Clinical trial NCT06108544: A Study About How Well TAK-279 Works and Its Safety in Participants With Moderate-to-severe Plaque Psoriasis During 60 Weeks of Treatment With a Withdrawal and Retreatment Period
Official title: A Phase 3, Randomized, Multicenter, Double-Blind, Placebo- and Active Comparator-Controlled Study With a Randomized Withdrawal and Retreatment Period to Evaluate the Efficacy, Safety, and Tolerability of TAK-279 in Subjects With Moderate-to-Severe Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Plaque Psoriasis
Keywords: Drug Therapy
Latitude Psoriasis 2, Latitude Research Program
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2023-10-31
Enrollment: 1108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main aim of this study is to show how well TAK-279 reduces the skin plaques compared to placebo, in participants with moderate-to-severe plaque psoriasis. Participants will be assigned to one of the 3 study treatments (TAK-279, apremilast (an approved treatment), or a placebo). Participants will be in the study for up to 69 weeks.

Detailed description: The drug being tested in this study is called TAK-279. TAK-279 is being tested to treat people with moderate to severe plaque psoriasis.

The study will enroll approximately 1000 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the three treatment groups for TAK-279, placebo, or apremilast in a ratio of 2:1:1 which will remain undisclosed to the patient and investigator during the study (unless there is an urgent medical need):

* TAK-279
* Apremilast
* Placebo

This multi-center trial will be conducted worldwide. The overall time to participate in this study is 69 weeks. Participants will go through a screening process to make sure they meet the rules for taking part in the study. This will take up to 35 days. If participants meet the study rules, they will be treated for up to 60 weeks. There will be a safety follow-up visit 4 weeks after their last day of treatment.

Eligibility criteria: Inclusion Criteria:

1. Plaque psoriasis for at least 6 months.
2. Moderate to severe disease.
3. Candidate for phototherapy or systemic therapy.

Exclusion Criteria:

1. Other forms of psoriasis.
2. History of recent infection.
3. Prior exposure to TAK-279 or active comparator.

Other protocol defined inclusion/exclusion criteria apply.

Primary outcomes:
measure: Percentage of Participants Achieving a Static Physician's Global Assessment (sPGA) of Clear (0) or Almost Clear (1) With a ≥2-Point Decrease from Baseline at Week 16 Comparing TAK-279 Against Placebo
timeFrame: Baseline, Week 16
measure: Percentage of Participants Achieving ≥75% Improvement from Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 16 Comparing TAK-279 Against Placebo
timeFrame: Baseline, Week 16
Secondary outcomes:
measure: Percentage of Participants Achieving 90% Improvement from Baseline in PASI (PASI-90) at Week 16 Comparing TAK-279 Against Placebo
timeFrame: Baseline, Week 16
measure: Percentage of Participants Achieving an sPGA of Clear (0) at Week 16 Comparing TAK-279 Against Placebo
timeFrame: Week 16
measure: Percentage of Participants Achieving PASI-100 at Week 16 Comparing TAK-279 Against Placebo
timeFrame: Week 16
measure: Percentage of Participants Achieving a Scalp-specific Physician's Global Assessment (ssPGA) of Clear (0) or Almost Clear (1) With a ≥2-Point Decrease from Baseline at Week 16 Comparing TAK-279 Against Placebo
timeFrame: Baseline, Week 16
measure: Percentage of Participants with a Baseline Dermatology Life Quality Index (DLQI) Score ≥2 who Achieve DLQI Score of 0 or 1 at Week 16 Comparing TAK-279 Against Placebo
timeFrame: Week 16
measure: Percentage of Participants With a Baseline Psoriasis Symptoms and Signs Diary (PSSD) ≥1 who Achieve Weekly Mean Psoriasis Symptoms and Signs Diary (PSSD) Symptom Score of 0 at Week 16 Comparing TAK-279 Against Placebo
timeFrame: Week 16
measure: Change from Baseline in Nail Psoriasis Severity Index (NAPSI) at Week 16 Among Participants With Nail Involvement at Baseline Comparing TAK-279 Against Placebo
timeFrame: Baseline, Week 16
measure: Change from Baseline in Body Surface Area (BSA) Affected by Psoriasis at Week 16 Comparing TAK-279 Against Placebo
timeFrame: Week 16
measure: Percentage Change from Baseline in BSA Affected by Psoriasis at Week 16 Comparing TAK-279 Against Placebo
timeFrame: Week 16
measure: Percentage of Participants Achieving a Physician's Global Assessment (PGA) of the Hands and/or Feet of Clear (0) or Almost Clear (1) With a ≥2-Point Decrease From Baseline at Week 16 Comparing TAK-279 Against Placebo
timeFrame: Baseline, Week 16
measure: Change from Baseline in DLQI at Week 16 Comparing TAK-279 Against Placebo
timeFrame: Baseline, Week 16
measure: Change from Baseline in the Short Form-36 Health Survey (SF-36) Version 2 Scores at Week 16 Comparing TAK-279 Against Placebo
timeFrame: Baseline, Week 16
measure: Change from Baseline in the EuroQoL 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Scores at Week 16 Comparing TAK-279 Against Placebo
timeFrame: Baseline, Week 16
measure: Change in Work Productivity and Activity Impairment-Psoriasis (WPAI-PSO) Questionnaire Scores at Week 16 Comparing TAK-279 Against Placebo
timeFrame: Week 16
measure: Percentage of Participants Achieving an sPGA of Clear (0) or Almost Clear (1) With a ≥2-Point Decrease from Baseline at Week 16 Comparing TAK-279 Against Apremilast
timeFrame: Baseline to Week 16
measure: Percentage of Participants Achieving PASI-75 at Week 16 Comparing TAK-279 Against Apremilast
timeFrame: Week 16
measure: Percentage of Participants Achieving PASI-90 at Week 16 Comparing TAK-279 Against Apremilast
timeFrame: Week 16
measure: Percentage of Participants Achieving an sPGA of Clear (0) or Almost Clear (1) With a ≥2-Point Decrease from Baseline at Week 24 Comparing TAK-279 Against Apremilast
timeFrame: Baseline to Week 24
measure: Percentage of Participants Achieving PASI-75 at Week 24 Comparing TAK-279 Against Apremilast
timeFrame: Week 24
measure: Percentage of Participants Achieving PASI-90 at Week 24 Comparing TAK-279 Against Apremilast
timeFrame: Week 24
measure: Change from Baseline in Weekly Mean PSSD Symptom Score at Week 16 Comparing TAK-279 Against Apremilast
timeFrame: Baseline to Week 16
measure: Percentage of Participants Achieving an ssPGA of Clear (0) or Almost Clear (1) With a ≥2-Point Decrease from Baseline at Week 16 Comparing TAK-279 Against Apremilast
timeFrame: Baseline to Week 16
measure: Percentage of Participants Achieving PASI-100 at Week 16 Comparing TAK-279 Against Apremilast
timeFrame: Week 16
measure: Percentage of Participants Achieving PASI-100 at Week 24 Comparing TAK-279 Against Apremilast
timeFrame: Week 24
measure: Percentage of Participants Achieving an sPGA of Clear (0) at Week 16 Comparing TAK-279 Against Apremilast
timeFrame: Week 16
measure: Percentage of Participants with a Baseline DLQI Score ≥2 who Achieve DLQI Score of 0/1 at Week 16 Comparing TAK-279 Against Apremilast
timeFrame: Week 16
measure: Percentage of Participants With a Baseline PSSD ≥1 who Achieve a Weekly Mean PSSD Symptom Score of 0 at Week 16 Comparing TAK-279 Against Apremilast
timeFrame: Week 16
measure: Change from Baseline in NAPSI Among Participants With Nail Involvement at Weeks 16 and 24 Comparing TAK-279 Against Apremilast
timeFrame: Baseline, Weeks 16 and 24
measure: Percentage of Participants Achieving an ssPGA of Clear (0) or Almost Clear (1) With a ≥2-Point Decrease from Baseline at Week 24 Comparing TAK-279 Against Apremilast
timeFrame: Baseline to Week 24
measure: Change from Baseline in DLQI at Weeks 16 and 24 Comparing TAK-279 Against Apremilast
timeFrame: Baseline, Weeks 16 and 24
measure: Change from Baseline in BSA Affected by Psoriasis at Weeks 16 and 24 Comparing TAK-279 Against Apremilast
timeFrame: Baseline, Weeks 16 and 24
measure: Percent Change from Baseline in BSA Affected by Psoriasis at Weeks 16 and 24 Comparing TAK-279 Against Apremilast
timeFrame: Baseline, Weeks 16 and 24
measure: Percentage of Participants Achieving an sPGA of Clear (0) at Week 24 Comparing TAK-279 Against Apremilast
timeFrame: Week 24
measure: Percentage of Participants With a Baseline DLQI Score ≥2 who Achieve a DLQI Score of 0/1 at Week 24 Comparing TAK-279 Against Apremilast
timeFrame: Week 24
measure: Percentage of Participants With a Baseline PSSD ≥1 who Achieve a Weekly Mean PSSD Symptom Score of 0 at Week 24 Comparing TAK-279 Against Apremilast
timeFrame: Week 24
measure: Change from Baseline in ssPGA at Weeks 16 and 24 Comparing TAK-279 Against Apremilast
timeFrame: Baseline, Weeks 16 and 24
measure: Percentage of Participants Achieving a PGA of the Hands and/or Feet of Clear (0) or Almost Clear (1) With a ≥2-Point Decrease From Baseline at Weeks 16 and 24 Comparing TAK-279 Against Apremilast
timeFrame: Baseline, Weeks 16 and 24
measure: Change from Baseline in SF-36 Version 2 Scores at Weeks 16 and 24 Comparing TAK-279 Against Apremilast
timeFrame: Baseline, Weeks 16 and 24
measure: Change from Baseline in the EQ-5D-5L Scores at Weeks 16 and 24 Comparing TAK-279 Against Apremilast
timeFrame: Baseline, Weeks 16 and 24
measure: Change from Baseline in the WPAI-PSO Scores at Weeks 16 and 24 Comparing TAK-279 Against Apremilast
timeFrame: Baseline, Weeks 16 and 24
measure: Percentage of Participants Achieving an sPGA of Clear (0) or Almost Clear (1) With a ≥2-Point Decrease from Baseline at Weeks 24 and 40 Comparing TAK-279 Against Apremilast
timeFrame: Baseline, Weeks 24 and 40
measure: Percentage of Participants Achieving PASI-75 at Weeks 24 and 40 Comparing TAK-279 Against Apremilast
timeFrame: Weeks 24 and 40
measure: Percentage of Participants Achieving PASI-90 at Weeks 24 and 40 Comparing TAK-279 Against Apremilast
timeFrame: Weeks 24 and 40
measure: Time to Relapse for PASI-75 Responders at Week 40 Comparing TAK-279 Against Placebo
timeFrame: Up to Week 60
measure: Percentage of Participants With Maintenance of PASI-75 Response at Week 60 Comparing TAK-279 Against Placebo
timeFrame: Week 60
measure: Percentage of Participants with Maintenance of sPGA of Clear (0) or Almost Clear (1) With a ≥2-Point Decrease from Baseline at Week 60 Comparing TAK-279 Against Placebo
timeFrame: Baseline to Week 60
measure: Percentage of Participants With a Disease Relapse Comparing TAK-279 Against Placebo
timeFrame: Week 40
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Adverse Events of Special Interest (AESI)
timeFrame: Up to week 69
measure: Number of Participants With Clinically Significant Abnormalities in Vital Signs
timeFrame: Up to week 69
measure: Number of Participants With Clinically Significant Laboratory Values
timeFrame: Up to week 69
measure: Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings
timeFrame: Up to week 69
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Total Dermatology
state: Alabama
city: Hoover
country: United States
facility: Cahaba Dermatology Skin Health Center
state: Alabama
city: Phoenix
country: United States
facility: Medical Dermatology Specialists
state: Arizona
city: Tucson
country: United States
facility: Noble Clinical Research
state: Arizona
city: Fort Smith
country: United States
facility: Johnson Dermatology Clinic
state: Arkansas
city: Hot Springs
country: United States
facility: Burke Pharmaceutical Research
state: Arkansas
city: Beverly Hills
country: United States
facility: Zenith Research, Inc.
