A Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-279 With a Randomized Withdrawal and Retreatment Period in Subjects With Moderate-to-Severe Plaque Psoriasis

Phase 1

Recruiting

Conditions: Moderate to Severe Plaque Psoriasis
MedDRA version: 20.0Level: LLTClassification code: 10071117Term: Plaque psoriasis Class: 10040785
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: CTIS2023-505842-24-00

Lead Sponsor: Takeda Development Center Americas Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 1117

Inclusion Criteria

1.Subject 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 2. Subject has provided written informed consent and any required privacy authorization before the initiation of any study procedures 3. Subject has a diagnosis of chronic plaque psoriasis for =6 months prior to the screening visit 4. Subject 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 (information obtained from medical chart or subject’s physician, or directly from the subject). 5. Subject has moderate-to-severe plaque psoriasis as defined by a PASI score =12 and a sPGA score =3 at screening and Day 1. 6. Subject has plaque psoriasis covering =10% of his or her total BSA at screening and Day 1. 7. Subject must be a candidate for phototherapy or systemic therapy. 8. Subject is aged 18 years or older at the time of consent. 9. Subject meets the following birth control requirement: A surgically sterile female subject; or a female subject of nonchildbearing potential with laboratory confirmation of postmenopausal status (ie, follicle-stimulating hormone levels >40 mIU/mL); or, if sexually active with a nonsterilized male partner, a female subject who agrees to use an effective method of contraception from the signing of informed consent throughout the duration of the study and for 10 days after the last dose

Exclusion Criteria

(1-7) Subject has evidence of non-plaque psoriasis (erythrodermic, pustular, predominantly guttate psoriasis, predominantly inverse, or drug-induced psoriasis). Subject requires systemic treatment, other than nonsteroidal anti-inflammatory drugs, during the trial period for an immune-related disease (eg, inflammatory bowel disease). Subject has a history of excessive sun exposure, has used tanning booths within 4 weeks prior to Day 1, or is not willing to minimize natural and artificial sunlight exposure during the study period. Use of sunscreen products and protective apparel is recommended when sun exposure cannot be avoided. Subject has concomitant comorbid skin condition that, in the opinion of the investigator, would interfere with the study assessments. Tuberculosis: a. Subject has history of active TB infection, regardless of treatment status. b. Subject has signs or symptoms of active TB (including but not limited to chronic fever, chronic productive cough, night sweats, or weight loss) as judged by the investigator. c. Subject has evidence of latent TB infection (LTBI) as evidenced by a positive QuantiFERON-TB Gold (QFT) result OR 2 indeterminant QFT results and subject does not have documentation of appropriate LTBI prophylaxis or is not able or not willing to initiate appropriate LTBI prophylaxis. Subject remains eligible if there are no signs/symptoms of active TB AND documentation of no history of active TB can be provided AND (1) subject can provide documentation of prior and complete treatment for LTBI (appropriate in duration and type per current local country guidelines) or (2) subject has initiated prophylaxis (appropriate in duration and type per current local guidelines) a minimum of 2 weeks prior to Day 1. Note: TB prophylaxis regimens should be administered according to local guidelines; however, because of potential interactions with TAK-279 and apremilast, rifampin should not be used. TB testing should be conducted using QuantiFERON-TB Gold submitted to central lab unless alternate or additional tests are required per local guidelines. d. Subject has had any imaging study during or 6 months prior to screening, including x-ray, chest computed tomography, magnetic resonance imaging, or other chest imaging suggesting evidence of current active or a history of active TB. Herpes infection: a. Subject has active herpes virus infection, including herpes zoster or herpes simplex 1 and 2 (demonstrated on physical examination and/or medical history) at screening or Day 1. b. Subject has history of serious herpetic infection that includes any episode of disseminated disease, multidermatomal herpes simplex virus, herpes encephalitis, ophthalmic herpes, or recurrent herpes zoster (defined as 2 episodes within 2 years). Non-herpetic viral diseases: a. Subject has presence of hepatitis C virus (HCV) antibody and a positive confirmatory test result for HCV RNA (nucleic acid test or polymerase chain reaction). b. Subject has presence of positive hepatitis B surface antigen (HBsAg+), presence of hepatitis B virus DNA, or positive anti-hepatitis B core antibody without concurrent positive hepatitis B surface antibody (HBcAb+ and HBsAb-). c. Subject has positive results for human immunodeficiency virus (HIV)., (8-9) Other infectious diseases: a. Subject has a history of active infection or febrile illness within 7 days prior to Day 1, as assessed by the investigator. b. Subject has history of symptoms suggestive of system