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

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

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.

Study Overview

• Status: Completed
• Conditions: Plaque Psoriasis
• Intervention / Treatment: Drug: TAK-279; Drug: Placebo; Drug: Apremilast

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.

• Study Type: Interventional
• Enrollment (Actual): 1108
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1425BEA
    • Instituto de Neumonologia y Dermatologia
  • Buenos Aires, Argentina, C1023AAB
    • Stat Research S.A.
  • Buenos Aires, Argentina, C1012
    • CONEXA Investigacion Clinica S.A.
  • Ciudad Autónomade Buenos Aires, Argentina, C1060ABN
    • Centro de Investigacion Clínica - CEDIC
  • San Miguel de Tucumán, Argentina, T4000
    • Centro de Investigaciones Médicas Tucumán - PPDS
• Bulgaria
  • Dobrich, Bulgaria, 9300
    • Multiprofile Hospital for Active Treatment - Dobrich AD
  • Gabrovo, Bulgaria, 5300
    • Multiprofile Hospital For Active Treatment Dr Tota Venkova
  • Haskovo, Bulgaria, 6300
    • Diagnostic Consultative Center Sveti Georgi EOOD
  • Pleven, Bulgaria, 5800
    • Medical center Medconsult Pleven OOD
  • Pleven, Bulgaria, 5801
    • Medical Center Exacta Medica - Vasil Levski 60
  • Pleven, Bulgaria
    • University Multiprofile Hospital for Active Treatment -Dr. Georgi Stranski -Gen. V. Vazov Str 91
  • Gabrovo
    • Sevlievo, Gabrovo, Bulgaria, 5400
      • Medical Center Unimed Eood
  • Kyustendil
    • Dupnitsa, Kyustendil, Bulgaria, 2600
      • Medical Center Asklepii OOD
  • Sofia
    • Elin Pelin, Sofia, Bulgaria, 2115
      • MBAL Skin Systems, Doganovo
  • Sofia-Grad
    • Sofia, Sofia-Grad, Bulgaria, 1431
      • Diagnostic and Consulting Center Aleksandrovska EOOD
    • Sofia, Sofia-Grad, Bulgaria, 1463
      • Diagnostic Consultative Centre - Focus-5 - LZIP EOOD
    • Sofia, Sofia-Grad, Bulgaria, 1510
      • Medical Center Hera EOOD
    • Sofia, Sofia-Grad, Bulgaria, 1592
      • Diagnostic Consultative Center XXVIII - Sofia - EOOD
    • Sofia, Sofia-Grad, Bulgaria, 1606
      • Ambulatory for Specialized Medical Care- Group Practice in Dermatology - Clinic EuroDerma OOD
    • Sofia, Sofia-Grad, Bulgaria, 1606
      • Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia
    • Sofia, Sofia-Grad, Bulgaria, 1612
      • MC Comac Medical - IRN - PPDS
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T3A 2N1
      • Dermatology Research Institute, Inc. - Probity - PPDS
    • Edmonton, Alberta, Canada, T6G 1C2 Canada
      • Alberta DermaSurgery Centre - Probity - PPDS
    • Edmonton, Alberta, Canada, T6H 4J8
      • VIDA Dermatology - Probity - PPDS
    • Red Deer, Alberta, Canada, T4N 7C3
      • CaRe Clinic-Red Deer
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 0V9
      • Wiseman Dermatology Research Inc. - Probity - PPDS
  • New Brunswick
    • Fredericton, New Brunswick, Canada, E3B 1G9
      • Brunswick Dermatology Centre - Probity - PPDS
  • Ontario
    • Hamilton, Ontario, Canada, L8N 1Y2
      • Dermatrials Research
    • Hamilton, Ontario, Canada, L8L 3C3
      • Lima's Excellence In Allergy And Dermatology Research (Leader) Inc. - Probity - PPDS
    • London, Ontario, Canada, N6H 5L5
      • DermEffects - Probity - PPDS
    • Markham, Ontario, Canada, L3P 1X3
      • Lynderm Research Inc - Probity - PPDS
    • Mississauga, Ontario, Canada, L4Y 4C5
      • DermEdge Research - Probity - PPDS
    • Oakville, Ontario, Canada, L6J 7W5
      • The Centre for Clinical Trials Inc. - Probity - PPDS
    • Oshawa, Ontario, Canada, L1R 1R7
      • Oshawa Clinic-117 King St
    • Peterborough, Ontario, Canada, K9J 1Z2
      • SKiN Centre for Dermatology - Peterborough - Probity - PPDS
    • Richmond Hill, Ontario, Canada, L4B 1M5
      • Centre For Dermatology and Cosmetic Surgery - Probity - PPDS
    • Richmond Hill, Ontario, Canada, L4C 9M7
      • Dr. S. K. Siddha Medicine Professional Corporation - Probity - PPDS
    • Toronto, Ontario, Canada, M3B 0A7
      • Canadian Dermatology Centre - Probity - PPDS
    • Toronto, Ontario, Canada, M3H 5Y8
      • Toronto Research Centre - Probity - PPDS
    • Waterloo, Ontario, Canada, N2J 1C4
      • Alliance Clinical Trials - Probity - PPDS
    • Windsor, Ontario, Canada, N8X 3V6
      • XLR8 Medical Research - Probity - PPDS
  • Quebec
    • Westmount, Quebec, Canada, H3Z 2S6
      • Siena Medical Research
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7K 0H6
      • Skinsense Medical Research - 411 2nd Ave N - Probity - PPDS
• China
  • Shanghai, China, 200040
    • Huashan Hospital Fudan University - PPDS
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100029
      • China-Japan Friendship Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Guangdong Provincial People's Hospital
  • Henan
    • Zhengzhou, Henan, China, 450003
      • Henan Provincial People's Hospital
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
  • Hunan
    • Changsha, Hunan, China, 410013
      • The Third Xiangya Hospital of Central South University
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • The First Affiliated Hospital With Nanjing Medical University(Jiangsu Province Hospital)
    • Zhenjiang, Jiangsu, China, 212001
      • Affiliated Hospital of Jiangsu University
  • Jiangxi
    • Nanchang, Jiangxi, China, 330008
      • The Second Affiliated Hospital of Nanchang University
  • Shanxi
    • Taiyuan, Shanxi, China, 030001
      • First Hospital of Shanxi Medical University
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital Sichuan University
  • Yunnan
    • Kunming, Yunnan, China, 650000
      • The Second Affiliated Hospital of Kunming Medical University
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310016
      • Sir Run Run Shaw Hospital Zhejiang University School of Medicine - Qingchun Campus
• Czechia
  • Pardubice, Czechia, 530 02
    • Pratia Pardubice a.s. - PRATIA - PPDS
  • Prague, Czechia, 100 34
    • Fakultni nemocnice Kralovske Vinohrady
  • Prague, Czechia, 110 00
    • Prof. MUDr. Petr Arenberger, DrSc. - CRC - PPDS
  • Královéhradecký kraj
    • Náchod, Královéhradecký kraj, Czechia, 547 01
      • Dermamedica, s.r.o. - Kozni Ambulance Nachod
  • Moravskoslezský kraj
    • Nový Jičín, Moravskoslezský kraj, Czechia, 741 01
      • Nemocnice AGEL Novy Jicin a.s
    • Ostrava, Moravskoslezský kraj, Czechia, 702 00
      • CCR Ostrava s.r.o.
  • Ohio
    • Prague, Ohio, Czechia, 150 00
      • Praglandia s.r.o.
  • Olomoucký kraj
    • Olomouc, Olomoucký kraj, Czechia, 779 00
      • Dermskin s.r.o.
  • Praha, Hlavní Mesto
    • Prague, Praha, Hlavní Mesto, Czechia, 100 00
      • CLINTRIAL s.r.o.
  • South Moravian
    • Brno, South Moravian, Czechia, 602 00
      • Pratia Brno s.r.o. - PRATIA - PPDS
• France
  • Marseille, France, 13885
    • AP-HM- Hôpital de La Timone
  • Rouen, France, 76031
    • Hopital Charles Nicolle-1 Rue de Germont
  • Ohio
    • Le Mans, Ohio, France, 72037
      • Centre Hospitalier Le Mans
• Germany
  • Berlin, Germany, 10629
    • FutureMeds - Berlin - PPDS
  • Hamburg, Germany, 20354
    • Dermatologikum Hamburg
  • Kiel, Germany, 24148
    • Medizinisches Versorgungszentrum DermaKiel GmbH
  • Lower Saxony
    • Bad Bentheim, Lower Saxony, Germany, 48455
      • Fachklinik Bad Bentheim
  • Saxony
    • Dresden, Saxony, Germany, 01069
      • Klinische Forschung Dresden GmbH (KFGN) - PRATIA - PPDS
    • Dresden, Saxony, Germany, 01097
      • Praxis fur Dermatologie and Venerologie
  • Thuringia
    • Gera, Thuringia, Germany, 07548
      • SRH Wald-Klinikum Gera GmbH
• Greece
  • Thessaloniki, Greece, 564 29
    • Papageorgiou General Hospital Of Thessaloniki
  • Thessaloniki, Greece, 546 43
    • Hospital Of Skin And Venereal Diseases of Thessaloniki
  • Attica
    • Athens, Attica, Greece, 161 21
      • Hospital A.Syggros
    • Chaïdári, Attica, Greece, 124 62
      • University General Hospital ''ATTIKON''
  • Loannina
    • Loannina, Loannina, Greece, 455 00
      • University Hospital of Ioannina
• Hungary
  • Pécs, Hungary, 7632
    • Pécsi Tudomanyegyetem - Vasvari Pal u.
  • Csongrád megye
    • Szeged, Csongrád megye, Hungary, 6720
      • Szegedi Tudomanyegyetem
  • Hajdú-Bihar
    • Debrecen, Hajdú-Bihar, Hungary, 4032
      • Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus
  • Jász-Nagykun-Szolnok
    • Szolnok, Jász-Nagykun-Szolnok, Hungary, 5000
      • Allergo-Derm Bakos Kft- Szolnok-Baross utca 20
  • Somogy County
    • Kaposvár, Somogy County, Hungary, 7400
      • Somogy Varmegyei Kaposi Mor Oktato Korhaz
  • Vas County
    • Szombathely, Vas County, Hungary, 9700
      • Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz
• Israel
  • Afula, Israel, 18101
    • Haemek Medical Center
  • Petah Tikva, Israel, 49100
    • Rabin Medical Center - PPDS
  • Jerusalem
    • Jerusalem, Jerusalem, Israel, 9112002
      • Hadassah Medical Center- Ein Kerem - PPDS
  • Tel Aviv
    • Ramat Gan, Tel Aviv, Israel, 52621
      • The Chaim Sheba Medical Center - PPDS
    • Tel Aviv, Tel Aviv, Israel, 64239
      • Tel Aviv Sourasky Medical Center Ichilov - PPDS 27004
• Latvia
  • Kuldīga, Latvia, LV-3301
    • Semigallia
  • Riga, Latvia, LV-1001
    • Riga 1st Hospital
  • Riga, Latvia, LV-1003
    • Health Center 4, Center of Diagnostics
  • Riga, Latvia, LV-1003
    • J. Kisis
  • Riga, Latvia, LV-1009
    • Veseliba un estetika
  • Riga, Latvia, LV-1013
    • Health Center 4, Clinic of Dermatology
  • Ohio
    • Riga, Ohio, Latvia, LV-1011
      • Adoria
  • Talsu Aprinkis
    • Talsi, Talsu Aprinkis, Latvia, LV-3201
      • Smite Aija doctor practice in dermatology, venerology
• Poland
  • Bochnia, Poland, 32-700
    • Centrum Uslug Medycznych MaxMed
  • Elblag, Poland, 82-300
    • Ambulatorium Barbara Bazela
  • Klodzko Dolnoslaskie, Poland, 57-300
    • Globe Badania Kliniczne Spolka z o.o. - Klodzko
  • Krakow, Poland, 31-559
    • Diamond Clinic
  • Krakow, Poland, 30-727
    • MCM Krakow - PRATIA - PPDS
  • Lublin, Poland, 20-314
    • ETG Lublin - PPDS
  • Olsztyn, Poland, 10-117
    • Etyka Osrodek Badan Klinicznych
  • Osielsko, Poland, 86-031
    • DermoDent Centrum Medyczne Aldona Czajkowska Rafał Czajkowski, s.c.
  • Warsaw, Poland
    • Royalderm
  • Wroclaw, Poland, 51-503
    • dermMEDICA Sp. z o.o
  • Greater Poland Voivodeship
    • Poznan, Greater Poland Voivodeship, Poland, 60-101
      • SOLUMED Centrum Medyczne
    • Poznan, Greater Poland Voivodeship, Poland, 61-293
      • Twoja Przychodnia PCM
  • Lesser Poland Voivodeship
    • Krakow, Lesser Poland Voivodeship, Poland, 30-033
      • Centrum Medyczne ALL-MED
    • Krakow, Lesser Poland Voivodeship, Poland, 31-501
      • Krakowskie Centrum Medyczne - FutureMeds - PPDS
  • Lower Silesian Voivodeship
    • Wroclaw, Lower Silesian Voivodeship, Poland, 51-685
      • WroMedica
  • Lublin Voivodeship
    • Lublin, Lublin Voivodeship, Poland, 20-573
      • Luxderm Specjalistyczny Gabinet Dermatologiczny Dorota Krasowska
  • Lubusz Voivodeship
    • Nowa Sól, Lubusz Voivodeship, Poland, 67-100
      • Twoja Przychodnia Nowosolskie Centrum Medyczne sp. z o.o
  • Lódzkie
    • Lódz, Lódzkie, Poland, 90-338
      • Centrum Terapii Wspolczesnej
    • Skierniewice, Lódzkie, Poland, 96-100
      • ClinMedica Research
  • Masovian Voivodeship
    • Siedlce, Masovian Voivodeship, Poland, 08-110
      • ETG Siedlce - PPDS
    • Sochaczew, Masovian Voivodeship, Poland, 96-500
      • RCMed Oddzial Sochaczew
    • Warsaw, Masovian Voivodeship, Poland, 01-142
      • Clinical Research Group Sp. z o.o
    • Warsaw, Masovian Voivodeship, Poland, 02-672
      • AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Warszawie
    • Warsaw, Masovian Voivodeship, Poland, 02-677
      • ETG Warszawa - PPDS
    • Warsaw, Masovian Voivodeship, Poland, 03-291
      • FutureMeds - Targowek - PPDS
  • Ohio
    • Torun, Ohio, Poland, 87-100
      • MICS Centrum Medyczne Torun - MICS - PPDS
  • Podlaskie Voivodeship
    • Bialystok, Podlaskie Voivodeship, Poland, 15-351
      • NZOZ Osteo Medic SC Artur Racewicz Jerzy Supronik
  • Pomeranian Voivodeship
    • Chojnice, Pomeranian Voivodeship, Poland, 89-600
      • Centrum Medyczne Chojnice - PRATIA - PPDS
    • Gdansk, Pomeranian Voivodeship, Poland, 80-546
      • Centrum Badan Klinicznych PI-House sp. z o.o.
    • Gdynia, Pomeranian Voivodeship, Poland, 81-537
      • AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdyni
  • Silesian Voivodeship
    • Katowice, Silesian Voivodeship, Poland, 40-648
      • Pro Familia Altera Sp. z o.o.
    • Katowice, Silesian Voivodeship, Poland, 40-040
      • AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Katowicach
    • Katowice, Silesian Voivodeship, Poland, 40-611
      • Centrum Medyczne Angelius Provita
  • Świętokrzyskie Voivodeship
    • Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, Poland, 27-400
      • Dermedic Jacek Zdybski
    • Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, Poland, 27-400
      • Ostrowieckie Centrum Medyczne
• Puerto Rico
  • San Juan, Puerto Rico, 00909-3004
    • GCM Medical Group, PSC -62 Calle Jose Marti
• Spain
  • Barcelona, Spain, 08041
    • Hospital de la Santa Creu i Sant Pau
  • Las Palmas de Gran Canaria, Spain, 35010
    • Hospital Universitario de Gran Canaria Doctor Negrín
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz - PPDS
  • Barcelona
    • Badalona, Barcelona, Spain, 08915
      • Hospital Universitario Germans Trias i Pujol
  • Valencia
    • Manises, Valencia, Spain, 46940
      • Hospital de Manises
• United Kingdom
  • Buckinghamshire
    • High Wycombe, Buckinghamshire, United Kingdom, HP11 2QW
      • Velocity Clinical Research, High Wycombe - PPDS
  • Essex
    • Ilford, Essex, United Kingdom, IG1 4HP
      • 4 Medical Clinical Solutions (4MCS) Swinton - PPDS
  • Lancashire
    • Chorley, Lancashire, United Kingdom, PR7 7NA
      • Accellacare of Yorkshire
    • Salford, Lancashire, United Kingdom, M6 8HD
      • Salford Royal Hospital - PPDS
  • London, City of
    • London, London, City of, United Kingdom, E11 1NR
      • Whipps Cross Hospital
  • Middlesex
    • Harrow, Middlesex, United Kingdom, HA1 3UJ
      • Accellacare of Northamptonshire
    • London, Middlesex, United Kingdom, N12 8BU
      • Velocity Clinical Research, North London - PPDS
    • Northwood, Middlesex, United Kingdom, HA6 2RN
      • Accellacare - North London Clinical Studies Centre
  • West Yorkshire
    • Bradford, West Yorkshire, United Kingdom, BD5 0NA
      • St Luke's Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Total Dermatology
    • Hoover, Alabama, United States, 35244-2111
      • Cahaba Dermatology Skin Health Center
  • Arizona
    • Phoenix, Arizona, United States, 85006-2722
      • Medical Dermatology Specialists
    • Tucson, Arizona, United States, 85704-7892
      • Noble Clinical Research
  • Arkansas
    • Fort Smith, Arkansas, United States, 72916-6103
      • Johnson Dermatology Clinic
    • Hot Springs, Arkansas, United States, 71913-6475
      • Burke Pharmaceutical Research
  • California
    • Beverly Hills, California, United States, 90211-1705
      • Zenith Research, Inc.
    • Encino, California, United States, 91436-2428
      • UNISON Clinical Trials (Shahram Jacobs md inc.)
    • Fountain Valley, California, United States, 92708-3701
      • First OC Dermatology Research Inc.
    • Long Beach, California, United States, 90805-4587
      • Long Beach Research Institute, LLC
    • Los Angeles, California, United States, 90017-5310
      • Metropolis Dermatology Downtown LA - Probity - PPDS
    • Northridge, California, United States, 91325-4122
      • Northridge Clinical Trials
    • San Diego, California, United States, 92123
      • University Clinical Trials
    • San Diego, California, United States, 92123-1523
      • TCR Medical Corporation
    • Santa Monica, California, United States, 90404-2216
      • Dermatology Institute and Skin Care Center
  • Florida
    • Doral, Florida, United States, 33122-1902
      • Revival Research Corporation - Florida - ClinEdge - PPDS
    • Miami, Florida, United States, 33136-1003
      • Florida Academic Centers Research
    • Miami Lakes, Florida, United States, 33014-5602
      • San Marcus Research Clinic Inc
    • Miramar, Florida, United States, 33027-4714
      • FXM Research Miramar
    • Sweetwater, Florida, United States, 33172-2741
      • Lenus Research & Medical Group
    • Tampa, Florida, United States, 33607-6429
      • Advanced Clinical Research Institute (ACRI) - Florida
    • Tampa, Florida, United States, 33615
      • Olympian Clinical Research - 6331 Memorial Hwy
  • Georgia
    • Atlanta, Georgia, United States, 30315-2042
      • Divine Dermatology and Aesthetics, LLC
    • Atlanta, Georgia, United States, 30342-1418
      • Advanced Medical Research, PC
    • Macon, Georgia, United States, 31217-3861
      • Skin Care Physicians of Georgia
  • Illinois
    • Skokie, Illinois, United States, 60077-1049
      • NorthShore Medical Group Dermatology - Skokie
  • Indiana
    • Clarksville, Indiana, United States, 47129-2201
      • DS Research - 1005 E. Lewis & Clark Pkwy Indiana Location
  • Kentucky
    • Louisville, Kentucky, United States, 40217-1444
      • Skin Sciences, PLLC
    • Louisville, Kentucky, United States, 40241-6162
      • DS Research of Kentucky
  • Louisiana
    • Lake Charles, Louisiana, United States, 70605-1213
      • Dermatology & Advanced Aesthetics
  • Maryland
    • Rockville, Maryland, United States, 20850-6363
      • Lawrence J Green, MD LLC
  • Massachusetts
    • Beverly, Massachusetts, United States, 01915
      • Allcutis Research LLC
    • Brockton, Massachusetts, United States, 02301
      • Beacon Clinical Research LLC
  • Michigan
    • Ann Arbor, Michigan, United States, 48103-9746
      • David Fivenson MD Dermatology PLLC
    • Ann Arbor, Michigan, United States, 48109-5360
      • University of Michigan Hospital - 1500 E Medical Center Dr
    • Auburn Hills, Michigan, United States, 48326-3396
      • Oakland Hills Dermatology - 3400 Auburn Rd
  • Minnesota
    • Fridley, Minnesota, United States, 55432-3134
      • Minnesota Clinical Study Center
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Skin Specialists PC
  • Nevada
    • Las Vegas, Nevada, United States, 89119-5190
      • Vivida Dermatology - Flamingo Rd - Probity - PPDS
  • New Hampshire
    • Portsmouth, New Hampshire, United States, 03801-03804
      • ALLCUTIS Research, LLC.
  • New Jersey
    • East Windsor, New Jersey, United States, 08520
      • Psoriasis Treatment Center of Central New Jersey
  • New York
    • New York, New York, United States, 10029-6504
      • Mount Sinai Doctors -234 E 85th St
    • New York, New York, United States, 10075-0385
      • Sadick Research Group
    • Stony Brook, New York, United States, 11790
      • Derm Research Center of NY
    • The Bronx, New York, United States, 10467-1402
      • Montefiore Dermatology - BRANY - PPDS
  • North Carolina
    • Durham, North Carolina, United States, 27710-4000
      • Duke Dermatology Clinic
    • Winston-Salem, North Carolina, United States, 27103-7109
      • The Skin Surgery Center for Clinical Research - Objective Health - PPDS
    • Winston-Salem, North Carolina, United States, 27157-0001
      • Wake Forest Baptist Health Department of Dermatology - 4618 Country Club Rd
  • Ohio
    • Columbus, Ohio, United States, 43213-4445
      • ClinOhio Research Services
    • Fairborn, Ohio, United States, 45324
      • Wright State Physicians
    • Mayfield Heights, Ohio, United States, 44124-4005
      • Apex Clinical Research Center
  • Oregon
    • Portland, Oregon, United States, 97239-4501
      • Oregon Medical Research Center PC
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213-3403
      • University of Pittsburgh Medical Center-3601 5th Ave
  • Tennessee
    • Hermitage, Tennessee, United States, 37076-3497
      • Cumberland Skin Center for Clinical Research - Objective Health - PPDS
    • Nashville, Tennessee, United States, 37215-2888
      • Tennessee Clinical Research Center
  • Texas
    • Arlington, Texas, United States, 76011-3800
      • Arlington Research Center
    • Bellaire, Texas, United States, 77401-3535
      • UT Physicians Dermatology - Bellaire Station
    • Dallas, Texas, United States, 75231-6077
      • Modern Research Associates
    • Frisco, Texas, United States, 75034
      • North Texas Center for Clinical Research
    • Pflugerville, Texas, United States, 78660-6148
      • Austin Institute for Clinical Research, Inc. - Pflugerville - ClinEdge - PPDS
    • San Antonio, Texas, United States, 78229-3409
      • Dermatology Clinical Research Center of San Antonio
    • San Antonio, Texas, United States, 78218-3128
      • Texas Dermatology and Laser Specialists
    • Sugar Land, Texas, United States, 77479-1001
      • Houston Center for Clinical Research, LLC
    • Webster, Texas, United States, 77598-4927
      • Center For Clinical Studies, LTD. LLP - 451 N Texas Ave
    • Webster, Texas, United States, 77598-4927
      • Center For Clinical Studies,LTD. LLP - 451 N Texas Ave
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Virginia Clinical Research - 6160 Kempsville Cir

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Specified drug on specified days.
Active Comparator: Apremilast	Drug: Apremilast; Specified drug on specified days.
Experimental: TAK-279	Drug: TAK-279; Specified drug on specified days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scaling, and induration. The average of the 3 scales, rounded to the nearest whole number, is the final sPGA score. The sPGA score ranges from 0 to 4 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). Higher scores indicate more severe disease activity. 'Clear' and 'Almost clear' will include all participants who score a 0 or 1.	Baseline, Week 16
Percentage of Participants Achieving ≥75% Improvement from Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 16 Comparing TAK-279 Against Placebo	PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. Percentage of participants showing at least 75% improvement in PASI score relative to baseline PASI score will be reported.	Baseline, Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving an sPGA of Clear (0) at Week 16 Comparing TAK-279 Against Placebo	The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scaling, and induration. The average of the 3 scales, rounded to the nearest whole number, is the final sPGA score. The sPGA score ranges from 0 to 4 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). Higher scores indicate more severe disease activity. Higher scores indicate worsening. 'Clear' will include all participants who score a 0.	Week 16
Percentage of Participants Achieving PASI-100 at Week 16 Comparing TAK-279 Against Placebo	PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. Percentage of participants showing 100% improvement in PASI score relative to baseline PASI score will be reported.	Week 16
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	The DLQI is a 10-item validated questionnaire completed by the participant or caregiver used to assess the impact of skin disease on the participant's quality of life (QoL) during the previous week. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment. Each question is scored from 0=not at all, 1=a little, 2=a lot, and 3=very much, giving a total score ranging from 0 to 30. A high score is indicative of a poor QoL. DLQI scores indicate: 0-1 (no effect on participant's life), 2-5 (small effect on participant's life), 6-10 (moderate effect on participant's life), 11-20 (very large effect on participant's life), 21-30 (extremely large effect on participant's life).	Week 16
Change in Work Productivity and Activity Impairment-Psoriasis (WPAI-PSO) Questionnaire Scores at Week 16 Comparing TAK-279 Against Placebo	The WPAI-PSO consists of 6 questions to determine employment status, hours missed from work because of psoriasis, hours missed from work for other reasons, hours actually worked, the degree to which psoriasis affected work productivity while at work, and the degree to which psoriasis affected activities outside of work. Four scores are derived: absenteeism, presenteeism (reduced productivity while at work), an overall work impairment score that combines absenteeism and presenteeism and impairment in activities performed outside of work. Each WPAI score will be expressed as impairment percentages (0-100) with higher numbers indicating greater impairment and less productivity, that is, worse outcomes.	Week 16
Percentage of Participants Achieving PASI-75 at Week 16 Comparing TAK-279 Against Apremilast	PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. Percentage of participants showing at least 75% improvement in PASI score relative to baseline PASI score will be reported.	Week 16
Percentage of Participants Achieving PASI-90 at Week 16 Comparing TAK-279 Against Apremilast	PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. Percentage of participants showing at least 90% improvement in PASI score relative to baseline PASI score will be reported.	Week 16
Percentage of Participants Achieving PASI-75 at Week 24 Comparing TAK-279 Against Apremilast	PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. Percentage of participants showing at least 75% improvement in PASI score relative to baseline PASI score will be reported.	Week 24
Percentage of Participants Achieving PASI-90 at Week 24 Comparing TAK-279 Against Apremilast	PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. Percentage of participants showing at least 90% improvement in PASI score relative to baseline PASI score will be reported.	Week 24
Percentage of Participants Achieving PASI-100 at Week 16 Comparing TAK-279 Against Apremilast	PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. Percentage of participants showing 100% improvement in PASI score relative to baseline PASI score will be reported.	Week 16
Percentage of Participants Achieving PASI-100 at Week 24 Comparing TAK-279 Against Apremilast	PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. Percentage of participants showing 100% improvement in PASI score relative to baseline PASI score will be reported.	Week 24
Percentage of Participants Achieving an sPGA of Clear (0) at Week 16 Comparing TAK-279 Against Apremilast	The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scaling, and induration. The average of the 3 scales, rounded to the nearest whole number, is the final sPGA score. The sPGA score ranges from 0 to 4 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). Higher scores indicate more severe disease activity. 'Clear' will include all participants who score a 0.	Week 16
Percentage of Participants with a Baseline DLQI Score ≥2 who Achieve DLQI Score of 0/1 at Week 16 Comparing TAK-279 Against Apremilast	The DLQI is a 10-item validated questionnaire completed by the participant or caregiver used to assess the impact of skin disease on the participant's QoL during the previous week. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment. Each question is scored from 0=not at all, 1=a little, 2=a lot, and 3=very much, giving a total score ranging from 0 to 30. A high score is indicative of a poor QoL. DLQI scores indicate: 0-1 (no effect on participant's life), 2-5 (small effect on participant's life), 6-10 (moderate effect on participant's life), 11-20 (very large effect on participant's life), 21-30 (extremely large effect on participant's life).	Week 16
