Testing Deucravacitinib against a placebo for plaque psoriasis

Inclusion

• +Participants must not have herpes simplex/zoster, active tuberculosis (TB), hepatitis C virus (HCV), hepatitis B virus (HBV), human immunodeficiency virus (HIV) infection-related exclusions.
• +Participants must have stable plaque psoriasis for 6 months or more prior to ScreeningScreeningThe checks done before joining, to see whether a study fits.Read more →.
• +Participants must have moderate to severe psoriasis defined by:.
• +i) Psoriasis Area and Severity Index (PASI) ≥ 12, at screening visit and Day 1.
• +ii) Static Physician's Global Assessment (sPGA) ≥ 3, at screening visit and Day 1.
• +iii) Body Surface Area (BSA) ≥ 10% involvement, at screening visit and Day 1.
• +Exclusion CriteriaExclusion criteriaThe things that would prevent someone from taking part.Read more →
• +Participants must not weigh \< 30.0 kg at Screening and Day 1.
• +Participants must not have non-plaque psoriasis (ie, guttate, inverse, pustular, erythrodermic, or drug-induced psoriasis) or any skin condition other than plaque psoriasis that could interfere with assessments of treatment effect at Screening or Day 1.
• +Participants must not have a history of serious bacterial, fungal, or viral infection requiring hospitalization and intravenous (IV) antimicrobial treatment within 60 days prior to Day 1.
• +Participants must not have any untreated bacterial infection within 60 days prior to Day 1.
• +Participants must not have any ongoing evidence of chronic bacterial infection (eg, chronic pyelonephritis, chronic osteomyelitis, chronic bronchiectasis).
• +Participants must not have received live vaccines or BCG within 60 days prior to Day 1 or plans to receive a live vaccine during the study, or within 60 days after completing study intervention.
• +Participants must not have had any prior exposure to deucravacitinib.
• +Participants must not have received any medication that is specifically prohibited.
• +Participants must not have a laboratory finding that is exclusionary.
• +Participants must not have any major illness/condition or evidence of an unstable clinical condition (eg, renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, psychiatric, neurologic, immunologic, or local active infection/infectious illness) that, in the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →'s judgment or after consultation with the SponsorSponsorThe organisation responsible for the study overall.Read more →'s Medical Monitor, will substantially increase the risk to the participant if he or she participates in the study.
• +Participants must not have cancer or history of cancer (solid organ or hematologic including myelodysplastic syndrome) or lymphoproliferative disease within the previous 5 years.
• +Other protocolProtocolThe detailed plan a study must follow.Read more →-defined InclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more →/Exclusion criteria apply.
• +\- A female (as assigned at birth) participant is eligible to participate if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies:.
• +i) Is not an individual of childbearing potential (IOCBP).
• +ii) Is an IOCBP and using a contraceptive method that is highly effective (with a failure rate of \< 1% per year) during the study intervention period and for at least 3 days after discontinuation of the study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction for the same period.