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Plaque PsoriasisPhase 3ONWARD2NCT06588738

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

A Phase 3 study testing Envudeucitinib and Apremilast in people with Plaque Psoriasis, run by Alumis Inc at 124 sites in 12 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
862 participants
Where
124 sitesin 12 countries
Study dates
20 Aug 2024to 18 Dec 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). 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
Show all 21Show 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
  • 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
  • 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 patient's immune status
  • Lab abnormalities indicating significant renal, hepatic or bone marrow dysfunction
  • History of any immune-mediated or inflammatory medical condition for which patient requires current systemic corticosteroids

Trial locations and contacts

124 sites in 12 countries.

124 sites in 12 countries

United States43 sites
  • Asheville Clinical Trials

    Asheville, North Carolina, 28803

  • Zenith Research Inc.

    Beverly Hills, California, 90211-1705

  • Total Skin and Beauty Dermatology Center, PC

    Birmingham, Alabama, 35203

  • Optima Research Boardman

    Boardman, Ohio, 44512

  • Chandler Clinical Trials

    Chandler, Arizona, 85224

  • Michigan Center for Research Company

    Clarkston, Michigan, 48346

  • DS Research of Southern Indiana

    Clarksville, Indiana, 47129

  • Modern Research Associates PLLC

    Dallas, Texas, 75231

  • Henry Ford Medical Center - Farmington Road

    Detroit, Michigan, 48202

  • NYC Health and Hospitals Elmhurst

    Elmhurst, New York, 11373

  • Raoof MD

    Encino, California, 91436

  • FXM Clinical Research Ft. Lauderdale LLC

    Fort Lauderdale, Florida, 33308

  • Direct Helpers Research Center (DHRC)

