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

Phase 2

Completed

• Conditions: Plaque Psoriasis
• Interventions: Drug: ESK-001; Drug: Placebo

• Registration Number: NCT05600036
• Lead Sponsor: Alumis Inc

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2022-09-27
• Study First Submitted: 2022-10-12
• Study First Submitted QC: 2022-10-27
• Study First Posted: 2022-10-31
• Primary Completion: 2023-06-29
• Study Completion: 2023-07-25
• Status Verified: 2024-06
• Results First Submitted: 2024-06-26
• Results First Submitted QC: 2024-06-26
• Last Update Submitted: 2024-06-26
• Results First Posted: 2024-07-23
• Last Update Posted: 2024-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 228

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ESK-001 Dose Level 1	ESK-001	ESK-001 administered as an oral tablet
Placebo	Placebo	Placebo administered as an oral tablet
ESK-001 Dose Level 3	ESK-001	ESK-001 administered as an oral tablet
ESK-001 Dose Level 5	ESK-001	ESK-001 administered as an oral tablet
ESK-001 Dose Level 2	ESK-001	ESK-001 administered as an oral tablet
ESK-001 Dose Level 4	ESK-001	ESK-001 administered as an oral tablet

Primary Outcome Measures

Name	Time	Method
To Compare the Psoriasis Area and Severity Index (PASI-75) Between Doses of ESK-001 and Placebo	12 weeks	Proportion of patients with moderate to severe psoriasis achieving ≥75% reduction in PASI score

Secondary Outcome Measures

Name	Time	Method
To Assess the Safety and Tolerability of ESK-001 Dose in Moderate to Severe Psoriasis Patients	12 weeks	Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs). See Adverse Events section.
To Assess the Response Rate in Static Physician's Global Assessment (sPGA) Score	12 weeks	Proportion of patients achieving an sPGA score of "0" ("cleared") or "1" ("minimal")
To Characterize the Pharmacokinetics (PK) of ESK-001	14 weeks	Plasma concentrations and PK parameters of ESK-001.

Trial Locations

Locations (53)

Investigator Site #1035; 🇺🇸 Macon, Georgia, United States

Investigator Site #1017; 🇺🇸 Owensboro, Kentucky, United States

Investigator Site #1031; 🇺🇸 New Brighton, Minnesota, United States

Investigator Site #2009; 🇨🇦 Toronto, Ontario, Canada

Investigator Site # 1015; 🇺🇸 Houston, Texas, United States

Investigator Site #1016; 🇺🇸 San Diego, California, United States

Investigator Site #1042; 🇺🇸 Tampa, Florida, United States

Investigator Site #1034; 🇺🇸 Louisville, Kentucky, United States

Investigator Site #1006; 🇺🇸 San Antonio, Texas, United States

Investigator Site #2003; 🇨🇦 Winnipeg, Manitoba, Canada

Investigator Site #1036; 🇺🇸 Overland Park, Kansas, United States

Investigator Site #1033; 🇺🇸 Oklahoma City, Oklahoma, United States

Investigator Site # 1001; 🇺🇸 Phoenix, Arizona, United States

Investigator Site #2010; 🇨🇦 Quebec City, Quebec, Canada

Investigator Site #1025; 🇺🇸 Hialeah, Florida, United States

Investigator Site #1029; 🇺🇸 Birmingham, Alabama, United States

Investigator Site #1021; 🇺🇸 Encinitas, California, United States

Investigator Site #1024; 🇺🇸 Los Angeles, California, United States

Investigator Site # 1008; 🇺🇸 Fremont, California, United States

Investigator Site #1039; 🇺🇸 Brandon, Florida, 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 #1013; 🇺🇸 Brandon, Florida, United States

Investigator Site #1030; 🇺🇸 Fort Lauderdale, Florida, United States

Investigator Site #1028; 🇺🇸 Miami, Florida, United States

Investigator Site #1043; 🇺🇸 Sandy Springs, Georgia, United States

Investigator Site #1011; 🇺🇸 Indianapolis, Indiana, United States

Investigator Site # 1005; 🇺🇸 Rolling Meadows, Illinois, United States

Investigator Site #1027; 🇺🇸 South Bend, Indiana, United States

Investigator Site #1026; 🇺🇸 Rockville, Maryland, United States

Investigator Site #1009; 🇺🇸 Bay City, Michigan, United States

Investigator Site #1038; 🇺🇸 Warren, Michigan, United States

Investigator Site #1014; 🇺🇸 Las Vegas, Nevada, United States

Investigator Site # 1010; 🇺🇸 Clarkston, Michigan, United States

Investigator Site # 1019; 🇺🇸 Portland, Oregon, United States

Investigator Site #1022; 🇺🇸 Philadelphia, Pennsylvania, United States

Investigator Site #1012; 🇺🇸 Rapid City, South Dakota, United States

Investigator Site #2001; 🇨🇦 Edmonton, Alberta, Canada

Investigator Site #1041; 🇺🇸 South Jordan, Utah, United States

Investigator Sie #2008; 🇨🇦 Surrey, British Columbia, Canada

Investigator Site #2004; 🇨🇦 Mississauga, Ontario, Canada

Investigator Site #2005; 🇨🇦 Oakville, Ontario, Canada

Investigator Site #2002; 🇨🇦 Waterloo, Ontario, Canada

Investigator Site #5515; 🇨🇿 Svitavy, Pardubice, Czechia

Investigator Site #5514; 🇨🇿 Pardubice, Czechia

Investigator Site #5506; 🇨🇿 Praha 10, Czechia

Investigator Site #5507; 🇨🇿 Novy Jicin, Czechia

Investigator Site #5505; 🇨🇿 Praha 10, Czechia

Investigator Site #1023; 🇺🇸 Rogers, Arkansas, United States

Investigator Site #2007; 🇨🇦 North Bay, Ontario, Canada

Investigator Site #2006; 🇨🇦 London, Ontario, Canada

Investigator Site #1037; 🇺🇸 Portsmouth, New Hampshire, United States