A Study of TAK-279 in Participants With Moderate-to-Severe Plaque Psoriasis
A Phase 3, Multicenter, Open-Label Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of TAK-279 in Subjects With Moderate-to-Severe Plaque Psoriasis
3 other identifiers
interventional
1,950
20 countries
278
Brief Summary
The main aim of this study is to check the side effects of TAK-279 and how well it is tolerated in participants with moderate-to-severe plaque psoriasis. All participants will be assigned to study treatments of TAK-279 and will be treated with TAK-279 if the participants meet the study rules. Participants will be in the study for up to 217 weeks, including up to 35 days for the screening period, 52 weeks (Part A) up to 156 additional weeks (Part B) study treatment and 4 weeks follow up period. During the study, participants will visit their study clinic multiple times.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2024
278 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 8, 2024
CompletedFirst Posted
Study publicly available on registry
August 12, 2024
CompletedStudy Start
First participant enrolled
September 4, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 7, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 7, 2026
CompletedJanuary 15, 2026
January 1, 2026
1.7 years
August 8, 2024
January 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Part A and Part B: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAE)
A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. An SAE is any untoward medical occurrence that at any dose: results in death, life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent, significant disability/incapacity, a congenital abnormality/birth defect, an important medical event in the opinion of the healthcare provider, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above. TEAEs consist of both serious and non-serious adverse events.
From start of the drug administration up to Week 56 (Part A) and Week 160 (Part B)
Secondary Outcomes (2)
Part A and B: Number of Participants Achieving 75% Improvement from Baseline in Psoriasis Area and Severity Index (PASI-75) Score
Baseline up to Week 52 (Part A) and Week 156 (Part B)
Part A and B: Number of Participants Achieving a Static Physician's Global Assessment (sPGA) of Clear (0) or Almost Clear (1) With a >=2-point Decrease from Baseline
Baseline up to Week 52 (Part A) and Week 156 (Part B)
Study Arms (1)
Part A (De Novo Cohort) + Part B (Open Label Extension): TAK-279
EXPERIMENTALPart A: Participants will receive TAK-279, oral tablet once daily (QD) for up to 52 weeks. Part B: Participants who completed the treatment period of parent studies (TAK-279-3001 \[NCT06088043\], TAK-279-3002 \[NCT06108544\], or TAK-279-PsO-3004 \[NCT06973291\]) or who completed Part A will receive TAK-279, oral tablet QD for up to 156 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- Part A:
- Participant is willing and able to understand and fully comply with study procedures and requirements (including digital tools and applications), in the opinion of the investigator.
- Participant has provided written informed consent and any required privacy authorization before the initiation of any study procedures.
- Participant is aged 18 years or older at the time of consent.
- Participant has a diagnosis of chronic plaque psoriasis for \>=6 months prior to the screening visit.
- Participant has stable plaque psoriasis defined as no significant flare or change in morphology (as assessed by the investigator) in psoriasis for \>=6 months before screening.
- Participant has moderate-to-severe plaque psoriasis as defined by a PASI score \>=12 and a sPGA score \>=3 at screening and Day 1.
- Participant has plaque psoriasis covering \>=10% of his or her total BSA at screening and Day 1.
- Participant must be a candidate for phototherapy or systemic therapy.
- Part B:
- \- Participant has completed 52 weeks of treatment (TAK-279-3001 or Part A) or 60 weeks of treatment (TAK-279-3002), or 16 weeks of treatment (TAK-279-PsO-3004) in their parent study.
You may not qualify if:
- Part A:
- Participant requires systemic treatment, other than nonsteroidal anti-inflammatory drugs, during the trial period for an immune-related disease (e.g., inflammatory bowel disease).
- Participant has any clinically significant medical condition, evidence of an unstable clinical condition (e.g., cardiovascular, renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, or immunologic), or vital signs/physical/laboratory/ECG abnormality that would, in the opinion of the investigator, put the participant at undue risk or interfere with interpretation of study results. These include but are not limited to:
- Participant has a history of known or suspected condition/illness that is consistent with compromised immunity, including but not limited to any identified congenital or acquired immunodeficiency; splenectomy.
