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

Alumis

Status and phase

Completed

Phase 2

Conditions

Plaque Psoriasis

Treatments

Drug: ESK-001

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT05600036

ESK-001-006

Details and patient eligibility

About

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

Full description

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.

Enrollment

228 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

228 participants in 6 patient groups, including a placebo group

ESK-001 Dose Level 1

Experimental group

Description: