A Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Moderate to Severe Plaque Psoriasis (ONWARD1)

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)

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.

Study Overview

• Status: Completed
• Conditions: Plaque Psoriasis
• Intervention / Treatment: Drug: Placebo; Drug: Apremilast; Drug: Envudeucitinib

• Study Type: Interventional
• Enrollment (Actual): 912
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Kogarah, New South Wales, Australia, 2217
      • Premier Specialists
    • Westmead, New South Wales, Australia, 2145
      • Westmead Hospital
  • South Australia
    • Campbelltown, South Australia, Australia, 5074
      • North Eastern Health Specialists (NEHS)
  • Victoria
    • Carlton, Victoria, Australia, 3053
      • Skin Health Institute Inc.
    • East Melbourne, Victoria, Australia, 3002
      • Sinclair Dermatology
• Bulgaria
  • Pleven, Bulgaria, 5800
    • Medikal Center Kordis
  • Sofia, Bulgaria, 1404
    • Skin and Venereal Diseases Center EOOD
  • Sofia, Bulgaria, 1431
    • Diagnostic Consultative Center Aleksandrovska EOOD
  • Gabrovo
    • Gabrovo, Gabrovo, Bulgaria, 5300
      • Multiprofile Hospital For Active Treatment Dr Tota Venkova
  • Stara Zagora
    • Stara Zagora, Stara Zagora, Bulgaria, 6000
      • Clineca
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T5J 3S9
      • Rejuvenation Medical Group Edmonton Downtown
  • British Columbia
    • Surrey, British Columbia, Canada, V3V 0C6
      • Enverus Medical Research
  • Ontario
    • Hamilton, Ontario, Canada, L8N 1Y2
      • Dermatrials Research Inc.
    • London, Ontario, Canada, N6H 5L5
      • DermEffects
    • London, Ontario, Canada, N6A 2C2
      • Centricity Research
    • Markham, Ontario, Canada, L3P 1X3
      • Lynderm Research Inc.
    • Mississauga, Ontario, Canada, L4Y 4C5
      • DermEdge Research
    • Oakville, Ontario, Canada, L6J 7W5
      • Institute of Cosmetic & Laser Surgery
    • Richmond Hill, Ontario, Canada, L4B 1A5
      • The Centre for Dermatology
    • Toronto, Ontario, Canada, M2N3A6
      • North York Research Inc.
    • Toronto, Ontario, Canada, M4W 2N4
      • Dermatology on Bloor
    • Toronto, Ontario, Canada, M3B 0A7
      • Canadian Dermatology Centre
    • Waterloo, Ontario, Canada, N2J 1C4
      • Alliance Clinical Trials
  • Quebec
    • Québec, Quebec, Canada, G1V 4X7
      • "Centre de Recherche Dermatologique du Quebec Metropolitain Inc."
    • Verdun, Quebec, Canada, H4G 3E7
      • Dermatologie Sima Inc.
• Czechia
  • Kutná Hora, Czechia, 28401
    • Kozni ambulance Kutna Hora, s.r.o.
  • Nový Jičín, Czechia, 74101
    • Nemocnice Nový Jičín, A.S.
  • Náchod, Czechia, 54701
    • DERMAMEDICA, s.r.o.
  • Ostrava, Czechia, 70200
    • CCR Ostrava, s.r.o.
  • Ostrava, Czechia, 70200
    • Vesalion sro
  • Pardubice, Czechia, 53002
    • Pratia Pardubice a.s.
  • Prague, Czechia, 100 00
    • CLINTRIAL s.r.o.
  • Prague, Czechia, 10034
    • Fakultni Nemocnice Kralovske Vinohrady FNKV Dermatovenerologicka Klinika
  • Prague, Czechia, 110 00
    • Sanatorium Profesora Arenbergera
  • Prague, Czechia, 13000
    • Pratia Prague, s.r.o.
  • Prague, Czechia, 15000
    • Praglandia
  • Svitavy, Czechia, 568 02
    • Dermatologicka ambulance - Svitavy
  • Svitavy, Czechia, 56802
    • MUDr Radka Neumannova
  • Bory
    • Pilsen, Bory, Czechia, 301 00
      • Fakultni nemocnice Plzen Dermatovenerologicka klinika
  • Moravia
    • Brno, Moravia, Czechia, 60200
      • Pratia Brno s.r.o.
    • Olomouc, Moravia, Czechia, 77900
      • Dermskin, s.r.o.
• Germany
  • Baden-Wurttemberg
    • Tübingen, Baden-Wurttemberg, Germany, 72070
      • Eberhard Karls Universitaet Tuebingen Universitaets Hautklinik Tuebingen
  • Bavaria
    • Augsburg, Bavaria, Germany, 86150
      • Hautarztpraxis Dr. Mihaescu
  • Brandenburg
    • Mahlow, Brandenburg, Germany, 15831
      • Hautarztpraxis Mahlow
  • Hesse
    • Frankfurt am Main, Hesse, Germany, 60590
      • Universitatsklinikum Frankfurt
  • Lower Saxony
    • Bad Bentheim, Lower Saxony, Germany, 48455
      • Fachklinik Bad Bentheim
    • Bramsche, Lower Saxony, Germany, 49565
      • Hautarztpraxis an der Hase
    • Lohne, Lower Saxony, Germany, 49393
      • Siteworks
  • North Rhine-Westphalia
    • Bielefeld, North Rhine-Westphalia, Germany, 33647
      • Klinikum Bielefeld
    • Dülmen, North Rhine-Westphalia, Germany, 48249
      • Pro Derma
    • Remscheid, North Rhine-Westphalia, Germany, 42897
      • Intramedis CSS
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany, 24105
      • Universitätsklinikum Schleswig-Holstein
• Japan
  • Fukuoka-shi
    • Fukuoka, Fukuoka-shi, Japan, 814-0180
      • Fukuoka University Hospital
  • Hokkaido
    • Asahikawa, Hokkaido, Japan, 078-8510
      • Asahikawa Medical University Hospital
  • Itabashi-Ku
    • Tokyo, Itabashi-Ku, Japan, 173-8610
      • Nihon University Itabashi Hospital
  • Kagoshima-Shi
    • Kagoshima, Kagoshima-Shi, Japan, 890-0046
      • Saruwatari Dermatology Clinic
  • Kawasaki-shi
    • Kanagawa, Kawasaki-shi, Japan, 211-8510
      • Kanto Rosai Hospital
  • Nagoya-shi
    • Aichi, Nagoya-shi, Japan, 467-8602
      • Nagoya City University Hospital
  • Okayama-shi
    • Okayama, Okayama-shi, Japan, 700-8558
      • Okayama University Hospital
  • Osaka-Shi
    • Osaka, Osaka-Shi, Japan, 550-0006
      • Nippon Life Hospital
  • Osaka-shi
    • Osaka, Osaka-shi, Japan, 545-8586
      • Osaka Metropolitan University Hospital
  • Sagamihara
    • Kanagawa, Sagamihara, Japan, 252-0392
      • National Hospital Organization Sagamihara National Hospital
  • Saka-Shi
    • Osaka, Saka-Shi, Japan, 593-8324
      • Dermatology and Ophthalmology Kume Clinic
  • Sapporo-shi
    • Hokkaido, Sapporo-shi, Japan, 060-8648
      • Hokkaido University Hospital
  • Sayama-Shi
    • Osaka, Sayama-Shi, Japan, 589-8511
      • Kindai University Hospital
  • Shinjuku-Ku
    • Tokyo, Shinjuku-Ku, Japan, 160-0023
      • Tokyo Medical University Hospital
  • Suita-shi
    • Osaka, Suita-shi, Japan, 565-0871
      • Osaka University Hospital
  • Tachikawa-shi
    • Tokyo, Tachikawa-shi, Japan, 190-0023
      • Medical Corporation Jitai kai Tachikawa Dermatology Clinic
  • Tsu-shi
    • Mie, Tsu-shi, Japan, 514-8507
      • Mie University Hospital
  • Ube-shi
    • Yamaguchi, Ube-shi, Japan, 755-8505
      • Yamaguchi University Hospital
  • Yokohama-shi
    • Kanagawa, Yokohama-shi, Japan, 236-0004
      • Yokohama City University Hospital
• Poland
  • Gdansk, Poland, 80-546
    • Centrum Badań Klinicznych PI House Sp. Z O.O.
  • Krakow, Poland, 30-727
    • Pratia Małopolskie Centrum Medyczne (MCM) Kraków
  • Warsaw, Poland, 02-118
    • Rheuma Medicus
  • Warsaw, Poland, 02-672
    • Centrum Medyczne Synexus Warszawa
  • Kuyavian-Pomeranian Voivodeship
    • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85796
      • Centrum Medyczne PRATIA Bydgoszcz
  • Lesser Poland Voivodeship
    • Krakow, Lesser Poland Voivodeship, Poland, 30-033
      • Specjalistyczny Ośrodek Alergologiczno-Internistyczny "ALL-MED"
  • Lower Silesian Voivodeship
    • Wroclaw, Lower Silesian Voivodeship, Poland, 51-685
      • WroMedica
    • Wroclaw, Lower Silesian Voivodeship, Poland, 50-381
      • Centrum Medyczne Synexus Wroclaw
  • Malopolska
    • Krakow, Malopolska, Poland, 31-559
      • Diamond Clinic
  • Masovian Voivodeship
    • Warsaw, Masovian Voivodeship, Poland, 00-874
      • MICS Medical Center Warsaw
    • Warsaw, Masovian Voivodeship, Poland, 00215
      • FutureMeds Warszawa Centrum
