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Plaque PsoriasisPhase 3ONWARD1NCT06586112

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

A Phase 3 study testing Envudeucitinib and Apremilast in people with Plaque Psoriasis, run by Alumis Inc at 156 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Plaque Psoriasis
What is being tested?
Envudeucitinib and Apremilast
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
912 participants
Where
156 sitesin 10 countries
Study dates
25 Jul 2024to 20 Nov 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 28Show fewer
  • 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
  • Evidence of recent or recurrent herpes zoster or herpes simplex viral infection
  • Evidence of active infection or positive test result for hepatitis B, hepatitis C, HIV or TB
  • History of serious bacterial, fungal, or viral infections that led to hospitalization, or any recent serious infection requiring antibiotic treatment
  • Any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status
  • Lab abnormalities indicating significant renal, hepatic or bone marrow dysfunction
  • 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
  • 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
  • Live vaccines within 4 weeks prior to Study Day 1
  • Participant has planned surgery during the study period
  • 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
  • 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
  • Evidence of severe depressive symptoms or active suicidal ideation or behavior

Trial locations and contacts

156 sites in 10 countries.

156 sites in 10 countries

United States55 sites

  • Velocity Clinical Research at The Dermatology Clinic, Baton Rouge

    Baton Rouge, Louisiana, 70808

  • UT Health Houston Department of Dermatology

    Bellaire, Texas, 77401

  • Clearlyderm Dermatology - West Boca Raton

    Boca Raton, Florida, 33428

  • Equity Medical - Bowling Green

    Bowling Green, Kentucky, 42104

  • MetroBoston Clinical Partners

    Brighton, Massachusetts, 02135

  • MetroMed Clinical Trials

    Chicago, Illinois, 60614-3625

  • Exalt Clinical Research

    Chula Vista, California, 91910

  • Dawes Fretzin Clinical Research Group

    Columbus, Indiana, 47201

  • Driven Clinical Research

    Coral Gables, Florida, 33134

  • Studies in Dermatology, LLC

    Cypress, Texas, 77429

  • California Dermatology & Clinical Research Institute

    Encinitas, California, 92024-7700

  • First OC Dermatology Research Inc

    Fountain Valley, California, 92708

  • Reveal Research Institute

    Frisco, Texas, 75033

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

    Gahanna, Ohio, 43230-5317

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

    Goodlettsville, Tennessee, 37072-2301

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

    Hermitage, Tennessee, 37076

  • Center for Clinical Studies - Texas Medical Center

    Houston, Texas, 77004

  • Austin Institute for Clinical Research - Houston

    Houston, Texas, 77056

  • Marvel Clinical Research, LLC

    Huntington Beach, California, 92647

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216

  • Cleaver Dermatology

    Kirksville, Missouri, 63501-5362

  • Sunwise Clinical Research, LLC

    Lafayette, California, 94549

  • Wallace Medical Group Inc

    Los Angeles, California, 90056

  • Skin Care Physicians of Georgia - Warner Robins

    Macon, Georgia, 31217

  • Glick Skin Institute - Margate

    Margate, Florida, 33063-7011

  • Dermatologists of Southwestern Ohio, LLC

    Mason, Ohio, 45040-4520

  • Velocity Clinical Research, Medford

    Medford, Oregon, 97504

  • San Marcus Research Clinic, Inc - Miami

    Miami Lakes, Florida, 33014

  • Savin Medical Group LLC

    Miami Lakes, Florida, 33014

  • Frontier Dermatology

    Mill Creek, Washington, 98012

  • University of Utah Health Care - Midvalley Health Center

    Murray, Utah, 84107

  • Tulane University School of Medicine

    New Orleans, Louisiana, 70112

  • OptiSkin

    New York, New York, 10128-0724

  • Oceanic Research Group

    North Miami Beach, Florida, 33169

  • Northridge Clinical Trials - Elite Clinical Network

    Northridge, California, 91325

  • Unity Clinical Research (UCR)

    Oklahoma City, Oklahoma, 73118

  • Pasadena Clinical Trials

    Pasadena, California, 91101

  • Paddington Testing Company Inc.