    Hialeah, Florida, 33012

  • Clinical Partners LLC

    Johnston, Rhode Island, 02919

  • Las Vegas Clinical Trials

    Las Vegas, Nevada, 89030

  • Long Beach Research Institute

    Long Beach, California, 90805

  • Dermatology Research Associates

    Los Angeles, California, 90045

  • DS Research of Kentucky

    Louisville, Kentucky, 40241

  • SMS Clinical Research

    Mesquite, Texas, 75149

  • AppleMed Research Group under WCG

    Miami, Florida, 33126

  • FAX Pharma Clinical Research Inc

    Miami, Florida, 33146

  • FXM Clinical Research - Miami LLC

    Miami, Florida, 33175

  • Las Mercedes Medical Research

    Miami, Florida, 33196

  • FXM Clinical Research Miramar LLC

    Miramar, Florida, 33027

  • Associated Skin Care Specialists - Minnesota Clinical Study Center

    New Brighton, Minnesota, 55112

  • Pioneer Clinical Research NY

    New York, New York, 10016

  • Cameron Dermatology

    New York, New York, 10023

  • Renstar Medical Research

    Ocala, Florida, 34470

  • Schlessinger MD

    Omaha, Nebraska, 68144

  • The Indiana Clinical Trials Center

    Plainfield, Indiana, 46168

  • Empire Clinical Research - Pomona

    Pomona, California, 91767

  • Integrative Skin Science and Research

    Sacramento, California, 95815

  • Progressive Clinical Research - San Antonio

    San Antonio, Texas, 78213

  • UC San Diego

    San Diego, California, 92122

  • Southern California Clinical Research

    Santa Ana, California, 92701

  • Clinical Science Institute Dermatology Institute

    Santa Monica, California, 90404

  • Jordan Valley Dermatology

    South Jordan, Utah, 84095

  • DermResearchCenter of New York

    Stony Brook, New York, 11790

  • Revival Research Institute

    Troy, Michigan, 48084

  • Noble Clinical Research

    Tucson, Arizona, 85704

  • Grekin Skin Institute

    Warren, Michigan, 48088

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

    Webster, Texas, 77598

  • WDC Cosmetic and Research

    Wilmington, North Carolina, 28405

Other trials in United States

Poland18 sites
  • Specderm

    Bialystok, Podlaskie Voivodeship, 15-375

  • Pratia Gdynia

    Gdynia, Pomeranian Voivodeship, 81-338

  • Pratia Katowice

    Katowice, Silesian Voivodeship, 40-018

  • Research Solutions

    Katowice, Silesian Voivodeship, 40-748

  • Care Clinic Katowice

    Katowice, 40-568

  • FutureMeds Krakow

    Krakow, Lesser Poland Voivodeship, 31-501

  • Centrum Medyczne dr Rajzer Spolka Zoo

    Krakow, Malopolska, 30-438

  • Dermoklinika

    Lodz, Łódź Voivodeship, 90-436

  • FutureMeds Lodz

    Lodz, Łódź Voivodeship, 91-363

  • Luxderm

    Lublin, 20-573

  • Zanamed Medical Clinic Sp z o o

    Lublin, 20-601

  • Klinika Dermatologii Uniwersytecki Szpital Kliniczny im F Chopina

    Rzeszów, Podkarpackie Voivodeship, 50-368

  • RCMed Oddział Sochaczew

    Sochaczew, Masovian Voivodeship, 96-500

  • Clinical Best Solutions

    Warsaw, Masovian Voivodeship, 00-710

  • Centrum Medyczne Evimed

    Warsaw, Masovian Voivodeship, 02-625

  • MTZ Clinical Research Sp z o o

    Warsaw, 02-172

  • Klinika Ambroziak Dermatologia Kliniczna

    Warsaw, 02-953

  • dermMedica

    Wroclaw, 51-503

Other trials in Poland

Canada17 sites
  • CCA Medical Research Corp

    Ajax, Ontario, L1S 7K8

  • SimcoDerm Medical and Surgical Dermatology Center

    Barrie, Ontario, L4M 7G1

  • Beacon Dermatology

    Calgary, Alberta, T3E 0B2

  • SKiN Health

    Cobourg, Ontario, K9A 0Z4

  • Alberta DermaSurgery

    Edmonton, Alberta, T6G 1C3

  • VIDA Dermatology/VIDA Clinical Research

    Edmonton, Alberta, T6H 4J8

  • Guelph Dermatology Research

    Guelph, Ontario, N1L 0B3

  • Mediprobe Research

    London, Ontario, N5X 2P1

  • Innovaderm

    Montreal, Quebec, H2X 2V1

  • Clear Skin Dermatology

    Newmarket, Ontario, L3Y 5G8

  • North Bay Dermatology Centre

    North Bay, Ontario, P1B 3Z7

  • Rejuvination Dermatology Oakville

    Oakville, Ontario, L6H 6P8

  • CaRe Clinic Red Deer

    Red Deer, Alberta, T4P 1K4

  • SkinSense Medical Research

    Saskatoon, Saskatchewan, S7K 2C1

  • Skincare Studio

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

  • Toronto Research Centre

    Toronto, Ontario, M3H 5Y8

  • XLR8 Medical Research

    Windsor, Ontario, N8T 1E6

Other trials in Canada

Germany13 sites
  • ISA - Interdisciplinary Study Association GmbH

    Berlin, 10789

  • Hautarztpraxis Dr Niesmann and Dr Othlinghaus

    Bochum, North Rhine-Westphalia, 44793

  • Rosenpark Research

    Darmstadt, Hesse, 64283

  • Praxis fur Dermatologie und Venerologie