state: California
city: Encino
country: United States
facility: UNISON Clinical Trials (Shahram Jacobs md inc.)
state: California
city: Fountain Valley
country: United States
facility: First OC Dermatology Research Inc.
state: California
city: Long Beach
country: United States
facility: Long Beach Research Institute, LLC
state: California
city: Los Angeles
country: United States
facility: Metropolis Dermatology Downtown LA - Probity - PPDS
state: California
city: Northridge
country: United States
facility: Northridge Clinical Trials
state: California
city: San Diego
country: United States
facility: TCR Medical Corporation
state: California
city: San Diego
country: United States
facility: University Clinical Trials
state: California
city: Santa Monica
country: United States
facility: Dermatology Institute and Skin Care Center
state: California
city: Doral
country: United States
facility: Revival Research Corporation - Florida - ClinEdge - PPDS
state: Florida
city: Miami Lakes
country: United States
facility: San Marcus Research Clinic Inc
state: Florida
city: Miami
country: United States
facility: Florida Academic Centers Research
state: Florida
city: Miramar
country: United States
facility: FXM Research Miramar
state: Florida
city: Sweetwater
country: United States
facility: Lenus Research & Medical Group
state: Florida
city: Tampa
country: United States
facility: Advanced Clinical Research Institute (ACRI) - Florida
state: Florida
city: Tampa
country: United States
facility: Olympian Clinical Research - 6331 Memorial Hwy
state: Florida
city: Atlanta
country: United States
facility: Divine Dermatology and Aesthetics, LLC
state: Georgia
city: Atlanta
country: United States
facility: Advanced Medical Research, PC
state: Georgia
city: Macon
country: United States
facility: Skin Care Physicians of Georgia
state: Georgia
city: Skokie
country: United States
facility: NorthShore Medical Group Dermatology - Skokie
state: Illinois
city: Clarksville
country: United States
facility: DS Research - 1005 E. Lewis & Clark Pkwy Indiana Location
state: Indiana
city: Louisville
country: United States
facility: Skin Sciences, PLLC
state: Kentucky
city: Louisville
country: United States
facility: DS Research of Kentucky
state: Kentucky
city: Lake Charles
country: United States
facility: Dermatology & Advanced Aesthetics
state: Louisiana
city: Rockville
country: United States
facility: Lawrence J Green, MD LLC
state: Maryland
city: Beverly
country: United States
facility: Allcutis Research LLC
state: Massachusetts
city: Brockton
country: United States
facility: Beacon Clinical Research LLC
state: Massachusetts
city: Ann Arbor
country: United States
facility: David Fivenson MD Dermatology PLLC
state: Michigan
city: Ann Arbor
country: United States
facility: University of Michigan Hospital - 1500 E Medical Center Dr
state: Michigan
city: Auburn Hills
country: United States
facility: Oakland Hills Dermatology - 3400 Auburn Rd
state: Michigan
city: Fridley
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Omaha
country: United States
facility: Skin Specialists PC
state: Nebraska
city: Las Vegas
country: United States
facility: Vivida Dermatology - Flamingo Rd - Probity - PPDS
state: Nevada
city: Portsmouth
country: United States
facility: ALLCUTIS Research, LLC.
