Ignite Creation Date:
2024-10-25 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06586112
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-14
Brief Title:
A Study to Evaluate the Efficacy and Safety of ESK-001 in Patients with Moderate to Severe Plaque Psoriasis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multicenter Randomized Double-Blind Placebo and Active Comparator Controlled Phase 3 Study to Evaluate the Efficacy and Safety of ESK-001 in Patients with Moderate to Severe Plaque Psoriasis ONWARD1
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ONWARD1
Brief 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 peoples 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
Does ESK-001 reduce the severity of peoples 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None