Long-term Safety and Efficacy of ESK-001 in Moderate to Severe Plaque Psoriasis

Purpose

The objective of the ESK-001-018 long term extension is to evaluate the safety and efficacy of ESK-001 over time. The scientific questions it aims to answer are: - How safe is taking ESK-001 long-term in people with moderate to severe plaque psoriasis? - Does taking ESK-001 long-term reduce the severity of people's plaque psoriasis? Patients will enter the long-term extension study following completion of one of the parent studies (ESK-001-016 or ESK-001-017) and will receive open-label ESK-001 twice daily for 24 weeks. After 24 weeks, the first 200 patients meeting at least PASI-75 clinical response will be randomly assigned to receive ESK-001 or placebo. At any point during this time, the patients losing the initial clinical response may return to the open-label ESK-001 treatment. Patients who complete Week 48 will return to open-label ESK-001 treatment and they will receive ESK-001 until the end of the study or discontinuation. All the remaining patients not meeting the entry criteria for the randomized withdrawal phase will continue to receive open-label ESK-001 for the remainder of the study. Patients taking part in the study must be men or women aged at least 18 years old and have completed a previous (parent) study of ESK-001 in moderate to severe plaque psoriasis. Patients must consent and agree to: - ensure drug daily compliance until end of study or discontinuation. - visit the clinic for checkups and assessments. - provide blood and urine samples.

Conditions

  • Plaque Psoriasis
  • Psoriasis (PsO)
  • Psoriasis
  • Moderate Psoriasis
  • Severe Psoriasis

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Males or females, age ≥18 years 2. Completed either of the two previous (parent) studies of ESK-001 (ESK-001-016 or ESK-001-017) 3. ESK-001 safety and tolerability were acceptable in the parent study 4. Women of childbearing potential (WOCBP) and males who are sexually active with WOCBP must agree to adhere to highly effective methods of contraception for the entirety of the study

Exclusion Criteria

  1. Pregnant, lactating, or planning to get pregnant during the study period 2. Any acute or chronic illness/condition or evidence of an unstable clinical condition that in the Investigator's judgment will substantially increase the risk to the patient if they continue to receive ESK-001 treatment in this extension study 3. Deemed by the Investigator to be inappropriate for the study or unable to comply with the protocol

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Open-Label ESK-001 		Open-Label ESK-001 administered as an oral tablet
  • Drug: Open-Label ESK-001
    Open-Label ESK-001
Experimental
Blinded ESK-001 		Blinded ESK-001 administered as an oral tablet
  • Drug: Blinded ESK-001
    Blinded ESK-001 during Randomized Treatment Withdrawal Period
Placebo Comparator
Placebo 		Matching placebo administered as an oral tablet
  • Drug: Placebo
    Placebo during Randomized Treatment Withdrawal Period

Recruiting Locations

Total Dermatology
Birmingham 4049979, Alabama 4829764 35203

Chandler Clinical Trials
Chandler 5289282, Arizona 5551752 85224

Alliance Dermatology
Pheonix, Arizona 5551752 85032

Scottsdale Clinical Trials
Scottsdale 5313457, Arizona 5551752 85260

Noble Clinical Research
Tucson 5318313, Arizona 5551752 85704

Northwest AR Clinical Trials Center PLLC
Rogers 4128894, Arkansas 4099753 72758

Zenith Research Inc.
Beverly Hills 5328041, California 5332921 90212

Exalt Clinical Research Inc
Chula Vista 5336899, California 5332921 91910

California Dermatology and Clinical Research Institute
Encinitas 5346646, California 5332921 92024

Raoof MD
Encino 5346649, California 5332921 91436

First OC Dermatology Research Inc
Fountain Valley 5350207, California 5332921 92708

Marvel Clinical Research LLC
Huntington Beach 5358705, California 5332921 92647

Long Beach Research Institute
Long Beach 5367929, California 5332921 90805

Olive View UCLA Education and Research Institute
Los Angeles 5368361, California 5332921 90024

Dermatology Research Associates
Los Angeles 5368361, California 5332921 90045

Wallace Medical Group Inc
Los Angeles 5368361, California 5332921 90056

Northridge Clinical Trials
Northridge 5377985, California 5332921 91325

Pasadena Clinical Trials
Pasadena 5381396, California 5332921 91101

Empire Clinical Research Pomona
Pomona 5384170, California 5332921 91767

Integrative Skin Science and Research
Sacramento 5389489, California 5332921 95815

Therapeutics Clinical Research
San Diego 5391811, California 5332921 92123

Southern California Clinical Research
Santa Ana 5392900, California 5332921 92701

Clinical Science Institute Dermatology Institute
Santa Monica 5393212, California 5332921 90404

Unison Clinical Trials
Sherman Oaks 5395244, California 5332921 91403

California Dermatology Institute Thousand Oaks
Thousand Oaks 5402405, California 5332921 91320

Sunwise Clinical Research LLC
Walnut Creek 5406990, California 5332921 94596

Clearlyderm Dermatology West Boca Raton
Boca Raton 4148411, Florida 4155751 33428

Driven Clinical Research
Coral Gables 4151871, Florida 4155751 33134

FXM Clinical Research Ft. Lauderdale LLC
Fort Lauderdale 4155966, Florida 4155751 33308

Direct Helpers Research Center
Hialeah 4158476, Florida 4155751 33012

Jacksonville Center for Clinical Research
Jacksonville 4160021, Florida 4155751 32216

