Home › Trials › NCT06846541

Long-term evaluation of ESK-001 for moderate to severe plaque psoriasis

An Extension Study in Patients With Moderate to Severe Plaque Psoriasis to Evaluate the Long-term Safety, Efficacy, and Durability of Response to ESK-001

Phase 3 Interventional Alumis Inc · NCT06846541

This study is testing a new treatment called ESK-001 to see if it can safely help people with moderate to severe plaque psoriasis feel better over a long period.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1680 (estimated)
Ages18 Years and up
SexAll
SponsorAlumis Inc Industry-sponsored
Locations68 sites (Birmingham, Alabama and 67 other locations)
Trial IDNCT06846541 on ClinicalTrials.gov

What this trial studies

This study aims to assess the long-term safety and efficacy of ESK-001 in patients with moderate to severe plaque psoriasis. Participants who have completed prior studies will receive open-label ESK-001 for 24 weeks, followed by a randomized assignment to either ESK-001 or placebo based on their clinical response. The study will monitor the safety profile and effectiveness of ESK-001 in reducing psoriasis severity over an extended period. Patients who do not maintain their initial response can return to open-label treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have completed prior studies of ESK-001 and found it safe and tolerable.

Not a fit: Patients who are pregnant, lactating, or have unstable clinical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new long-term treatment option for patients suffering from moderate to severe plaque psoriasis.

How similar studies have performed: Other studies have shown promising results with similar treatments for plaque psoriasis, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Males or females, age ≥18 years
2. Completed either of the two previous (parent) studies of ESK-001 (ESK-001-016 or ESK-001-017)
3. ESK-001 safety and tolerability were acceptable in the parent study
4. Women of childbearing potential (WOCBP) and males who are sexually active with WOCBP must agree to adhere to highly effective methods of contraception for the entirety of the study

Exclusion Criteria:

1. Pregnant, lactating, or planning to get pregnant during the study period
2. Any acute or chronic illness/condition or evidence of an unstable clinical condition that in the Investigator's judgment will substantially increase the risk to the patient if they continue to receive ESK-001 treatment in this extension study
3. Deemed by the Investigator to be inappropriate for the study or unable to comply with the protocol

Where this trial is running

Birmingham, Alabama and 67 other locations

+18 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 PsoriasisPsoriasisModerate PsoriasisSevere PsoriasisPASISafetyESK-001
Last reviewed 2026-06-13 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.