A Study About How Well TAK-279 Works and Its Safety in Participants With Moderate-to-severe Plaque Psoriasis During 52 Weeks of Treatment

A Phase 3, Randomized, Multicenter, Double-Blind, Placebo- and Active Comparator-Controlled Study 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 61 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 600 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the following treatment groups in a ratio of 3:1:1 to receive TAK-279, placebo, or apremilast which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):

1. TAK-279
2. Placebo
3. Apremilast

This multi-center trial will be conducted worldwide. 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 52 weeks (1 year). There will be a safety follow-up visit 4 weeks after their last day of treatment.

• Study Type: Interventional
• Enrollment (Actual): 693
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Kogarah, New South Wales, Australia, 2217
      • St George Dermatology and Skin Cancer Center - Probity - PPDS
  • Queensland
    • Benowa, Queensland, Australia, 4217
      • The Skin Center - Probity - PPDS
    • Brisbane, Queensland, Australia, 4102
      • Veracity Clinical Research Pty Ltd
  • Victoria
    • Carlton, Victoria, Australia, 3053
      • Skin Health Institute Inc - Probity - PPDS
    • East Melbourne, Victoria, Australia, 3002
      • Sinclair Dermatology-East Melbourne
    • Parkville, Victoria, Australia, 3050
      • Royal Melbourne Hospital
    • Parkville, Victoria, Australia, 3004
      • Alfred Health
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T3A 2N1
      • Beacon Dermatology - Probity - PPDS
  • British Columbia
    • Surrey, British Columbia, Canada, V3R 6A7
      • Enverus Medical Research - Probity - PPDS
  • Ontario
    • Ajax, Ontario, Canada, L1S 7K8
      • CCA Medical Research - Probity - PPDS
    • Barrie, Ontario, Canada, L4M 7G1
      • SimcoDerm Medical and Surgical Dermatology Centre - Probity - PPDS
    • Etobicoke, Ontario, Canada, M8X 1Y9
      • Kingsway Clinical Research - Probity - PPDS
    • Guelph, Ontario, Canada, N1H 1B1
      • Guelph Dermatology Research - Probity - PPDS
    • London, Ontario, Canada, N5X 2P1
      • Mediprobe Research Inc
    • North Bay, Ontario, Canada, P1B 3Z7
      • North Bay Dermatology Center - Probity - PPDS
    • North York, Ontario, Canada, M2M 4J5
      • North York Research Inc. - Probity - PPDS
    • Toronto, Ontario, Canada, M4W 2N4
      • Research Toronto - Probity - PPDS
• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100191
      • Peking University Third Hospital
    • Beijing, Beijing Municipality, China, 100044
      • Peking University People's Hospital
    • Beijing, Beijing Municipality, China, 100050
      • Beijing Friendship Hospital, Capital Medical University - PPDS
    • Beijing, Beijing Municipality, China, 100730
      • Beijing Tongren Hospital, Capital Medical University
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China, 400016
      • The First Affiliated Hospital of Chongqing Medical University
  • Fujian
    • Fuzhou, Fujian, China, 350005
      • The First Affiliated Hospital of Fujian Medical University
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
    • Guangzhou, Guangdong, China, 510280
      • Zhujiang Hospital of Southern Medical University
    • Guangzhou, Guangdong, China, 510091
      • Dermatology Hospital of Southern Medical University
    • Shenzhen, Guangdong, China, 518053
      • The University of Hong Kong - Shenzhen Hospital
  • Hebei
    • Shijiazhuang, Hebei, China, 050031
      • The First Hospital of Hebei Medical University
  • Hubei
    • Wuhan, Hubei, China, 430060
      • Renmin Hospital of Wuhan University
    • Wuhan, Hubei, China
      • Union Hospital Tongji Medical College Huazhong University of Science and Technology
  • Liaoning
    • Shenyang, Liaoning, China, 110001
      • The First Hospital of China Medical University
  • Ningxia
    • Yinchuan, Ningxia, China, 750004
      • General Hospital of Ningxia Medical University
  • Shaanxi
    • Xi'an, Shaanxi, China, 710004
      • The Second Affiliated Hospital of Xi'an Jiaotong University
  • Shandong
    • Jinan, Shandong, China, 250021
      • Shandong Provincial Hospital
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200020
      • Shanghai Skin Disease Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Zhejiang Provincial People's Hospital
    • Wenzhou, Zhejiang, China, 325000
      • The 1st Affiliated Hospital of Wenzhou Medical University - Nanbaixiang Campus
• Germany
  • Brandenburg
    • Blankenfelde-Mahlow, Brandenburg, Germany, 15831
      • Hautarztpraxis Mahlow
  • Lower Saxony
    • Oldenburg (Oldenburg), Lower Saxony, Germany, 26133
      • Klinikum Oldenburg AöR