Glick Skin Institute
Margate 4163407, Florida 4155751 33063

AppleMed Research Group
Miami 4164138, Florida 4155751 33126

FAX Pharma Clinical Research Inc
Miami 4164138, Florida 4155751 33146

FXM Clinical Research Miami LLC
Miami 4164138, Florida 4155751 33175

Las Mercedes Medical Research
Miami 4164138, Florida 4155751 33196

Procare Research Center
Miami Gardens 4164167, Florida 4155751 33014

San Marcus Research Clinic Inc - Miami
Miami Lakes 4164186, Florida 4155751 33014

Savin Medical Group LLC
Miami Lakes 4164186, Florida 4155751 33014

FXM Clinical Research Miramar LLC
Miramar 4164601, Florida 4155751 33027

Oceanic Research Group
North Miami Beach 4166233, Florida 4155751 33169

Renstar Medical Research
Ocala 4166673, Florida 4155751 34470

Lenus Research and Medical Group LLC
Sweetwater 4174600, Florida 4155751 33172

Advanced Clinical Research Institute
Tampa 4174757, Florida 4155751 33607

ForCare Medical Center
Tampa 4174757, Florida 4155751 33613

Arlington Dermatology
Rolling Meadows 4908052, Illinois 4896861 60008

NorthShore Medical Group Dermatology Skokie
Skokie 4911600, Illinois 4896861 60077

Dundee Dermatology
West Dundee 4915977, Illinois 4896861 60118

DS Research of Southern Indiana
Clarksville 4255836, Indiana 4921868 47129

Dawes Fretzin Clinical Research Group
Columbus 4256038, Indiana 4921868 47201

The Indiana Clinical Trials Center
Plainfield 4263108, Indiana 4921868 46168

The South Bend Clinic
South Bend 4926563, Indiana 4921868 46617

Equity Medical
Bowling Green 4285268, Kentucky 6254925 42104

DS Research of Kentucky
Louisville 4299276, Kentucky 6254925 40241

Velocity Clinical Research
Baton Rouge 4315588, Louisiana 4331987 70808

Tulane University School of Medicine
New Orleans 4335045, Louisiana 4331987 70112

MetroBoston Clinical Partners
Brighton 4931353, Massachusetts 6254926 02135

Michigan Center for Research Company
Clarkston 4988997, Michigan 5001836 48346

Henry Ford Medical Center Farmington
Detroit 4990729, Michigan 5001836 48202

Revival Research Institute
Troy 5012639, Michigan 5001836 48084

Grekin Skin Institute
Warren 5014051, Michigan 5001836 48088

Associated Skin Care Specialists Minnesota Clinical Study Center
New Brighton 5039080, Minnesota 5037779 55112

Cleaver Dermatology
Kirksville 5055787, Missouri 4398678 63501

Schlessinger MD
Omaha 5074472, Nebraska 5073708 68144

Las Vegas Clinical Trials
Las Vegas 5506956, Nevada 5509151 89030

NYC Health and Hospitals Elmhurst
Elmhurst 5116495, New York 5128638 11373

Pioneer Clinical Research NY
New York 5128581, New York 5128638 10016

Cameron Dermatology
New York 5128581, New York 5128638 10023

OptiSkin
New York 5128581, New York 5128638 10128

DermResearchCenter of New York
Stony Brook 5139865, New York 5128638 11790

Asheville Clinical Trials
Asheville 4453066, North Carolina 4482348 28803

WDC Cosmetic and Research
Wilmington 4499379, North Carolina 4482348 28405

Optima Research Boardman
Boardman 5147784, Ohio 5165418 44512

The Ohio State University Wexner Medical Center OSUWMC OSU Dermatology East Columbus
Gahanna 5155393, Ohio 5165418 43230

Dermatologists of Southwestern Ohio LLC
Mason 4517698, Ohio 5165418 45040

Unity Clinical Research UCR
Oklahoma City 4544349, Oklahoma 4544379 73118

Velocity Clinical Research
Medford 5740099, Oregon 5744337 97504

Oregon Medical Research Center
Portland 5746545, Oregon 5744337 97201

Paddington Testing Company Inc
Philadelphia 4560349, Pennsylvania 6254927 19103

UPMC Department of Dermatology
Pittsburgh 5206379, Pennsylvania 6254927 15213

Clinical Partners LLC
Johnston 8604682, Rhode Island 5224323 02919

Studies in Dermatology LLC
Cypress 4684724, Texas 4736286 77433

Modern Research Associates PLLC
Dallas 4684888, Texas 4736286 75231

Reveal Research Institute
Frisco 4692559, Texas 4736286 75033

Center for Clinical Studies Texas Medical Center
Houston 4699066, Texas 4736286 77004

Austin Institute for Clinical Research
Houston 4699066, Texas 4736286 77056

SMS Clinical Research
Mesquite 4710826, Texas 4736286 75149

Progressive Clinical Research San Antonio
San Antonio 4726206, Texas 4736286 78213

Center for Clinical Studies (CCS) - Webster/Clear Lake Location
Webster 4740423, Texas 4736286 77598

University of Utah Health Care Midvalley Health Center
Murray 5778755, Utah 5549030 84107

Jordan Valley Dermatology
South Jordan 5781770, Utah 5549030 84095

Frontier Dermatology
Mill Creek 5803457, Washington 5815135 98012

Centro Reumatologico de Cagus
Caguas 4563008, Puerto Rico, Puerto Rico 00725

Ponce Medical School Foundation Inc
Ponce 4566880, Puerto Rico, Puerto Rico 00716

Clinical Research Puerto Rico
San Juan 4568127, Puerto Rico, Puerto Rico 00909

GCM Medical Group PSC Hato Rey Site
San Juan 4568127, Puerto Rico 00917

More Details

NCT ID
NCT06846541
Status
Recruiting
Sponsor
Alumis Inc

Study Contact

Alumis Information
(650) 231-6625
clinicaltrials@alumis.com

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center