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
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.
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.
Main Inclusion Criteria:
Part A:
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:
Participant has received any of the following biologics or biosimilar versions within the time frame indicated or 5 half-lives, whichever is longer:
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:
Los Angeles, California 90017-5310, United States
Clarksville, Indiana 47129-2201, United States
Louisville, Kentucky 40241-6162, United States
Ann Arbor, Michigan 48109-5360, United States
Winston-Salem, North Carolina 27103-7109, United States
Pittsburgh, Pennsylvania 15213-3403, United States
Hermitage, Tennessee 37076-3497, United States
San Antonio, Texas 78218-3128, United States
Ciudad Autónomade Buenos Aires, C1060ABN, Argentina
Kogarah, New South Wales 2217, Australia
Sofia, Sofia-Grad 1606, Bulgaria
Hamilton, Ontario L8L 3C3, Canada
Chongqing, Chongqing Municipality 400016, China
Wuhan, Hubei 430022, China
Wuhan, Hubei 430030, China
Fukutsu-shi, Fukuoka 811-3217, Japan
Obihiro-Shi, Hokkaidô 080-0013, Japan
Kusatsu-shi, Shiga 525-8585, Japan
Shimotsuke-shi, Tochigi 329-0498, Japan
Chuo-ku, Tokyo 104-8560, Japan
Sumida-Ku, Tokyo, Japan
Tachikawa-shi, Tokyo 190-0023, Japan
Shinjuku-ku, Tokyo-To 169-0073, Japan
Takaoka-shi, Toyama 933-0871, Japan
Poznan, Greater Poland Voivodeship 60-702, Poland
Katowice, Lower Silesian Voivodeship 40-081, Poland
Wroclaw, Lower Silesian Voivodeship 50-566, Poland
Lublin, Lublin Voivodeship 20-573, Poland
Lódz, Lódzkie 90-338, Poland
Warsaw, Masovian Voivodeship 02-672, Poland
Gdansk, Pomeranian Voivodeship 80-382, Poland
Gdansk, Pomeranian Voivodeship 80-462, Poland
Katowice, Silesian Voivodeship 40-040, Poland
Szczecin, West Pomeranian Voivodeship 71-500, Poland
Lodz, 90-647, Poland
Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship 27-400, Poland
Beon-gil Bundang-gu, Gyeonggi-do 13620, South Korea
Bucheon-si, Gyeonggido 14647, South Korea
Gwangjin-Gu, Seoul Teugbyeolsi 05030, South Korea
Seocho-Gu, Seoul Teugbyeolsi 06591, South Korea
Zhong Zheng Qu, 100, Taiwan
High Wycombe, Buckinghamshire HP11 2QW, United Kingdom