    Dresden, Saxony, 01097

  • Klinische Forschung Dresden GmbH

    Dresden, Saxony, 1069

  • Universitatsklinikum Erlangen

    Erlangen, Bavaria, 91054

  • MVZ DermaKiel GmbH

    Kiel, D-24148

  • Haut Ambulatorium Magdeburg

    Magdeburg, 39104

  • Dermatologische Praxis Dres Quist

    Mainz, Rhinelkand-Palatinate, 55128

  • Universitaetsklinikum Muenster

    Münster, North Rhine-Westphalia, 48149

  • Klinikum Oldenburg

    Oldenburg, Lower Saxony, 26133

  • KliFOs Klinische Forschung Osnabruck

    Osnabrück, 49074

  • Klinische Forschung Schwerin GmbH

    Schwerin, Mecklenburg-Vorpommern, 19055

Other trials in Germany

Hungary8 sites
  • DermaMed Research Kf

    Békés, Oroshaza, 5900

  • Uno Medical Trials Kft

    Budapest, 1152

  • Borgyogyaszati Klinika Debreceni Egyetem Orvos es Egeszsegtudomenyi Centrum

    Debrecen, Hajdú-Bihar, 4032

  • DERMA B Kft

    Debrecen, Hajdú-Bihar Megye, 4031

  • Orvostudomanyi Kutato es Fejleszto Kft

    Debrecen, 4027

  • Bacs Kiskun County Teaching Hospital

    Kecskemét, Bács-Kiskun county, 6000

  • Allergo Derm Bakos Kft

    Szolnok, 5000

  • Medmare Bt

    Veszprém, 8200

Other trials in Hungary

Latvia7 sites
  • Semigallia Ltd

    Kuldīga, Kuldigas, LV3301

  • Riga 1st Hospital

    Riga, LV1001

  • Med Art Clinic

    Riga, LV1003

  • Veselibas Centrs 4

    Riga, LV1003

  • SIA Veseliba un estetika

    Riga, LV1009

  • Veselibas Centrs 4 Filiale Dermatologijas Klinika

    Riga, LV1013

  • Smite Aija Medical Practice in Dermatology Venereology

    Talsi, LV3201

Other trials in Latvia

Spain5 sites
  • University General Hospital Dr Balmis

    Alicante, 3010

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 8041

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital de Manises

    Manises, 46940

  • Hospital Clínico Universitario de Santiago de Compostela

    Santiago de Compostela, A Coruña, 15706

Other trials in Spain

Estonia4 sites
  • Innomedica

    Tallinn, Harju, 10117

  • Center for Clinical and Basic Research AS

    Tallinn, 10128

  • Tartu University Hospital

    Tartu, Tartu, 50411

  • Kliiniliste Uuringute Keskus OU

    Tartu, 50106

Other trials in Estonia

Puerto Rico4 sites
  • Centro Reumatologico de Caguas

    Caguas, 00725

  • Ponce Medical School Foundation Inc

    Ponce, 00716

  • Clinical Research Puerto Rico

    Ponce, 00909

  • GCM Medical Group PSC Hato Rey Site

    San Juan, PR, 00917

Other trials in Puerto Rico

France3 sites
  • Centre Azur Nice

    Nice, 06000

  • Polyclinique de Courlancy

    Reims, 51100

  • CHU de Rouen

    Rouen, Normandy, 76031

Other trials in France

Austria1 site
  • Klinik Hietzing

    Vienna, 1220

Other trials in Austria

Israel1 site
  • Sheba Tel HaShomer Medical Centre

    Ramat Gan, 526200

Other trials in Israel

About this study

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)

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, Placebo, Apremilast

What participants receive

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

  • EnvudeucitinibDrug

    ESK-001

  • PlaceboDrug

    Placebo

  • ApremilastDrug

    Apremilast

Study groups in NCT06588738
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 patients achieving ≥75% reduction in PASI score. Proportion of patients 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 patients 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 patients 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 patients 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 patients 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 patients 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 patients 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 (scale is from 0 (no pain) to 10 (severe pain)).

    Measured: 24 weeks

  9. Proportion of patients 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 start20 Aug 2024
  3. Primary completion23 Sep 2025
  4. Study completion18 Dec 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
862 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06588738
Sponsor's protocol ID
ESK-001-017
Acronym
ONWARD2
Status last verified
Oct 2026
First submitted
7 Sep 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 124 sites in 12 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 21 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 124 sites in United States, Poland, Canada, Germany, Hungary and 7 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?
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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