  • North Rhine-Westphalia
    • Münster, North Rhine-Westphalia, Germany, 48149
      • Universitätsklinikum Münster
  • Schleswig-Holstein
    • Lübeck, Schleswig-Holstein, Germany, 23562
      • Universitatsklinikum Schleswig-Holstein - Campus Lubeck
• Italy
  • Abruzzo
    • L’Aquila, Abruzzo, Italy, 67100
      • ASL 1 L'Aquila - Presidio Ospedaliero San Salvatore
  • Campania
    • Napoli, Campania, Italy, 80131
      • Azienda Ospedaliera Universitaria Luigi Vanvitelli - Via Pansini 5
  • Liguria
    • Genoa, Liguria, Italy, 16132
      • IRCCS Az. Osp. Universitaria San Martino- IST
  • Lombardy
    • Milan, Lombardy, Italy, 20122
      • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico -Via Pace 9
    • Rozzano, Lombardy, Italy, 20089
      • IRCCS Istituto Clinico Humanitas
    • San Donato Milanese, Lombardy, Italy, 20097
      • IRCCS Policlinico San Donato
  • Sicily
    • Catania, Sicily, Italy, 95123
      • Presidio Ospedaliero Gaspare Rodolico
  • Tuscany
    • Florence, Tuscany, Italy, 50125
      • Azienda Usl Toscana Centro - Firenze
• Japan
  • Kumamoto, Japan, 861-4101
    • Ohyama Dermatology Clinic
  • Aiti
    • Nagoya, Aiti, Japan, 467-0802
      • Nagoya City University Hospital
  • Hokkaidô
    • Obihiro-Shi, Hokkaidô, Japan, 080-0013
      • Takagi Dermatological Clinic
    • Sapporo, Hokkaidô, Japan, 060-0033
      • JR Sapporo Hospital
    • Sapporo, Hokkaidô, Japan, 060-0063
      • Medical Corporation Kojinkai Sapporo Skin Clinic
  • Hukuoka
    • Fukuoka, Hukuoka, Japan, 814-0180
      • Fukuoka University Hospital
  • Kagoshima-ken
    • Kagoshima, Kagoshima-ken, Japan, 892-0826
      • Saruwatari Dermatology Clinic
  • Kanagawa
    • Isehara-Shi, Kanagawa, Japan, 259-1143
      • Tokai University Hospital
  • Tochigi
    • Shimotsuke-Shi, Tochigi, Japan, 329-0431
      • Jichi Medical University Hospital
  • Tokyo
    • Itabashi-Ku, Tokyo, Japan, 173-0003
      • Teikyo University Hospital
    • Shinjuku-Ku, Tokyo, Japan, 160-0023
      • Tokyo Medical University Hospital
    • Shinjuku-Ku, Tokyo, Japan, 169-0073
      • JCHO Tokyo Yamate Medical Center
    • Sumida-Ku, Tokyo, Japan
      • Tokyo Teishin Hospital
  • Ôsaka
    • Sakaishi, Ôsaka, Japan, 593-8324
      • Dermatology and Ophthalmology Kume Clinic
• Poland
  • Bydgoszcz, Poland, 85-796
    • Centrum Medyczne Bydgoszcz- PRATIA - PPDS
  • Krakow, Poland, 31-411
    • Centrum Medyczne Promed
  • Lodz, Poland, 90-647
    • Uniwersytecki Szpital Kliniczny im. WAM - Centralny Szpital Weteranow-Lodz-ul. Plac J. Hallera 1
  • Greater Poland Voivodeship
    • Poznan, Greater Poland Voivodeship, Poland, 60-702
      • AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Poznaniu
  • Lower Silesian Voivodeship
    • Wroclaw, Lower Silesian Voivodeship, Poland, 50-566
      • Cityclinic Przychodnia Lekarsko Psychologiczna Matusiak Spółka Partnerska
  • Lublin Voivodeship
    • Lublin, Lublin Voivodeship, Poland, 20-078
      • Clinical Best Solutions - Lublin
  • Lódzkie
    • Lódz, Lódzkie, Poland, 90-436
      • Dermoklinika-Centrum Medyczne s.c
  • Masovian Voivodeship
    • Nadarzyn, Masovian Voivodeship, Poland, 05-830
      • Rheumatology Clinic NZOZ Lecznica MAK-MED
    • Warsaw, Masovian Voivodeship, Poland, 00-710
      • Clinical Best Solutions - Warszawa
    • Warsaw, Masovian Voivodeship, Poland, 00-874
      • MICS Centrum Medyczne Warszawa - MICS - PPDS
    • Warsaw, Masovian Voivodeship, Poland, 01-817
      • High-Med Przychodnia Specjalistyczna
    • Warsaw, Masovian Voivodeship, Poland, 02-665
      • Klinika Reuma Park sp . zoo Sp.k.
    • Warsaw, Masovian Voivodeship, Poland, 02-953
      • Klinika Ambroziak - Kosiarzy 9A
  • Podlaskie Voivodeship
    • Bialystok, Podlaskie Voivodeship, Poland, 15-879
      • ClinicMed Daniluk, Nowak Spolka Komandytowa
  • Pomeranian Voivodeship
    • Gdansk, Pomeranian Voivodeship, Poland, 80-382
      • AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdansku
    • Gdansk, Pomeranian Voivodeship, Poland, 80-462
      • Copernicus Podmiot Leczniczy Sp. z o.o. - al. Jana Pawla II 50
    • Gdynia, Pomeranian Voivodeship, Poland, 81-415
      • Derm-art
  • Silesian Voivodeship
    • Katowice, Silesian Voivodeship, Poland, 40-081
      • Centrum Medyczne Katowice - PRATIA - PPDS
  • West Pomeranian Voivodeship
    • Szczecin, West Pomeranian Voivodeship, Poland, 71-500
      • Twoja Przychodnia SCM - Slowackiego
• South Korea
  • Seoul, South Korea, 02447
    • Kyung Hee University Hospital
  • Seoul, South Korea, 06973
    • Chung-Ang University Hospital
  • Wŏnju, South Korea, 26426
    • Yonsei University Wonju Severance Christian Hospital
  • Busan Gwangyeogsi
    • Seogu, Busan Gwangyeogsi, South Korea, 49241
      • Pusan National University Hospital
  • Daejeon Gwang'yeogsi
    • Daejeon, Daejeon Gwang'yeogsi, South Korea, 35015
      • Chungnam national university hospital
  • Georgia
    • Savannah, Georgia, South Korea, 31419-1768
      • Georgia Skin and Cancer Clinic
  • Gwangju Gwang'yeogsi
    • Gwangju, Gwangju Gwang'yeogsi, South Korea, 61453
      • Chosun University Hospital
  • Gyeonggido
    • Bucheon-si, Gyeonggido, South Korea, 14647
      • The Catholic University of Korea, Bucheon St. Mary's Hospital
    • Bundang-Gu, Gyeonggido, South Korea, 13620
      • Seoul National University Bundang Hospital
    • Bundang-Gu Seongnam-Si, Gyeonggido, South Korea, 13496
      • CHA Bundang Medical Center, CHA University - PPDS
  • Seoul Teugbyeolsi
    • Gwangjin-Gu, Seoul Teugbyeolsi, South Korea, 05030
      • Konkuk University Medical Center
    • Jongno-Gu, Seoul Teugbyeolsi, South Korea, 03080
      • Seoul National University Hospital
    • Seocho-Gu, Seoul Teugbyeolsi, South Korea, 06591
      • The Catholic University of Korea, Seoul St. Mary's Hospital
    • Seoul, Seoul Teugbyeolsi, South Korea, 04401
      • Soon Chun Hyang University Hospital Seoul
    • Seoul, Seoul Teugbyeolsi, South Korea, 07804
      • Ewha Womans University Seoul Hospital
• Taiwan
  • Hsinchu, Taiwan, 300
    • National Taiwan University Hospital - Hsin-Chu Branch
  • Kaohsiung City, Taiwan, 81362
    • Kaohsiung Veterans General Hospital
  • New Taipei City, Taiwan, 23561
    • Taipei Medical University Shuang Ho Hospital
  • Tainan City, Taiwan, 70403
    • National Cheng Kung University Hospital
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
  • Taipei, Taiwan, 104
    • Mackay Memorial Hospital-Taipei branch
  • Taoyuan, Taiwan, 33305
    • Chang Gung Memorial Hospital, Linkou
  • Zhong Zheng Qu, Taiwan, 100
    • National Taiwan University Hospital
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85008-3884
      • Saguaro Dermatology Associates, LLC - Probity - PPDS
  • California
    • Fountain Valley, California, United States, 92708-3701
      • First OC Dermatology - Fountain Valley
    • Fremont, California, United States, 94538-1614
      • Center for Dermatology Clinical Research
    • Los Angeles, California, United States, 90024
      • UCLA University of California Los Angeles
    • Sacramento, California, United States, 95816-3370
      • UC Davis Dermatology Clinic
  • Florida
    • Coral Gables, Florida, United States, 33134-3901
      • Driven Research Llc
    • Fort Lauderdale, Florida, United States, 33308-5211
      • FXM Clinical Research Ft. Lauderdale, LLC
    • Hialeah, Florida, United States, 33012-3618
      • Direct Helpers Research Center
    • Miami, Florida, United States, 33175-3582
      • FXM Clinical Research Miami, LLC
    • Ocala, Florida, United States, 34470-6657
      • Renstar Medical Research -21 NE 1st Ave
  • Georgia
    • Marietta, Georgia, United States, 30060-7902
      • Marietta Dermatology & The Skin Cancer Center - Marietta
  • Idaho
    • Idaho Falls, Idaho, United States, 83404-8322
      • Leavitt Clinical Research - 1542 Elk Creek Dr
  • Illinois
    • Rolling Meadows, Illinois, United States, 60008-3811
      • Arlington Dermatology
  • Indiana
    • Indianapolis, Indiana, United States, 46256-4697
      • Dawes Fretzin Clinical Research Group-7910 N Shadeland Ave
  • Maryland
    • Columbia, Maryland, United States, 21046-1246
      • Kindred Hair & Skin Center - CAR
  • Michigan
    • Troy, Michigan, United States, 48084-3536
      • Revival Research Corporation - Michigan - ClinEdge - PPDS
    • Warren, Michigan, United States, 48088-3671
      • Grekin Skin Institute
  • Nevada
    • Henderson, Nevada, United States, 89052-5016
      • Henderson Clinical Trials
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03766-1937
      • Dartmouth Hitchcock Medical Center
    • Portsmouth, New Hampshire, United States, 03801-6822
      • ALLCUTIS Research, LLC.
  • New York
    • New York, New York, United States, 10003-3314
      • Northwell Health Physician Partners Dermatology at Lake Success - BRANY - PPDS
  • North Carolina
    • Cary, North Carolina, United States, 27518-7414
      • Accellacare of Cary
  • Ohio
    • Bexley, Ohio, United States, 43209
      • Bexley Dermatology Research - Probity - PPDS
  • South Carolina
    • Charleston, South Carolina, United States, 29407-5347
      • Clinical Research Center of the Carolinas, LLC
  • Tennessee
    • Murfreesboro, Tennessee, United States, 37130-2450
      • International Clinical Research-Tennessee LLC
  • Texas
    • Bellaire, Texas, United States, 77401-3505
      • Bellaire Dermatology Associates
    • San Antonio, Texas, United States, 78213-2250
      • Progressive Clinical Research PA - San Antonio

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 (PASI-75 Response) 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 90% Improvement from Baseline in PASI (PASI-90 Response) 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 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
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 and 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.	Baseline and Week 16
Percent 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.	Baseline and 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 and 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 and 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
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 and Week 16
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
Change from Baseline in NAPSI, Among Participants with Nail Involvement at Baseline 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
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 PASI-75 at Weeks 24, 40, and 52 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, 40 and 52
Percentage of Participants Achieving PASI-90 at Weeks 24, 40, and 52 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, 40 and 52
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 56
Number of Participants with Clinically Significant Vital Signs		Up to Week 56
Number of Participants with Clinically Significant Laboratory Values		Up to Week 56
Number of Participants with Clinically Significant Electrocardiogram (ECG) Findings		Up to Week 56
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 and 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
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
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 and 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 and 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 and 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 and Week 24
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.	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
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
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 and 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 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 an sPGA of Clear (0) or Almost Clear (1) with a >=2-Point Decrease from Baseline at Weeks 24, 40, and 52 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, 40 and 52

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2023
• Primary Completion (Actual): January 22, 2025
• Study Completion (Actual): October 22, 2025

Study Registration Dates

• First Submitted: October 12, 2023
• First Submitted That Met QC Criteria: October 12, 2023
• First Posted (Actual): October 18, 2023

Study Record Updates

• Last Update Posted (Estimated): October 24, 2025
• Last Update Submitted That Met QC Criteria: October 23, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Drug Therapy; Latitude Psoriasis 1, Latitude Research Program
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Substandard Drugs; Pharmaceutical Preparations; apremilast
• Other Study ID Numbers: TAK-279-3001; jRCT2031230583 (Registry Identifier: jRCT); 2023-505841-22-00 (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