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

Conditions

• Plaque Psoriasis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Envudeucitinib — DRUG
  ESK-001
• Placebo — DRUG
  Placebo
• Apremilast — DRUG
  Apremilast

Study Details

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.

Key Dates

Start date

Aug 20, 2024

Status verified

Apr 2026

Primary completion

Sep 23, 2025

Completion

Dec 18, 2025

Study Design

Enrollment

862 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: ESK-001
  ESK-001 administered as an oral tablet
• Placebo Comparator: Placebo
  Matching oral placebo
• Active Comparator: Apremilast
  Apremilast administered as an oral capsule

Primary Outcome Measure

To determine whether ESK-001 reduces the severity of psoriasis by 75% (using the PASI) or by at least 2 points (using sPGA score) compared to placebo [ Time Frame: 16 weeks ]

Locations (43)

Find similar trials in Birmingham, AL

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