Warsaw, Poland

Royalderm

Psoriasis

ESK-001

Alumis

condition

allSponsorName

gender

Male

Female

overallStatus

Recruiting

Not yet recruiting

Active, not recruiting

Enrolling by invitation

Completed

Terminated

Withdrawn

Suspended

Unknown

type

Interventional

Observational

Expanded Access

phase

Early Phase 1

Phase 1

Phase 2

Phase 3

Phase 4

Not Applicable

funderTypes

Industry

Other U.S. Federal agency

All others

ageGroup

Child (birth-17)

Adult (18-64)

Older Adult (65+)

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.

A Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With 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 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.

Long-term Safety and Efficacy of ESK-001 in Moderate to Severe Plaque Psoriasis

Royalderm | Warsaw, Poland

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Active trials

A Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Moderate to Severe Plaque Psoriasis (ONWARD1)

Long-term Safety and Efficacy of ESK-001 in Moderate to Severe Plaque Psoriasis (ONWARD3)

Trial sponsors