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

NCT06846541 | Active Not Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: ESK-001-018
• Study Type: interventional
• Target: 1,680
• Locations: 15 countries
• Sites: 261

Brief Summary

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

Keywords

Psoriasis; PASI; Safety; ESK-001

Outcome Measures

Primary Outcomes (1)

• To assess the long-term safety and tolerability of ESK-001 throughout the duration of the study

  Incidence and severity of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)

  Approximately 4 years

Secondary Outcomes (10)

• To assess the long-term efficacy of ESK-001 using the Psoriasis Area and Severity Index (PASI-75)

  24, 48, 72, and 96 weeks

• To assess the long-term efficacy of ESK-001 using the Psoriasis Area and Severity Index (PASI-90)

  24, 48, 72, and 96 weeks

• To assess the long-term efficacy of ESK-001 using the Psoriasis Area and Severity Index (PASI-100)

  24, 48, 72, and 96 weeks

• To assess the long-term efficacy of ESK-001 using the Static Physician's Global Assessment (sPGA 0/1)

  24, 48, 72, and 96 weeks

• To assess the long-term efficacy of ESK-001 based on change in Psoriasis Area and Severity Index (PASI)

  24, 48, 72, and 96 weeks

Study Arms (3)

Open-Label ESK-001

EXPERIMENTAL

Open-Label ESK-001 administered as an oral tablet

Drug: Open-Label Envudeucitinib

Blinded ESK-001

EXPERIMENTAL

Blinded ESK-001 administered as an oral tablet

Drug: Blinded Envudeucitinib

Placebo

PLACEBO COMPARATOR

Matching placebo administered as an oral tablet

Drug: Placebo

Interventions

Placebo DRUG

Placebo during Randomized Treatment Withdrawal Period

Placebo

Open-Label Envudeucitinib DRUG

Open-Label ESK-001

Open-Label ESK-001

Blinded Envudeucitinib DRUG

Blinded ESK-001 during Randomized Treatment Withdrawal Period

Blinded ESK-001

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females, age ≥18 years
• Completed either of the two previous (parent) studies of ESK-001 (ESK-001-016 or ESK-001-017)
• ESK-001 safety and tolerability were acceptable in the parent study
• 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

You may not qualify if:

• Pregnant, lactating, or planning to get pregnant during the study period
• 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
• Deemed by the Investigator to be inappropriate for the study or unable to comply with the protocol

Sponsors & Collaborators

• Alumis Inc: lead

Study Sites (268)

Total Dermatology

Birmingham, Alabama, 35203, United States

Location

Chandler Clinical Trials

Chandler, Arizona, 85224, United States

Location

Alliance Dermatology

Pheonix, Arizona, 85032, United States

Location

Scottsdale Clinical Trials

Scottsdale, Arizona, 85260, United States

Location

Noble Clinical Research

Tucson, Arizona, 85704, United States

Location

Northwest AR Clinical Trials Center PLLC

Rogers, Arkansas, 72758, United States

Location

Zenith Research Inc.

Beverly Hills, California, 90212, United States

Location

Exalt Clinical Research Inc

Chula Vista, California, 91910, United States

Location

California Dermatology and Clinical Research Institute

Encinitas, California, 92024, United States

Location

Raoof MD

Encino, California, 91436, United States

Location

First OC Dermatology Research Inc

Fountain Valley, California, 92708, United States

Location

Marvel Clinical Research LLC

Huntington Beach, California, 92647, United States

Location

Long Beach Research Institute

Long Beach, California, 90805, United States

Location

Olive View UCLA Education and Research Institute

Los Angeles, California, 90024, United States

Location

Dermatology Research Associates

Los Angeles, California, 90045, United States

Location

Wallace Medical Group Inc

Los Angeles, California, 90056, United States

Location

Northridge Clinical Trials

Northridge, California, 91325, United States

Location

Pasadena Clinical Trials

Pasadena, California, 91101, United States

Location

Empire Clinical Research Pomona

Pomona, California, 91767, United States

Location

Integrative Skin Science and Research

Sacramento, California, 95815, United States

Location

Therapeutics Clinical Research

San Diego, California, 92123, United States

Location

Southern California Clinical Research

Santa Ana, California, 92701, United States

Location

Clinical Science Institute Dermatology Institute

Santa Monica, California, 90404, United States

Location

Unison Clinical Trials

Sherman Oaks, California, 91403, United States

Location

California Dermatology Institute Thousand Oaks

Thousand Oaks, California, 91320, United States

Location

Sunwise Clinical Research LLC

Walnut Creek, California, 94596, United States

Location

Clearlyderm Dermatology West Boca Raton

Boca Raton, Florida, 33428, United States

Location

Driven Clinical Research

Coral Gables, Florida, 33134, United States

Location

FXM Clinical Research Ft. Lauderdale LLC

Fort Lauderdale, Florida, 33308, United States

Location

Direct Helpers Research Center

Hialeah, Florida, 33012, United States

Location

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

Location

Glick Skin Institute

Margate, Florida, 33063, United States

Location

AppleMed Research Group

Miami, Florida, 33126, United States

Location

FAX Pharma Clinical Research Inc

Miami, Florida, 33146, United States

Location

FXM Clinical Research Miami LLC

Miami, Florida, 33175, United States

Location

Las Mercedes Medical Research

Miami, Florida, 33196, United States

Location

Procare Research Center

Miami Gardens, Florida, 33014, United States

Location

San Marcus Research Clinic Inc - Miami

Miami Lakes, Florida, 33014, United States

Location

Savin Medical Group LLC

Miami Lakes, Florida, 33014, United States

Location

FXM Clinical Research Miramar LLC

Miramar, Florida, 33027, United States

Location

Oceanic Research Group

North Miami Beach, Florida, 33169, United States

Location

Renstar Medical Research

Ocala, Florida, 34470, United States

Location

Lenus Research and Medical Group LLC

Sweetwater, Florida, 33172, United States

Location

Advanced Clinical Research Institute

Tampa, Florida, 33607, United States

Location

ForCare Medical Center

Tampa, Florida, 33613, United States

Location

Arlington Dermatology

Rolling Meadows, Illinois, 60008, United States

Location

NorthShore Medical Group Dermatology Skokie

Skokie, Illinois, 60077, United States

Location

Dundee Dermatology

West Dundee, Illinois, 60118, United States

Location

DS Research of Southern Indiana

Clarksville, Indiana, 47129, United States

Location

Dawes Fretzin Clinical Research Group

Columbus, Indiana, 47201, United States

Location

The Indiana Clinical Trials Center

Plainfield, Indiana, 46168, United States

Location

The South Bend Clinic

South Bend, Indiana, 46617, United States

Location

Equity Medical

Bowling Green, Kentucky, 42104, United States

Location

DS Research of Kentucky

Louisville, Kentucky, 40241, United States

Location

Velocity Clinical Research

Baton Rouge, Louisiana, 70808, United States

Location

Tulane University School of Medicine

New Orleans, Louisiana, 70112, United States

Location

MetroBoston Clinical Partners

Brighton, Massachusetts, 02135, United States

Location

Michigan Center for Research Company

Clarkston, Michigan, 48346, United States

Location

Henry Ford Medical Center Farmington

Detroit, Michigan, 48202, United States

Location

Revival Research Institute

Troy, Michigan, 48084, United States

Location

Grekin Skin Institute

Warren, Michigan, 48088, United States

Location

Associated Skin Care Specialists Minnesota Clinical Study Center

New Brighton, Minnesota, 55112, United States

Location

Cleaver Dermatology

Kirksville, Missouri, 63501, United States

Location

Schlessinger MD

Omaha, Nebraska, 68144, United States

Location

Las Vegas Clinical Trials

Las Vegas, Nevada, 89030, United States

Location

NYC Health and Hospitals Elmhurst

Elmhurst, New York, 11373, United States

Location

Pioneer Clinical Research NY

New York, New York, 10016, United States

Location

Cameron Dermatology

New York, New York, 10023, United States

Location

OptiSkin

New York, New York, 10128, United States

Location

DermResearchCenter of New York

Stony Brook, New York, 11790, United States

Location

Asheville Clinical Trials

Asheville, North Carolina, 28803, United States

Location

WDC Cosmetic and Research

Wilmington, North Carolina, 28405, United States

Location

Optima Research Boardman

Boardman, Ohio, 44512, United States

Location

The Ohio State University Wexner Medical Center OSUWMC OSU Dermatology East Columbus

Gahanna, Ohio, 43230, United States

Location

Dermatologists of Southwestern Ohio LLC

Mason, Ohio, 45040, United States

Location

Unity Clinical Research UCR

Oklahoma City, Oklahoma, 73118, United States

Location

Velocity Clinical Research

Medford, Oregon, 97504, United States

Location

Oregon Medical Research Center

Portland, Oregon, 97201, United States

Location

Paddington Testing Company Inc

Philadelphia, Pennsylvania, 19103, United States

Location

UPMC Department of Dermatology

Pittsburgh, Pennsylvania, 15213, United States

Location

Clinical Partners LLC

Johnston, Rhode Island, 02919, United States

Location

Studies in Dermatology LLC

Cypress, Texas, 77433, United States

Location

Modern Research Associates PLLC

Dallas, Texas, 75231, United States

Location

Reveal Research Institute

Frisco, Texas, 75033, United States

Location

Center for Clinical Studies Texas Medical Center

Houston, Texas, 77004, United States

Location

Austin Institute for Clinical Research

Houston, Texas, 77056, United States

Location

SMS Clinical Research

Mesquite, Texas, 75149, United States

Location

Progressive Clinical Research San Antonio

San Antonio, Texas, 78213, United States

Location

Center for Clinical Studies (CCS) - Webster/Clear Lake Location

Webster, Texas, 77598, United States

Location

University of Utah Health Care Midvalley Health Center

Murray, Utah, 84107, United States

Location

Jordan Valley Dermatology

South Jordan, Utah, 84095, United States

Location

Frontier Dermatology

Mill Creek, Washington, 98012, United States

Location

Premier Specialist

Kogarah, New South Wales, 2217, Australia

Location

North Eastern Health Specialists

Campbelltown, South Australia, 5074, Australia

Location

Skin Health Institute

Carlton, Victoria, 3053, Australia

Location

Sinclair Dermatology

East Melbourne, Victoria, 3002, Australia

Location

Multiprofile Hospital for Active Treatment Dr Tota Venkova

Gabrovo, 5300, Bulgaria

Location

Medikal Center Kordis

Pleven, 5800, Bulgaria

Location

Skin and Venereal Diseases Center EOOD

Sofia, 1404, Bulgaria

Location

DCC Aleksandrovka

Sofia, 1431, Bulgaria

Location

University Multiprofile Hospital for Active Treatment Alexandrovska

Sofia, 1431, Bulgaria

Location

Rejuvenation Medical Group Edmonton Downtown

Edmonton, Alberta, T5J 3S9, Canada

Location

Alberta DermaSurgery

Edmonton, Alberta, T6G 1C3, Canada

Location

VIDA Dermatology/VIDA Clinical Research

Edmonton, Alberta, T6H 4J8, Canada

Location

CaRe Clinic Red Deer

Red Deer, Alberta, T4P 1K4, Canada

Location

Enverus Medical

Surrey, British Columbia, V3V 0C6, Canada

Location

CCA Medical Research Corp

Ajax, Ontario, L1S 7K8, Canada

Location

SimcoDerm Medical and Surgical Dermatology Center

Barrie, Ontario, L4M 7G1, Canada

Location

SKiN Health

Coburg, Ontario, K9A 0Z4, Canada

Location

Guelph Dermatology Research

Guelph, Ontario, N1L 0B3, Canada

Location

Dermatrials Research Inc

Hamilton, Ontario, L8N 1Y2, Canada

Location

Centricity Research London

London, Ontario, N6A 2C2, Canada

Location

Derm Effects

London, Ontario, N6H 5L5, Canada

Location

Lynderm Research

Markham, Ontario, L3P1X2, Canada

Location

DermEdge Research Inc

Mississauga, Ontario, L4Y 4C5, Canada

Location

Clear Skin Dermatology

Newmarket, Ontario, L3Y 5G8, Canada

Location

North Bay Dermatolgy Centre

North Bay, Ontario, P1B 3Z7, Canada

Location

Canadian Dermatology Centre

North York, Ontario, M3B 0A7, Canada

Location

Rejuvenation Dermatology - Oakville

Oakville, Ontario, L6H6P8, Canada

Location

Institute of Cosmetic and Laser Surgery

Oakville, Ontario, L6J 7W5, Canada

Location

The Centre for Dermatology

Richmond Hill, Ontario, L4B 1A5, Canada

Location

North York Research Inc

Toronto, Ontario, M2N 3A6, Canada

Location

Toronto Research Centre

Toronto, Ontario, M3H 5Y8, Canada

Location

Dermatology on Bloor

Toronto, Ontario, M4W 2N4, Canada

Location

Alliance Clinical Trials Inc

Waterloo, Ontario, N2J 1C4, Canada

Location

XLR8 Medical Research

Windsor, Ontario, N8T 1E6, Canada

Location

Innovaderm

Montreal, Quebec, H2X 2V1, Canada

Location

Centre of Research in Dermatology Quebec CRDQ

Québec, Quebec, G1V 4X7, Canada

Location

Dermatologie Sima Inc

Verdun, Quebec, H4G 3E7, Canada

Location

Skinsense Medical Research

Saskatoon, Saskatchewan, S7K 2C1, Canada

Location

Dermamedica

Náchod, Královéhradecký kraj, 547 01, Czechia

Location

Vesalion s.r.o

Ostrava, Moravian Silesian, 70200, Czechia

Location

Sanatorium Profesora Arenbergera

Prague, Prague, 1 110 00, Czechia

Location

Clintrial sro

Prague, Prague, 100 00, Czechia

Location

Pratia Brno

Brno, 602 00, Czechia

Location

Lékárna Pod Kaňkem

Kutná Hora, 284 01, Czechia

Location

Nemocnice Novy Jicin

Nový Jičín, 74101, Czechia

Location

Dermskin sro

Olomouc, 77900, Czechia

Location

CCR Ostrava

Ostrava, 70200, Czechia

Location

Pratia Pardubice as

Pardubice, 530 02, Czechia

Location

Fakultni nemocnice Plzen Dermatovenerologicka klinika

Pilsen, 301 00, Czechia

Location

Fakultni Nemocnice Kralovske Vinohrady FNKV Dermatovenerologicka Klinika

Prague, 10034, Czechia

Location

Pratia Prague

Prague, 101 00, Czechia

Location

Praglandia

Prague, 15000, Czechia

Location

Dermatologicka ambulance Svitavy

Svitavy, 568 02, Czechia

Location

Innomedica

Tallinn, Harju, 10117, Estonia

Location

Tartu University Hospital

Tartu, Tartu, 50417, Estonia

Location

Center for Clinical and Basic Research AS

Tallinn, 10128, Estonia

Location

Kliiniliste Uuringute Keskus OU

Tartu, 50106, Estonia

Location

Centre Azur Nice

Nice, Alpes Maritimes, 6000, France

Location

CHU de Rouen

Rouen, Essais Cliniques, 76031, France

Location

Hautarztpraxis Dr Mihaescu

Augsburg, Augsburg, 86150, Germany

Location

Eberhard Karls Universitaet Tuebingen Universitaets Hautklinik Tuebingen

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Universitatsklinikum Erlangen

Erlangen, Bavaria, 91054, Germany

Location

Hautarztpraxis Mahlow

Mahlow, Brandenburg, 15831, Germany

Location

Rosenpark Research

Darmstadt, Hesse, 64283, Germany

Location

Universitatsklinikum Frankfurt

Frankfurt am Main, Hesse, 60590, Germany

Location

Fachklinik Bad Bentheim

Bad Bentheim, Lower Saxony, 48455, Germany

Location

Hautarztpraxis an der Hase

Bramsche, Lower Saxony, 49565, Germany

Location

Klinikum Oldenburg

Oldenburg, Lower Saxony, 26133, Germany

Location

Klinische Forschung Schwerin GmbH

Schwerin, Mecklenburg-Vorpommern, 19055, Germany

Location

Klinikum Bielefeld

Bielefeld, North Rhine-Westphalia, 33647, Germany

Location

Hautarztpraxis Dr Niesmann and Dr Othlinghaus

Bochum, North Rhine-Westphalia, 44793, Germany

Location

Intramedis CSS

Remscheid, North Rhine-Westphalia, 42897, Germany

Location

Dermatologische Praxis Dres Quist

Mainz, Rhinelkand-Palatinate, 55128, Germany

Location

Klinische Forschung Dresden GmbH

Dresden, Saxony, 1069, Germany

Location

Praxis fur Dermatologie und Venerologie

Dresden, Saxony, 1097, Germany

Location

Haut Ambulatorium Magdeburg

Magdeburg, Saxony-Anhalt, 39104, Germany

Location

Universitatsklinikum Schleswig Holstein

Kiel, Schleswig-Holstein, 24105, Germany

Location

MVZ DermaKiel GmbH

Kiel, Schleswig-Holstein, 24148, Germany

Location

Universitatsklinikum Schleswig Holstein

Lübeck, Schleswig-Holstein, 23538, Germany

Location

ISA - Interdisciplinary Study Association GmbH

Berlin, 10789, Germany

Location

Universitaetsklinikum Muenster

Münster, NRW 48149, Germany

Location

KliFOs Klinische Forschung Osnabruck

Osnabrück, 49074, Germany

Location

Bacs Kiskun County Teaching Hospital

Kecskemét, Bács-Kiskun county, 6000, Hungary

Location

Bőrgyógyászati Klinika, Debreceni Egyetem Orvos - és Egészségtudományi Centrum

Debrecen, Hajdú-Bihar, 4032, Hungary

Location

Allergo-Derm Bakos Kft

Szolnok, JN, 5000, Hungary

Location

DermaMed Research Kf

Békés, Oroshaza, 5900, Hungary

Location

UNO Medical Trials Kft.

Budapest, 1152, Hungary

Location

Orvostudomanyi Kutato es Fejleszto Kft

Debrecen, 4027, Hungary

Location

DERMA B Kft

Debrecen, 4031, Hungary

Location

Medmare Bt

Veszprém, 8200, Hungary

Location

Nagoya City University Hospital

Nagoya, Aichi-ken, 467-8602, Japan

Location

Fukuoka University Hospital

Fukuoka, Fukuoka, 814-0180, Japan

Location

Asahikawa Medical University Hospital

Asahikawa, Hokkaido, 078-8510, Japan

Location

Tokyo Medical University Ibaraki Medical Center

Ibaraki, Inashiki-gun, 300-0395, Japan

Location

Saruwatari Dermatology Clinic

Kagoshima, Kagoshima-Shi, 890-0046, Japan

Location

National Hospital Organization Sagamihara National Hospital

Sagamihara, Kanagawa, 252-0392, Japan

Location

Yokohama City University Hospital

Yokohama, Kanagawa-shi, 236-0004, Japan

Location

Kanto Rosai Hospital

Kanagawa, Kawasaki-shi, 211-8510, Japan

Location

Mie University Hospital

Tsu, Mie-ken, 514-8507, Japan

Location

Okayama University Hospital

Okayama, Okayama-shi, 700-8558, Japan

Location

Dermatology and Ophthalmology Kume Clinic

Sakai, Osaka, 593-8324, Japan

Location

Osaka University Hospital

Suita, Osaka, 565-0871, Japan

Location

Osaka Metropolitan University Hospital

Osaka, Osaka-shi, 545-8586, Japan

Location

Nippon Life Hospital

Osaka, Osaka-Shi, 550-0006, Japan

Location

Hokkaido University Hospital

Hokkaido, Sapporo-shi, 060-8648, Japan

Location

Kindai University Hospital

Osaka, Sayama-Shi, 589-8511, Japan

Location

Tokyo Medical University Hospital

Tokyo, Shinjuku-Ku, 160-0023, Japan

Location

Nihon University Itabashi Hospital

tabashi City, Tokyo, 173-8610, Japan

Location

Medical Corporation Jitai kai Tachikawa Dermatology Clinic

Tachikawa, Tokyo, 190-0023, Japan

Location

Yamaguchi University Hospital

Ube, Yamaguchi, 755-8505, Japan

Location

Semigallia Ltd

Kuldīga, Kuldigas, LV3301, Latvia

Location

Riga 1st Hospital

Riga, Rīga, LV1001, Latvia

Location

SIA Veseliba un estetika

Riga, Rīga, LV1009, Latvia

Location

Smite Aija medical practice in dermatology venereology

Talsi, Talsi, LV3201, Latvia

Location

Med Art clinic

Riga, LV1003, Latvia

Location

Veselibas Centrs 4

Riga, LV1003, Latvia

Location

Veselibas Centrs 4 Filiale Dermatologijas Klinika

Riga, LV1013, Latvia

Location

Specderm

Podlaski, Bialystok, 15 - 375, Poland

Location

Centrum Medyczne Pratia Bydgoszcz

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland

Location

Synexus Centrum Medyczne Osteomed Wroclaw

Wroclaw, Lower Silesian Voivodeship, 50-381, Poland

Location

WroMedica

Wroclaw, Lower Silesian Voivodeship, 51-685, Poland

Location

Centrum Medyczne dr Rajzer spolka zoo

Krakow, Malopolska, 30-438, Poland

Location

Diamond Clinic

Krakow, Malopolska, 31-559, Poland

Location

RCMed Oddział Sochaczew

Sochaczew, Masovian Voivodeship, 96-500, Poland

Location

FutureMeds Warszawa Centrum

Warsaw, Masovian Voivodeship, 00-215, Poland

Location

Clinical Best Solutions

Warsaw, Masovian Voivodeship, 00-710, Poland

Location

MICS Medical Center Warsaw

Warsaw, Masovian Voivodeship, 00-874, Poland

Location

High Med Przychodnia Specjalistyczna

Warsaw, Masovian Voivodeship, 01-817, Poland

Location

Centrum Medyczne Evimed

Warsaw, Masovian Voivodeship, 02-625, Poland

Location

Centrum Medyczne Reuma Park

Warsaw, Masovian Voivodeship, 02-665, Poland

Location

RoyalDerm

Warsaw, Mazowiecke, 02-962, Poland

Location

ClinicMed Daniluk Nowak SpK

Bialystok, Podlaskie Voivodeship, 15-879, Poland

Location

AES Gdansk

Gdansk, Pomeranian Voivodeship, 80-382, Poland

Location

Pratia Gdynia

Gdynia, Pomeranian Voivodeship, 81-338, Poland

Location

Derm Art Institute

Gdynia, Pomeranian Voivodeship, 81-415, Poland

Location

Synexus Sp zo o Oddzial w Gdyni

Gdynia, Pomeranian Voivodeship, 81-537, Poland

Location

Centrum Badan Klinicznych PI House

Gdansk, Poneranian, 80-546, Poland

Location

Pratia Katowice

Katowice, Silesian Voivodeship, 40-018, Poland

Location

Centrum Medyczne Angelius Provita

Katowice, Silesian Voivodeship, 40-611, Poland

Location

Research Solutions

Katowice, Silesian Voivodeship, 40-748, Poland

Location

Laser Clinic

Szczecin, West Pomeranian Voivodeship, 70-332, Poland

Location

Care Clinic Katowice

Katowice, 40-568, Poland

Location

Centrum Medyczne All Med Badania Kliniczne

Krakow, 30-033, Poland

Location

Pratia MCM Krakow

Krakow, 30-727, Poland

Location

Krakowskie Centrum Medyczne

Krakow, 31-501, Poland

Location

Luxderm

Lublin, 20-573, Poland

Location

Zanamed Medical Clinic Sp z o o

Lublin, 20-601, Poland

Location

Klinika Dermatologii Uniwersytecki Szpital Kliniczny im F Chopina

Rzeszów, 35-329, Poland

Location

Rheuma Medicus

Warsaw, 02-118, Poland

Location

MTZ Clinical Research Sp z o o

Warsaw, 02-172, Poland

Location

Centrum Medyczne Synexus Warszawa

Warsaw, 02-672, Poland

Location

Klinika Ambroziak Dermatologia Kliniczna

Warsaw, 02-953, Poland

Location

dermMedica

Wroclaw, 51-503, Poland

Location

Dermoklinika

Lodz, Łódź Voivodeship, 90-436, Poland

Location

FutureMeds Lodz

Lodz, Łódź Voivodeship, 91-363, Poland

Location

Velocity Clinical Research Skierniewice

Skierniewice, Łódź Voivodeship, 96-100, Poland

Location

Hospital da Senhora da Oliveira

Guimarães, Braga District, 4835-044, Portugal

Location

Hospital CUF Descobertas

Lisbon, Lisbon District, 1998-018, Portugal

Location

Unidade Local de Saude Santo Antonio Hospital de Santo Antonio

Porto, 4099-001, Portugal

Location

Centro Reumatologico de Cagus

Caguas, Puerto Rico, 00725, Puerto Rico

Location

Ponce Medical School Foundation Inc

Ponce, Puerto Rico, 00716, Puerto Rico

Location

Clinical Research Puerto Rico

San Juan, Puerto Rico, 00909, Puerto Rico

Location

GCM Medical Group PSC Hato Rey Site

San Juan, 00917, Puerto Rico

Location

Pusan National University Hospital

Seogu, Busan, 49241, South Korea

Location

Chosun Universtiy Hospital

Gwangju, Dong-gu, 61453, South Korea

Location

Hallym University Sacred Heart Hospital

Anyang-si, Gyeonggi-do, 14068, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

Seoul National University Hospital

Seoul, 3080, South Korea

Location

Konkuk University Medical Center

Seoul, 5030, South Korea

Location

University General Hospital Dr Balmis

Alicante, Alicante, 3010, Spain

Location

Hospital del Mar

Barcelona, Barcelona, 8003, Spain

Location

Hospital Universitario La Paz

Madrid, Madrid, 28046, Spain

Location

Hospital Clínico Universitario de Santiago de Compostela

A Coruña, Santiago de Compostela, 15706, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 8041, Spain

Location

Hospital Germans Trias i Pujol

Barcelona, 8916, Spain

Location

Hospital de Manises

Manises, 46940, Spain

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: February 26, 2025
• Study Start: January 8, 2025
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

LA (7); DE (23); ES (4); US (92); CA (29); FR (2); HU (8); CZ (15); BU (5); PR (4); KR (6); AU (4); PL (39); JP (20); PT (3)