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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04772079




Registration number
NCT04772079
Ethics application status
Date submitted
24/02/2021
Date registered
26/02/2021
Date last updated
20/02/2024

Titles & IDs
Public title
A Study to Evaluate the Drug Levels, Efficacy and Safety of Deucravacitinib in Pediatric Participants With Moderate to Severe Plaque Psoriasis
Scientific title
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
Secondary ID [1] 0 0
2019-004879-39
Secondary ID [2] 0 0
IM011-126
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Plaque Psoriasis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Deucravacitinib
Other interventions - Placebo matching deucravacitinib

Experimental: Active treatment deucravacitinib standard dose -

Experimental: Active treatment deucravacitinib half-standard dose -

Placebo Comparator: Placebo -


Treatment: Drugs: Deucravacitinib
Specified dose on specified days

Other interventions: Placebo matching deucravacitinib
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Geometric mean observed average concentration at steady state (Cavg.ss) for deucravacitinib at Week 2
Timepoint [1] 0 0
Week 2
Primary outcome [2] 0 0
Maximum observed plasma concentration at steady state (Cmax.ss) for deucravacitinib at Week 2
Timepoint [2] 0 0
Week 2
Primary outcome [3] 0 0
Trough observed plasma concentration (Ctrough) for deucravacitinib at Week 2
Timepoint [3] 0 0
Week 2
Primary outcome [4] 0 0
Proportion of subjects with at least 75% improvement in Psoriasis Area and Severity Index (PASI 75) at Week 16
Timepoint [4] 0 0
Week 16
Primary outcome [5] 0 0
Proportion of subjects with an static Physician's Global Assessment (sPGA) score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline at Week 16
Timepoint [5] 0 0
Week 16
Primary outcome [6] 0 0
Incidence of Adverse Events (AEs)
Timepoint [6] 0 0
Up to 316 weeks
Primary outcome [7] 0 0
Incidence of serious adverse events (SAEs)
Timepoint [7] 0 0
Up to 316 weeks
Primary outcome [8] 0 0
Monitoring of growth: Body weight
Timepoint [8] 0 0
Up to 316 weeks
Primary outcome [9] 0 0
Monitoring of growth: Height
Timepoint [9] 0 0
Up to 316 weeks
Primary outcome [10] 0 0
Monitoring of growth: Tanner staging (sexual maturation)
Timepoint [10] 0 0
Up to 316 weeks
Secondary outcome [1] 0 0
Incidence of Adverse Events (AEs)
Timepoint [1] 0 0
Up to 424 days
Secondary outcome [2] 0 0
Incidence of serious adverse events (SAEs)
Timepoint [2] 0 0
Up to 466 days
Secondary outcome [3] 0 0
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Timepoint [3] 0 0
Up to 466 days
Secondary outcome [4] 0 0
Incidence of clinically significant changes in clinical laboratory results: Chemistry panel tests
Timepoint [4] 0 0
Up to 466 days
Secondary outcome [5] 0 0
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Timepoint [5] 0 0
Up to 466 days
Secondary outcome [6] 0 0
Incidence of clinically significant changes in clinical laboratory results: Hemoglobin A1C tests
Timepoint [6] 0 0
Up to 410 days
Secondary outcome [7] 0 0
Incidence of clinically significant changes in clinical laboratory results: Infectious serologies tests
Timepoint [7] 0 0
Up to 42 days
Secondary outcome [8] 0 0
Incidence of clinically significant changes in clinical laboratory results: Tuberculosis (TB) tests
Timepoint [8] 0 0
Up to 42 days
Secondary outcome [9] 0 0
Incidence of clinically significant changes in clinical laboratory results: Lipid panel tests
Timepoint [9] 0 0
Up to 368 days
Secondary outcome [10] 0 0
Incidence of clinically significant changes in clinical laboratory results: Serum immunoglobulin level tests
Timepoint [10] 0 0
Up to 368 days
Secondary outcome [11] 0 0
Incidence of clinically significant changes in clinical laboratory results: Fasting plasma glucose tests
Timepoint [11] 0 0
Up to 368 days
Secondary outcome [12] 0 0
Incidence of clinically significant changes in clinical laboratory results: Pregnancy test for women of childbearing potential only
Timepoint [12] 0 0
Up to 466 days
Secondary outcome [13] 0 0
Incidence of clinically significant changes in lymphocyte subsets and function
Timepoint [13] 0 0
Up to 466 days
Secondary outcome [14] 0 0
Incidence of clinically significant changes in cytokine levels
Timepoint [14] 0 0
Up to 466 days
Secondary outcome [15] 0 0
Incidence of clinically significant changes in physical examination findings
Timepoint [15] 0 0
Up to 466 days
Secondary outcome [16] 0 0
Incidence of clinically significant changes in vital signs: Body temperature
Timepoint [16] 0 0
Up to 466 days
Secondary outcome [17] 0 0
Incidence of clinically significant changes in vital signs: Respiratory rate
Timepoint [17] 0 0
Up to 466 days
Secondary outcome [18] 0 0
Incidence of clinically significant changes in vital signs: Systolic and diastolic blood pressure
Timepoint [18] 0 0
Up to 466 days
Secondary outcome [19] 0 0
Incidence of clinically significant changes in vital signs: Heart rate
Timepoint [19] 0 0
Up to 466 days
Secondary outcome [20] 0 0
Monitoring of growth: Body weight
Timepoint [20] 0 0
Up to 466 days
Secondary outcome [21] 0 0
Monitoring of growth: Height
Timepoint [21] 0 0
Up to 466 days
Secondary outcome [22] 0 0
Monitoring of growth: Tanner staging (sexual maturation)
Timepoint [22] 0 0
Up to 466 days
Secondary outcome [23] 0 0
Proportion of subjects with at least 75% improvement in PASI (PASI 75) at Week 16 for the comparison of the half-standard dose of deucravacitinib vs placebo
Timepoint [23] 0 0
Week 16
Secondary outcome [24] 0 0
Proportion of subjects with an sPGA score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline at Week 16 for the comparison of the half-standard dose of deucravacitinib vs placebo
Timepoint [24] 0 0
Week 16
Secondary outcome [25] 0 0
Proportion of subjects with at least 90% improvement in PASI (PASI 90) at Week 16 for the comparison of deucravacitinib vs placebo
Timepoint [25] 0 0
Week 16
Secondary outcome [26] 0 0
Change from baseline in PASI at Week 16 for comparison of deucravacitinib vs placebo
Timepoint [26] 0 0
Week 16
Secondary outcome [27] 0 0
Change from baseline in BSA involvement at Week 16 for comparison of deucravacitinib vs placebo
Timepoint [27] 0 0
Week 16
Secondary outcome [28] 0 0
Change from baseline in CDLQI score at Week 16 for comparison of deucravacitinib vs placebo
Timepoint [28] 0 0
Week 16
Secondary outcome [29] 0 0
Change from baseline in subject reported visual analog scale (VAS) for subject's assessment of joint pain at Week 16 (only for subjects with confirmed JPsA prior to baseline) for comparison of deucravacitinib vs placebo
Timepoint [29] 0 0
Week 16
Secondary outcome [30] 0 0
Change from baseline in VAS for subject's Global Assessment of Joint Disease; at Week 16 (only for subjects with confirmed JPsA prior to baseline) for comparison of deucravacitinib vs placebo
Timepoint [30] 0 0
Week 16
Secondary outcome [31] 0 0
Proportion of subjects achieving American College of Rheumatology Pediatric 30 (ACR Pedi 30) response at Week 16 for subjects with confirmed JPsA prior to baseline
Timepoint [31] 0 0
Week 16
Secondary outcome [32] 0 0
Proportion of subjects using topical corticosteroid at Week 16 for comparison of deucravacitinib vs placebo
Timepoint [32] 0 0
Week 16
Secondary outcome [33] 0 0
Proportion of subjects with protective titers of antibodies to measles, tetanus and pertussis at Week 16
Timepoint [33] 0 0
Week 16
Secondary outcome [34] 0 0
Geometric mean observed average concentration at steady state (Cavg.ss) for deucravacitinib at Week 16
Timepoint [34] 0 0
Week 16
Secondary outcome [35] 0 0
Maximum observed plasma concentration at steady state (Cmax.ss) for deucravacitinib at Week 16
Timepoint [35] 0 0
Week 16
Secondary outcome [36] 0 0
Trough observed plasma concentration (Ctrough) for deucravacitinib at Week 16
Timepoint [36] 0 0
Week 16
Secondary outcome [37] 0 0
Proportion of participants with 75% improvement in PASI (PASI 75) over time
Timepoint [37] 0 0
Up to 316 weeks
Secondary outcome [38] 0 0
Proportion of participants with an sPGA score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline over time
Timepoint [38] 0 0
Up to 316 weeks

Eligibility
Key inclusion criteria
- Males and females aged 12 to <18 years for Cohort 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
Minimum age
4 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Participants weighing = 30.0 kg at screening 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 active comparator

- Evidence of active TB for LTE period

Other protocol-defined inclusion/exclusion criteria apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/03/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
8/09/2033
Actual
Sample size
Target
153
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
The Skin Hospital - Darlinghurst
Recruitment hospital [2] 0 0
Local Institution - 0002 - Westmead
Recruitment hospital [3] 0 0
Local Institution - 0072 - Brisbane
Recruitment hospital [4] 0 0
Veracity Clinical Research - Woolloongabba
Recruitment hospital [5] 0 0
Monash Health - Clayton
Recruitment hospital [6] 0 0
Local Institution - 0001 - Melbourne
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4101 - Brisbane
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [5] 0 0
3168 - Clayton
Recruitment postcode(s) [6] 0 0
3995 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Argentina
State/province [2] 0 0
Caba
Country [3] 0 0
Brazil
State/province [3] 0 0
Bahia
Country [4] 0 0
Brazil
State/province [4] 0 0
São Paulo
Country [5] 0 0
Canada
State/province [5] 0 0
Alberta
Country [6] 0 0
Canada
State/province [6] 0 0
Ontario
Country [7] 0 0
France
State/province [7] 0 0
Dijon
Country [8] 0 0
France
State/province [8] 0 0
Nice
Country [9] 0 0
France
State/province [9] 0 0
Paris
Country [10] 0 0
Germany
State/province [10] 0 0
Nordrhein-Westfalen
Country [11] 0 0
Germany
State/province [11] 0 0
Rheinland-Pfalz
Country [12] 0 0
Germany
State/province [12] 0 0
Sachsen
Country [13] 0 0
Germany
State/province [13] 0 0
Berlin
Country [14] 0 0
Germany
State/province [14] 0 0
Hamburg
Country [15] 0 0
Japan
State/province [15] 0 0
Aichi
Country [16] 0 0
Japan
State/province [16] 0 0
Fukuoka
Country [17] 0 0
Japan
State/province [17] 0 0
Kanagawa
Country [18] 0 0
Japan
State/province [18] 0 0
Mie
Country [19] 0 0
Japan
State/province [19] 0 0
Tokyo
Country [20] 0 0
Japan
State/province [20] 0 0
Osaka
Country [21] 0 0
Korea, Republic of
State/province [21] 0 0
Seoul-teukbyeolsi [Seoul]
Country [22] 0 0
Mexico
State/province [22] 0 0
Distrito Federal
Country [23] 0 0
Mexico
State/province [23] 0 0
Jalisco
Country [24] 0 0
Mexico
State/province [24] 0 0
Veracruz
Country [25] 0 0
Poland
State/province [25] 0 0
Krakow
Country [26] 0 0
Poland
State/province [26] 0 0
Lodz
Country [27] 0 0
Poland
State/province [27] 0 0
Warsaw
Country [28] 0 0
Poland
State/province [28] 0 0
Wroclaw
Country [29] 0 0
Romania
State/province [29] 0 0
Bucure?ti
Country [30] 0 0
Romania
State/province [30] 0 0
Ia?i
Country [31] 0 0
Romania
State/province [31] 0 0
Mure?
Country [32] 0 0
Spain
State/province [32] 0 0
Alicante
Country [33] 0 0
Spain
State/province [33] 0 0
Barakaldo
Country [34] 0 0
Spain
State/province [34] 0 0
Esplugues de Llobregat
Country [35] 0 0
Spain
State/province [35] 0 0
Las Palmas De GC
Country [36] 0 0
Spain
State/province [36] 0 0
Madrid
Country [37] 0 0
United Kingdom
State/province [37] 0 0
Connor Downs

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this pediatric study is to evaluate the drug levels, efficacy and safety of
Deucravacitinib in pediatric 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 pediatric 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 pediatric participants with psoriasis who have
completed Parts A or B of the study.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04772079
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
BMS Study Connect Contact Center www.BMSStudyConnect.com
Address 0 0
Country 0 0
Phone 0 0
855-907-3286
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04772079