- Participant had a major surgery within 60 days prior to Day 1 or has a major surgery planned during the study.
- Participant has unstable, poorly controlled, or severe hypertension at screening, confirmed by 2 repeat assessments.
- Participant has a history of Class III or IV congestive heart failure as defined by New York Heart Association criteria.
- Participant has a history of cancer or lymphoproliferative disease, with the exception of successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix.
- For participants with asthma, chronic obstructive pulmonary disease, or other pulmonary illnesses, participant has been hospitalized in the past 3 months, has ever required intubation for treatment, currently requires oral corticosteroids, or has required more than 1 course of oral corticosteroids within 6 months prior to Day 1.
- Participant has any of the following cardiovascular disease history: A new diagnosis of atrial fibrillation or an episode of atrial fibrillation with rapid ventricular response or other dysrhythmia, non-acute cardiac hospitalization (e.g., pacemaker implantation), pulmonary embolism, or deep venous thrombosis within the past 6 months prior to screening. Any history of cerebrovascular event, myocardial infarction, coronary stenting, or aortocoronary bypass surgery. If, however, the investigator determines there are no suitable treatment alternatives available for the participant and it has been at least 6 months since the occurrence of any such event, the participant may enroll.
- Participant has ECG abnormalities that are considered clinically significant and would pose an unacceptable risk to the participant if he or she participated in the study, in the opinion of the investigator.
- Participant has significant/uncontrolled psychiatric illness, in the opinion of the investigator.
- Participant has any lifetime history of suicidal ideation, suicidal behavior, or suicidal attempts by 1) medical history; or 2) by Columbia-Suicide Severity Rating Scale (C-SSRS) documentation at screening or by answering "yes" to Question 5 for suicidal ideation on the C-SSRS at screening; or 3) is clinically deemed to have a suicide risk by the investigator.
- Participant has a patient health questionnaire - 8 (PHQ-8) score of 15 or above at screening.
- Participant has a history of clinically significant drug or alcohol abuse within 12 months prior to Day 1.
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (278)
Total Dermatology
Birmingham, Alabama, 35205, United States
University of Alabama Hospital - Whitaker Clinic -
Birmingham, Alabama, 35233-2110, United States
Cahaba Dermatology Skin Health Center
Hoover, Alabama, 35244-2111, United States
Medical Dermatology Specialists
Phoenix, Arizona, 85006, United States
Saguaro Dermatology Associates, LLC - Probity - PPDS
Phoenix, Arizona, 85008-3884, United States
Noble Clinical Research
Tucson, Arizona, 85704, United States
Johnson Dermatology Clinic
Fort Smith, Arkansas, 72916-6103, United States
Burke Pharmaceutical Research
Hot Springs, Arkansas, 71913-6475, United States
Zenith Research, Inc.
Beverly Hills, California, 90212, United States
First OC Dermatology Research Inc.
Fountain Valley, California, 92708, United States
Center for Dermatology Clinical Research
Fremont, California, 94538, United States
Long Beach Research Institute
Long Beach, California, 90805, United States
Metropolis Dermatology Downtown LA - Probity - PPDS
Los Angeles, California, 90017-5310, United States
UCLA University of California Los Angeles
Los Angeles, California, 90024, United States
Northridge Clinical Trials
Northridge, California, 91325-4122, United States
UC Davis Dermatology Clinic
Sacramento, California, 95816-3370, United States
TCR Medical Corporation
San Diego, California, 92123-1523, United States
University Clinical Trials
San Diego, California, 92123, United States
Dermatology Institute and Skin Care Center
Santa Monica, California, 90404-2216, United States
UNISON Clinical Trials (Shahram Jacobs md inc.)
