Long-term Safety and Efficacy of ESK-001 in Moderate to Severe Plaque Psoriasis
Purpose
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.
Conditions
- Plaque Psoriasis
- Psoriasis (PsO)
- Psoriasis
- Moderate Psoriasis
- Severe Psoriasis
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Males or females, age ≥18 years 2. Completed either of the two previous (parent) studies of ESK-001 (ESK-001-016 or ESK-001-017) 3. ESK-001 safety and tolerability were acceptable in the parent study 4. Women of childbearing potential (WOCBP) and males who are sexually active with WOCBP must agree to adhere to highly effective methods of contraception for the entirety of the study
Exclusion Criteria
- Pregnant, lactating, or planning to get pregnant during the study period 2. Any acute or chronic illness/condition or evidence of an unstable clinical condition that in the Investigator's judgment will substantially increase the risk to the patient if they continue to receive ESK-001 treatment in this extension study 3. Deemed by the Investigator to be inappropriate for the study or unable to comply with the protocol
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Open-Label ESK-001 |
Open-Label ESK-001 administered as an oral tablet |
|
|
Experimental Blinded ESK-001 |
Blinded ESK-001 administered as an oral tablet |
|
|
Placebo Comparator Placebo |
Matching placebo administered as an oral tablet |
|
Recruiting Locations
Birmingham, Alabama 35203
Chandler, Arizona 85224
Pheonix, Arizona 85032
Chula Vista, California 91910
Encino, California 91436
Huntington Beach, California 92647
Long Beach, California 90805
Los Angeles, California 90045
Northridge, California 91325
Pomona, California 91767
San Diego, California 92123
Santa Ana, California 92701
Sherman Oaks, California 91403
Thousand Oaks, California 91320
Walnut Creek, California 94596
Boca Raton, Florida 33428
Fort Lauderdale, Florida 33308
Hialeah, Florida 33012
Margate, Florida 33063
Miami Gardens, Florida 33014
Miami Lakes, Florida 33014
Miami, Florida 33126
Miami, Florida 33146
Miami, Florida 33175
Miami, Florida 33196
Miramar, Florida 33027
Sweetwater, Florida 33172
Tampa, Florida 33613
Rolling Meadows, Illinois 60008
Skokie, Illinois 60077
Clarksville, Indiana 47129
Columbus, Indiana 47201
South Bend, Indiana 46617
Louisville, Kentucky 40241
Baton Rouge, Louisiana 70808
Clarkston, Michigan 48346
Troy, Michigan 48084
New Brighton, Minnesota 55112
New York, New York 10128
Wilmington, North Carolina 28405
Mason, Ohio 45040
Oklahoma City, Oklahoma 73118
Portland, Oregon 97201
Johnston, Rhode Island 02919
Cypress, Texas 77433
Dallas, Texas 75231
Houston, Texas 77004
Houston, Texas 77056
Mesquite, Texas 75149
San Antonio, Texas 78213
Webster, Texas 77598
Caguas, Puerto Rico 00725
Ponce, Puerto Rico 00716
San Juan, Puerto Rico 00909
More Details
- NCT ID
- NCT06846541
- Status
- Recruiting
- Sponsor
- Alumis Inc