    • Warsaw, Masovian Voivodeship, Poland, 01-817
      • High Med Przychodnia Specjalistyczna
    • Warsaw, Masovian Voivodeship, Poland, 02-665
      • Centrum Medyczne Reuma Park
  • Mazowiecke
    • Warsaw, Mazowiecke, Poland, 02-962
      • Royalderm
  • Podlaskie Voivodeship
    • Bialystok, Podlaskie Voivodeship, Poland, 15-879
      • ClinicMed Daniluk, Nowak Spolka Komandytowa
  • Pomeranian Voivodeship
    • Gdansk, Pomeranian Voivodeship, Poland, 80-382
      • AES Gdansk
    • Gdynia, Pomeranian Voivodeship, Poland, 81-415
      • Derm Art Institute
    • Gdynia, Pomeranian Voivodeship, Poland, 81-537
      • Centrum Medyczne Synexus Gdynia
  • Silesian Voivodeship
    • Katowice, Silesian Voivodeship, Poland, 40-611
      • Centrum Medyczne Angelius Provita (Angelius Provita Medical Centre)
  • West Pomeranian Voivodeship
    • Szczecin, West Pomeranian Voivodeship, Poland, 70-332
      • Laser Clinic
  • Łódź Voivodeship
    • Skierniewice, Łódź Voivodeship, Poland, 96-100
      • Velocity Clinical Research, Skierniewice
• Portugal
  • Braga District
    • Guimarães, Braga District, Portugal, 4835-044
      • Hospital da Senhora da Oliveira
  • Lisbon District
    • Lisbon, Lisbon District, Portugal, 1998-018
      • Hospital CUF Descobertas
  • Porto District
    • Porto, Porto District, Portugal, 4099-001
      • Unidade Local de Saude Santo Antonio Hospital de Santo Antonio
• South Korea
  • Busan, South Korea, 49241
    • Pusan National University Hospital
  • Seoul, South Korea, 03080
    • Seoul National University Hospital
  • Dong-gu
    • Gwangju, Dong-gu, South Korea, 61453
      • Chosun Universtiy Hospital
  • Gwangjin-gu
    • Seoul, Gwangjin-gu, South Korea, 05030
      • Konkuk University Medical Center
  • Gyeonggi-do
    • Anyang-si, Gyeonggi-do, South Korea, 14068
      • Hallym University Sacred Heart Hospital
    • Seongnam-si, Gyeonggi-do, South Korea, 13620
      • Seoul National University Bundang Hospital
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • Alliance Dermatology
    • Scottsdale, Arizona, United States, 85260
      • Scottsdale Clinical Trials
  • Arkansas
    • Rogers, Arkansas, United States, 72758-8600
      • Northwest Arkansas Clinical Trials Center (NWACTC), PLLC
  • California
    • Chula Vista, California, United States, 91910
      • Exalt Clinical Research
    • Encinitas, California, United States, 92024-7700
      • California Dermatology & Clinical Research Institute
    • Fountain Valley, California, United States, 92708
      • First OC Dermatology Research Inc
    • Huntington Beach, California, United States, 92647
      • Marvel Clinical Research, LLC
    • Lafayette, California, United States, 94549
      • Sunwise Clinical Research, Llc
    • Los Angeles, California, United States, 90056
      • Wallace Medical Group Inc
    • Northridge, California, United States, 91325
      • Northridge Clinical Trials - Elite Clinical Network
    • Pasadena, California, United States, 91101
      • Pasadena Clinical Trials
    • San Diego, California, United States, 92123
      • Therapeutics Clinical Research
    • Sherman Oaks, California, United States, 91403-1814
      • Unison Clinical Trials/ Shahram Jacobs MD
    • Sylmar, California, United States, 91342
      • Olive View - UCLA Education & Research Institute
    • Thousand Oaks, California, United States, 91320-2130
      • California Dermatology Institute - Thousand Oaks
  • Florida
    • Boca Raton, Florida, United States, 33428
      • Clearlyderm Dermatology - West Boca Raton
    • Coral Gables, Florida, United States, 33134
      • Driven Clinical Research
    • Jacksonville, Florida, United States, 32216
      • Jacksonville Center for Clinical Research
    • Margate, Florida, United States, 33063-7011
      • Glick Skin Institute - Margate
