Plaque Psoriasis
Conditions
Keywords
Psoriasis, Rash, Itch, Teen, Dermatology, Derm, POETYK-PsO-Peds-1
Brief summary
The purpose of this study is to evaluate the efficacy, safety, and drug levels of Deucravacitinib (BMS-986165) in adolescent participants with moderate to severe plaque psoriasis
Interventions
DRUGDeucravacitinib
Specified dose on specified days
OTHERPlacebo
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Participants must have stable plaque psoriasis for 6 months or more prior to Screening. * 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. \- 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.
Exclusion criteria
* 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 herpes simplex/zoster, active tuberculosis (TB), hepatitis C virus (HCV), hepatitis B virus (HBV), human immunodeficiency virus (HIV) infection-related exclusions. * 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 investigator's judgment or after consultation with the Sponsor'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 protocol-defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants achieving at least 75% improvement in Psoriasis Area and Severity Index (PASI 75) | At week 16 |
| Number of participants achieving a static Physicians Global Assessment (sPGA) score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline | At week 16 |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants achieving at least 90% improvement in PASI (PASI 90) | At week 16 |
| Change from baseline in PASI | At week 16 |
| Change from baseline in body surface area (BSA) involvement | At week 16 |
| Change from baseline in worst itch numeric rating scale (WI-NRS) | At week 16 |
| Number of participants achieving ≥ 4 improvement from baseline in the WI-NRS score (in participants with baseline score ≥ 4) | At week 16 |
| Change from baseline in Children's Dermatology Life Quality Index (CDLQI) score | At week 16 |
| Number of participants achieving CDLQI 0/1 (among participants with a baseline CDLQI score ≥ 2) | At week 16 |
| Number of participants with treatment emergent adverse events | Up to 5 years |
| Number of participants with serious adverse events | Up to 5 years |
| Number of participants with clinically significant changes in laboratory parameters | Up to 5 years |
| Number of participants with clinically significant changes in physical examinations | Up to 5 years |
| Number of participants with clinically significant changes in vital signs | Up to 5 years |
| Number of participants with protective titers of antibodies to measles | At week 16 |
| Number of participants with protective titers of antibodies to tetanus | At week 16 |
| Number of participants with protective titers of antibodies to pertussis | At week 16 |
| Body weight | Up to 5 years |
| Height | Up to 5 years |
| Sexual maturation | Up to 5 years |
Countries
Argentina, Belgium, Brazil, Canada, China, Colombia, Germany, Hungary, Italy, Mexico, Poland, Puerto Rico, Romania, Spain, Taiwan, United States
Contacts
CONTACTBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACTFirst line of the email MUST contain NCT # and Site #.
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed