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NCT Number: NCT06846541

Long-term Safety and Efficacy of ESK-001 in Moderate to Severe Plaque Psoriasis

The objective of the ESK-001-018 long term extension is to evaluate the safety and efficacy of ESK-001 over time. The scientific questions it aims to answer are:

* How safe is taking ESK-001 long-term in people with moderate to severe plaque psoriasis? * Does taking ESK-001 long-term reduce the severity of people's plaque psoriasis?

Patients will enter the long-term extension study following completion of one of the parent studies (ESK-001-016 or ESK-001-017) and will receive open-label ESK-001 twice daily for 24 weeks. After 24 weeks, the first 200 patients meeting at least PASI-75 clinical response will be randomly assigned to receive ESK-001 or placebo. At any point during this time, the patients losing the initial clinical response may return to the open-label ESK-001 treatment. Patients who complete Week 48 will return to open-label ESK-001 treatment and they will receive ESK-001 until the end of the study or discontinuation. All the remaining patients not meeting the entry criteria for the randomized withdrawal phase will continue to receive open-label ESK-001 for the remainder of the study.

Patients taking part in the study must be men or women aged at least 18 years old and have completed a previous (parent) study of ESK-001 in moderate to severe plaque psoriasis.

Patients must consent and agree to:

* ensure drug daily compliance until end of study or discontinuation. * visit the clinic for checkups and assessments. * provide blood and urine samples.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Plaque Psoriasis Moderate Psoriasis Psoriasis Psoriasis (PsO) Severe Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Premier Specialist, Kogarah, New South Wales, Australia

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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
  • Completed either of the two previous (parent) studies of ESK-001 (ESK-001-016 or ESK-001-017)
  • ESK-001 safety and tolerability were acceptable in the parent study
  • 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

  • Pregnant, lactating, or planning to get pregnant during the study period
  • 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
  • Deemed by the Investigator to be inappropriate for the study or unable to comply with the protocol

Treatment and study plan

Open-Label Envudeucitinib

Drug

Open-Label ESK-001

Blinded Envudeucitinib

Drug

Blinded ESK-001 during Randomized Treatment Withdrawal Period

Placebo

Drug

Placebo during Randomized Treatment Withdrawal Period

Primary outcomes

  1. To assess the long-term safety and tolerability of ESK-001 throughout the duration of the study

    Time frame: Approximately 4 years

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

Secondary outcomes

  1. To assess the long-term efficacy of ESK-001 using the Psoriasis Area and Severity Index (PASI-75)

    Time frame: 24, 48, 72, and 96 weeks

    Proportion of patients achieving ≥75% reduction in PASI

  2. To assess the long-term efficacy of ESK-001 using the Psoriasis Area and Severity Index (PASI-90)

    Time frame: 24, 48, 72, and 96 weeks

    Proportion of patients achieving ≥90% reduction in PASI

  3. To assess the long-term efficacy of ESK-001 using the Psoriasis Area and Severity Index (PASI-100)

    Time frame: 24, 48, 72, and 96 weeks

    Proportion of patients achieving 100% reduction in PASI

  4. To assess the long-term efficacy of ESK-001 using the Static Physician's Global Assessment (sPGA 0/1)

    Time frame: 24, 48, 72, and 96 weeks

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

  5. To assess the long-term efficacy of ESK-001 based on change in Psoriasis Area and Severity Index (PASI)

    Time frame: 24, 48, 72, and 96 weeks

    Change in Psoriasis Area and Severity Index (PASI) from baseline assessments

  6. To assess the long-term efficacy of ESK-001 based on change in Affected Body Surface Area (%BSA)

    Time frame: 24, 48, 72, and 96 weeks

    Change in affected body surface area (%BSA) from baseline assessments

  7. To characterize the loss of PASI-75 response following withdrawal of ESK-001 treatment (only for patients randomized to the treatment withdrawal phase)

    Time frame: Week 48

    Median time to loss of PASI-75 response

  8. To characterize the loss of PASI-90 response following withdrawal of ESK-001 treatment (only for patients randomized to the treatment withdrawal phase)

    Time frame: Week 48

    Median time to loss of PASI-90 response

  9. To characterize the loss of sPGA-0/1 response following withdrawal of ESK-001 treatment (only for patients randomized to the treatment withdrawal phase)

    Time frame: Week 48

    Median time to loss of sPGA-0/1 response

  10. To assess the change in quality of life (QoL) using Dermatology Life Quality Index after long-term ESK-001 administration

    Time frame: Week 24, Week 48, and Week 72

    Proportion of patients achieving a DLQI-0/1 score of 0 (no effect) or 1 (minimal effect)

Sponsors and collaborators

Lead sponsor

Alumis Inc

Industry

Registry information

Official study title

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

Acronym: ONWARD3

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Feb 26, 2025
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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