    • Miami Lakes, Florida, United States, 33014
      • Savin Medical Group LLC
    • Miami Lakes, Florida, United States, 33014
      • San Marcus Research Clinic, Inc - Miami
    • North Miami Beach, Florida, United States, 33169
      • Oceanic Research Group
    • Sweetwater, Florida, United States, 33172
      • LENUS Research
    • Tampa, Florida, United States, 33607
      • Caban Skin Institute
    • Tampa, Florida, United States, 33613-1244
      • ForCare Medical Center
  • Georgia
    • Macon, Georgia, United States, 31217
      • Skin Care Physicians of Georgia - Warner Robins
  • Illinois
    • Chicago, Illinois, United States, 60614-3625
      • MetroMed Clinical Trials
    • Rolling Meadows, Illinois, United States, 60008
      • Arlington Dermatology
    • Skokie, Illinois, United States, 60077-1049
      • NorthShore Medical Group - Dermatology - Skokie
    • West Dundee, Illinois, United States, 60118
      • Dundee Dermatology
  • Indiana
    • Columbus, Indiana, United States, 47201
      • Dawes Fretzin Clinical Research Group
    • South Bend, Indiana, United States, 46617
      • The South Bend Clinic
  • Kentucky
    • Bowling Green, Kentucky, United States, 42104
      • Equity Medical - Bowling Green
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Velocity Clinical Research at The Dermatology Clinic, Baton Rouge
    • New Orleans, Louisiana, United States, 70112
      • Tulane University School of Medicine
  • Massachusetts
    • Brighton, Massachusetts, United States, 02135
      • MetroBoston Clinical Partners
  • Missouri
    • Kirksville, Missouri, United States, 63501-5362
      • Cleaver Dermatology
  • New York
    • New York, New York, United States, 10128-0724
      • OPTISKIN
  • Ohio
    • Gahanna, Ohio, United States, 43230-5317
      • The Ohio State University Wexner Medical Center (OSUWMC) - OSU Dermatology East - Columbus
    • Mason, Ohio, United States, 45040-4520
      • Dermatologists of Southwestern Ohio, LLC
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73118
      • Unity Clinical Research (UCR)
  • Oregon
    • Medford, Oregon, United States, 97504
      • Velocity Clinical Research, Medford
    • Portland, Oregon, United States, 97201
      • Oregon Medical Research Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19103
      • Paddington Testing Company Inc.
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC Department of Dermatology
  • South Dakota
    • Rapid City, South Dakota, United States, 57702-9208
      • Health Concepts
  • Tennessee
    • Goodlettsville, Tennessee, United States, 37072-2301
      • Discover Dermatology, LLC d/b/a Goodlettsville Dermatology Research
    • Hermitage, Tennessee, United States, 37076
      • Discover Dermatology, LLC d/b/a Cumberland Skin Center for Clinical Research under Objective Health
  • Texas
    • Bellaire, Texas, United States, 77401
      • UT Health Houston Department of Dermatology
    • Cypress, Texas, United States, 77429
      • Studies in Dermatology, LLC
    • Frisco, Texas, United States, 75033
      • Reveal Research Institute
    • Houston, Texas, United States, 77004
      • Center for Clinical Studies - Texas Medical Center
    • Houston, Texas, United States, 77056
      • Austin Institute for Clinical Research - Houston
  • Utah
    • Murray, Utah, United States, 84107
      • University of Utah Health Care - Midvalley Health Center
  • Washington
    • Mill Creek, Washington, United States, 98012
      • Frontier Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Matching oral placebo	Drug: Placebo; Placebo
Experimental: ESK-001; ESK-001 administered as an oral tablet	Drug: Envudeucitinib; ESK-001
Active Comparator: Apremilast; Apremilast administered as an oral capsule	Drug: Apremilast; Apremilast

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
To compare the affected body surface area (%BSA) between ESK-001 and placebo or apremilast	Change from baseline in %BSA	24 weeks
To characterize the pharmacokinetics of ESK-001	Maximum [Cmax] and minimum [Cmin] plasma concentration	24 weeks
To compare the Pruritus numeric rating scale (NRS) between ESK-001 and placebo	Change from baseline in Pruritus NRS	24 weeks
To compare the Psoriasis Area and Severity Index (PASI-90 and PASI-100) between ESK-001 and placebo or apremilast	Proportion of participants achieving of ≥90% or 100% reduction in PASI	24 weeks
To compare the Psoriasis Area and Severity Index (PASI-75) between ESK-001 and apremilast	Proportion of participants achieving of ≥75% reduction in PASI	24 weeks
To compare the Static Physician's Global Assessment (sPGA-0/1) between ESK-001 and apremilast	Proportion of participants achieving a score of 0 or 1 on sPGA	24 weeks
To compare the scalp specific Physician's Global Assessment (ssPGA) between ESK-001 and placebo or apremilast.	Proportion of participants achieving a score of 0 or 1 on ssPGA	24 weeks
To compare the Psoriasis Symptoms and Signs Diary (PSSD) between ESK-001 and placebo or apremilast	Proportion of participants achieving a score of 0	24 weeks
To compare the Dermatology Life Quality Index (DLQI) between ESK-001 and placebo or apremilast	Proportion of participants achieving a score of 0 or 1	24 weeks
Proportion of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)	Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)	24 weeks

Collaborators and Investigators

• Sponsor: Alumis Inc

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2024
• Primary Completion (Actual): September 19, 2025
• Study Completion (Actual): November 20, 2025

Study Registration Dates

• First Submitted: August 14, 2024
• First Submitted That Met QC Criteria: September 3, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Psoriasis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Antirheumatic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Anti-Inflammatory Agents, Non-Steroidal; Phosphodiesterase Inhibitors; Phosphodiesterase 4 Inhibitors; apremilast
• Other Study ID Numbers: ESK-001-016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The Sponsor Alumis Inc. is a clinical-stage biopharmaceutical company that has not yet adopted an Individual Participant Data (IPD) sharing plan.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No