state: New Hampshire
city: East Windsor
country: United States
facility: Psoriasis Treatment Center of Central New Jersey
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Dermatology - BRANY - PPDS
state: New York
city: New York
country: United States
facility: Mount Sinai Doctors -234 E 85th St
state: New York
city: New York
country: United States
facility: Sadick Research Group
state: New York
city: Stony Brook
country: United States
facility: Derm Research Center of NY
state: New York
city: Durham
country: United States
facility: Duke Dermatology Clinic
state: North Carolina
city: Winston-Salem
country: United States
facility: The Skin Surgery Center for Clinical Research - Objective Health - PPDS
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health Department of Dermatology - 4618 Country Club Rd
state: North Carolina
city: Columbus
country: United States
facility: ClinOhio Research Services
state: Ohio
city: Fairborn
country: United States
facility: Wright State Physicians
state: Ohio
city: Mayfield Heights
country: United States
facility: Apex Clinical Research Center
state: Ohio
city: Portland
country: United States
facility: Oregon Medical Research Center PC
state: Oregon
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center-3601 5th Ave
state: Pennsylvania
city: Hermitage
country: United States
facility: Cumberland Skin Center for Clinical Research - Objective Health - PPDS
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Clinical Research Center
state: Tennessee
city: Arlington
country: United States
facility: Arlington Research Center
state: Texas
city: Bellaire
country: United States
facility: UT Physicians Dermatology - Bellaire Station
state: Texas
city: Dallas
country: United States
facility: Modern Research Associates
state: Texas
city: Frisco
country: United States
facility: North Texas Center for Clinical Research
state: Texas
city: Pflugerville
country: United States
facility: Austin Institute for Clinical Research, Inc. - Pflugerville - ClinEdge - PPDS
state: Texas
city: San Antonio
country: United States
facility: Texas Dermatology and Laser Specialists
state: Texas
city: San Antonio
country: United States
facility: Dermatology Clinical Research Center of San Antonio
state: Texas
city: Sugar Land
country: United States
facility: Houston Center for Clinical Research, LLC
state: Texas
city: Webster
country: United States
facility: Center For Clinical Studies, LTD. LLP - 451 N Texas Ave
state: Texas
city: Webster
country: United States
facility: Center For Clinical Studies,LTD. LLP - 451 N Texas Ave
state: Texas
city: Norfolk
country: United States
facility: Virginia Clinical Research - 6160 Kempsville Cir
state: Virginia
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Conexa Investigación Clínica S.A.
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: STAT Research S.A.
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Instituto de Neumonologia y Dermatologia
city: Ciudad Autónomade Buenos Aires
country: Argentina
facility: Centro de Investigacion Clínica - CEDIC
city: San Miguel de Tucumán
country: Argentina
facility: Centro de Investigaciones Médicas Tucumán - PPDS
city: Sevlievo
country: Bulgaria
facility: Medical Center Unimed EOOD
state: Gabrovo
city: Dupnitsa
country: Bulgaria
facility: Medical Center Asklepii OOD
state: Kjustendil
city: Sofia
country: Bulgaria
facility: Diagnostic and Consulting Center Aleksandrovska EOOD
state: Sofia-Grad
city: Sofia
country: Bulgaria
facility: Diagnostic Consultative Centre - Focus-5 - LZIP EOOD
state: Sofia-Grad
city: Sofia
country: Bulgaria
facility: Medical Center Hera EOOD
state: Sofia-Grad
city: Sofia
country: Bulgaria
facility: Diagnostic Consultative Center XXVIII - Sofia - EOOD
state: Sofia-Grad
city: Sofia
country: Bulgaria
facility: Ambulatory for Specialized Medical Care- Group Practice in Dermatology - Clinic EuroDerma OOD
state: Sofia-Grad
city: Sofia
country: Bulgaria
facility: Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia
state: Sofia-Grad
city: Sofia
country: Bulgaria
facility: MC Comac Medical - IRN - PPDS
state: Sofia-Grad
city: Elin Pelin
country: Bulgaria
facility: MBAL Skin Systems, Doganovo
state: Sofia
city: Dobrich
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment - Dobrich AD
city: Gabrovo
country: Bulgaria
facility: Multiprofile Hospital For Active Treatment Dr Tota Venkova
city: Haskovo
country: Bulgaria
facility: Diagnostic Consultative Center Sveti Georgi EOOD
city: Pleven
country: Bulgaria
facility: Medical Center Medconsult Pleven OOD
city: Pleven
country: Bulgaria
facility: Medical Center Exacta Medica - Vasil Levski 60
city: Pleven
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment -Dr. Georgi Stranski -Gen. V. Vazov Str 91
city: Calgary
country: Canada
facility: Dermatology Research Institute, Inc. - Probity - PPDS
state: Alberta
city: Edmonton
country: Canada
facility: Alberta DermaSurgery Centre - Probity - PPDS
state: Alberta
city: Edmonton
country: Canada
facility: VIDA Dermatology - Probity - PPDS
state: Alberta
city: Red Deer
country: Canada
facility: CaRe Clinic-Red Deer
state: Alberta
city: Winnipeg
country: Canada
facility: Wiseman Dermatology Research Inc. - Probity - PPDS
state: Manitoba
city: Fredericton
country: Canada
facility: Brunswick Dermatology Centre - Probity - PPDS
state: New Brunswick
city: Hamilton
country: Canada
facility: Lima's Excellence In Allergy And Dermatology Research (Leader) Inc. - Probity - PPDS
state: Ontario
city: Hamilton
country: Canada
facility: Dermatrials Research
state: Ontario
city: London
country: Canada
facility: DermEffects - Probity - PPDS
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research Inc - Probity - PPDS
state: Ontario
city: Mississauga
country: Canada
facility: DermEdge Research - Probity - PPDS
state: Ontario
city: Oakville
country: Canada
facility: The Centre for Clinical Trials Inc. - Probity - PPDS
state: Ontario
city: Oshawa
country: Canada
facility: Oshawa Clinic-117 King St
state: Ontario
city: Peterborough
country: Canada
facility: SKiN Centre for Dermatology - Peterborough - Probity - PPDS
state: Ontario
city: Richmond Hill
country: Canada
facility: Centre For Dermatology and Cosmetic Surgery - Probity - PPDS
state: Ontario
city: Richmond Hill
country: Canada
facility: Dr. S. K. Siddha Medicine Professional Corporation - Probity - PPDS
state: Ontario
city: Toronto
country: Canada
facility: Canadian Dermatology Centre - Probity - PPDS
state: Ontario
city: Toronto
country: Canada
facility: Toronto Research Centre - Probity - PPDS
state: Ontario
city: Waterloo
country: Canada
facility: Alliance Clinical Trials - Probity - PPDS
state: Ontario
city: Windsor
country: Canada
facility: XLR8 Medical Research - Probity - PPDS
state: Ontario
city: Westmount
country: Canada
facility: Siena Medical Research
state: Quebec
city: Saskatoon
country: Canada
facility: Skinsense Medical Research - 411 2nd Ave N - Probity - PPDS
state: Saskatchewan
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Wuhan
country: China
facility: Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
city: Nanjing
country: China
facility: The First Affiliated Hospital With Nanjing Medical University(Jiangsu Province Hospital)
state: Jiangsu
city: Zhenjiang
country: China
facility: Affiliated Hospital of Jiangsu University
state: Jiangsu
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
state: Jiangxi
city: Taiyuan
country: China
facility: First Hospital of Shanxi Medical University
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital Sichuan University
state: Sichuan
city: Kunming
country: China
facility: The Second Affiliated Hospital of Kunming Medical University
state: Yunnan
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital Zhejiang University School of Medicine - Qingchun Campus
state: Zhejiang
city: Shanghai
country: China
facility: Huashan Hospital Fudan University - PPDS
city: Brno
country: Czechia
facility: Pratia Brno s.r.o. - PRATIA - PPDS
state: Jihomoravský Kraj
city: Nachod
country: Czechia
facility: Dermamedica, s.r.o. - Kozni Ambulance Nachod
state: Královéhradecký Kraj
city: Novy Jicin
country: Czechia
facility: Nemocnice AGEL Novy Jicin a.s
state: Moravskoslezský Kraj
city: Ostrava
country: Czechia
facility: CCR Ostrava s.r.o.
state: Moravskoslezský Kraj
city: Praha 5
country: Czechia
facility: Praglandia s.r.o.
state: Ohio
city: Olomouc
country: Czechia
facility: Dermskin s.r.o.
state: Olomoucký Kraj
city: Praha
country: Czechia
facility: CLINTRIAL s.r.o.
