AzTrials
AzTrials

Plaque PsoriasisPhase 3NCT06550076

A Study of TAK-279 in Participants With Moderate-to-Severe Plaque Psoriasis

A Phase 3 study testing TAK-279 in people with Plaque Psoriasis, run by Takeda at 278 sites in 20 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The main aim of this study is to check the side effects of TAK-279 and how well it is tolerated in participants with moderate-to-severe plaque psoriasis. All participants will be assigned to study treatments of TAK-279 and will be treated with TAK-279 if the participants meet the study rules. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Plaque Psoriasis
What is being tested?
TAK-279
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,099 participants
Where
278 sitesin 20 countries
Study dates
4 Sep 2024to 5 Aug 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Main Inclusion Criteria:

Part A:

  • Participant is willing and able to understand and fully comply with study procedures and requirements (including digital tools and applications), in the opinion of the investigator.
  • Participant has provided written informed consent and any required privacy authorization before the initiation of any study procedures.
  • Participant is aged 18 years or older at the time of consent.
  • Participant has a diagnosis of chronic plaque psoriasis for >=6 months prior to the screening visit.
  • Participant has stable plaque psoriasis defined as no significant flare or change in morphology (as assessed by the investigator) in psoriasis for >=6 months before screening.
  • Participant has moderate-to-severe plaque psoriasis as defined by a PASI score >=12 and a sPGA score >=3 at screening and Day 1.
  • Participant has plaque psoriasis covering >=10% of his or her total BSA at screening and Day 1.
  • Participant must be a candidate for phototherapy or systemic therapy.

Part B:

  • Participant has completed 52 weeks of treatment (TAK-279-3001 or Part A) or 60 weeks of treatment (TAK-279-3002), or 16 weeks of treatment (TAK-279-PsO-3004) in their parent study.

Main Exclusion Criteria

Part A:

  • Participant has evidence of non-plaque psoriasis (erythrodermic, pustular, predominantly guttate psoriasis, predominantly inverse, or drug-induced psoriasis). If a participant meets criteria for inclusion based on typical plaque psoriasis presentation, a limited amount of inverse psoriasis is not exclusionary.
  • Participant requires systemic treatment, other than nonsteroidal anti-inflammatory drugs, during the trial period for an immune-related disease (e.g., inflammatory bowel disease).
  • Participant has any clinically significant medical condition, evidence of an unstable clinical condition (e.g., cardiovascular, renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, or immunologic), or vital signs/physical/laboratory/ECG abnormality that would, in the opinion of the investigator, put the participant at undue risk or interfere with interpretation of study results. These include but are not limited to:
  1. Participant has a history of known or suspected condition/illness that is consistent with compromised immunity, including but not limited to any identified congenital or acquired immunodeficiency; splenectomy.
  2. Participant had a major surgery within 60 days prior to Day 1 or has a major surgery planned during the study.
  3. Participant has unstable, poorly controlled, or severe hypertension at screening, confirmed by 2 repeat assessments.
  4. Participant has a history of Class III or IV congestive heart failure as defined by New York Heart Association criteria.
  5. Participant has a history of cancer or lymphoproliferative disease, with the exception of successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix.
  6. For participants with asthma, chronic obstructive pulmonary disease, or other pulmonary illnesses, participant has been hospitalized in the past 3 months, has ever required intubation for treatment, currently requires oral corticosteroids, or has required more than 1 course of oral corticosteroids within 6 months prior to Day 1.
  7. Participant has any of the following cardiovascular disease history: A new diagnosis of atrial fibrillation or an episode of atrial fibrillation with rapid ventricular response or other dysrhythmia, non-acute cardiac hospitalization (e.g., pacemaker implantation), pulmonary embolism, or deep venous thrombosis within the past 6 months prior to screening. Any history of cerebrovascular event, myocardial infarction, coronary stenting, or aortocoronary bypass surgery. If, however, the investigator determines there are no suitable treatment alternatives available for the participant and it has been at least 6 months since the occurrence of any such event, the participant may enroll.
  8. Participant has ECG abnormalities that are considered clinically significant and would pose an unacceptable risk to the participant if he or she participated in the study, in the opinion of the investigator.
  9. Participant has significant/uncontrolled psychiatric illness, in the opinion of the investigator.
  10. Participant has any lifetime history of suicidal ideation, suicidal behavior, or suicidal attempts by 1) medical history; or 2) by Columbia-Suicide Severity Rating Scale (C-SSRS) documentation at screening or by answering "yes" to Question 5 for suicidal ideation on the C-SSRS at screening; or 3) is clinically deemed to have a suicide risk by the investigator.
  11. Participant has a patient health questionnaire - 8 (PHQ-8) score of 15 or above at screening.
  12. Participant has a history of clinically significant drug or alcohol abuse within 12 months prior to Day 1.
  • Participant has received any of the following biologics or biosimilar versions within the time frame indicated or 5 half-lives, whichever is longer:
  1. Antibodies to interleukin (IL) -12/-23, IL-17, or IL-23 (eg, ustekinumab, secukinumab, tildrakizumab, ixekizumab, or guselkumab) within 6 months prior to Day 1.
  2. Tumor necrosis factor inhibitor(s) (e.g., etanercept, adalimumab, infliximab, certolizumab) within 2 months prior to Day 1.
  3. Agents that modulate integrin pathways to impact lymphocyte trafficking (e.g., natalizumab) or agents that modulate B cells or T cells (e.g., alemtuzumab, abatacept, or visilizumab) within 3 months prior to Day 1.
  4. Rituximab or other immune cell-depleting therapy within 6 months prior to Day 1.
  • Participant has any previous exposure to TAK-279 (also known as NDI-034858) or other TYK2 inhibitors, including deucravacitinib, or participant participated in any study that included a TYK2 inhibitor (e.g., deucravacitinib, VTX958, GLPG3667, etc.), unless the participant has documentation of post-trial unblinding that confirms the partcipant did not receive a TYK2 inhibitor.
  • Participant has a known or suspected allergy to TAK-279 or any of its components.

Part B:

  • Participant has completed the parent study or Part A but was permanently discontinued from treatment.
  • Participant had evidence of significant noncompliance with study visits or study drug in the parent study or Part A, as defined in the parent study protocol or in the opinion of the investigator.
  • Participant has met criteria for termination from the parent study or Part A, regardless of whether or not the participant was terminated from the parent study or Part A.
  • Participant has developed evidence of non-plaque psoriasis (erythrodermic, pustular, predominantly guttate psoriasis, predominantly inverse, or drug-induced psoriasis) since enrollment in the parent study or Part A.
  • Participant has developed a concomitant comorbid skin condition that, in the opinion of the investigator, would interfere with the study assessments.
  • Participant has received a prohibited psoriasis treatment during the parent study or Part A, whether or not that treatment was documented as a concomitant medication and is expected to continue that treatment.

Trial locations and contacts

278 sites in 20 countries.

278 sites in 20 countries

United States74 sites

  • University of Michigan Hospital - 1500 E Medical Center Dr

    Ann Arbor, Michigan, 48109-5360

  • Arlington Research Center

    Arlington, Texas, 76011-3800

  • Divine Dermatology and Aesthetics, LLC

    Atlanta, Georgia, 30315-2042

  • Oakland Hills Dermatology - 3400 Auburn Rd

    Auburn Hills, Michigan, 48326-3396

  • Bellaire Dermatology Associates

    Bellaire, Texas, 77401-3505

  • UT Physicians Dermatology - Bellaire Station

    Bellaire, Texas, 77401

  • Zenith Research, Inc.

    Beverly Hills, California, 90212

  • Bexley Dermatology Research - Probity - PPDS

    Bexley, Ohio, 43209

  • Total Dermatology

    Birmingham, Alabama, 35205

  • University of Alabama Hospital - Whitaker Clinic -

    Birmingham, Alabama, 35233-2110

  • Accellacare of Cary

    Cary, North Carolina, 27518

  • DS Research - 1005 E. Lewis & Clark Pkwy Indiana Location

    Clarksville, Indiana, 47129-2201

  • Driven Research LLC

    Coral Gables, Florida, 33134-3901

  • Modern Research Associates

    Dallas, Texas, 75231-6077

  • Revival Research Corporation - Florida - ClinEdge - PPDS

    Doral, Florida, 33122-1902

  • Psoriasis Treatment Center of Central New Jersey

    East Windsor, New Jersey, 08520

  • Wright State Physicians

    Fairborn, Ohio, 45324

  • FXM Clinical Research Ft. Lauderdale, LLC

    Fort Lauderdale, Florida, 33308-5211

  • Johnson Dermatology Clinic

    Fort Smith, Arkansas, 72916-6103

  • First OC Dermatology Research Inc.

    Fountain Valley, California, 92708

  • Center for Dermatology Clinical Research

    Fremont, California, 94538

  • North Texas Center for Clinical Research

    Frisco, Texas, 75034

  • Henderson Clinical Trials

    Henderson, Nevada, 89052

  • Cumberland Skin Center for Clinical Research - Objective Health - PPDS

    Hermitage, Tennessee, 37076-3497

  • Direct Helpers Medical Center

    Hialeah, Florida, 33012

  • Cahaba Dermatology Skin Health Center

    Hoover, Alabama, 35244-2111

  • Burke Pharmaceutical Research

    Hot Springs, Arkansas, 71913-6475

  • Leavitt Clinical Research

    Idaho Falls, Idaho, 83404-8322

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis, Indiana, 46250

  • Dartmouth Hitchcock Medical Center - Old Etna Rd

    Lebanon, New Hampshire, 03766-1937

  • Long Beach Research Institute

    Long Beach, California, 90805

  • Metropolis Dermatology Downtown LA - Probity - PPDS

    Los Angeles, California, 90017-5310

  • UCLA University of California Los Angeles

    Los Angeles, California, 90024

  • Skin Sciences, PLLC

    Louisville, Kentucky, 40217-1444

  • Dermatology Specialists Research - 3810 Springhurst Blvd

    Louisville, Kentucky, 40241-6162

  • Marietta Dermatology & The Skin Cancer Center - Marietta

    Marietta, Georgia, 30060-7902

  • Apex Clinical Research Center

    Mayfield Heights, Ohio, 44124-4005

  • Florida Academic Centers Research

    Miami, Florida, 33136-1003

  • FXM Clinical Research Miami, LLC

    Miami, Florida, 33175-3582

  • San Marcus Research Clinic Inc

    Miami Lakes, Florida, 33014

  • FXM Research Miramar

    Miramar, Florida, 33027-4714

  • International Clinical Research US LLC

    Murfreesboro, Tennessee, 37130-2450

  • Minnesota Clinical Study Center

    New Brighton, Minnesota, 55112

  • Sadick Research Group

    New York, New York, 10075-0385

  • Virginia Clinical Research - 6160 Kempsville Cir

    Norfolk, Virginia, 23507

  • Northridge Clinical Trials

    Northridge, California, 91325-4122

  • Renstar Medical Research -21 NE 1st Ave

    Ocala, Florida, 34470

  • Skin Specialists PC

    Omaha, Nebraska, 68144

  • Medical Dermatology Specialists

    Phoenix, Arizona, 85006

  • Saguaro Dermatology Associates, LLC - Probity - PPDS

    Phoenix, Arizona, 85008-3884

  • University of Pittsburgh Medical Center-3601 5th Ave

    Pittsburgh, Pennsylvania, 15213-3403

  • Oregon Medical Research Center PC

    Portland, Oregon, 97201

  • ALLCUTIS Research, LLC.

    Portsmouth, New Hampshire, 03801

  • Lawrence J Green, MD LLC

    Rockville, Maryland, 20850

  • Arlington Dermatology

    Rolling Meadows, Illinois, 60008-3811

  • UC Davis Dermatology Clinic

    Sacramento, California, 95816-3370

  • San Antonio

    San Antonio, Texas, 78213-2250

  • Texas Dermatology and Laser Specialists-San Antonio-7703 Floyd Curl Dr

    San Antonio, Texas, 78218-3128

  • Dermatology Clinical Research Center of San Antonio

    San Antonio, Texas, 78229-3409

  • TCR Medical Corporation

    San Diego, California, 92123-1523

  • University Clinical Trials

    San Diego, California, 92123

  • Advanced Medical Research, PC

    Sandy Springs, Georgia, 30328

  • Dermatology Institute and Skin Care Center

    Santa Monica, California, 90404-2216

  • Georgia Skin and Cancer Clinic

    Savannah, Georgia, 31419-1768

  • UNISON Clinical Trials (Shahram Jacobs md inc.)

    Sherman Oaks, California, 91403

  • NorthShore Medical Group Dermatology - Skokie

    Skokie, Illinois, 60077-1049

  • Houston Center for Clinical Research, LLC

    Sugar Land, Texas, 77479-1001

  • Lenus Research & Medical Group

    Sweetwater, Florida, 33172

  • Advanced Clinical Research Institute (ACRI) - Florida

    Tampa, Florida, 33607-6429

  • Montefiore AOA - BRANY

    The Bronx, New York, 10467

  • Revival Research Corporation - ClinEdge

    Troy, Michigan, 48084-3536

  • Noble Clinical Research

    Tucson, Arizona, 85704

  • Center For Clinical Studies, LTD. LLP - 451 N Texas Ave

    Webster, Texas, 77598-4927

  • The Skin Surgery Center for Clinical Research - Objective Health - PPDS

    Winston-Salem, North Carolina, 27103-7109

Other trials in United States

Poland49 sites

  • NZOZ Osteo Medic SC Artur Racewicz Jerzy Supronik

    Bialystok, Podlaskie Voivodeship, 15-351

  • ClinicMed Daniluk, Nowak Spolka Komandytowa

    Bialystok, Podlaskie Voivodeship, 15-879

  • Centrum Uslug Medycznych MaxMed

    Bochnia, 32-700

  • Centrum Medyczne Bydgoszcz- PRATIA

    Bydgoszcz, 85-796

  • Ambulatorium Sp. z o.o.

    Elblag, 82-300

  • AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdansku

    Gdansk, Pomeranian Voivodeship, 80-382

  • Copernicus Podmiot Leczniczy Sp. z o.o, Szpital Sw. Wojciecha, Oddzial Dermatologii

    Gdansk, Pomeranian Voivodeship, 80-462

  • Centrum Badan Klinicznych Pi-house Sp. Z O. O.

    Gdansk, Pomeranian Voivodeship, 80-546

  • Derm-art

    Gdynia, Pomeranian Voivodeship, 81-415

  • Centrum Medyczne Katowice - PRATIA

    Katowice, Lower Silesian Voivodeship, 40-081

  • AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Katowicach

    Katowice, Silesian Voivodeship, 40-040

  • Centrum Medyczne Angelius Provita

    Katowice, Silesian Voivodeship, 40-611

  • Pro Familia Altera Sp. z o.o.

    Katowice, Silesian Voivodeship, 40-648

  • Globe Badania Kliniczne Spolka z o.o. - Klodzko

    Kłodzko, Lower Silesian Voivodeship, 57-300

  • Centrum Medyczne ALL-MED

    Krakow, Lesser Poland Voivodeship, 30-033

  • Pratia MCM Krakow

    Krakow, Lesser Poland Voivodeship, 30-727

  • Krakowskie Centrum Medyczne Sp. z o.o.

    Krakow, Lesser Poland Voivodeship, 31-501

  • Promed P. Lach R. Głowacki Sp. j., Centrum Medyczne Promed

    Krakow, 31-411

  • Diamond Clinic Sp. z o.o., Diamond Medical Center

    Krakow, 31-559

  • Uniwersytecki Szpital Kliniczny nr 2 Uniwersytetu Medycznego w Lodzi, Klinika Dermatologii i Wenerologii

    Lodz, 90-647

  • Dermoklinika-Centrum Medyczne s.c

    Lodz, Łódź Voivodeship, 90-436

  • Centrum Terapii Współczesnej J.M. Jasnorzewska S.K.A.

    Lódz, Lódzkie, 90-338

  • Clinical Best Solutions Sp. z o.o. S.K.

    Lublin, Lublin Voivodeship, 20-011

  • Luxderm Specjalistyczny Gabinet Dermatologiczny Dorota Krasowska

    Lublin, Lublin Voivodeship, 20-573

  • Pro Life Medica Sp. z o.o. ETG Lublin

    Lublin, 20-412

  • Rheumatology Clinic NZOZ Lecznica MAK-MED

    Nadarzyn, Masovian Voivodeship, 05-830

  • Twoja Przychodnia - Nowosolskie Centrum Medyczne sp. z o.o

    Nowa Sól, 67-100

  • ETYKA Osrodek Badan Klinicznych

    Olsztyn, 10-117

  • Dermedic Jacek Zdybski

    Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, 27-400

  • Ostrowieckie Centrum Medyczne Anna Olech Cudzik Krzysztof Cudzik s.c.

    Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, 27-400

  • AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Poznaniu

    Poznan, Greater Poland Voivodeship, 60-702

  • Twoja Przychodnia PCM

    Poznan, Greater Poland Voivodeship, 61-293

  • ETG Siedlce - PPDS

    Siedlce, Masovian Voivodeship, 08-110

  • Velocity Skierniewice Sp. z o.o.

    Skierniewice, Łódź Voivodeship, 96-100

  • RCMed Oddzial Sochaczew

    Sochaczew, Masovian Voivodeship, 96-500

  • Twoja Przychodnia Szczecińskie Centrum Medyczne Sp. z o.o.

    Szczecin, West Pomeranian Voivodeship, 71-500

  • MICS Centrum Medyczne Torun

    Torun, 87-100

  • Clinical Best Solutions Sp. z o.o. S.K.

    Warsaw, Masovian Voivodeship, 00-710

  • MICS Centrum Medyczne Warszawa

    Warsaw, Masovian Voivodeship, 00-874

  • Clinical Research Group Sp. z o.o

    Warsaw, Masovian Voivodeship, 01-142

  • High-Med Przychodnia Specjalistyczna

    Warsaw, Masovian Voivodeship, 01-817

  • AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Warszawie

    Warsaw, Masovian Voivodeship, 02-672

  • ETG Warszawa - PPDS

    Warsaw, Masovian Voivodeship, 02-677

  • Klinika Reuma Park sp . zoo Sp.k.

    Warsaw, Masovian Voivodeship, 02-691

  • Klinika Ambroziak Dermatologia

    Warsaw, Masovian Voivodeship, 02-953

  • FutureMeds - Targowek - PPDS

    Warsaw, Masovian Voivodeship, 03-291

  • Royalderm Agnieszka Nawrocka

    Warsaw, 02 962

  • Cityclinic Przychodnia lekarsko psychologiczna Matusiak sp.p

    Wroclaw, Lower Silesian Voivodeship, 50-566

  • dermMEDICA Sp. z o.o. | Krzysztofa Kolumba 6

    Wroclaw, 51-503

Other trials in Poland

Canada31 sites

  • CCA Medical Research - Probity

    Ajax, Ontario, L1S 7K8

  • SimcoDerm Medical and Surgical Dermatology Centre - Probity

    Barrie, Ontario, L4M 7G1

  • Beacon Dermatology - Probity

    Calgary, Alberta, T3A 2N1

  • Dermatology Research Institute, Inc.

    Calgary, Alberta, T3A 2N1

  • Alberta DermaSurgery Centre - Probity

    Edmonton, Alberta, T6G 1C2

  • VIDA Dermatology - Probity

    Edmonton, Alberta, T6H 4J8

  • Kingsway Clinical Research - Probity

    Etobicoke, Ontario, M8X 1Y9

  • Guelph Dermatology Research - Probity

    Guelph, Ontario, N1L 0B7

  • Lima's Excellence In Allergy And Dermatology Research (Leader) Inc. - Probity

    Hamilton, Ontario, L8L 3C3

  • Dermatrials Research

    Hamilton, Ontario, L8N 1Y2

  • Mediprobe Research Inc

    London, Ontario, N5X 2P1

  • DermEffects

    London, Ontario, N6H 5L5

  • Lynderm Research Inc - Probity

    Markham, Ontario, L3P 1X3

  • DermEdge Research - Probity

    Mississauga, Ontario, L5H 1G9

  • Siena Medical Research Corporation

    Montreal, Quebec, H3Z 2S6

  • Dr. S. K. Siddha Medicine Professional Corporation | Newmarket, Canada

    Newmarket, Ontario

  • North Bay Dermatology Center - Probity

    North Bay, Ontario, P1B 3Z7

  • The Centre for Clinical Trials Inc.

    Oakville, Ontario, L6J 7W5

  • Skin Centre for Dermatology

    Peterborough, Ontario, K9J 5K2

  • Care Clinic

    Red Deer, Alberta, T4P 1K4

  • The Centre For Dermatology

    Richmond Hill, Ontario, L4B 1A5

  • Skinsense Medical Research - Probity

    Saskatoon, Saskatchewan, S7K 0H6

  • Karma Clinical Trials

    St. John's, Newfoundland and Labrador, A1A 4Y3

  • Enverus Medical Research - Probity

    Surrey, British Columbia, V3V 0C6

  • North York Research Inc. - Probity

    Toronto, Ontario, M2N 3A6

  • Canadian Dermatology Centre - Probity

    Toronto, Ontario, M3B 0A7

  • Toronto Research Centre

    Toronto, Ontario, M3H 5Y8

  • Toronto Research Centre - Probity

    Toronto, Ontario, M4W 2N4

  • Alliance Clinical Trials

    Waterloo, Ontario, N2J 1C4

  • XLR8 Medical Research

    Windsor, Ontario, N8T 1E6

  • Wiseman Dermatology Research Inc.

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

China25 sites

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100044

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100050

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100191

  • Beijing Tongren Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100730

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400016

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian, 350005

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, 510080

  • Dermatology Hospital of Southern Medical University

    Guangzhou, Guangdong, 510091

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510120

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510280

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang, 310000

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310016

  • Shandong Provincial Hospital

    Jinan, Shandong, 250013

  • Huashan Hospital Fudan University - PPDS

    Shanghai, Minhang District, 201100

  • Shanghai Skin Disease Hospital

    Shanghai, Shanghai Municipality, 200020

  • The University of Hong Kong - Shenzhen Hospital

    Shenzhen

  • The First Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050031

  • First Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030001

  • The 1st Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000

  • Union Hospital Tongji Medical College of Huazhong University of Science and Technology (HUST)

    Wuhan, Hubei, 430022

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology

    Wuhan, Hubei, 430030

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei, 430060

  • The 2nd Hospital of Xi'An Jiaotong University

    Xi'an, Shan'xi, 710004

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia Hui, 750004

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, Jiangsu, 212001

Other trials in China

Japan17 sites

  • St. Luke's International Hospital

    Chuo-ku, Tokyo, 104-8560

  • Fukuoka University Hospital

    Fukuoka, Hukuoka, 814-0180

  • Hino Dermatology Clinic

    Fukutsu-shi, Fukuoka, 811-3217

  • Ohyama Dermatology Clinic

    Kumamoto, 861-4101

  • Seikoukai Omi Medical Center

    Kusatsu-shi, Shiga, 525-8585

  • Nagoya City University Hospital

    Nagoya, Aichi-ken, 467-8602

  • Takagi Dermatological Clinic

    Obihiro-Shi, Hokkaidô, 080-0013

  • Nippon Life Hospital

    Osaka, Osaka, 550-0006

  • Dermatology and Ophthalmology Kume Clinic

    Sakaishi, Ôsaka, 593-8324

  • JR Sapporo Hospital

    Sapporo, Hokkaidô, 060-0033

  • Medical Corporation Kojinkai Sapporo Skin Clinic

    Sapporo, Hokkaidô, 060-0063

  • Jichi Medical University Hospital

    Shimotsuke-shi, Tochigi, 329-0498

  • JCHO Tokyo Yamate Medical Center

    Shinjuku-ku, Tokyo-To, 169-0073

  • Tokyo Teishin Hospital

    Sumida-Ku, Tokyo

  • Medical Corporation Jitai-kai Tachikawa Dermatology Clinic

    Tachikawa-shi, Tokyo, 190-0023

  • Shirasaki Dermatology Clinic

    Takaoka-shi, Toyama, 933-0871

  • Tokyo Medical University Hospital

    Tokyo, 160-0023

Other trials in Japan

Bulgaria11 sites

  • Medical Center Asklepii OOD

    Dupnitsa, Kyustendil, 2600

  • Multiprofile Hospital For Active Treatment Dr Tota Venkova

    Gabrovo

  • Diagnostic Consultative Center Sveti

    Haskovo, 6300

  • Medical Center Medconsult Pleven OOD

    Pleven

  • Medical Center Unimed EOOD-Sevlievo

    Sevlievo, Gabrovo, 5400

  • Diagnostic and Consulting Center Aleksandrovska EOOD

    Sofia, Sofia-Grad, 1431

  • Diagnostic Consultative Centre - Focus-5 - LZIP EOOD

    Sofia, Sofia-Grad, 1463

  • Medical Center Hera EOOD-Sofia

    Sofia, Sofia-Grad, 1510

  • Diagnostic Consultative Center XXVIII - Sofia - EOOD

    Sofia, Sofia-Grad, 1592

  • Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia

    Sofia, Sofia-Grad, 1606

  • MC Comac Medical

    Sofia, Sofia-Grad, 1612

Other trials in Bulgaria

Czechia10 sites

  • Pratia Brno s.r.o. - PRATIA - PPDS

    Brno, South Moravian, 602 00

  • Dermamedica, s.r.o. - Kozni Ambulance Nachod

    Náchod, Hradec Králové Region, 547 01

  • Nemocnice AGEL Novy Jicin a.s

    Nový Jičín, Moravian-Silesian Region

  • Dermskin s.r.o

    Olomouc, Olomouc Region, 779 00

  • CCR Ostrava s.r.o.

    Ostrava, Moravian-Silesian Region, 702 00

  • Pratia Pardubice a.s. - PRATIA - PPDS

    Pardubice, Pardubice Region, 530 02

  • CLINTRIAL s.r.o.

    Prague, 100 00

  • Prof. MUDr. Petr Arenberger, DrSc. - CRC - PPDS

    Prague, 110 00

  • Praglandia

    Prague, 150 00

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, 779 00

Other trials in Czechia

South Korea10 sites

  • Seoul National University Bundang Hospital

    Beon-gil Bundang-gu, Gyeonggi-do, 13620

  • The Catholic University of Korea, Bucheon St. Mary's Hospital

    Bucheon-si, Gyeonggido, 14647

  • Konkuk University Medical Center

    Gwangjin-Gu, Seoul Teugbyeolsi, 05030

  • Chosun University Hospital

    Gwangju, Gwangju Gwang'yeogsi, 61453

  • The Catholic University of Korea, Seoul St. Mary's Hospital

    Seocho-Gu, Seoul Teugbyeolsi, 06591

  • Soon Chun Hyang University Hospital Seoul

    Seoul, Seoul Teugbyeolsi, 04401

  • Kyung Hee University Hospital

    Seoul, 2447

  • Seoul National University Hospital

    Seoul, 3080

  • Chung-Ang University Hospital

    Seoul

  • Yonsei University Wonju Severance Christian Hospital

    Wŏnju, Gangwon-do, 220-701

Other trials in South Korea

Latvia8 sites

  • Semigallia

    Kuldīga, LV-3301

  • Riga 1st Hospital

    Riga, LV-1001

  • Aesthetic dermatology clinic of prof. J. Kisis

    Riga, LV-1003

  • Health Center 4-1 Grebenscikova Str

    Riga, LV-1003

  • Veseliba un estetika Ltd.

    Riga, LV-1009

  • Outpatient Clinic Adoria

    Riga, LV-1011

  • Health Center 4-Skanstes iela 50

    Riga, LV-1013

  • Smite Aija medical practice in dermatology, venerology

    Talsi, Talsu Aprinkis, LV-3201

Other trials in Latvia

Germany7 sites

  • Fachklinik Bad Bentheim

    Bad Bentheim, Lower Saxony, 48455

  • Hautarztpraxis Mahlow

    Blankenfelde-Mahlow, Brandenburg, 15831

  • Klinische Forschung Dresden Gmbh

    Dresden, Saxony, 01069

  • Praxis fur Dermatologie and Venerologie

    Dresden, Saxony, 01097

  • SRH Wald-Klinikum Gera GmbH

    Gera, Thuringia, 07548

  • Dermatologikum Hamburg

    Hamburg, 20354

  • Klinikum Oldenburg

    Oldenburg, Lower Saxony, 26133

Other trials in Germany

Taiwan6 sites

  • National Taiwan University Hospital, Hsin-Chu Branch

    Hsinchu, 300

  • Kaohsiung Veterans General Hospital

    Kaohsiung City, 81362

  • National Cheng Kung University

    Tainan, Tainan City, 70403

  • Taipei Veterans General Hospital

    Taipei, 11217

  • Mackay Memorial Hospital-Taipei branch

    Taipei

  • National Taiwan University Hospital

    Zhong Zheng Qu, 100

Other trials in Taiwan

United Kingdom6 sites

  • Accellacare of Northamptonshire

    Harrow, Middlesex, HA1 3UJ

  • Velocity Clinical Research - High Wycombe - PPDS

    High Wycombe, Buckinghamshire, HP11 2QW

  • 4 Medical Clinical Solutions - Swinton - PPDS

    Ilford, Essex, IG1 4HP

  • Whipps Cross University Hospital

    London, London, City of, E11 1NR

  • Velocity Clinical Research North London - Percy Road - PPDS

    London, Middlesex, N12 8BU

  • Salford Royal Hospital - PPDS

    Salford, Lancashire, M6 8HD

Other trials in United Kingdom

Australia5 sites

  • The Skin Center - Probity

    Benowa, Queensland, 4217

  • Skin Health Institute Inc - Probity - PPDS

    Carlton, Victoria, 3053

  • St George Dermatology and Skin Cancer Center - Probity - PPDS

    Kogarah, New South Wales, 2217

  • Alfred Health

    Parkville, Victoria, 3050

  • Western Health - Sunshine Hospital

    Parkville, Victoria, 3050

Other trials in Australia

France4 sites

  • Centre Hospitalier Le Mans

    Le Mans, Sarthe, 72037

  • Office of Mireille Ruer-Mulard, MD

    Martigues, Paca, 13500

  • Hopital Charles Nicolle-1 Rue de Germont

    Rouen, 76031fr

  • Centre Hospitalier Universitaire de Saint Etienne

    Saint-Etienne, 42270

Other trials in France

Hungary4 sites

  • Debreceni Egyetem

    Debrecen, 4032

  • Somogy Megyei Kaposi Mór Oktató Kórház

    Kaposvár, Somogy County, 7400

  • Allergo-Derm Bakos Kft.

    Szolnok, Jász-Nagykun-Szolnok, 5000

  • Markusovszky Egyetemi Oktatókórház

    Szombathely, Vas County

Other trials in Hungary

Argentina3 sites

  • Conexa Investigación Clínica S.A.

    Buenos Aires, Ciudad Autónoma de BuenosAires, C1012

  • Centro de Investigacion Clinica

    Ciudad Autónomade Buenos Aires, C1060ABN

  • Centro de Investigaciones Médicas Tucumán

    San Miguel de Tucumán, Tucumán Province, T4000

Other trials in Argentina

Italy3 sites

  • Presidio Ospedaliero Gaspare Rodolico

    Catania, Sicily, 95123

  • Azienda Usl Toscana Centro - Firenze

    Florence, Tuscany, 50125

  • IRCCS Istituto Clinico Humanitas

    Rozzano, Milano, 20089

Other trials in Italy

Israel2 sites

  • Rabin Medical Center - PPDS

    Petah Tikva

  • Chaim Sheba Medical Center

    Ramat Gan, 5265602

Other trials in Israel

Spain2 sites

  • Hospital Clinico San Carlos

    Donostia / San Sebastian, Guipúzcoa, 20004

  • Hospital de Manises

    Manises, Valencia, 46940

Other trials in Spain

Puerto Rico1 site

  • GCM Medical Group

    San Juan, 00909-3004

Other trials in Puerto Rico

About this study

Official title: A Phase 3, Multicenter, Open-Label Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of TAK-279 in Subjects With Moderate-to-Severe Plaque Psoriasis

The main aim of this study is to check the side effects of TAK-279 and how well it is tolerated in participants with moderate-to-severe plaque psoriasis.

All participants will be assigned to study treatments of TAK-279 and will be treated with TAK-279 if the participants meet the study rules.

Participants will be in the study for up to 217 weeks, including up to 35 days for the screening period, 52 weeks (Part A) up to 156 additional weeks (Part B) study treatment and 4 weeks follow up period. During the study, participants will visit their study clinic multiple times.

Read the detailed description

This study consists of 2 parts: Part A and Part B.

Part A: Participants who did not participate in one of the parent studies (TAK-279-3001 [NCT06088043], TAK-279-3002 [NCT06108544], or TAK-279-PsO-3004 [NCT06973291]) may be enrolled and will be treated for up to 52 weeks. Participants who successfully complete Part A of the study are eligible to continue in Part B, but investigators must confirm their eligibility to continue in Part B.

Part B: Participants who complete the treatment period of TAK-279-3001 (NCT06088043), TAK-279-3002 (NCT06108544), or TAK-279-PsO-3004 (NCT06973291) parent studies or who complete Part A are eligible to enroll directly into open label extension treatment in Part B and will be treated for up to 156 weeks.

Being tested
TAK-279
Keywords
Latitude Psoriasis 3, Latitude Research Program, Latitude PsO OLE

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TAK-279Drug

    TAK-279 oral tablet

Study groups in NCT06550076
Study groupRoleWhat they receive
Part A (De Novo Cohort) + Part B (Open Label Extension): TAK-279ExperimentalPart A: Participants will receive TAK-279, oral tablet once daily (QD) for up to 52 weeks. Part B: Participants who completed the treatment period of parent studies (TAK-279-3001 [NCT06088043], TAK-279-3002 [NCT06108544], or TAK-279-PsO-3004 [NCT06973291]) or who completed Part A will receive TAK-279, oral tablet QD for up to 156 weeks.
Receives: Drug: TAK-279

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A and Part B: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAE)

    A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. An SAE is any untoward medical occurrence that at any dose: results in death, life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent, significant disability/incapacity, a congenital abnormality/birth defect, an important medical event in the opinion of the healthcare provider, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above. TEAEs consist of both serious and non-serious adverse events.

    Measured: From start of the drug administration up to Week 56 (Part A) and Week 160 (Part B)

Secondary outcomes (2)

  1. Part A and B: Number of Participants Achieving 75% Improvement from Baseline in Psoriasis Area and Severity Index (PASI-75) Score

    The PASI is a composite score based on the degree of effect on body surface area of psoriasis and extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign is assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. The PASI-75 is defined as 75% improvement from baseline in PASI score.

    Measured: Baseline up to Week 52 (Part A) and Week 156 (Part B)

  2. Part A and B: Number of Participants Achieving a Static Physician's Global Assessment (sPGA) of Clear (0) or Almost Clear (1) With a >=2-point Decrease from Baseline

    The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA composite score ranges from 0 to 4 and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean greater than (>) 0, less than (<) 1.5; Mild (2) = mean greater than or equal to (>=) 1.5, <2.5; Moderate (3) = mean >=2.5, <3.5; and Severe (4) = mean >=3.5.

    Measured: Baseline up to Week 52 (Part A) and Week 156 (Part B)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2024
  2. Study start4 Sep 2024
  3. Primary completion5 Aug 2029 (estimated)
  4. Study completion5 Aug 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
2,099 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06550076
Sponsor's protocol ID
TAK-279-PsO-3003
Other IDs
2024-512496-12-00, jRCT2031240413
Status last verified
May 2026
First submitted
8 Aug 2024
Last updated
2 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TAK-279 in people with Plaque Psoriasis, run by Takeda at 278 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 278 sites in United States, Poland, Canada, China, Japan and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A and Part B: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAE) (time frame: From start of the drug administration up to Week 56 (Part A) and Week 160 (Part B)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06550076.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.

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