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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05620407




Registration number
NCT05620407
Ethics application status
Date submitted
10/11/2022
Date registered
17/11/2022

Titles & IDs
Public title
A Study to Evaluate Effectiveness and Safety of Deucravacitinib (BMS-986165) Compared With Placebo in Participants With Active Systemic Lupus Erythematosus
Scientific title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants With Active Systemic Lupus Erythematosus (SLE) (POETYK SLE-2)
Secondary ID [1] 0 0
2022-500700-22
Secondary ID [2] 0 0
IM011-247
Universal Trial Number (UTN)
Trial acronym
POETYK SLE-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Systemic Lupus Erythematosus 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

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

Experimental: Arm 1: Deucravacitinib -

Placebo comparator: Arm 2: Placebo -


Treatment: Drugs: Deucravacitinib
Specified dose on specified days

Other interventions: Placebo
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
Proportion of participants who achieve Systemic Lupus Erythematosus Responder Index-4 [SRI(4)] response
Timepoint [1] 0 0
At week 52
Secondary outcome [1] 0 0
Proportion of participants who achieve British Isles Lupus Assessment Group-based Combined Lupus Assessment (BICLA) response
Timepoint [1] 0 0
At week 52
Secondary outcome [2] 0 0
Proportion of participants who achieve both SRI(4) and BICLA (dual responders)
Timepoint [2] 0 0
At week 52
Secondary outcome [3] 0 0
Proportion of participants with a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score = 10 at baseline who achieve a CLASI response, defined as a decrease of = 50% from baseline CLASI activity score
Timepoint [3] 0 0
At week 52
Secondary outcome [4] 0 0
Proportion of participants who achieve Lupus Low Disease Activity State (LLDAS)
Timepoint [4] 0 0
At week 52
Secondary outcome [5] 0 0
Proportion of participants taking = 7.5 mg/day prednisone (or equivalent) at Week 24 with no dose increase beyond protocol-specified limits
Timepoint [5] 0 0
Up to 52 weeks
Secondary outcome [6] 0 0
Proportion of participants with = 6 active (tender + swollen) joints at baseline who achieve at least 50% from baseline reduction in active (tender + swollen) joints
Timepoint [6] 0 0
At week 52
Secondary outcome [7] 0 0
Change from baseline in patient-reported fatigue according to Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue
Timepoint [7] 0 0
At week 52
Secondary outcome [8] 0 0
Number of participants with adverse events (AEs)
Timepoint [8] 0 0
Up to 156 weeks
Secondary outcome [9] 0 0
Number of participants with serious adverse events (SAEs)
Timepoint [9] 0 0
Up to 156 weeks
Secondary outcome [10] 0 0
Number of participants with AEs leading to discontinuation of treatment
Timepoint [10] 0 0
Up to 156 weeks
Secondary outcome [11] 0 0
Number of participants with AEs leading to study discontinuation
Timepoint [11] 0 0
Up to 156 weeks
Secondary outcome [12] 0 0
Number of participants with target adverse events of special interest (AESIs)
Timepoint [12] 0 0
Up to 156 weeks
Secondary outcome [13] 0 0
Number of participants with laboratory abnormalities
Timepoint [13] 0 0
Up to 156 weeks
Secondary outcome [14] 0 0
Number of participants with electrocardiogram (ECG) abnormalities
Timepoint [14] 0 0
Up to 156 weeks
Secondary outcome [15] 0 0
Number of participants with vital sign abnormalities
Timepoint [15] 0 0
Up to 156 weeks

Eligibility
Key inclusion criteria
Inclusion Criteria

* Diagnosed with Systemic Lupus Erythematosus (SLE) at least 24 weeks before the screening visit.
* Meet the European Alliance of Associations for Rheumatology (EULAR)/American College of Rheumatology (ACR) 2019 classification criteria for SLE.
* One of the following: positive antinuclear antibodies (ANA) = 1:80 at screening OR positive anti dsDNA OR positive anti Smith (anti Sm) as determined by the central laboratory at screening.
* Total Systemic Lupus Erythematosus Disease Activity Index-2K (SLEDAI-2K) score = 6 points and clinical SLEDAI 2K score = 4 points with joint involvement, and/or cutaneous vasculitis, and/or rash.
* Lupus headache, alopecia, organic brain syndrome, and mucosal ulcers must be recorded on SLEDAI 2K, if indicated, but do not count toward the points required for screening at entry.
* At least one SLE background therapy(immunosuppressant and/or antimalarial) is required for = 12 weeks before the screening visit, must be at a stable dose for = 8 weeks before the screening visit, and must remain stable until randomization and throughout study participation.
* Oral corticosteroid (OCS; prednisone or equivalent) background therapy is permitted but not required. For participants taking OCS, the dose must be stable for = 2 weeks before the screening visit, cannot exceed 30 mg/day at screening, and must remain stable until the Week 4 visit. Participants can be on an OCS as well as an antimalarial and/or an immunosuppressant.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

* Diagnosis of drug-induced SLE rather than idiopathic SLE.
* Other autoimmune diseases (eg, multiple sclerosis, psoriasis, inflammatory bowel disease, etc.) are excluded. Participants with type I autoimmune diabetes mellitus, thyroid autoimmune disease, Celiac disease, or secondary Sjögren's syndrome are not excluded -SLE overlap syndromes including, but not limited to, rheumatoid arthritis, scleroderma, and mixed connective tissue disease are excluded.
* Active or unstable lupus neuropsychiatric manifestations, including, but not limited to, any condition defined by BILAG A criteria.
* Active, severe Class III, and IV, lupus nephritis that requires or may require treatment with cytotoxic agents or high-dose CS.
* History of congenital or acquired immunodeficiency.
* Known active infection, or any major episode of infection requiring hospitalization or treatment with parenteral (intramuscular or IV) antimicrobial agents (eg, antibiotics antiviral, antifungal, or antiparasitic agents) within 30 days of randomization, or treatment with oral antimicrobial agents within 2 weeks of randomization -Currently on any therapy for chronic infection (eg, pneumocystis, herpes zoster, cytomegalovirus, invasive bacterial or fungal infections, or atypical mycobacteria).
* Taking more than 1 immunosuppressant at screening.
* In Japan only: Participants with positive result of ß - D-glucan assay.
* 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
Parallel
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
12/01/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
17/12/2027
Actual
Sample size
Target
490
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 0 0
BJC Health - Paramatta
Recruitment hospital [3] 0 0
Rheumatology Research Unit - Maroochydore
Recruitment hospital [4] 0 0
Austin Health - Repatriation Hospital - Ivanhoe
Recruitment hospital [5] 0 0
RK Will Pty Ltd - Victoria Park
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
2150 - Paramatta
Recruitment postcode(s) [3] 0 0
4558 - Maroochydore
Recruitment postcode(s) [4] 0 0
3079 - Ivanhoe
Recruitment postcode(s) [5] 0 0
6100 - Victoria Park
Recruitment outside Australia
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United States of America
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California
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Florida
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Illinois
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Massachusetts
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Madrid
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País Vasco
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Sevilla
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Valladolid
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València
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Taiwan
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Kaohsiung
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Taipei
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Thailand
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Krung Thep Maha Nakhon
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Ankara
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Antalya
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Gaziantep
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Istanbul
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England
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Greater London
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Middlesbrough
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Bradford
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United Kingdom
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Oxford

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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 Clinical Trials Contact Center www.BMSClinicalTrials.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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria.

Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at:

https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
See Plan Description
Available to whom?
See Plan Description
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05620407