    Philadelphia, Pennsylvania, 19103

  • Alliance Dermatology

    Phoenix, Arizona, 85032

  • UPMC Department of Dermatology

    Pittsburgh, Pennsylvania, 15213

  • Oregon Medical Research Center

    Portland, Oregon, 97201

  • Health Concepts

    Rapid City, South Dakota, 57702-9208

  • Northwest Arkansas Clinical Trials Center (NWACTC), PLLC

    Rogers, Arkansas, 72758-8600

  • Arlington Dermatology

    Rolling Meadows, Illinois, 60008

  • Therapeutics Clinical Research

    San Diego, California, 92123

  • Scottsdale Clinical Trials

    Scottsdale, Arizona, 85260

  • Unison Clinical Trials/ Shahram Jacobs MD

    Sherman Oaks, California, 91403-1814

  • NorthShore Medical Group - Dermatology - Skokie

    Skokie, Illinois, 60077-1049

  • The South Bend Clinic

    South Bend, Indiana, 46617

  • LENUS Research

    Sweetwater, Florida, 33172

  • Olive View - UCLA Education & Research Institute

    Sylmar, California, 91342

  • Caban Skin Institute

    Tampa, Florida, 33607

  • ForCare Medical Center

    Tampa, Florida, 33613-1244

  • California Dermatology Institute - Thousand Oaks

    Thousand Oaks, California, 91320-2130

  • Dundee Dermatology

    West Dundee, Illinois, 60118

Other trials in United States

Poland21 sites

  • ClinicMed Daniluk, Nowak Spolka Komandytowa

    Bialystok, Podlaskie Voivodeship, 15-879

  • Centrum Medyczne Pratia Bydgoszcz

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85796

  • AES Gdansk

    Gdansk, Pomeranian Voivodeship, 80-382

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

    Gdansk, 80-546

  • Derm Art Institute

    Gdynia, Pomeranian Voivodeship, 81-415

  • Centrum Medyczne Synexus Gdynia

    Gdynia, Pomeranian Voivodeship, 81-537

  • Centrum Medyczne Angelius Provita (Angelius Provita Medical Centre)

    Katowice, Silesian Voivodeship, 40-611

  • Specjalistyczny Ośrodek Alergologiczno-Internistyczny "ALL-MED"

    Krakow, Lesser Poland Voivodeship, 30-033

  • Diamond Clinic

    Krakow, Malopolska, 31-559

  • Pratia Małopolskie Centrum Medyczne (MCM) Kraków

    Krakow, 30-727

  • Velocity Clinical Research, Skierniewice

    Skierniewice, Łódź Voivodeship, 96-100

  • Laser Clinic

    Szczecin, West Pomeranian Voivodeship, 70-332

  • MICS Medical Center Warsaw

    Warsaw, Masovian Voivodeship, 00-874

  • FutureMeds Warszawa Centrum

    Warsaw, Masovian Voivodeship, 00215

  • High Med Przychodnia Specjalistyczna

    Warsaw, Masovian Voivodeship, 01-817

  • Centrum Medyczne Reuma Park

    Warsaw, Masovian Voivodeship, 02-665

  • RoyalDerm

    Warsaw, Mazowiecke, 02-962

  • Rheuma Medicus

    Warsaw, 02-118

  • Centrum Medyczne Synexus Warszawa

    Warsaw, 02-672

  • Centrum Medyczne Synexus Wroclaw

    Wroclaw, Lower Silesian Voivodeship, 50-381

  • WroMedica

    Wroclaw, Lower Silesian Voivodeship, 51-685

Other trials in Poland

Japan19 sites

  • Nagoya City University Hospital

    Aichi, Nagoya-shi, 467-8602

  • Asahikawa Medical University Hospital

    Asahikawa, Hokkaido, 078-8510

  • Fukuoka University Hospital

    Fukuoka, Fukuoka-shi, 814-0180

  • Hokkaido University Hospital

    Hokkaido, Sapporo-shi, 060-8648

  • Saruwatari Dermatology Clinic

    Kagoshima, Kagoshima-Shi, 890-0046

  • Kanto Rosai Hospital

    Kanagawa, Kawasaki-shi, 211-8510

  • National Hospital Organization Sagamihara National Hospital

    Kanagawa, Sagamihara, 252-0392

  • Yokohama City University Hospital

    Kanagawa, Yokohama-shi, 236-0004

  • Mie University Hospital

    Mie, Tsu-shi, 514-8507

  • Okayama University Hospital

    Okayama, Okayama-shi, 700-8558

  • Osaka Metropolitan University Hospital

    Osaka, Osaka-shi, 545-8586

  • Nippon Life Hospital

    Osaka, Osaka-Shi, 550-0006

  • Dermatology and Ophthalmology Kume Clinic

    Osaka, Saka-Shi, 593-8324

  • Kindai University Hospital

    Osaka, Sayama-Shi, 589-8511

  • Osaka University Hospital

    Osaka, Suita-shi, 565-0871

  • Nihon University Itabashi Hospital

    Tokyo, Itabashi-Ku, 173-8610

  • Tokyo Medical University Hospital

    Tokyo, Shinjuku-Ku, 160-0023

  • Medical Corporation Jitai kai Tachikawa Dermatology Clinic

    Tokyo, Tachikawa-shi, 190-0023

  • Yamaguchi University Hospital

    Yamaguchi, Ube-shi, 755-8505

Other trials in Japan

Czechia16 sites

  • Pratia Brno s.r.o.

    Brno, Moravia, 60200

  • Kozni ambulance Kutna Hora, s.r.o.

    Kutná Hora, 28401

  • DERMAMEDICA, s.r.o.

    Náchod, 54701

  • Nemocnice Nový Jičín, A.S.

    Nový Jičín, 74101

  • Dermskin, s.r.o.

    Olomouc, Moravia, 77900

  • CCR Ostrava, s.r.o.

    Ostrava, 70200

  • Vesalion sro

    Ostrava, 70200

  • Pratia Pardubice a.s.

    Pardubice, 53002

  • Fakultni nemocnice Plzen Dermatovenerologicka klinika

    Pilsen, Bory, 301 00

  • Clintrial s.r.o.

    Prague, 100 00

  • Fakultni Nemocnice Kralovske Vinohrady FNKV Dermatovenerologicka Klinika

    Prague, 10034

  • Sanatorium Profesora Arenbergera

    Prague, 110 00

  • Pratia Prague, s.r.o.

    Prague, 13000

  • Praglandia

    Prague, 15000

  • Dermatologicka ambulance - Svitavy

    Svitavy, 568 02

  • MUDr Radka Neumannova

    Svitavy, 56802

Other trials in Czechia

Canada15 sites

  • Rejuvenation Medical Group Edmonton Downtown

    Edmonton, Alberta, T5J 3S9

  • Dermatrials Research Inc.

    Hamilton, Ontario, L8N 1Y2

  • Centricity Research

    London, Ontario, N6A 2C2

  • DermEffects

    London, Ontario, N6H 5L5

  • Lynderm Research Inc.

    Markham, Ontario, L3P 1X3

  • DermEdge Research

    Mississauga, Ontario, L4Y 4C5

  • Institute of Cosmetic & Laser Surgery

    Oakville, Ontario, L6J 7W5

  • "Centre de Recherche Dermatologique du Quebec Metropolitain Inc."

    Québec, Quebec, G1V 4X7

  • The Centre for Dermatology

    Richmond Hill, Ontario, L4B 1A5

  • Enverus Medical Research

    Surrey, British Columbia, V3V 0C6

  • North York Research Inc.

    Toronto, Ontario, M2N3A6

  • Canadian Dermatology Centre

    Toronto, Ontario, M3B 0A7

  • Dermatology on Bloor

    Toronto, Ontario, M4W 2N4

  • Dermatologie Sima Inc.

