Dermatologikum Hamburg | Hamburg, Germany
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
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.
Full description
This study consists of 2 parts: Part A and Part B.
Part A: Participants who did not participate in either parent study (TAK-279-3001 [NCT06088043] or TAK-279-3002 [NCT06108544]) 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) or TAK-279-3002 (NCT06108544) 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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Main Inclusion Criteria:
Part A:
Part B:
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:
Primary purpose
Allocation
Interventional model
Masking
1,300 participants in 1 patient group
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Central trial contact
Takeda Contact
Data sourced from clinicaltrials.gov
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