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

NCT05600036 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: ESK-001-006
• Study Type: interventional
• Target: 228
• Locations: 3 countries
• Sites: 53

Brief Summary

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

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• 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

  12 weeks

Secondary Outcomes (3)

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

  12 weeks

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

  12 weeks

• To Characterize the Pharmacokinetics (PK) of ESK-001

  14 weeks

Study Arms (6)

ESK-001 Dose Level 1

EXPERIMENTAL

ESK-001 administered as an oral tablet

Drug: ESK-001

ESK-001 Dose Level 2

EXPERIMENTAL

ESK-001 administered as an oral tablet

Drug: ESK-001

ESK-001 Dose Level 3

EXPERIMENTAL

ESK-001 administered as an oral tablet

Drug: ESK-001

ESK-001 Dose Level 4

EXPERIMENTAL

ESK-001 administered as an oral tablet

Drug: ESK-001

ESK-001 Dose Level 5

EXPERIMENTAL

ESK-001 administered as an oral tablet

Drug: ESK-001

Placebo

PLACEBO COMPARATOR

Placebo administered as an oral tablet

Drug: Placebo

Interventions

ESK-001 DRUG

Oral tablet

ESK-001 Dose Level 1; ESK-001 Dose Level 2; ESK-001 Dose Level 3; ESK-001 Dose Level 4; ESK-001 Dose Level 5

Placebo DRUG

Oral tablet

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alumis Inc: lead

Study Sites (53)

Investigator Site #1029

Birmingham, Alabama, 35205, United States

Location

Investigator Site # 1001

Phoenix, Arizona, 85032, United States

Location

Investigator Site #1023

Rogers, Arkansas, 72758, United States

Location

Investigator Site #1021

Encinitas, California, 92024, United States

Location

Investigator Site # 1008

Fremont, California, 94538, United States

Location

Investigator Site #1024

Los Angeles, California, 90033, United States

Location

Investigator Site # 1018

Los Angeles, California, 90045, United States

Location

Investigator Site #1016

San Diego, California, 92123, United States

Location

Investigator Site # 1007

Santa Monica, California, 90404, United States

Location

Investigator Site # 1002

Sherman Oaks, California, 91403, United States

Location

Investigator Site #1039

Brandon, Florida, 33511, United States

Location

Investigator Site #1013

Brandon, Florida, 33756, United States

Location

Investigator Site #1030

Fort Lauderdale, Florida, 33308, United States

Location

Investigator Site #1025

Hialeah, Florida, 33012, United States

Location

Investigator Site #1028

Miami, Florida, 33175, United States

Location

Investigator Site #1042

Tampa, Florida, 33613, United States

Location

Investigator Site #1035

Macon, Georgia, 31217, United States

Location

Investigator Site #1043

Sandy Springs, Georgia, 30328, United States

Location

Investigator Site # 1005

Rolling Meadows, Illinois, 60008, United States

Location

Investigator Site #1011

Indianapolis, Indiana, 46250, United States

Location

Investigator Site #1027

South Bend, Indiana, 46617, United States

Location

Investigator Site #1036

Overland Park, Kansas, 66210, United States

Location

Investigator Site #1034

Louisville, Kentucky, 40241, United States

Location

Investigator Site #1017

Owensboro, Kentucky, 42303, United States

Location

Investigator Site #1026

Rockville, Maryland, 20850, United States

Location

Investigator Site #1009

Bay City, Michigan, 48706, United States

Location

Investigator Site # 1010

Clarkston, Michigan, 48346, United States

Location

Investigator Site #1038

Warren, Michigan, 48088, United States

Location

Investigator Site #1031

New Brighton, Minnesota, 55112, United States

Location

Investigator Site #1014

Las Vegas, Nevada, 89148, United States

Location

Investigator Site #1037

Portsmouth, New Hampshire, 03801, United States

Location

Investigator Site #1033

Oklahoma City, Oklahoma, 73170, United States

Location

Investigator Site # 1019

Portland, Oregon, 97223, United States

Location

Investigator Site #1022

Philadelphia, Pennsylvania, 19103, United States

Location

Investigator Site #1012

Rapid City, South Dakota, 57702, United States

Location

Investigator Site # 1015

Houston, Texas, 77056, United States

Location

Investigator Site #1006

San Antonio, Texas, 78213, United States

Location

Investigator Site #1041

South Jordan, Utah, 84095, United States

Location

Investigator Site #2001

Edmonton, Alberta, T6G 1C3, Canada

Location

Investigator Sie #2008

Surrey, British Columbia, V3V 0C6, Canada

Location

Investigator Site #2003

Winnipeg, Manitoba, R3M 3Z4, Canada

Location

Investigator Site #2006

London, Ontario, N6H 5L5, Canada

Location

Investigator Site #2004

Mississauga, Ontario, L4Y 4C5, Canada

Location

Investigator Site #2007

North Bay, Ontario, P1B 3Z7, Canada

Location

Investigator Site #2005

Oakville, Ontario, L6J 7W5, Canada

Location

Investigator Site #2009

Toronto, Ontario, M3H 5Y8, Canada

Location

Investigator Site #2002

Waterloo, Ontario, N2J 1C4, Canada

Location

Investigator Site #2010

Québec, Quebec, G1V 4X7, Canada

Location

Investigator Site #5515

Svitavy, Pardubice, 568 02, Czechia

Location

Investigator Site #5507

Nový Jičín, 741 01, Czechia

Location

Investigator Site #5514

Pardubice, 530 02, Czechia

Location

Investigator Site #5506

Prague, 100 00, Czechia

Location

Investigator Site #5505

Prague, 100 34, Czechia

Location

Results Point of Contact

• Title: SVP, Development Operations
• Organization: Alumis Inc.

clinicaltrials@alumis.com

(650) 231-6625

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: October 31, 2022
• Study Start: September 27, 2022
• Primary Completion: June 29, 2023
• Study Completion: July 25, 2023
• Last Updated: June 18, 2025
• Results First Posted: July 23, 2024

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (5); CA (10); US (38)