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ACTIVE NOT RECRUITING Phase 3

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

NCT06586112 · View on ClinicalTrials.gov ↗

Study Summary

The goal of this clinical trial is to learn if ESK-001 works to treat moderate to severe plaque psoriasis. The main questions it aims to answer are: * Does ESK-001 reduce the severity of people's psoriasis? * How safe is ESK-001 in people with moderate to severe plaque psoriasis? The study includes 2 comparators: a placebo control (a 'dummy' tablet that does not contain the medicine ESK-001 but looks just like it) and an active control (apremilast, which is a medicine approved to treat psoriasis). People taking part in this study must be men or women aged at least 18 years and have had plaque psoriasis for at least 6 months, currently moderate to severe. Participants will: * take drug every day for 24 weeks. * visit the clinic for checkups and tests. * fill out questionnaires about their psoriasis, itch severity, and change in quality of life. * be assessed for health issues and side effects, physical examinations, vital signs, heart electrical activity measurements, and psychological health. * provide blood and urine samples.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG ESK-001
  • DRUG Apremilast

Study Locations (20)

California

  • Exalt Clinical Research — Chula Vista
  • California Dermatology & Clinical Research Institute — Encinitas
  • First OC Dermatology Research Inc — Fountain Valley
  • Marvel Clinical Research, LLC — Huntington Beach
  • Sunwise Clinical Research, LLC — Lafayette
  • Wallace Medical Group Inc — Los Angeles
  • Northridge Clinical Trials - Elite Clinical Network — Northridge
  • Pasadena Clinical Trials — Pasadena
  • Therapeutics Clinical Research — San Diego
  • Unison Clinical Trials/ Shahram Jacobs MD — Sherman Oaks
  • Olive View - UCLA Education & Research Institute — Sylmar
  • California Dermatology Institute - Thousand Oaks — Thousand Oaks

Florida

  • Clearlyderm Dermatology - West Boca Raton — Boca Raton
  • Driven Clinical Research — Coral Gables
  • Jacksonville Center for Clinical Research — Jacksonville
  • Glick Skin Institute - Margate — Margate
  • San Marcus Research Clinic, Inc - Miami — Miami Lakes

Arizona

  • Alliance Dermatology — Phoenix
  • Scottsdale Clinical Trials — Scottsdale

Arkansas

  • Northwest Arkansas Clinical Trials Center (NWACTC), PLLC — Rogers

Trial Details

FieldValue
Enrollment Target 840 participants
Start Date 2024-07-25
Est. Completion 2025-12
Phase Phase 3

Sponsor

Alumis

34 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06586112

The ClinicalTrials.gov registry entry for NCT06586112 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 840 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 1 condition, with Plaque 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: NCT06586112 reports 20 study locations spanning 4 distinct geographic areas — top geographies include California, Florida, Arizona. 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 NCT06586112 about?

NCT06586112 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Moderate to Severe Plaque Psoriasis". The goal of this clinical trial is to learn if ESK-001 works to treat moderate to severe plaque psoriasis. The main questions it aims to answer are: * Does ESK-001 reduce the severity of people's psoriasis? * How safe is ESK-001 in people with moderate to severe plaque psoriasis? The study include...

What is the current status of trial NCT06586112?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 840 participants. The study started on 2024-07-25. Estimated completion is 2025-12.

What conditions does trial NCT06586112 study?

This clinical trial studies the following conditions: Plaque 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 NCT06586112?

The interventions under investigation include: Placebo (DRUG), ESK-001 (DRUG), Apremilast (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06586112?

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 NCT06586112 being conducted?

This trial has 20 study locations across Arizona, Arkansas, California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial