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Completed

NCT Number: NCT06588738

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

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.

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Key information

Conditions

Plaque Psoriasis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Klinik Hietzing, Vienna, State of Vienna, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Envudeucitinib

Drug

ESK-001

Placebo

Drug

Placebo

Apremilast

Drug

Apremilast

Primary outcomes

  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

    Time frame: 16 weeks

    Proportion of patients achieving ≥75% reduction in PASI score. Proportion of patients achieving a score of 0 or 1 on sPGA.

Secondary outcomes

  1. To compare the Psoriasis Area and Severity Index (PASI-90 and PASI-100) between ESK-001 and placebo or apremilast

    Time frame: 24 weeks

    Proportion of patients achieving of ≥90% or 100% reduction in PASI

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

    Time frame: 24 weeks

    Proportion of patients achieving of ≥75% reduction in PASI

  3. To compare the Static Physician's Global Assessment (sPGA-0/1) between ESK-001 and apremilast

    Time frame: 24 weeks

    Proportion of patients achieving a score of 0 or 1 on sPGA

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

    Time frame: 24 weeks

    Change from baseline in %BSA

  5. To compare the scalp specific Physician's Global Assessment (ssPGA) between ESK-001 and placebo or apremilast

    Time frame: 24 weeks

    Proportion of patients achieving a score of 0 or 1 on ssPGA

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

    Time frame: 24 weeks

    Proportion of patients achieving a score of 0

  7. To compare the Dermatology Life Quality Index (DLQI) between ESK-001 and placebo or apremilast

    Time frame: 24 weeks

    Proportion of patients achieving a score of 0 or 1

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

    Time frame: 24 weeks

    Change from baseline in Pruritus NRS (scale is from 0 (no pain) to 10 (severe pain)).

  9. Proportion of patients with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)

    Time frame: 24 weeks

    Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)

  10. To characterize the pharmacokinetics of ESK-001

    Time frame: 24 weeks

    Maximum [Cmax] and minimum [Cmin] plasma concentration

Sponsors and collaborators

Lead sponsor

Alumis Inc

Industry

Registry information

Official study 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)

Acronym: ONWARD2

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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