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Long-term Safety and Efficacy of ESK-001 in Moderate to Severe Plaque Psoriasis
NCT06846541 · View on ClinicalTrials.gov ↗
Study Summary
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 Studied
Interventions
- DRUG Placebo
- DRUG Open-Label ESK-001
- DRUG Blinded ESK-001
Study Locations (20)
California
- Zenith Research Inc. — Beverly Hills
- Exalt Clinical Research Inc — Chula Vista
- California Dermatology and Clinical Research Institute — Encinitas
- Raoof MD — Encino
- First OC Dermatology Research Inc — Fountain Valley
- Marvel Clinical Research LLC — Huntington Beach
- Long Beach Research Institute — Long Beach
- Olive View UCLA Education and Research Institute — Los Angeles
- Dermatology Research Associates — Los Angeles
- Wallace Medical Group Inc — Los Angeles
- Northridge Clinical Trials — Northridge
- Pasadena Clinical Trials — Pasadena
- Empire Clinical Research Pomona — Pomona
- Integrative Skin Science and Research — Sacramento
Arizona
- Chandler Clinical Trials — Chandler
- Alliance Dermatology — Pheonix
- Scottsdale Clinical Trials — Scottsdale
- Noble Clinical Research — Tucson
Alabama
- Total Dermatology — Birmingham
Arkansas
- Northwest AR Clinical Trials Center PLLC — Rogers
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,680 participants |
| Start Date | 2025-01-08 |
| Est. Completion | 2028-11 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06846541
The ClinicalTrials.gov registry entry for NCT06846541 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,680 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alumis, which has 34 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 5 conditions, with Psoriasis appearing as the primary indexed condition, and to 3 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06846541 reports 20 study locations spanning 4 distinct geographic areas — top geographies include California, Arizona, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06846541 about?
NCT06846541 is a clinical study titled "Long-term Safety and Efficacy of ESK-001 in Moderate to Severe Plaque Psoriasis". 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 sev...
What is the current status of trial NCT06846541?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,680 participants. The study started on 2025-01-08. Estimated completion is 2028-11.
What conditions does trial NCT06846541 study?
This clinical trial studies the following conditions: Psoriasis, Plaque Psoriasis, Psoriasis (PsO), Moderate Psoriasis, Severe Psoriasis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06846541?
The interventions under investigation include: Placebo (DRUG), Open-Label ESK-001 (DRUG), Blinded ESK-001 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06846541?
This trial is sponsored by Alumis, which has 34 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06846541 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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