    Verdun, Quebec, H4G 3E7

  • Alliance Clinical Trials

    Waterloo, Ontario, N2J 1C4

Other trials in Canada

Germany11 sites

  • Hautarztpraxis Dr. Mihaescu

    Augsburg, Bavaria, 86150

  • Fachklinik Bad Bentheim

    Bad Bentheim, Lower Saxony, 48455

  • Klinikum Bielefeld

    Bielefeld, North Rhine-Westphalia, 33647

  • Hautarztpraxis an der Hase

    Bramsche, Lower Saxony, 49565

  • Pro Derma

    Dülmen, North Rhine-Westphalia, 48249

  • Universitatsklinikum Frankfurt

    Frankfurt am Main, Hesse, 60590

  • Universitatsklinikum Schleswig-Holstein

    Kiel, Schleswig-Holstein, 24105

  • Siteworks

    Lohne, Lower Saxony, 49393

  • Hautarztpraxis Mahlow

    Mahlow, Brandenburg, 15831

  • Intramedis CSS

    Remscheid, North Rhine-Westphalia, 42897

  • Eberhard Karls Universitaet Tuebingen Universitaets Hautklinik Tuebingen

    Tübingen, Baden-Wurttemberg, 72070

Other trials in Germany

South Korea6 sites

  • Hallym University Sacred Heart Hospital

    Anyang-si, Gyeonggi-do, 14068

  • Pusan National University Hospital

    Busan, 49241

  • Chosun Universtiy Hospital

    Gwangju, Dong-gu, 61453

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • Konkuk University Medical Center

    Seoul, Gwangjin-gu, 05030

  • Seoul National University Hospital

    Seoul, 03080

Other trials in South Korea

Australia5 sites

  • North Eastern Health Specialists (NEHS)

    Campbelltown, South Australia, 5074

  • Skin Health Institute Inc.

    Carlton, Victoria, 3053

  • Sinclair Dermatology

    East Melbourne, Victoria, 3002

  • Premier Specialists

    Kogarah, New South Wales, 2217

  • Westmead Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

Bulgaria5 sites

  • Multiprofile Hospital for Active Treatment Dr Tota Venkova

    Gabrovo, 5300

  • Medikal Center Kordis

    Pleven, 5800

  • Skin and Venereal Diseases Center EOOD

    Sofia, 1404

  • Diagnostic Consultative Center Aleksandrovska EOOD

    Sofia, 1431

  • Clineca

    Stara Zagora, 6000

Other trials in Bulgaria

Portugal3 sites

  • Hospital da Senhora da Oliveira

    Guimarães, Braga District, 4835-044

  • Hospital CUF Descobertas

    Lisbon, 1998-018

  • Unidade Local de Saude Santo Antonio Hospital de Santo Antonio

    Porto, 4099-001

Other trials in Portugal

About this study

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)

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?
Read more

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.
Being tested
Envudeucitinib, Apremilast, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EnvudeucitinibDrug

    ESK-001

  • ApremilastDrug

    Apremilast

  • PlaceboDrug

    Placebo

Study groups in NCT06586112
Study groupRoleWhat they receive
ESK-001ExperimentalESK-001 administered as an oral tablet
Receives: Drug: Envudeucitinib
PlaceboPlacebo comparatorMatching oral placebo
Receives: Drug: Placebo
ApremilastActive comparatorApremilast administered as an oral capsule
Receives: Drug: Apremilast

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 16 weeks

Secondary outcomes (10)

  1. 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

    Measured: 24 weeks

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

    Proportion of participants achieving of ≥75% reduction in PASI

    Measured: 24 weeks

  3. 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

    Measured: 24 weeks

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

    Change from baseline in %BSA

    Measured: 24 weeks

  5. 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

    Measured: 24 weeks

  6. To compare the Psoriasis Symptoms and Signs Diary (PSSD) between ESK-001 and placebo or apremilast

    Proportion of participants achieving a score of 0

    Measured: 24 weeks

  7. 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

    Measured: 24 weeks

  8. To compare the Pruritus numeric rating scale (NRS) between ESK-001 and placebo

    Change from baseline in Pruritus NRS

    Measured: 24 weeks

  9. 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)

    Measured: 24 weeks

  10. To characterize the pharmacokinetics of ESK-001

    Maximum [Cmax] and minimum [Cmin] plasma concentration

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start25 Jul 2024
  3. Primary completion19 Sep 2025
  4. Study completion20 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
912 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06586112
Sponsor's protocol ID
ESK-001-016
Acronym
ONWARD1
Status last verified
Oct 2026
First submitted
14 Aug 2024
Last updated
28 Oct 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided: The Sponsor Alumis Inc. is a clinical-stage biopharmaceutical company that has not yet adopted an Individual Participant Data (IPD) sharing plan.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Envudeucitinib and Apremilast in people with Plaque Psoriasis, run by Alumis Inc at 156 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 156 sites in United States, Poland, Japan, Czechia, Canada and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06586112.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.

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