Sherman Oaks, California, 91403, United States
Driven Research LLC
Coral Gables, Florida, 33134-3901, United States
Revival Research Corporation - Florida - ClinEdge - PPDS
Doral, Florida, 33122-1902, United States
FXM Clinical Research Ft. Lauderdale, LLC
Fort Lauderdale, Florida, 33308-5211, United States
Direct Helpers Medical Center
Hialeah, Florida, 33012, United States
Florida Academic Centers Research
Miami, Florida, 33136-1003, United States
FXM Clinical Research Miami, LLC
Miami, Florida, 33175-3582, United States
San Marcus Research Clinic Inc
Miami Lakes, Florida, 33014, United States
FXM Research Miramar
Miramar, Florida, 33027-4714, United States
Renstar Medical Research -21 NE 1st Ave
Ocala, Florida, 34470, United States
Lenus Research & Medical Group
Sweetwater, Florida, 33172, United States
Advanced Clinical Research Institute (ACRI) - Florida
Tampa, Florida, 33607-6429, United States
Divine Dermatology and Aesthetics, LLC
Atlanta, Georgia, 30315-2042, United States
Marietta Dermatology & The Skin Cancer Center - Marietta
Marietta, Georgia, 30060-7902, United States
Advanced Medical Research, PC
Sandy Springs, Georgia, 30328, United States
Georgia Skin and Cancer Clinic
Savannah, Georgia, 31419-1768, United States
Leavitt Clinical Research
Idaho Falls, Idaho, 83404-8322, United States
Arlington Dermatology
Rolling Meadows, Illinois, 60008-3811, United States
NorthShore Medical Group Dermatology - Skokie
Skokie, Illinois, 60077-1049, United States
DS Research - 1005 E. Lewis & Clark Pkwy Indiana Location
Clarksville, Indiana, 47129-2201, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46250, United States
Skin Sciences, PLLC
Louisville, Kentucky, 40217-1444, United States
Dermatology Specialists Research - 3810 Springhurst Blvd
Louisville, Kentucky, 40241-6162, United States
Lawrence J Green, MD LLC
Rockville, Maryland, 20850, United States
University of Michigan Hospital - 1500 E Medical Center Dr
Ann Arbor, Michigan, 48109-5360, United States
Oakland Hills Dermatology - 3400 Auburn Rd
Auburn Hills, Michigan, 48326-3396, United States
Revival Research Corporation - ClinEdge
Troy, Michigan, 48084-3536, United States
Minnesota Clinical Study Center
New Brighton, Minnesota, 55112, United States
Skin Specialists PC
Omaha, Nebraska, 68144, United States
Henderson Clinical Trials
Henderson, Nevada, 89052, United States
Dartmouth Hitchcock Medical Center - Old Etna Rd
Lebanon, New Hampshire, 03766-1937, United States
ALLCUTIS Research, LLC.
Portsmouth, New Hampshire, 03801, United States
Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey, 08520, United States
Sadick Research Group
New York, New York, 10075-0385, United States
Montefiore AOA - BRANY
The Bronx, New York, 10467, United States
Accellacare of Cary
Cary, North Carolina, 27518, United States
The Skin Surgery Center for Clinical Research - Objective Health - PPDS
Winston-Salem, North Carolina, 27103-7109, United States
Bexley Dermatology Research - Probity - PPDS
Bexley, Ohio, 43209, United States
Wright State Physicians
Fairborn, Ohio, 45324, United States
Apex Clinical Research Center
Mayfield Heights, Ohio, 44124-4005, United States
Oregon Medical Research Center PC
Portland, Oregon, 97201, United States
University of Pittsburgh Medical Center-3601 5th Ave
Pittsburgh, Pennsylvania, 15213-3403, United States
Cumberland Skin Center for Clinical Research - Objective Health - PPDS
Hermitage, Tennessee, 37076-3497, United States
International Clinical Research US LLC
Murfreesboro, Tennessee, 37130-2450, United States
Arlington Research Center
Arlington, Texas, 76011-3800, United States
Bellaire Dermatology Associates
Bellaire, Texas, 77401-3505, United States
UT Physicians Dermatology - Bellaire Station
Bellaire, Texas, 77401, United States
Modern Research Associates
Dallas, Texas, 75231-6077, United States
North Texas Center for Clinical Research
Frisco, Texas, 75034, United States
San Antonio
San Antonio, Texas, 78213-2250, United States
Texas Dermatology and Laser Specialists-San Antonio-7703 Floyd Curl Dr
San Antonio, Texas, 78218-3128, United States
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, 78229-3409, United States
Houston Center for Clinical Research, LLC
Sugar Land, Texas, 77479-1001, United States
Center For Clinical Studies, LTD. LLP - 451 N Texas Ave
Webster, Texas, 77598-4927, United States
Virginia Clinical Research - 6160 Kempsville Cir
Norfolk, Virginia, 23507, United States
Conexa Investigación Clínica S.A.
