Long-term Safety and Efficacy of ESK-001 in Moderate to Severe Plaque Psoriasis
Public ClinicalTrials.gov record NCT06846541. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Extension Study in Patients With Moderate to Severe Plaque Psoriasis to Evaluate the Long-term Safety, Efficacy, and Durability of Response to ESK-001
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06846541
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,680 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 8, 2025 (Actual)
- Primary completion
- Nov 2028 (Estimated)
- Completion
- Nov 2028 (Estimated)
- Last update posted
- Apr 13, 2026
2025 – 2028
United States locations
- U.S. sites
- 92
- U.S. states
- 25
- U.S. cities
- 82
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Total Dermatology | Birmingham | Alabama | 35203 | — |
| Chandler Clinical Trials | Chandler | Arizona | 85224 | — |
| Alliance Dermatology | Pheonix | Arizona | 85032 | — |
| Scottsdale Clinical Trials | Scottsdale | Arizona | 85260 | — |
| Noble Clinical Research | Tucson | Arizona | 85704 | — |
| Northwest AR Clinical Trials Center PLLC | Rogers | Arkansas | 72758 | — |
| Zenith Research Inc. | Beverly Hills | California | 90212 | — |
| Exalt Clinical Research Inc | Chula Vista | California | 91910 | — |
| California Dermatology and Clinical Research Institute | Encinitas | California | 92024 | — |
| Raoof MD | Encino | California | 91436 | — |
| First OC Dermatology Research Inc | Fountain Valley | California | 92708 | — |
| Marvel Clinical Research LLC | Huntington Beach | California | 92647 | — |
| Long Beach Research Institute | Long Beach | California | 90805 | — |
| Olive View UCLA Education and Research Institute | Los Angeles | California | 90024 | — |
| Dermatology Research Associates | Los Angeles | California | 90045 | — |
| Wallace Medical Group Inc | Los Angeles | California | 90056 | — |
| Northridge Clinical Trials | Northridge | California | 91325 | — |
| Pasadena Clinical Trials | Pasadena | California | 91101 | — |
| Empire Clinical Research Pomona | Pomona | California | 91767 | — |
| Integrative Skin Science and Research | Sacramento | California | 95815 | — |
| Therapeutics Clinical Research | San Diego | California | 92123 | — |
| Southern California Clinical Research | Santa Ana | California | 92701 | — |
| Clinical Science Institute Dermatology Institute | Santa Monica | California | 90404 | — |
| Unison Clinical Trials | Sherman Oaks | California | 91403 | — |
| California Dermatology Institute Thousand Oaks | Thousand Oaks | California | 91320 | — |
| Sunwise Clinical Research LLC | Walnut Creek | California | 94596 | — |
| Clearlyderm Dermatology West Boca Raton | Boca Raton | Florida | 33428 | — |
| Driven Clinical Research | Coral Gables | Florida | 33134 | — |
| FXM Clinical Research Ft. Lauderdale LLC | Fort Lauderdale | Florida | 33308 | — |
| Direct Helpers Research Center | Hialeah | Florida | 33012 | — |
| Jacksonville Center for Clinical Research | Jacksonville | Florida | 32216 | — |
| Glick Skin Institute | Margate | Florida | 33063 | — |
| AppleMed Research Group | Miami | Florida | 33126 | — |
| FAX Pharma Clinical Research Inc | Miami | Florida | 33146 | — |
| FXM Clinical Research Miami LLC | Miami | Florida | 33175 | — |
| Las Mercedes Medical Research | Miami | Florida | 33196 | — |
| Procare Research Center | Miami Gardens | Florida | 33014 | — |
| San Marcus Research Clinic Inc - Miami | Miami Lakes | Florida | 33014 | — |
| Savin Medical Group LLC | Miami Lakes | Florida | 33014 | — |
| FXM Clinical Research Miramar LLC | Miramar | Florida | 33027 | — |
| Oceanic Research Group | North Miami Beach | Florida | 33169 | — |
| Renstar Medical Research | Ocala | Florida | 34470 | — |
| Lenus Research and Medical Group LLC | Sweetwater | Florida | 33172 | — |
| Advanced Clinical Research Institute | Tampa | Florida | 33607 | — |
| ForCare Medical Center | Tampa | Florida | 33613 | — |
| Arlington Dermatology | Rolling Meadows | Illinois | 60008 | — |
| NorthShore Medical Group Dermatology Skokie | Skokie | Illinois | 60077 | — |
| Dundee Dermatology | West Dundee | Illinois | 60118 | — |
| DS Research of Southern Indiana | Clarksville | Indiana | 47129 | — |
| Dawes Fretzin Clinical Research Group | Columbus | Indiana | 47201 | — |
| The Indiana Clinical Trials Center | Plainfield | Indiana | 46168 | — |
| The South Bend Clinic | South Bend | Indiana | 46617 | — |
| Equity Medical | Bowling Green | Kentucky | 42104 | — |
| DS Research of Kentucky | Louisville | Kentucky | 40241 | — |
| Velocity Clinical Research | Baton Rouge | Louisiana | 70808 | — |
| Tulane University School of Medicine | New Orleans | Louisiana | 70112 | — |
| MetroBoston Clinical Partners | Brighton | Massachusetts | 02135 | — |
| Michigan Center for Research Company | Clarkston | Michigan | 48346 | — |
| Henry Ford Medical Center Farmington | Detroit | Michigan | 48202 | — |
| Revival Research Institute | Troy | Michigan | 48084 | — |
| Grekin Skin Institute | Warren | Michigan | 48088 | — |
| Associated Skin Care Specialists Minnesota Clinical Study Center | New Brighton | Minnesota | 55112 | — |
| Cleaver Dermatology | Kirksville | Missouri | 63501 | — |
| Schlessinger MD | Omaha | Nebraska | 68144 | — |
| Las Vegas Clinical Trials | Las Vegas | Nevada | 89030 | — |
| NYC Health and Hospitals Elmhurst | Elmhurst | New York | 11373 | — |
| Pioneer Clinical Research NY | New York | New York | 10016 | — |
| Cameron Dermatology | New York | New York | 10023 | — |
| OptiSkin | New York | New York | 10128 | — |
| DermResearchCenter of New York | Stony Brook | New York | 11790 | — |
| Asheville Clinical Trials | Asheville | North Carolina | 28803 | — |
| WDC Cosmetic and Research | Wilmington | North Carolina | 28405 | — |
| Optima Research Boardman | Boardman | Ohio | 44512 | — |
| The Ohio State University Wexner Medical Center OSUWMC OSU Dermatology East Columbus | Gahanna | Ohio | 43230 | — |
| Dermatologists of Southwestern Ohio LLC | Mason | Ohio | 45040 | — |
| Unity Clinical Research UCR | Oklahoma City | Oklahoma | 73118 | — |
| Velocity Clinical Research | Medford | Oregon | 97504 | — |
| Oregon Medical Research Center | Portland | Oregon | 97201 | — |
| Paddington Testing Company Inc | Philadelphia | Pennsylvania | 19103 | — |
| UPMC Department of Dermatology | Pittsburgh | Pennsylvania | 15213 | — |
| Clinical Partners LLC | Johnston | Rhode Island | 02919 | — |
| Studies in Dermatology LLC | Cypress | Texas | 77433 | — |
| Modern Research Associates PLLC | Dallas | Texas | 75231 | — |
| Reveal Research Institute | Frisco | Texas | 75033 | — |
| Center for Clinical Studies Texas Medical Center | Houston | Texas | 77004 | — |
| Austin Institute for Clinical Research | Houston | Texas | 77056 | — |
| SMS Clinical Research | Mesquite | Texas | 75149 | — |
| Progressive Clinical Research San Antonio | San Antonio | Texas | 78213 | — |
| Center for Clinical Studies (CCS) - Webster/Clear Lake Location | Webster | Texas | 77598 | — |
| University of Utah Health Care Midvalley Health Center | Murray | Utah | 84107 | — |
| Jordan Valley Dermatology | South Jordan | Utah | 84095 | — |
| Frontier Dermatology | Mill Creek | Washington | 98012 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 176 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06846541, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 13, 2026 · Synced Oct 30, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06846541 live on ClinicalTrials.gov.