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NCT Number: NCT05600036

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

This is a multi-center, randomized, double-blind, placebo-controlled study in patients with moderate to severe plaque psoriasis.

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Key information

Conditions

Plaque Psoriasis

Age range

18 year–75 year

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 a 4 week screening period, 12 week treatment period, and a 4 week follow up period for a total of 20 weeks. Each participant will be randomized to receive ESK-001 or placebo daily for 12 weeks. An open label extension study will be available for those patients who complete the study.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Total body weight >40 kg (88 lb)
  • Men and woman age 18-75
  • Men and Women must use highly effective methods of contraception for the entirety of the study

Exclusion criteria

  • History of malignancy within the last 5 years
  • Positive for HIV, Hepatitis B or C
  • History of tuberculosis
  • Diagnosis of non-plaque psoriasis
  • Patients with QTcF >450 msec (males) or >470 msec (females) at screening
  • Live vaccines

Treatment and study plan

ESK-001

Drug

Oral tablet

Placebo

Drug

Oral tablet

Primary outcomes

  1. To Compare the Psoriasis Area and Severity Index (PASI-75) Between Doses of ESK-001 and Placebo

    Time frame: 12 weeks

    Proportion of patients with moderate to severe psoriasis achieving ≥75% reduction in PASI score

Secondary outcomes

  1. To Assess the Safety and Tolerability of ESK-001 Dose in Moderate to Severe Psoriasis Patients

    Time frame: 12 weeks

    Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs). See Adverse Events section.

  2. To Assess the Response Rate in Static Physician's Global Assessment (sPGA) Score

    Time frame: 12 weeks

    Proportion of patients achieving an sPGA score of "0" ("cleared") or "1" ("minimal")

  3. To Characterize the Pharmacokinetics (PK) of ESK-001

    Time frame: 14 weeks

    Plasma concentrations and PK parameters of ESK-001.

Sponsors and collaborators

Lead sponsor

Alumis Inc

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Moderate to Severe Plaque Psoriasis

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 31, 2022
Registry last updated
Jun 18, 2025

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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