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

Alumis Inc228 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

228

Conditions

Plaque Psoriasis

Interventions

ESK-001DRUG

Oral tablet

PlaceboDRUG

Oral tablet

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (53)

Outcomes

Primary Outcomes

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

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

Time frame: 12 weeks

Secondary Outcomes

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

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

Time frame: 12 weeks

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

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

Time frame: 12 weeks

To Characterize the Pharmacokinetics (PK) of ESK-001

Plasma concentrations and PK parameters of ESK-001.

Time frame: 14 weeks

Data from ClinicalTrials.gov

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Investigator Site #1029

Birmingham, Alabama, United States

Investigator Site # 1001

Phoenix, Arizona, United States

Investigator Site #1023

Rogers, Arkansas, United States

Investigator Site #1021

Encinitas, California, United States

Investigator Site # 1008

Fremont, California, United States

Investigator Site #1024

Los Angeles, California, United States

Investigator Site # 1018

Los Angeles, California, United States

Investigator Site #1016

San Diego, California, United States

Investigator Site # 1007

Santa Monica, California, United States

Investigator Site # 1002

Sherman Oaks, California, United States

...and 43 more locations