Buenos Aires, Ciudad Autónoma de BuenosAires, C1012, Argentina
Centro de Investigaciones Médicas Tucumán
San Miguel de Tucumán, Tucumán Province, T4000, Argentina
Centro de Investigacion Clinica
Ciudad Autónomade Buenos Aires, C1060ABN, Argentina
St George Dermatology and Skin Cancer Center - Probity - PPDS
Kogarah, New South Wales, 2217, Australia
The Skin Center - Probity
Benowa, Queensland, 4217, Australia
Skin Health Institute Inc - Probity - PPDS
Carlton, Victoria, 3053, Australia
Alfred Health
Parkville, Victoria, 3050, Australia
Western Health - Sunshine Hospital
Parkville, Victoria, 3050, Australia
Medical Center Unimed EOOD-Sevlievo
Sevlievo, Gabrovo, 5400, Bulgaria
Medical Center Asklepii OOD
Dupnitsa, Kyustendil, 2600, Bulgaria
Diagnostic and Consulting Center Aleksandrovska EOOD
Sofia, Sofia-Grad, 1431, Bulgaria
Diagnostic Consultative Centre - Focus-5 - LZIP EOOD
Sofia, Sofia-Grad, 1463, Bulgaria
Medical Center Hera EOOD-Sofia
Sofia, Sofia-Grad, 1510, Bulgaria
Diagnostic Consultative Center XXVIII - Sofia - EOOD
Sofia, Sofia-Grad, 1592, Bulgaria
Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia
Sofia, Sofia-Grad, 1606, Bulgaria
MC Comac Medical
Sofia, Sofia-Grad, 1612, Bulgaria
Multiprofile Hospital For Active Treatment Dr Tota Venkova
Gabrovo, Bulgaria
Diagnostic Consultative Center Sveti
Haskovo, 6300, Bulgaria
Medical Center Medconsult Pleven OOD
Pleven, Bulgaria
Beacon Dermatology - Probity
Calgary, Alberta, T3A 2N1, Canada
Dermatology Research Institute, Inc.
Calgary, Alberta, T3A 2N1, Canada
Alberta DermaSurgery Centre - Probity
Edmonton, Alberta, T6G 1C2, Canada
VIDA Dermatology - Probity
Edmonton, Alberta, T6H 4J8, Canada
Care Clinic
Red Deer, Alberta, T4P 1K4, Canada
Enverus Medical Research - Probity
Surrey, British Columbia, V3V 0C6, Canada
Wiseman Dermatology Research Inc.
