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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
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
Trial Officials
Study Director
Study Director
Takeda
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported