Long-term Safety and Efficacy of ESK-001 in Moderate to Severe Plaque Psoriasis
Launched by ALUMIS INC · Feb 20, 2025
Trial Information
Current as of August 19, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a medication called ESK-001 to see how safe it is when taken for a long time by people with moderate to severe plaque psoriasis, a skin condition that causes red, scaly patches. The trial aims to find out if taking ESK-001 regularly can help reduce the severity of psoriasis symptoms. Eligible participants are adults aged 18 and older who have previously taken part in related studies of ESK-001 and found it to be safe for them. Women who can become pregnant and men who are sexually active with such women must agree to use effective birth control during the study.
Participants will take ESK-001 twice a day for 24 weeks, and then some will be randomly chosen to continue with either ESK-001 or a placebo (a treatment that does not contain the active drug) for an additional period. Throughout the study, participants will have regular check-ups, provide blood and urine samples, and must keep taking the medication as prescribed. If at any time their psoriasis worsens, they can return to taking ESK-001. This study is currently recruiting participants, and it’s important for anyone considering joining to understand the commitment involved.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. 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:
- • 1. 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
About Alumis Inc
Alumis Inc. is a pioneering biotechnology company focused on developing innovative therapeutics aimed at addressing unmet medical needs in the fields of immunology and oncology. With a robust pipeline of clinical trials, Alumis Inc. leverages cutting-edge research and technology to advance novel treatment options that enhance patient outcomes. Committed to scientific excellence and ethical practices, the company collaborates with leading researchers and healthcare professionals to bring transformative solutions from the lab to the clinic, ultimately striving to improve the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Madrid, , Spain
San Diego, California, United States
Barcelona, , Spain
Tsu, Mie, Japan
Los Angeles, California, United States
San Juan, , Puerto Rico
Seoul, , Korea, Republic Of
Rolling Meadows, Illinois, United States
Dallas, Texas, United States
Surrey, British Columbia, Canada
South Bend, Indiana, United States
Oakville, Ontario, Canada
Seongnam Si, Gyeonggi Do, Korea, Republic Of
Plainfield, Indiana, United States
Seongnam Si, Gyeonggi Do, Korea, Republic Of
Johnston, Rhode Island, United States
Richmond Hill, Ontario, Canada
East Melbourne, Victoria, Australia
Encinitas, California, United States
Manises, , Spain
Hialeah, Florida, United States
Markham, Ontario, Canada
Toronto, Ontario, Canada
Huntington Beach, California, United States
Barrie, Ontario, Canada
Seoul, , Korea, Republic Of
Tucson, Arizona, United States
Berlin, , Germany
Kraków, , Poland
Mesquite, Texas, United States
Miami Lakes, Florida, United States
Campbelltown, South Australia, Australia
London, Ontario, Canada
Sakai, Osaka, Japan
Budapest, , Hungary
Sherman Oaks, California, United States
Katowice, Silesia, Poland
Tampa, Florida, United States
Carlton, Victoria, Australia
Philadelphia, Pennsylvania, United States
Lisbon, , Portugal
Houston, Texas, United States
Tampa, Florida, United States
Clarkston, Michigan, United States
Miami, Florida, United States
Miramar, Florida, United States
Riga, , Latvia
Kogarah, New South Wales, Australia
Medford, Oregon, United States
Brighton, Massachusetts, United States
Bad Bentheim, Lower Saxony, Germany
Skokie, Illinois, United States
New York, New York, United States
Kraków, , Poland
Margate, Florida, United States
Chandler, Arizona, United States
North York, Ontario, Canada
London, Ontario, Canada
North Miami Beach, Florida, United States
Encino, California, United States
Los Angeles, California, United States
Mississauga, Ontario, Canada
Northridge, California, United States
Portland, Oregon, United States
Boardman, Ohio, United States
Long Beach, California, United States
Cypress, Texas, United States
Troy, Michigan, United States
Webster, Texas, United States
Louisville, Kentucky, United States
Birmingham, Alabama, United States
Pardubice, , Czechia
Toronto, Ontario, Canada
Debrecen, , Hungary
Bowling Green, Kentucky, United States
Santa Ana, California, United States
Clarksville, Indiana, United States
Ajax, Ontario, Canada
Columbus, Indiana, United States
Miami, Florida, United States
Mill Creek, Washington, United States
Santa Monica, California, United States
Fort Lauderdale, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Wilmington, North Carolina, United States
South Jordan, Utah, United States
Guelph, Ontario, Canada
Newmarket, Ontario, Canada
Ponce, , Puerto Rico
Mahlow, Brandenburg, Germany
Remscheid, Nrw, Germany
Warsaw, Mazovia, Poland
Warsaw, Mazovia, Poland
Warsaw, , Poland
Warsaw, , Poland
Pheonix, Arizona, United States
Tartu, , Estonia
Riga, , Latvia
Riga, , Latvia
Riga, , Latvia
Talsi, , Latvia
Sochaczew, Mazowieckie, Poland
Gdynia, Pomorskie, Poland
Katowice, Silesia, Poland
Coral Gables, Florida, United States
Frisco, Texas, United States
Osaka, Osaka Shi, Japan
Gdynia, Pomorskie, Poland
Szczecin, Zachodniopomorskie, Poland
Guimaraes, Braga, Portugal
Porto, , Portugal
Pomona, California, United States
Thousand Oaks, California, United States
New Brighton, Minnesota, United States
Mason, Ohio, United States
Houston, Texas, United States
San Antonio, Texas, United States
Tallinn, Harjumaa, Estonia
Darmstadt, Hesse, Germany
łódź, Lodzkie, Poland
Kraków, Malopolska, Poland
Warsaw, , Poland
Alicante, , Spain
Mainz, Rhinelkand Palatinate, Germany
Walnut Creek, California, United States
Oklahoma City, Oklahoma, United States
Chula Vista, California, United States
Miami Gardens, Florida, United States
Sweetwater, Florida, United States
Hamilton, Ontario, Canada
Caguas, , Puerto Rico
Boca Raton, Florida, United States
Baton Rouge, Louisiana, United States
North Bay, Ontario, Canada
Prague, , Czechia
Gahanna, Ohio, United States
Montréal, Quebec, Canada
Debrecen, , Hungary
Québec, Quebec, Canada
Náchod, Kralovehradecky Kraj, Czechia
Prague, , Czechia
Praha, , Czechia
Kraków, , Poland
Rogers, Arkansas, United States
Los Angeles, California, United States
Kutná Hora, , Czechia
Nový Jičín, , Czechia
Olomouc, , Czechia
Ostrava, , Czechia
Prague, , Czechia
Wrocław, Dolnoslaskie, Poland
Skierniewice, Lodz, Poland
Kraków, Malopolska, Poland
Gdańsk, Pomorskie, Poland
Gdynia, Pomorskie, Poland
Gdańsk, Poneranian, Poland
Miami Lakes, Florida, United States
Brno, , Czechia
Szolnok, Jn, Hungary
Békés, Oroshaza, Hungary
Tachikawa, Tokyo, Japan
Białystok, Podlaskie, Poland
Wrocław, , Poland
Detroit, Michigan, United States
Verdun, Quebec, Canada
Ostrava, Moravian Silesian, Czechia
Svitavy, , Czechia
Bielefeld, North Rhine Westphalia, Germany
Dresden, Sachsen, Germany
Kiel, Schleswig Holstein, Germany
Luebeck, Schleswig Holstein, Germany
Augsburg, , Germany
Münster, , Germany
Kuldīga, Kuldigas, Latvia
Podlaski, Bialystok, Poland
Bydgoszcz, Kujawsko Pomorskie, Poland
łódź, Lodzkie, Poland
Wrocław, Lower Silesia, Poland
Warsaw, Mazovia, Poland
Warszawa, Mazowiecke, Poland
Rzeszów, , Poland
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported