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Tests treatment safety and results for Plaque Psoriasis
Official title A Study to Evaluate the Efficacy, Safety, and Drug Levels of Deucravacitinib (BMS-986165) in Adolescent Participants With Moderate to Severe Plaque Psoriasis
ClinicalTrials.gov ID: NCT06979453
What this study is testing
What is Deucravacitinib?
Deucravacitinib is an investigational medicine, being studied as a potential treatment for plaque psoriasis.
Also referred to as BMS-986165.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 17
You may be able to join if
- 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)...
You likely can't join if
- 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...
- Participants must not have a history of serious bacterial, fungal, or viral infection requiring hospitalization and intravenous (IV) antimicrobial...
- 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...
- Participants must not have herpes simplex/zoster, active tuberculosis (TB), hepatitis C virus (HCV), hepatitis B virus (HBV), human immunodeficiency...
See the full eligibility 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...
- 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...
- 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...
- 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/Exclusion criteria apply.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Phoenix, Arizona, United States
- Fountain Valley, California, United States
- Fremont, California, United States
- Los Angeles, California, United States
- Northridge, California, United States
- Sacramento, California, United States
- Walnut Creek, California, United States
- Wheat Ridge, Colorado, United States
- Clearwater, Florida, United States
- Margate, Florida, United States
- Miami, Florida, United States
- Miami Lakes, Florida, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Sandy Springs, Georgia, United States
- Ammon, Idaho, United States
- Indianapolis, Indiana, United States
- Murray, Kentucky, United States
- Metairie, Louisiana, United States
+ 91 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Phoenix, Arizona, United States; Fountain Valley, California, United States; Fremont, California, United States; Los Angeles, California, United States; Northridge, California, United States and 105 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.