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NCT06846541 · ClinicalTrials.gov registry record · Phase 3
Long-term Safety and Efficacy of ESK-001 in Moderate to Severe Plaque Psoriasis
A Phase 3 study of Psoriasis and Plaque Psoriasis, sponsored by Alumis.
- Active
- Registry status
- Phase 3
- Development phase
- 1,680
- Enrollment target
- 20
- Study locations
NCT06846541: Active Phase 3 study of Psoriasis and Plaque Psoriasis, sponsored by Alumis.
NCT06846541 is a Phase 3 study of Psoriasis and Plaque Psoriasis that is active but no longer recruiting, run by Alumis. The registered enrollment target is 1,680 participants, above the 475-participant average among 125 other Psoriasis trials with a reported enrollment target (254% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06846541, a Phase 3 study of Psoriasis and Plaque Psoriasis, is active but no longer recruiting, sponsored by Alumis.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,680 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Incidence and severity of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
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 |
What the registry record for NCT06846541 still lists
NCT06846541 is an interventional study that assigns participants to a tested intervention. Its 1,680 participants enrollment target places it among the larger protocols in the corpus, above the 475-participant average among 125 other Psoriasis trials with a reported enrollment target (254% higher).
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.
NCT06846541 names 20 study sites across 4 states, led by California, Arizona, Alabama.
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.
What interventions are being tested in trial NCT06846541?
The interventions under investigation include: Placebo (DRUG), Open-Label ESK-001 (DRUG), Blinded ESK-001 (DRUG).
Who is sponsoring clinical trial NCT06846541?
This trial is sponsored by Alumis, which has 13 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Psoriasis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06846541's enrollment target sits among peer trials
1,680 5th of 125 higher than 121 of 125 other Psoriasis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Psoriasis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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