Change from Baseline in DLQI at Weeks 16 and 24 Comparing TAK-279 Against Apremilast	The DLQI is a 10-item validated questionnaire completed by the participant or caregiver used to assess the impact of skin disease on the participant's QoL during the previous week. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment. Each question is scored from 0=not at all, 1=a little, 2=a lot, and 3=very much, giving a total score ranging from 0 to 30. A high score is indicative of a poor QoL. DLQI scores indicate: 0-1 (no effect on participant's life), 2-5 (small effect on participant's life), 6-10 (moderate effect on participant's life), 11-20 (very large effect on participant's life), 21-30 (extremely large effect on participant's life).	Baseline, Weeks 16 and 24
Change from Baseline in BSA Affected by Psoriasis at Weeks 16 and 24 Comparing TAK-279 Against Apremilast	Psoriasis BSA will be assessed by means of the handprint method, where the surface of the palm and 5 digits of the participant's hand represents 1% BSA. The sum of handprints equates to the total surface area of involvement.	Baseline, Weeks 16 and 24
Percent Change from Baseline in BSA Affected by Psoriasis at Weeks 16 and 24 Comparing TAK-279 Against Apremilast	Psoriasis BSA will be assessed by means of the handprint method, where the surface of the palm and 5 digits of the participant's hand represents 1% BSA. The sum of handprints equates to the total surface area of involvement.	Baseline, Weeks 16 and 24
Percentage of Participants Achieving an sPGA of Clear (0) at Week 24 Comparing TAK-279 Against Apremilast	The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scaling, and induration. The average of the 3 scales, rounded to the nearest whole number, is the final sPGA score. The sPGA score ranges from 0 to 4 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). Higher scores indicate more severe disease activity. 'Clear' will include all participants who score a 0.	Week 24
Change from Baseline in ssPGA at Weeks 16 and 24 Comparing TAK-279 Against Apremilast	ssPGA assesses the overall severity of active psoriasis on the participant's scalp. Scalp lesions will be evaluated in terms of clinical signs of erythema, induration, and scaling and scored on 5-point ssPGA scale where 0=absence of disease and 4=severe disease. Higher scores indicate worsening.	Baseline, Weeks 16 and 24
Change from Baseline in SF-36 Version 2 Scores at Weeks 16 and 24 Comparing TAK-279 Against Apremilast	The SF-36 is a self-administered, validated questionnaire designed to measure generic health-related QoL. This 36-item questionnaire measures 8 domains, including physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health, physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. Two summary scores, including the PCS and MCS, will be calculated ranging from 0 (worst) to 100 (best). Higher scores indicate better QoL.	Baseline, Weeks 16 and 24
Change from Baseline in the EQ-5D-5L Scores at Weeks 16 and 24 Comparing TAK-279 Against Apremilast	EQ-5D-5L includes 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and 5 response levels for each domain (1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems). The scores in the 5 dimensions will be summarized into a health state index score. The health state index value is a single value on a scale from less than 0 to 1 (negative values are valued as worse than dead) with higher scores indicating better health; 0=a health state equivalent to death, and 1=perfect health.	Baseline, Weeks 16 and 24
Change from Baseline in the WPAI-PSO Scores at Weeks 16 and 24 Comparing TAK-279 Against Apremilast	The WPAI-PSO consists of 6 questions to determine employment status, hours missed from work because of psoriasis, hours missed from work for other reasons, hours actually worked, the degree to which psoriasis affected work productivity while at work, and the degree to which psoriasis affected activities outside of work. Four scores are derived: absenteeism, presenteeism (reduced productivity while at work), an overall work impairment score that combines absenteeism and presenteeism and impairment in activities performed outside of work. Each WPAI score will be expressed as impairment percentages (0-100) with higher numbers indicating greater impairment and less productivity, that is, worse outcomes.	Baseline, Weeks 16 and 24
Percentage of Participants Achieving 90% Improvement from Baseline in PASI (PASI-90) at Week 16 Comparing TAK-279 Against Placebo	PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. Percentage of participants showing at least 90% improvement in PASI score relative to baseline PASI score will be reported.	Baseline, Week 16
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	ssPGA assesses the overall severity of active psoriasis on the participant's scalp. Scalp lesions will be evaluated in terms of clinical signs of erythema, induration, and scaling and scored on 5-point ssPGA scale where 0=absence of disease and 4=severe disease. Higher scores indicate worsening.	Baseline, Week 16
Change from Baseline in Nail Psoriasis Severity Index (NAPSI) at Week 16 Among Participants With Nail Involvement at Baseline Comparing TAK-279 Against Placebo	The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lunula, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each nail will be scored for both nail matrix and nail bed psoriasis for each quadrant (ranging from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores indicate more severe psoriasis.	Baseline, Week 16
Change from Baseline in Body Surface Area (BSA) Affected by Psoriasis at Week 16 Comparing TAK-279 Against Placebo	Psoriasis BSA will be assessed by means of the handprint method, where the surface of the palm and 5 digits of the participant's hand represents 1% BSA. The sum of handprints equates to the total surface area of involvement.	Week 16
Percentage Change from Baseline in BSA Affected by Psoriasis at Week 16 Comparing TAK-279 Against Placebo	Psoriasis BSA will be assessed by means of the handprint method, where the surface of the palm and 5 digits of the participant's hand represents 1% BSA. The sum of handprints equates to the total surface area of involvement.	Week 16
Change from Baseline in DLQI at Week 16 Comparing TAK-279 Against Placebo	The DLQI is a 10-item validated questionnaire completed by the participant or caregiver used to assess the impact of skin disease on the participant's QoL during the previous week. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment. Each question is scored from 0=not at all, 1=a little, 2=a lot, and 3=very much, giving a total score ranging from 0 to 30. A high score is indicative of a poor QoL. DLQI scores indicate: 0-1 (no effect on participant's life), 2-5 (small effect on participant's life), 6-10 (moderate effect on participant's life), 11-20 (very large effect on participant's life), 21-30 (extremely large effect on participant's life). It will be evaluated for participants with a baseline DLQI score ≥2.	Baseline, Week 16
Change from Baseline in the Short Form-36 Health Survey (SF-36) Version 2 Scores at Week 16 Comparing TAK-279 Against Placebo	The SF-36 is a self-administered, validated questionnaire designed to measure generic health-related QoL. This 36-item questionnaire measures 8 domains, including physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health, physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. Two summary scores, including the physical component summary (PCS) and mental component summary (MCS), will be calculated ranging from 0 (worst) to 100 (best). Higher scores indicate better QoL.	Baseline, Week 16
Change from Baseline in the EuroQoL 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Scores at Week 16 Comparing TAK-279 Against Placebo	EQ-5D-5L includes 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and 5 response levels for each domain (1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems). The scores in the 5 dimensions will be summarized into a health state index score. The health state index value is a single value on a scale from less than 0 to 1 (negative values are valued as worse than dead) with higher scores indicating better health; 0=a health state equivalent to death, and 1=perfect health.	Baseline, Week 16
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	The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scaling, and induration. The average of the 3 scales, rounded to the nearest whole number, is the final sPGA score. The sPGA score ranges from 0 to 4 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). Higher scores indicate more severe disease activity. Higher scores indicate worsening. 'Clear' and 'Almost clear' will include all participants who score a 0 or 1.	Baseline to Week 16
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	The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scaling, and induration. The average of the 3 scales, rounded to the nearest whole number, is the final sPGA score. The sPGA score ranges from 0 to 4 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). Higher scores indicate more severe disease activity. 'Clear' and 'Almost clear' will include all participants who score a 0 or 1.	Baseline to Week 24
Change from Baseline in Weekly Mean PSSD Symptom Score at Week 16 Comparing TAK-279 Against Apremilast	The PSSD is an 11-item validated questionnaire that assesses symptoms (itch, pain, stinging, burning, and skin tightness) and participant-observable signs (skin dryness, cracking, scaling, shedding/flaking, redness, and bleeding) of moderate-to-severe plaque psoriasis. These symptoms and signs will be evaluated by asking participants to assign a numerical score representing of worst intensity over the last 24-hour on a scale from 0 to 10, with 0 indicating absence of symptoms or signs and 10 indicating worst imaginable symptoms or signs. The PSSD is a composite score calculated based on the scores for each question that can range between 0 and 100. A higher score indicates more severe disease.	Baseline to Week 16
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	ssPGA assesses the overall severity of active psoriasis on the participant's scalp. Scalp lesions will be evaluated in terms of clinical signs of erythema, induration, and scaling and scored on 5-point ssPGA scale where 0=absence of disease and 4=severe disease. Higher scores indicate worsening.	Baseline to Week 16
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	The PSSD is an 11-item validated questionnaire that assesses symptoms (itch, pain, stinging, burning, and skin tightness) and participant-observable signs (skin dryness, cracking, scaling, shedding/flaking, redness, and bleeding) of moderate-to-severe plaque psoriasis. These symptoms and signs will be evaluated by asking participants to assign a numerical score representing of worst intensity over the last 24-hour on a scale from 0 to 10, with 0 indicating absence of symptoms or signs and 10 indicating worst imaginable symptoms or signs. The PSSD is a composite score calculated based on the scores for each question that can range between 0 and 100. A higher score indicates more severe disease.	Week 16
Change from Baseline in NAPSI Among Participants With Nail Involvement at Weeks 16 and 24 Comparing TAK-279 Against Apremilast	The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lunula, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each nail will be scored for both nail matrix and nail bed psoriasis for each quadrant (ranging from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores indicate more severe psoriasis.	Baseline, Weeks 16 and 24
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	ssPGA assesses the overall severity of active psoriasis on the participant's scalp. Scalp lesions will be evaluated in terms of clinical signs of erythema, induration, and scaling and scored on 5-point ssPGA scale where 0=absence of disease and 4=severe disease. Higher scores indicate worsening.	Baseline to Week 24
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	The DLQI is a 10-item validated questionnaire completed by the participant or caregiver used to assess the impact of skin disease on the participant's QoL during the previous week. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment. Each question is scored from 0=not at all, 1=a little, 2=a lot, and 3=very much, giving a total score ranging from 0 to 30. A high score is indicative of a poor QoL. DLQI scores indicate: 0-1 (no effect on participant's life), 2-5 (small effect on participant's life), 6-10 (moderate effect on participant's life), 11-20 (very large effect on participant's life), 21-30 (extremely large effect on participant's life).	Week 24
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	The PSSD is an 11-item validated questionnaire that assesses symptoms (itch, pain, stinging, burning, and skin tightness) and participant-observable signs (skin dryness, cracking, scaling, shedding/flaking, redness, and bleeding) of moderate-to-severe plaque psoriasis. These symptoms and signs will be evaluated by asking participants to assign a numerical score representing of worst intensity over the last 24-hour on a scale from 0 to 10, with 0 indicating absence of symptoms or signs and 10 indicating worst imaginable symptoms or signs. The PSSD is a composite score calculated based on the scores for each question that can range between 0 and 100. A higher score indicates more severe disease.	Week 24
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	The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scaling, and induration. The average of the 3 scales, rounded to the nearest whole number, is the final sPGA score. The sPGA score ranges from 0 to 4 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). Higher scores indicate more severe disease activity. 'Clear' and 'Almost clear' will include all participants who score a 0 or 1.	Baseline, Weeks 24 and 40
Percentage of Participants Achieving PASI-75 at Weeks 24 and 40 Comparing TAK-279 Against Apremilast	PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. Percentage of participants showing at least 75% improvement in PASI score relative to baseline PASI score will be reported.	Weeks 24 and 40
Percentage of Participants Achieving PASI-90 at Weeks 24 and 40 Comparing TAK-279 Against Apremilast	PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. Percentage of participants showing at least 90% improvement in PASI score relative to baseline PASI score will be reported.	Weeks 24 and 40
Time to Relapse for PASI-75 Responders at Week 40 Comparing TAK-279 Against Placebo	PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. Percentage of participants showing at least 75% improvement in PASI score relative to baseline PASI score will be reported.	Up to Week 60
Percentage of Participants With Maintenance of PASI-75 Response at Week 60 Comparing TAK-279 Against Placebo	PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. Percentage of participants showing at least 75% improvement in PASI score relative to baseline PASI score will be reported.	Week 60
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	The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scaling, and induration. The average of the 3 scales, rounded to the nearest whole number, is the final sPGA score. The sPGA score ranges from 0 to 4 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). Higher scores indicate more severe disease activity. 'Clear' and 'Almost clear' will include all participants who score a 0 or 1.	Baseline to Week 60
Percentage of Participants With a Disease Relapse Comparing TAK-279 Against Placebo	Relapse is defined as a percent change from baseline in PASI score that is at least 50% worse than that observed at Week 40. PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. Higher scores indicate worsening.	Week 40
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Adverse Events of Special Interest (AESI)	TEAE is defined as any event emerging or manifesting at or after the initiation of treatment with a study intervention or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the study intervention or medicinal product. An AESI (serious or nonserious) is an adverse event of scientific and medical concern specific to the compound or program, for which ongoing monitoring and rapid communication by the investigator may be appropriate.	Up to week 69
Number of Participants With Clinically Significant Abnormalities in Vital Signs		Up to week 69
Number of Participants With Clinically Significant Laboratory Values		Up to week 69
Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings		Up to week 69
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	PGA is a 5-point scale and a score of 0 to 4 should be assigned, based on the category that best describes the severity of active psoriasis of the participant's hands and/or feet (palmoplantar), where 0=clear and 4=severe. Higher scores indicate worsening of severity. It will be evaluated for participants with the presence of active hand or foot psoriasis on Day 1.	Baseline, Week 16
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	PGA is a 5-point scale and a score of 0 to 4 should be assigned, based on the category that best describes the severity of active psoriasis of the participant's hands and/or feet (palmoplantar), where 0=clear and 4=severe. Higher scores indicate worsening of severity. It will be evaluated for participants with the presence of active hand or foot psoriasis on Day 1.	Baseline, Weeks 16 and 24
Percentage of Participants Achieving PASI-75 at Week 4 Comparing TAK-279 Against Placebo	PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. Percentage of participants showing 75% improvement in PASI score relative to baseline PASI score will be reported.	Week 4
Percentage of Participants With a Baseline Psoriasis Symptoms and Signs Diary (PSSD) ≥1 who Achieve Weekly Mean PSSD Symptom Score of 0 at Week 16 Comparing TAK-279 Against Placebo	The PSSD is an 11-item validated questionnaire that assesses symptoms (itch, pain, stinging, burning, and skin tightness) and participant-observable signs (skin dryness, cracking, scaling, shedding/flaking, redness, and bleeding) of moderate-to-severe plaque psoriasis. These symptoms and signs will be evaluated by asking participants to assign a numerical score representing of worst intensity over the last 24-hour on a scale from 0 to 10, with 0 indicating absence of symptoms or signs and 10 indicating worst imaginable symptoms or signs. The PSSD is a composite score calculated based on the scores for each question that can range between 0 and 100. A higher score indicates more severe disease.	Week 16

Collaborators and Investigators

• Sponsor: Takeda
• Investigators: Study Director: Study Director, Takeda

Publications and helpful links

Helpful Links

• To obtain more information on the study, click here/on this link

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2023
• Primary Completion (Actual): December 6, 2024
• Study Completion (Actual): November 7, 2025

Study Registration Dates

• First Submitted: October 25, 2023
• First Submitted That Met QC Criteria: October 25, 2023
• First Posted (Actual): October 31, 2023

Study Record Updates

• Last Update Posted (Actual): November 20, 2025
• Last Update Submitted That Met QC Criteria: November 18, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Drug Therapy; Latitude Psoriasis 2, Latitude Research Program
• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Psoriasis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Antirheumatic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Anti-Inflammatory Agents, Non-Steroidal; Phosphodiesterase Inhibitors; Phosphodiesterase 4 Inhibitors; apremilast
• Other Study ID Numbers: TAK-279-3002; 2023-505842-24-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No