Testing Deucravacitinib against a placebo for plaque psoriasis
Official title: A Study to Evaluate the Drug Levels, Efficacy and Safety of Deucravacitinib in Children and Adolescent Participants With Moderate to Severe Plaque Psoriasis
A Multicenter, Randomized, Double-Blind Placebo-Controlled Phase 3 Study to Evaluate the Pharmacokinetics, Efficacy and Safety of Deucravacitinib (BMS-986165) in Pediatric Subjects With Moderate to Severe Plaque Psoriasis
- Phase 3
- 3 groups
- Sites in Calgary, Edmonton and 3 more cities
- Recruiting
Interventions
- Medication
Deucravacitinib
Specified dose on specified days
- Other intervention
Placebo matching deucravacitinib
Specified dose on specified days
Canadian Sites (5)
3 of 5 recruiting
- Recruiting
Alberta Dermasurgery Centre
Edmonton, Alberta
- Recruiting
Lynderm Research Inc.
Markham, Ontario
- Recruiting
The Hospital for Sick Children
Toronto, Ontario
- Completed
Local Institution - 0010
Calgary, Alberta
- Withdrawn
Local Institution - 0039
Hamilton, Ontario
Eligibility Criteria
See who this study is looking for18 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Males and females aged 12 to \<18 years for CohortCohortA group of participants sharing a characteristic, followed together.Read more → 1. Males and females aged 4 to \<12 years for Cohort 2.
- +Plaque psoriasis for at least 6 months.
- +Moderate to severe disease.
- +Candidate for phototherapy or systemic therapy.
- +Must have completed the Week 52 treatment period in Part A or B for long-term extension (LTE) period.
- +Exclusion CriteriaExclusion criteriaThe things that would prevent someone from taking part.Read more →
- +Participants weighing ≤ 30.0 kg at screeningScreeningThe checks done before joining, to see whether a study fits.Read more → for Cohort 1 (age 12 to \< 18 years), Part A and Part B. Participants weighing \< 18.0 kg at screening for Cohort 2 (age 4 to \< 12 years), Part A and Part B.
- +Other forms of psoriasis.
- +History of recent infection.
- +Prior exposure to deucravacitinib (BMS-986165) or another active comparatorControl groupThe group a new treatment is measured against.Read more →.
- +Evidence of active TB for LTE period.
- +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.
Exclusion
- −Participants weighing ≤ 30.0 kg at screeningScreeningThe checks done before joining, to see whether a study fits.Read more → for CohortCohortA group of participants sharing a characteristic, followed together.Read more → 1 (age 12 to \< 18 years), Part A and Part B. Participants weighing \< 18.0 kg at screening for Cohort 2 (age 4 to \< 12 years), Part A and Part B.
- −Other forms of psoriasis.
- −History of recent infection.
- −Prior exposure to deucravacitinib (BMS-986165) or another active comparatorControl groupThe group a new treatment is measured against.Read more →.
- −Evidence of active TB for LTE period.
- −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 criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → apply.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 3 groups in this study.
Groups A and B receive Deucravacitinib.
Registry label: A: Active treatment deucravacitinib standard dose · B: Active treatment deucravacitinib half-standard dose
Group C, the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group, receives Placebo matching deucravacitinib.
Registry label: C: Placebo
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 4 years to 18 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 153 people.
The study is currently expected to finish around September 2033.
The main measurement is taken over: Week 2.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Observed average concentration at steady state for deucravacitinib at Week 2 — measured over Week 2.
Maximum observed plasma concentration at steady state for deucravacitinib at Week 2 — measured over Week 2.
Trough observed plasma concentration for deucravacitinib at Week 2 — measured over Week 2.
Proportion of subjects with at least 75% improvement in Psoriasis Area and Severity Index (PASI 75) at Week 16 — measured over Week 16.
The study lists 6 further main measurements.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT04772079 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About DeucravacitinibDrug
Specified dose on specified days
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Placebo matching deucravacitinibOther
Specified dose on specified days
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 4 years to 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 4 years to 18 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Week 2.
The study as a whole is currently expected to finish around 2033-09-08.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 153 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 5 locations, including: Calgary, Alberta, Canada; Edmonton, Alberta, Canada; Hamilton, Ontario, Canada; Markham, Ontario, Canada; Toronto, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
The purpose of this pediatric study is to evaluate the drug levels, efficacy and safety of Deucravacitinib in children and adolescent participants aged 4 to \<18 years with moderate to severe plaque psoriasis. This study includes two cohorts; Cohort 1 (age 12 to \<18 years) and Cohort 2 (age 4 to \<12 years), with two parts; for each cohort. Part A will evaluate the drug levels of BMS-986165 to enable selection of 2 dose levels to be studied in Part B. Part B will assess the efficacy and safety of two dose levels in children and adolescent participants with moderate to severe plaque psoriasis. The 5-year long-term extension (LTE) period will observe the long-term safety and tolerability of deucravacitinib in children and adolescent participants with psoriasis who have completed Parts A or B of the study.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.