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NCT Number: NCT05739435

Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of ESK-001 in Plaque Psoriasis

This is a multi-center, open-label extension (OLE) study in patients with plaque psoriasis who have completed their participation in a previous plaque psoriasis study of ESK-001.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Plaque Psoriasis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Investigator Site #2001, Edmonton, Alberta, Canada

Loading trial locations.

About this study

This study will consist of patients who have completed their participation in a previous plaque psoriasis study of ESK-001. Each patient will be assigned to receive ESK-001 at one of two open-label dose levels. Patients have the option to remain on study until ESK-001 is commercially available.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Must have completed a prior ESK-001 study
  • Men and Women must use highly effective methods of contraception for the entirety of the study

Exclusion criteria

  • Pregnancy
  • Received a prohibited concomitant medication

Treatment and study plan

Envudeucitinib

Drug

Oral tablet

Primary outcomes

  1. To assess the safety and tolerability of long-term ESK-001 treatment

    Time frame: Approximately 3 years

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

Secondary outcomes

  1. To assess the long-term efficacy of ESK-001

    Time frame: Approximately 3 years

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

  2. To assess the change in quality of life (QoL) with long-term ESK-001 administration

    Time frame: Approximately 3 years

    Change from baseline in Dermatology Life Quality Index (DLQI) over time

  3. To assess the pharmacokinetics (PK) of ESK-001 (ctrough)

    Time frame: 2 years

    Plasma concentrations and PK parameters including steady-state trough observed plasma concentration (Ctrough) for ESK-001

Sponsors and collaborators

Lead sponsor

Alumis Inc

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Feb 22, 2023
Registry last updated
Jul 28, 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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