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

Phase 2Active Not RecruitingNCT05739435

Alumis Inc165 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

165

Conditions

Plaque Psoriasis

Interventions

envudeucitinibDRUG

Oral tablet

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (38)

Outcomes

Primary Outcomes

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

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

Time frame: Approximately 3 years

Secondary Outcomes

To assess the long-term efficacy of ESK-001

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

Time frame: Approximately 3 years

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

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

Time frame: Approximately 3 years

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

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

Time frame: 2 years

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 #1018

Los Angeles, California, United States

Investigator Site #1007

Santa Monica, California, United States

Investigator Site #1002

Sherman Oaks, California, United States

Investigator site # 1030

Fort Lauderdale, Florida, United States

Investigator Site #1025

Hialeah, Florida, United States

Investigator site # 1028

Miami, Florida, United States

...and 28 more locations