum CVK
city: Fukuoka
country: Japan
facility: Fukuoka University Hospital
state: Fukuoka-shi
city: Asahikawa
country: Japan
facility: Asahikawa Medical University Hospital
state: Hokkaido
city: Tokyo
country: Japan
facility: Nihon University Itabashi Hospital
state: Itabashi-Ku
city: Kagoshima
country: Japan
facility: Saruwatari Dermatology Clinic
state: Kagoshima-Shi
city: Kanagawa
country: Japan
facility: Kanto Rosai Hospital
state: Kawasaki-shi
city: Yamanashi
country: Japan
facility: Yamanashi Prefectural Central Hospital
state: Kofu-shi
city: Aichi
country: Japan
facility: Nagoya City University Hospital
state: Nagoya-shi
city: Okayama
country: Japan
facility: Okayama University Hospital
state: Okayama-shi
city: Osaka
country: Japan
facility: Osaka Metropolitan University Hospital
state: Osaka-shi
city: Osaka
country: Japan
facility: Nippon Life Hospital
state: Osaka-Shi
city: Kanagawa
country: Japan
facility: National Hospital Organization Sagamihara National Hospital
state: Sagamihara
city: Osaka
country: Japan
facility: Dermatology and Ophthalmology Kume Clinic
state: Saka-Shi
city: Hokkaido
country: Japan
facility: Hokkaido University Hospital
state: Sapporo-shi
city: Osaka
country: Japan
facility: Kindai University Hospital
state: Sayama-Shi
city: Miyagi
country: Japan
facility: Tohoku University Hospital
state: Sendai-Shi
city: Tokyo
country: Japan
facility: Tokyo Medical University Hospital
state: Shinjuku-Ku
city: Osaka
country: Japan
facility: Osaka University Hospital
state: Suita-shi
city: Tokyo
country: Japan
facility: Medical Corporation Jitai kai Tachikawa Dermatology Clinic
state: Tachikawa-shi
city: Mie
country: Japan
facility: Mie University Hospital
state: Tsu-shi
city: Yamaguchi
country: Japan
facility: Yamaguchi University Hospital
state: Ube-shi
city: Kanagawa
country: Japan
facility: Yokohama City University Hospital
state: Yokohama-shi
city: Gwangju
country: Korea, Republic of
facility: Chosun Universtiy Hospital
state: Dong-gu
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
state: Gwangjin-gu
city: Anyang-si
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: CHA Bundang Medical Center
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Songpa-gu
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul St Marys Hospital
city: Wroclaw
country: Poland
facility: Centrum Medyczne Synexus Wroclaw
state: Dolnoslaskie
city: Bydgoszcz
country: Poland
facility: Centrum Medyczne Pratia Bydgoszcz
state: Kujawsko-Pomorskie
city: Skierniewice
country: Poland
facility: Velocity Clinical Research, Skierniewice
state: Lodzkie
city: Wroclaw
country: Poland
facility: WroMedica
state: Lower Silesia
city: Krakow
country: Poland
facility: Diamond Clinic
state: Malopolska
city: Warsaw
country: Poland
facility: MICS Medical Center Warsaw
state: Mazovia
city: Warsaw
country: Poland
facility: FutureMeds Warszawa Centrum
state: Mazovia
city: Warsaw
country: Poland
facility: High Med Przychodnia Specjalistyczna
state: Mazovia
city: Warsaw
country: Poland
facility: Centrum Medyczne Reuma Park
state: Mazovia
city: Warsaw
country: Poland
facility: RoyalDerm
state: Mazowiecke
city: Krakow
country: Poland
facility: Specjalistyczny Ośrodek Alergologiczno-Internistyczny "ALL-MED"
state: MA
city: Bialystok
country: Poland
facility: ClinicMed Daniluk, Nowak Spolka Komandytowa
state: Podlaskie
city: Gdansk
country: Poland
facility: AES Gdansk
state: Pomorskie
city: Gdynia
country: Poland
facility: Derm Art Institute
state: Pomorskie
city: Gdynia
country: Poland
facility: Centrum Medyczne Synexus Gdynia
state: Pomorskie
city: Katowice
country: Poland
facility: Centrum Medyczne Angelius Provita (Angelius Provita Medical Centre)
state: Silesia
city: Szczecin
country: Poland
facility: Laser Clinic
state: Zachodniopomorskie
city: Gdańsk
country: Poland
facility: Centrum Badań Klinicznych PI House Sp. Z O.O.
city: Krakow
country: Poland
facility: Pratia Małopolskie Centrum Medyczne (MCM) Kraków
city: Warsaw
country: Poland
facility: Rheuma Medicus
city: Warsaw
country: Poland
facility: Centrum Medyczne Synexus Warszawa
city: Guimaraes
country: Portugal
facility: Hospital da Senhora da Oliveira
state: Braga
city: Braga
country: Portugal
facility: Unidade Local de Saude Braga
city: Lisbon
country: Portugal
facility: Hospital CUF Descobertas
city: Porto
country: Portugal
facility: Unidade Local de Saude Santo Antonio Hospital de Santo Antonio
Study officials:
References: