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Evaluating ESK-001 for treating moderate to severe plaque psoriasis

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)

Phase 3 Interventional Alumis Inc · NCT06586112

This study is testing a new medication called ESK-001 to see if it can help people with moderate to severe plaque psoriasis feel better over 24 weeks compared to a placebo and an existing treatment.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment840 (estimated)
Ages18 Years and up
SexAll
SponsorAlumis Inc Industry-sponsored
Locations183 sites (Phoenix, Arizona and 182 other locations)
Trial IDNCT06586112 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the efficacy and safety of ESK-001 in patients suffering from moderate to severe plaque psoriasis. Participants will take ESK-001 daily for 24 weeks and will be monitored through clinic visits, questionnaires, and various health assessments. The study includes a placebo control and an active comparator, apremilast, to evaluate the effectiveness of ESK-001 against existing treatments. The primary focus is on reducing psoriasis severity and ensuring patient safety throughout the treatment period.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of moderate to severe plaque psoriasis for at least six months.

Not a fit: Patients with nonplaque psoriasis or other inflammatory skin conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients with moderate to severe plaque psoriasis.

How similar studies have performed: Previous studies have shown promise with similar approaches, but the specific efficacy of ESK-001 is being evaluated for the first time.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Phoenix, Arizona and 182 other locations

+133 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Plaque Psoriasis
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.