Winnipeg, Manitoba, R3E 0V9, Canada
Karma Clinical Trials
St. John's, Newfoundland and Labrador, A1A 4Y3, Canada
CCA Medical Research - Probity
Ajax, Ontario, L1S 7K8, Canada
SimcoDerm Medical and Surgical Dermatology Centre - Probity
Barrie, Ontario, L4M 7G1, Canada
Kingsway Clinical Research - Probity
Etobicoke, Ontario, M8X 1Y9, Canada
Guelph Dermatology Research - Probity
Guelph, Ontario, N1L 0B7, Canada
Lima's Excellence In Allergy And Dermatology Research (Leader) Inc. - Probity
Hamilton, Ontario, L8L 3C3, Canada
Dermatrials Research
Hamilton, Ontario, L8N 1Y2, Canada
Mediprobe Research Inc
London, Ontario, N5X 2P1, Canada
DermEffects
London, Ontario, N6H 5L5, Canada
Lynderm Research Inc - Probity
Markham, Ontario, L3P 1X3, Canada
DermEdge Research - Probity
Mississauga, Ontario, L5H 1G9, Canada
Dr. S. K. Siddha Medicine Professional Corporation | Newmarket, Canada
Newmarket, Ontario, Canada
North Bay Dermatology Center - Probity
North Bay, Ontario, P1B 3Z7, Canada
The Centre for Clinical Trials Inc.
Oakville, Ontario, L6J 7W5, Canada
Skin Centre for Dermatology
Peterborough, Ontario, K9J 5K2, Canada
The Centre For Dermatology
Richmond Hill, Ontario, L4B 1A5, Canada
North York Research Inc. - Probity
Toronto, Ontario, M2N 3A6, Canada
Canadian Dermatology Centre - Probity
Toronto, Ontario, M3B 0A7, Canada
Toronto Research Centre
Toronto, Ontario, M3H 5Y8, Canada
Toronto Research Centre - Probity
Toronto, Ontario, M4W 2N4, Canada
Alliance Clinical Trials
Waterloo, Ontario, N2J 1C4, Canada
XLR8 Medical Research
Windsor, Ontario, N8T 1E6, Canada
Siena Medical Research Corporation
Montreal, Quebec, H3Z 2S6, Canada
Skinsense Medical Research - Probity
Saskatoon, Saskatchewan, S7K 0H6, Canada
Peking University People's Hospital
Beijing, Beijing Municipality, 100044, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050, China
Peking University Third Hospital
Beijing, Beijing Municipality, 100191, China
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, 100730, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080, China
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong, 510091, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510120, China
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510280, China
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050031, China
Union Hospital Tongji Medical College of Huazhong University of Science and Technology (HUST)
Wuhan, Hubei, 430022, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei, 430030, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, 212001, China
Huashan Hospital Fudan University - PPDS
Shanghai, Minhang District, 201100, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia Hui, 750004, China
The 2nd Hospital of Xi'An Jiaotong University
Xi'an, Shan'xi, 710004, China
Shandong Provincial Hospital
Jinan, Shandong, 250013, China
Shanghai Skin Disease Hospital
Shanghai, Shanghai Municipality, 200020, China
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310000, China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310016, China
The 1st Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
The University of Hong Kong - Shenzhen Hospital
Shenzhen, China
Dermamedica, s.r.o. - Kozni Ambulance Nachod
Náchod, Královéhradecký kraj, 547 01, Czechia
Nemocnice AGEL Novy Jicin a.s
Nový Jičín, Moravskoslezský kraj, Czechia
CCR Ostrava s.r.o.
Ostrava, Moravskoslezský kraj, 702 00, Czechia
Dermskin s.r.o
Olomouc, Olomoucký kraj, 779 00, Czechia
Pratia Pardubice a.s. - PRATIA - PPDS
Pardubice, Pardubický kraj, 530 02, Czechia
Pratia Brno s.r.o. - PRATIA - PPDS
Brno, South Moravian, 602 00, Czechia
CLINTRIAL s.r.o.
Prague, 100 00, Czechia
Prof. MUDr. Petr Arenberger, DrSc. - CRC - PPDS
Prague, 110 00, Czechia
Praglandia
Prague, 150 00, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, 779 00, Czechia
Office of Mireille Ruer-Mulard, MD
Martigues, Paca, 13500, France
Centre Hospitalier Le Mans
Le Mans, Sarthe, 72037, France
Hopital Charles Nicolle-1 Rue de Germont
Rouen, 76031fr, France
Centre Hospitalier Universitaire de Saint Etienne
Saint-Etienne, 42270, France
Hautarztpraxis Mahlow
Blankenfelde-Mahlow, Brandenburg, 15831, Germany
Fachklinik Bad Bentheim
Bad Bentheim, Lower Saxony, 48455, Germany
Klinikum Oldenburg
Oldenburg, Lower Saxony, 26133, Germany
Klinische Forschung Dresden Gmbh
Dresden, Saxony, 01069, Germany
Praxis fur Dermatologie and Venerologie
Dresden, Saxony, 01097, Germany
SRH Wald-Klinikum Gera GmbH
Gera, Thuringia, 07548, Germany
Dermatologikum Hamburg
Hamburg, 20354, Germany
Allergo-Derm Bakos Kft.
Szolnok, Jász-Nagykun-Szolnok, 5000, Hungary
Somogy Megyei Kaposi Mór Oktató Kórház
Kaposvár, Somogy County, 7400, Hungary
Markusovszky Egyetemi Oktatókórház
Szombathely, Vas County, Hungary
Debreceni Egyetem
Debrecen, 4032, Hungary
Rabin Medical Center - PPDS
Petah Tikva, Israel
Chaim Sheba Medical Center
Ramat Gan, 5265602, Israel
IRCCS Istituto Clinico Humanitas
Rozzano, Milano, 20089, Italy
Presidio Ospedaliero Gaspare Rodolico
Catania, Sicily, 95123, Italy
Azienda Usl Toscana Centro - Firenze
Florence, Tuscany, 50125, Italy
Nagoya City University Hospital
Nagoya, Aichi-ken, 467-8602, Japan
Hino Dermatology Clinic
Fukutsu-shi, Fukuoka, 811-3217, Japan
Takagi Dermatological Clinic
Obihiro-Shi, Hokkaidô, 080-0013, Japan
JR Sapporo Hospital
Sapporo, Hokkaidô, 060-0033, Japan
Medical Corporation Kojinkai Sapporo Skin Clinic
Sapporo, Hokkaidô, 060-0063, Japan
Fukuoka University Hospital
Fukuoka, Hukuoka, 814-0180, Japan
Nippon Life Hospital
Osaka, Osaka, 550-0006, Japan
Seikoukai Omi Medical Center
Kusatsu-shi, Shiga, 525-8585, Japan
Jichi Medical University Hospital
Shimotsuke-shi, Tochigi, 329-0498, Japan
St. Luke's International Hospital
Chuo-ku, Tokyo, 104-8560, Japan
Tokyo Teishin Hospital
Sumida-Ku, Tokyo, Japan
Medical Corporation Jitai-kai Tachikawa Dermatology Clinic
Tachikawa-shi, Tokyo, 190-0023, Japan
JCHO Tokyo Yamate Medical Center
Shinjuku-ku, Tokyo-To, 169-0073, Japan
Shirasaki Dermatology Clinic
Takaoka-shi, Toyama, 933-0871, Japan
Ohyama Dermatology Clinic
Kumamoto, 861-4101, Japan
Tokyo Medical University Hospital
Tokyo, 160-0023, Japan
Dermatology and Ophthalmology Kume Clinic
Sakaishi, Ôsaka, 593-8324, Japan
Smite Aija medical practice in dermatology, venerology
Talsi, Talsu Aprinkis, LV-3201, Latvia
Semigallia
Kuldīga, LV-3301, Latvia
Riga 1st Hospital
Riga, LV-1001, Latvia
Aesthetic dermatology clinic of prof. J. Kisis
Riga, LV-1003, Latvia
Health Center 4-1 Grebenscikova Str
Riga, LV-1003, Latvia
Veseliba un estetika Ltd.
Riga, LV-1009, Latvia
Outpatient Clinic Adoria
Riga, LV-1011, Latvia
Health Center 4-Skanstes iela 50
Riga, LV-1013, Latvia
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Poznaniu
Poznan, Greater Poland Voivodeship, 60-702, Poland
Twoja Przychodnia PCM
Poznan, Greater Poland Voivodeship, 61-293, Poland
Centrum Medyczne ALL-MED
Krakow, Lesser Poland Voivodeship, 30-033, Poland
Pratia MCM Krakow
Krakow, Lesser Poland Voivodeship, 30-727, Poland
Krakowskie Centrum Medyczne Sp. z o.o.
Krakow, Lesser Poland Voivodeship, 31-501, Poland
Centrum Medyczne Katowice - PRATIA
Katowice, Lower Silesian Voivodeship, 40-081, Poland
Globe Badania Kliniczne Spolka z o.o. - Klodzko
Kłodzko, Lower Silesian Voivodeship, 57-300, Poland
Cityclinic Przychodnia lekarsko psychologiczna Matusiak sp.p
Wroclaw, Lower Silesian Voivodeship, 50-566, Poland
Clinical Best Solutions Sp. z o.o. S.K.
Lublin, Lublin Voivodeship, 20-011, Poland
Luxderm Specjalistyczny Gabinet Dermatologiczny Dorota Krasowska
Lublin, Lublin Voivodeship, 20-573, Poland
Centrum Terapii Współczesnej J.M. Jasnorzewska S.K.A.
Lódz, Lódzkie, 90-338, Poland
Rheumatology Clinic NZOZ Lecznica MAK-MED
Nadarzyn, Masovian Voivodeship, 05-830, Poland
ETG Siedlce - PPDS
Siedlce, Masovian Voivodeship, 08-110, Poland
RCMed Oddzial Sochaczew
Sochaczew, Masovian Voivodeship, 96-500, Poland
Clinical Best Solutions Sp. z o.o. S.K.
Warsaw, Masovian Voivodeship, 00-710, Poland
MICS Centrum Medyczne Warszawa
Warsaw, Masovian Voivodeship, 00-874, Poland
Clinical Research Group Sp. z o.o
Warsaw, Masovian Voivodeship, 01-142, Poland
High-Med Przychodnia Specjalistyczna
Warsaw, Masovian Voivodeship, 01-817, Poland
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Warszawie
Warsaw, Masovian Voivodeship, 02-672, Poland
ETG Warszawa - PPDS
Warsaw, Masovian Voivodeship, 02-677, Poland
Klinika Reuma Park sp . zoo Sp.k.
Warsaw, Masovian Voivodeship, 02-691, Poland
Klinika Ambroziak Dermatologia
Warsaw, Masovian Voivodeship, 02-953, Poland
FutureMeds - Targowek - PPDS
Warsaw, Masovian Voivodeship, 03-291, Poland
NZOZ Osteo Medic SC Artur Racewicz Jerzy Supronik
Bialystok, Podlaskie Voivodeship, 15-351, Poland
ClinicMed Daniluk, Nowak Spolka Komandytowa
Bialystok, Podlaskie Voivodeship, 15-879, Poland
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdansku
Gdansk, Pomeranian Voivodeship, 80-382, Poland
Copernicus Podmiot Leczniczy Sp. z o.o, Szpital Sw. Wojciecha, Oddzial Dermatologii
Gdansk, Pomeranian Voivodeship, 80-462, Poland
Centrum Badan Klinicznych Pi-house Sp. Z O. O.
Gdansk, Pomeranian Voivodeship, 80-546, Poland
Derm-art
Gdynia, Pomeranian Voivodeship, 81-415, Poland
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Katowicach
Katowice, Silesian Voivodeship, 40-040, Poland
Centrum Medyczne Angelius Provita
Katowice, Silesian Voivodeship, 40-611, Poland
Pro Familia Altera Sp. z o.o.
Katowice, Silesian Voivodeship, 40-648, Poland
Twoja Przychodnia Szczecińskie Centrum Medyczne Sp. z o.o.
Szczecin, West Pomeranian Voivodeship, 71-500, Poland
Centrum Uslug Medycznych MaxMed
Bochnia, 32-700, Poland
Centrum Medyczne Bydgoszcz- PRATIA
Bydgoszcz, 85-796, Poland
Ambulatorium Sp. z o.o.
Elblag, 82-300, Poland
Promed P. Lach R. Głowacki Sp. j., Centrum Medyczne Promed
Krakow, 31-411, Poland
Diamond Clinic Sp. z o.o., Diamond Medical Center
Krakow, 31-559, Poland
Uniwersytecki Szpital Kliniczny nr 2 Uniwersytetu Medycznego w Lodzi, Klinika Dermatologii i Wenerologii
Lodz, 90-647, Poland
Pro Life Medica Sp. z o.o. ETG Lublin
Lublin, 20-412, Poland
Twoja Przychodnia - Nowosolskie Centrum Medyczne sp. z o.o
Nowa Sól, 67-100, Poland
ETYKA Osrodek Badan Klinicznych
Olsztyn, 10-117, Poland
MICS Centrum Medyczne Torun
Torun, 87-100, Poland
Royalderm Agnieszka Nawrocka
Warsaw, 02 962, Poland
dermMEDICA Sp. z o.o. | Krzysztofa Kolumba 6
Wroclaw, 51-503, Poland
Dermoklinika-Centrum Medyczne s.c
Lodz, Łódź Voivodeship, 90-436, Poland
Velocity Skierniewice Sp. z o.o.
Skierniewice, Łódź Voivodeship, 96-100, Poland
Dermedic Jacek Zdybski
Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, 27-400, Poland
Ostrowieckie Centrum Medyczne Anna Olech Cudzik Krzysztof Cudzik s.c.
Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, 27-400, Poland
GCM Medical Group
San Juan, 00909-3004, Puerto Rico
Yonsei University Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, 220-701, South Korea
Chosun University Hospital
Gwangju, Gwangju Gwang'yeogsi, 61453, South Korea
Seoul National University Bundang Hospital
Beon-gil Bundang-gu, Gyeonggi-do, 13620, South Korea
The Catholic University of Korea, Bucheon St. Mary's Hospital
Bucheon-si, Gyeonggido, 14647, South Korea
Konkuk University Medical Center
Gwangjin-Gu, Seoul Teugbyeolsi, 05030, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seocho-Gu, Seoul Teugbyeolsi, 06591, South Korea
Soon Chun Hyang University Hospital Seoul
Seoul, Seoul Teugbyeolsi, 04401, South Korea
Kyung Hee University Hospital
Seoul, 2447, South Korea
Seoul National University Hospital
Seoul, 3080, South Korea
Chung-Ang University Hospital
Seoul, South Korea
Hospital Clinico San Carlos
Donostia / San Sebastian, Guipúzcoa, 20004, Spain
Hospital de Manises
Manises, Valencia, 46940, Spain
National Cheng Kung University
Tainan, Tainan City, 70403, Taiwan
National Taiwan University Hospital, Hsin-Chu Branch
Hsinchu, 300, Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung City, 81362, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Mackay Memorial Hospital-Taipei branch
Taipei, Taiwan
National Taiwan University Hospital
Zhong Zheng Qu, 100, Taiwan
Velocity Clinical Research - High Wycombe - PPDS
High Wycombe, Buckinghamshire, HP11 2QW, United Kingdom
4 Medical Clinical Solutions - Swinton - PPDS
Ilford, Essex, IG1 4HP, United Kingdom
Salford Royal Hospital - PPDS
Salford, Lancashire, M6 8HD, United Kingdom
Whipps Cross University Hospital
London, London, City of, E11 1NR, United Kingdom
Accellacare of Northamptonshire
Harrow, Middlesex, HA1 3UJ, United Kingdom
Velocity Clinical Research North London - Percy Road - PPDS
London, Middlesex, N12 8BU, United Kingdom
Related Links
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 8, 2024
First Posted
August 12, 2024
Study Start
September 4, 2024
Primary Completion
May 7, 2026
Study Completion
May 7, 2026
Last Updated
January 15, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.