state: Praha, Hlavní Mesto
city: Pardubice
country: Czechia
facility: Pratia Pardubice a.s. - PRATIA - PPDS
city: Praha 10
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady
city: Praha 1
country: Czechia
facility: Prof. MUDr. Petr Arenberger, DrSc. - CRC - PPDS
city: Le Mans cedex 9
country: France
facility: Centre Hospitalier Le Mans
state: Ohio
city: Marseille
country: France
facility: AP-HM- Hôpital de La Timone
city: Rouen
country: France
facility: Hôpital Charles Nicolle-1 Rue de Germont
city: Bad Bentheim
country: Germany
facility: Fachklinik Bad Bentheim
state: Niedersachsen
city: Dresden
country: Germany
facility: Klinische Forschung Dresden GmbH (KFGN) - PRATIA - PPDS
state: Sachsen
city: Dresden
country: Germany
facility: Praxis fur Dermatologie and Venerologie
state: Sachsen
city: Gera
country: Germany
facility: SRH Wald-Klinikum Gera GmbH
state: Thüringen
city: Berlin
country: Germany
facility: FutureMeds - Berlin - PPDS
city: Hamburg
country: Germany
facility: Dermatologikum Hamburg
city: Kiel
country: Germany
facility: Medizinisches Versorgungszentrum DermaKiel GmbH
city: Athens
country: Greece
facility: Hospital A.Syggros
state: Attiki
city: Chaidari
country: Greece
facility: University General Hospital ''ATTIKON''
state: Attiki
city: Loannina
country: Greece
facility: University Hospital of Ioannina
city: Thessaloniki
country: Greece
facility: Hospital Of Skin And Venereal Diseases of Thessaloniki
city: Thessaloniki
country: Greece
facility: Papageorgiou General Hospital of Thessaloniki
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem
state: Csongrád
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus
state: Hajdú-Bihar
city: Szolnok
country: Hungary
facility: Allergo-Derm Bakos Kft- Szolnok-Baross utca 20
state: Jász-Nagykun-Szolnok
city: Kaposvár
country: Hungary
facility: Somogy Varmegyei Kaposi Mor Oktato Korhaz
state: Somogy
city: Szombathely
country: Hungary
facility: Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz
state: Vas
city: Pecs
country: Hungary
facility: Pécsi Tudomanyegyetem - Vasvari Pal u.
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center - PPDS
state: Tel-Aviv
city: Tel Aviv-Yafo
country: Israel
facility: Tel Aviv Sourasky Medical Center Ichilov - PPDS 27004
state: Tel-Aviv
city: Jerusalem
country: Israel
facility: Hadassah Medical Center- Ein Kerem - PPDS
state: Yerushalayim
city: Afula
country: Israel
facility: HaEmek Medical Center
city: Petach Tikva
country: Israel
facility: Rabin Medical Center - PPDS
city: Riga
country: Latvia
facility: Adoria
state: Ohio
city: Talsi
country: Latvia
facility: Smite Aija doctor practice in dermatology, venerology
state: Talsu Aprinkis
city: Kuldīga
country: Latvia
facility: Semigallia
city: Riga
country: Latvia
facility: Riga 1st Hospital
city: Riga
country: Latvia
facility: Health Center 4, Center of Diagnostics
city: Riga
country: Latvia
facility: J. Kisis
city: Riga
country: Latvia
facility: Veseliba un estetika
city: Riga
country: Latvia
facility: Health Center 4, Clinic of Dermatology
city: Wroclaw
country: Poland
facility: WroMedica
state: Dolnoslaskie
city: Lublin
country: Poland
facility: Luxderm Specjalistyczny Gabinet Dermatologiczny Dorota Krasowska
state: Lubelskie
city: Nowa Sol
country: Poland
facility: Twoja Przychodnia Nowosolskie Centrum Medyczne sp. z o.o
state: Lubuskie
city: Lódz
country: Poland
facility: Centrum Terapii Wspolczesnej
state: Lódzkie
city: Skierniewice
country: Poland
facility: ClinMedica Research
state: Lódzkie
city: Krakow
country: Poland
facility: Centrum Medyczne ALL-MED
state: Malopolskie
city: Kraków
country: Poland
facility: Krakowskie Centrum Medyczne - FutureMeds - PPDS
state: Malopolskie
city: Siedlce
country: Poland
facility: ETG Siedlce - PPDS
state: Mazowieckie
city: Sochaczew
country: Poland
facility: RCMed Oddzial Sochaczew
state: Mazowieckie
city: Warszawa
country: Poland
facility: Clinical Research Group Sp. z o.o
state: Mazowieckie
city: Warszawa
country: Poland
facility: AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Warszawie
state: Mazowieckie
city: Warszawa
country: Poland
facility: ETG Warszawa - PPDS
state: Mazowieckie
city: Warszawa
country: Poland
facility: FutureMeds - Targowek - PPDS
state: Mazowieckie
city: Torun
country: Poland
facility: MICS Centrum Medyczne Torun - MICS - PPDS
state: Ohio
city: Bialystok
country: Poland
facility: NZOZ Osteo Medic SC Artur Racewicz Jerzy Supronik
state: Podlaskie
city: Chojnice
country: Poland
facility: Centrum Medyczne Chojnice - PRATIA - PPDS
state: Pomorskie
city: Gdansk
country: Poland
facility: Centrum Badan Klinicznych PI-House sp. z o.o.
state: Pomorskie
city: Gdynia
country: Poland
facility: AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdyni
state: Pomorskie
city: Katowice
country: Poland
facility: AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Katowicach
state: Slaskie
city: Katowice
country: Poland
facility: Centrum Medyczne Angelius Provita
state: Slaskie
city: Katowice
country: Poland
facility: Pro Familia Altera Sp. z o.o.
state: Slaskie
city: Ostrowiec Swietokrzyski
country: Poland
facility: Dermedic Jacek Zdybski
state: Swietokrzyskie
city: Ostrowiec Swietokrzyski
country: Poland
facility: Ostrowieckie Centrum Medyczne
state: Swietokrzyskie
city: Poznan
country: Poland
facility: Solumed Centrum Medyczne
state: Wielkopolskie
city: Poznań
country: Poland
facility: Twoja Przychodnia PCM
state: Wielkopolskie
city: Bochnia
country: Poland
facility: Centrum Uslug Medycznych MaxMed
city: Elblag
country: Poland
facility: Ambulatorium Barbara Bazela
city: Klodzko Dolnoslaskie
country: Poland
facility: Globe Badania Kliniczne Spólka z o.o. - Klodzko
city: Krakow
country: Poland
facility: Diamond Clinic
city: Kraków
country: Poland
facility: MCM Krakow - PRATIA - PPDS
city: Lublin
country: Poland
facility: ETG Lublin - PPDS
city: Olsztyn
country: Poland
facility: ETYKA Osrodek Badan Klinicznych
city: Osielsko
country: Poland
facility: DermoDent Centrum Medyczne Aldona Czajkowska Rafał Czajkowski, s.c.
city: Warszawa
country: Poland
facility: Royalderm
city: Wrocław
country: Poland
facility: dermMEDICA Sp. z o.o
city: San Juan
country: Puerto Rico
facility: GCM Medical Group, PSC -62 Calle Jose Marti
city: Badalona
country: Spain
facility: Hospital Universitario Germans Trias i Pujol
state: Barcelona
city: Manises
country: Spain
facility: Hospital de Manises
state: Valencia
city: Barcelona
country: Spain
facility: Hospital de La Santa Creu i Sant Pau
city: las Palmas de Gran Canaria
country: Spain
facility: Hospital Universitario de Gran Canaria Doctor Negrin
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario La Paz - PPDS
city: High Wycombe
country: United Kingdom
facility: Velocity Clinical Research, High Wycombe - PPDS
state: Buckinghamshire
city: Ilford
country: United Kingdom
facility: 4 Medical Clinical Solutions (4MCS) Swinton - PPDS
state: Essex
city: Chorley
country: United Kingdom
facility: Accellacare of Yorkshire
state: Lancashire
city: Salford
country: United Kingdom
facility: Salford Royal Hospital - PPDS
state: Lancashire
city: London
country: United Kingdom
facility: Whipps Cross Hospital
state: London, City Of
city: Harrow
country: United Kingdom
facility: Accellacare of Northamptonshire
state: Middlesex
city: London
country: United Kingdom
facility: Velocity Clinical Research, North London - PPDS
state: Middlesex
city: Northwood
country: United Kingdom
facility: Accellacare - North London Clinical Studies Centre
state: Middlesex
city: Bradford
country: United Kingdom
facility: St Luke's Hospital
state: West Yorkshire
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: