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Search / Trial NCT06550076

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

Launched by TAKEDA · Aug 8, 2024

Trial Information

Current as of May 09, 2025

Recruiting

Keywords

Latitude Psoriasis 3 Latitude Research Program Latitude Ps O Ole

ClinConnect Summary

This clinical trial is studying a new medication called TAK-279 to see how well it works and how safe it is for people with moderate-to-severe plaque psoriasis, a skin condition that causes red, flaky patches. The trial is open to adults aged 18 and older who have had plaque psoriasis for at least six months and have a significant area of their skin affected. Participants must also be eligible for certain types of treatments like phototherapy or systemic therapy.

If you join the study, you will receive TAK-279 and be monitored for up to 217 weeks, which includes regular visits to the clinic. During these visits, the research team will check on your health and how your skin condition responds to the treatment. It’s important to know that there are specific health conditions that could prevent you from participating, such as certain heart issues or ongoing treatments for other diseases. If you think this study might be right for you, it's a good idea to talk to your doctor for more details.

Gender

ALL

Eligibility criteria

  • 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) in their parent study or Part A.
  • 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.

About Takeda

Takeda Pharmaceutical Company Limited is a global, research-driven biopharmaceutical organization committed to advancing patient care through innovative therapies. Founded in 1781 and headquartered in Osaka, Japan, Takeda focuses on key therapeutic areas including oncology, gastroenterology, neuroscience, and rare diseases. With a strong emphasis on research and development, Takeda leverages cutting-edge science and technology to deliver transformative medicines that address unmet medical needs. The company is dedicated to sustainability and ethical practices, ensuring that its clinical trials uphold the highest standards of safety and efficacy while fostering collaboration with healthcare professionals and communities worldwide.

Locations

Parkville, Victoria, Australia

Afula, , Israel

Parkville, , Australia

Hot Springs, Arkansas, United States

Shijiazhuang, Hebei, China

Seoul, , Korea, Republic Of

Chongqing, Chongqing, China

Busan, , Korea, Republic Of

San Antonio, Texas, United States

Seoul, , Korea, Republic Of

Omaha, Nebraska, United States

Guangzhou, Guangdong, China

Indianapolis, Indiana, United States

Hamilton, Ontario, Canada

Peterborough, Ontario, Canada

Tokyo, , Japan

Beijing, Beijing, China

Bad Bentheim, Niedersachsen, Germany

Fremont, California, United States

San Diego, California, United States

Wuhan, Hubei, China

Beijing, Beijing, China

Shenyang, Liaoning, China

Guangzhou, Guangdong, China

London, Ontario, Canada

Changsha, Hunan, China

Chengdu, Sichuan, China

Beijing, Beijing, China

Zhengzhou, Henan, China

Nagoya City, Aichi, Japan

Vancouver, British Columbia, Canada

Oldenburg, Niedersachsen, Germany

Taipei City, , Taiwan

Taipei, , Taiwan

Kaohsiung City, , Taiwan

Fuzhou, Fujian, China

Tel Aviv, , Israel

Shanghai, Shanghai, China

Manises, Valencia, Spain

Sweetwater, Florida, United States

Richmond Hill, Ontario, Canada

Taiyuan, Shanxi, China

Kaposvár, Somogy, Hungary

Beijing, Beijing, China

Debrecen, , Hungary

Elblag, , Poland

Yinchuan, Ningxia, China

Rozzano, Milano, Italy

Hamburg, , Germany

Hialeah, Florida, United States

Daejeon, , Korea, Republic Of

Kunming, Yunnan, China

Hangzhou, Zhejiang, China

Shimotsuke Shi, Tochigi Ken, Japan

East Windsor, New Jersey, United States

Toronto, Ontario, Canada

Oakville, Ontario, Canada

Zhenjiang, Jiangsu, China

Quilmes, Buenos Aires, Argentina

Rockville, Maryland, United States

Tainan, Tainan City, Taiwan

Brisbane, Queensland, Australia

Gabrovo, , Bulgaria

Shinjuku Ku, Tokyo To, Japan

Praha 10, , Czechia

Minato Ku, Tokyo To, Japan

Tucson, Arizona, United States

Olsztyn, , Poland

Wuhan, Hubei, China

Gera, Thüringen, Germany

Wenzhou, Zhejiang, China

Guangzhou, Guangdong, China

New Taipei City, , Taiwan

Dresden, Sachsen, Germany

Phoenix, Arizona, United States

Fairborn, Ohio, United States

Kraków, Malopolskie, Poland

Las Palmas De Gran Canaria, Las Palmas, Spain

Sofia, Sofia Grad, Bulgaria

London, London, City Of, United Kingdom

Katowice, Slaskie, Poland

Sandy Springs, Georgia, United States

Riga, , Latvia

Seoul, , Korea, Republic Of

London, Ontario, Canada

Beverly Hills, California, United States

Lublin, , Poland

Miami Lakes, Florida, United States

New Brighton, Minnesota, United States

Riga, , Latvia

Frisco, Texas, United States

Red Deer, Alberta, Canada

Beijing, Beijing, China

Guangzhou, Guangdong, China

Nanchang, Jiangxi, China

Ramat Gan, , Israel

Isehara Shi, Kanagawa Ken, Japan

Hangzhou, Zhejiang, China

Krakow, , Poland

Sochaczew, Mazowieckie, Poland

Poznan, Wielkopolskie, Poland

Pleven, , Bulgaria

Krakow, , Poland

Krakow, Malopolskie, Poland

Warszawa, Mazowieckie, Poland

Sherman Oaks, California, United States

Portsmouth, New Hampshire, United States

San Miguel De Tucuman, , Argentina

Warszawa, Mazowieckie, Poland

Lublin, Lubelskie, Poland

Elblag, , Poland

Torun, , Poland

Ciudad Autónoma De Buenos Aires, Buenos Aires, Argentina

Skierniewice, Lodzkie, Poland

Waterloo, Ontario, Canada

Warszawa, Mazowieckie, Poland

Seoul, Seoul Teugbyeolsi, Korea, Republic Of

Krakow, Malopolskie, Poland

Windsor, Ontario, Canada

Henderson, Nevada, United States

Henderson, Nevada, United States

Skokie, Illinois, United States

Warszawa, Mazowieckie, Poland

Gdansk, Pomorskie, Poland

Katowice, Slaskie, Poland

Poznan, Wielkopolskie, Poland

Long Beach, California, United States

Rolling Meadows, Illinois, United States

Troy, Michigan, United States

Bexley, Ohio, United States

Hot Springs, Arkansas, United States

Encino, California, United States

Los Angeles, California, United States

Doral, Florida, United States

Tampa, Florida, United States

Auburn Hills, Michigan, United States

New York, New York, United States

Mayfield Heights, Ohio, United States

Sugar Land, Texas, United States

Norfolk, Virginia, United States

Coral Gables, Florida, United States

Szolnok, Jász Nagykun Szolnok, Hungary

Wroclaw, Dolnoslaskie, Poland

Xi'an, Shanxi, China

Itabashi Ku, Tokyo, Japan

Phoenix, Arizona, United States

Fort Lauderdale, Florida, United States

Miami, Florida, United States

Marietta, Georgia, United States

Savannah, Georgia, United States

Idaho Falls, Idaho, United States

Charleston, South Carolina, United States

Bellaire, Texas, United States

Hoover, Alabama, United States

Fort Smith, Arkansas, United States

Northridge, California, United States

Miami, Florida, United States

Miramar, Florida, United States

Tampa, Florida, United States

Atlanta, Georgia, United States

Clarksville, Indiana, United States

Louisville, Kentucky, United States

Louisville, Kentucky, United States

Las Vegas, Nevada, United States

Winston Salem, North Carolina, United States

Portland, Oregon, United States

Dallas, Texas, United States

Webster, Texas, United States

Cary, North Carolina, United States

Fountain Valley, California, United States

Columbia, Maryland, United States

New York, New York, United States

Warszawa, Mazowieckie, Poland

Santa Monica, California, United States

Ann Arbor, Michigan, United States

Bronx, New York, United States

New York, New York, United States

Stony Brook, New York, United States

Pittsburgh, Pennsylvania, United States

Hermitage, Tennessee, United States

Shenzhen, , China

Nanjing, Jiangsu, China

East Melbourne, Victoria, Australia

Bialystok, Podlaskie, Poland

Los Angeles, California, United States

Sacramento, California, United States

Kagoshima Shi, Kagosima, Japan

Kumamoto, , Japan

Nadarzyn, Mazowieckie, Poland

Warsaw, Mazowieckie, Poland

Gdansk, Pomorskie, Poland

Gdynia, Pomorskie, Poland

Dupnitsa, Kjustendil, Bulgaria

Sofia, Sofia Grad, Bulgaria

Blankenfelde Mahlow, Brandenburg, Germany

Poznań, Wielkopolskie, Poland

Kogarah, New South Wales, Australia

Benowa, Queensland, Australia

Carlton, Victoria, Australia

Parkville, Victoria, Australia

Shanghai, Shanghai, China

Catania, Sicilia, Italy

Firenze, Toscana, Italy

Obihiro Shi, Hokkaidô, Japan

Sapporo Shi, Hokkaidô, Japan

Sapporo Shi, Hokkaidô, Japan

Fukuoka Shi, Hukuoka, Japan

Sumida Ku, Tokyo, Japan

Sakai Shi, ôsaka, Japan

Gwangju, Gwangju Gwang'yeogsi, Korea, Republic Of

Warszawa, Mazowieckie, Poland

Zhong Zheng Qu, , Taiwan

Birmingham, Alabama, United States

San Diego, California, United States

Winston Salem, North Carolina, United States

Arlington, Texas, United States

Sofia, Sofia Grad, Bulgaria

Sofia, Sofia Grad, Bulgaria

Sofia, Sofia Grad, Bulgaria

Haskovo, , Bulgaria

Shanghai, , China

Brno, Jihomoravský Kraj, Czechia

Nachod, Královéhradecký Kraj, Czechia

Ostrava, Moravskoslezský Kraj, Czechia

Praha 1, , Czechia

Dresden, Sachsen, Germany

Lublin, Lubelskie, Poland

Kraków, Malopolskie, Poland

Siedlce, Mazowieckie, Poland

Warszawa, Mazowieckie, Poland

Warszawa, Mazowieckie, Poland

Warszawa, Mazowieckie, Poland

Chojnice, Pomorskie, Poland

Katowice, Slaskie, Poland

Ostrowiec Swietokrzyski, Swietokrzyskie, Poland

Ostrowiec Swietokrzyski, Swietokrzyskie, Poland

Poznan, Wielkopolskie, Poland

Poznań, Wielkopolskie, Poland

Bochnia, , Poland

Chorley, Lancashire, United Kingdom

Harrow, Middlesex, United Kingdom

Northwood, Middlesex, United Kingdom

Skierniewice, Lodzkie, Poland

Bucheon Si, Gyeonggido, Korea, Republic Of

Gwangjin Gu, Seoul Teugbyeolsi, Korea, Republic Of

Seocho Gu, Seoul Teugbyeolsi, Korea, Republic Of

Ciudad Autónoma De Buenos Aires, , Argentina

Kuldīga, , Latvia

Salford, Lancashire, United Kingdom

Seoul, Seoul Teugbyeolsi, Korea, Republic Of

łódź, Lodzkie, Poland

Guangzhou, , China

Birmingham, Alabama, United States

Ocala, Florida, United States

Indianapolis, Indiana, United States

Beverly, Massachusetts, United States

Lebanon, New Hampshire, United States

Murfreesboro, Tennessee, United States

Bellaire, Texas, United States

San Antonio, Texas, United States

San Antonio, Texas, United States

Milwaukee, Wisconsin, United States

Ciudad Autónoma De Buenos Aires, Ciudad Autónoma De Buenosaires, Argentina

Ciudad Autónoma De Buenos Aires, Ciudad Autónoma De Buenosaires, Argentina

Palermo, Ciudad Autónoma De Buenosaires, Argentina

Buenos Aires, La Plata, Argentina

Buenos Aires, , Argentina

Ciudad Autónomade Buenos Aires, , Argentina

Kogarah, , Australia

Sevlievo, Gabrovo, Bulgaria

Sofia, Sofia Grad, Bulgaria

Calgary, Alberta, Canada

Calgary, Alberta, Canada

Edmonton, Alberta, Canada

Edmonton, Alberta, Canada

Surrey, British Columbia, Canada

Winnipeg, Manitoba, Canada

Fredericton, New Brunswick, Canada

St. John's, Newfoundland And Labrador, Canada

Ajax, Ontario, Canada

Barrie, Ontario, Canada

Etobicoke, Ontario, Canada

Guelph, Ontario, Canada

Hamilton, Ontario, Canada

Markham, Ontario, Canada

Mississauga, Ontario, Canada

North Bay, Ontario, Canada

North York, Ontario, Canada

Richmond Hill, Ontario, Canada

Toronto, Ontario, Canada

Toronto, Ontario, Canada

Montreal, Quebec, Canada

Saskatoon, Saskatchewan, Canada

Wuhan, Hubei, China

Jinan, Shandong, China

Nový Jičín, Moravskoslezský Kraj, Czechia

Olomouc, Olomoucký Kraj, Czechia

Pardubice, Pardubický Kraj, Czechia

Prague, , Czechia

Praha 10, , Czechia

Münster, Nordrhein Westfalen, Germany

Lübeck, Schleswig Holstein, Germany

Szombathely, Vas, Hungary

Jerusalem, , Israel

Petach Tikva, , Israel

Nagoya City, , Japan

Wonju Si, Gangwon Do, Korea, Republic Of

Beon Gil Bundang Gu, Gyeonggi Do, Korea, Republic Of

Seongnam Si, Gyeonggido, Korea, Republic Of

Talsi, Talsu Aprinkis, Latvia

Riga, , Latvia

Riga, , Latvia

Riga, , Latvia

Riga, , Latvia

Katowice, Dolnoslaskie, Poland

Klodzko, Dolnoslaskie, Poland

Lodz, Lodzkie, Poland

Lodz, Lodzkie, Poland

Bialystok, Podlaskie, Poland

Gdansk, Pomorskie, Poland

Szczecin, Zachodniopomorskie, Poland

Bydgoszcz, , Poland

Lodz, , Poland

Szczecin, , Poland

Warszawa, , Poland

Wrocław, , Poland

San Juan, , Puerto Rico

San Sebastian, Guipúzcoa, Spain

Barcelona, , Spain

Taoyuan City, Taoyuan, Taiwan

Hsinchu City, , Taiwan

Kaoshiung, , Taiwan

High Wycombe, Buckinghamshire, United Kingdom

Ilford, Essex, United Kingdom

London, Middlesex, United Kingdom

Bradford, West Yorkshire, United Kingdom

Lebanon, New Hampshire, United States

Portland, Oregon, United States

San Miguel De Tucuman, Tucumán, Argentina

Kogarah, New South Wales, Australia

Benowa, Queensland, Australia

Haskovo, , Bulgaria

Bronx, New York, United States

Ciudad Autónoma De Buenos Aires, Ciudad Autónoma De Buenosaires, Argentina

Newmarket, Ontario, Canada

Toronto, Ontario, Canada

Olomouc, Olomoucký Kraj, Czechia

Katowice, Dolnoslaskie, Poland

Lublin, Lubelskie, Poland

Lódz, Lódzkie, Poland

Warszawa, Mazowieckie, Poland

Gdansk, Pomorskie, Poland

Ostrowiec Swietokrzyski, Swietokrzyskie, Poland

Szczecin, Zachodniopomorskie, Poland

Krakow, , Poland

Krakow, , Poland

Lodz, , Poland

Lublin, , Poland

Nowa Sól, , Poland

Warszawa, , Poland

Troy, Michigan, United States

Toronto, Ontario, Canada

Parkville, Victoria, Australia

Shanghai, Minhang District, China

Patients applied

0 patients applied

Trial Officials

Study Director

Study Director

Takeda

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported