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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03252587




Registration number
NCT03252587
Ethics application status
Date submitted
15/08/2017
Date registered
17/08/2017
Date last updated
19/08/2019

Titles & IDs
Public title
An Investigational Study to Evaluate BMS-986165 in Patients With Systemic Lupus Erythematosus
Scientific title
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of BMS-986165 in Subjects With Systemic Lupus Erythematosus
Secondary ID [1] 0 0
2017-001203-79
Secondary ID [2] 0 0
IM011-021
Universal Trial Number (UTN)
Trial acronym
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 - BMS-986165
Other interventions - Placebo

Experimental: BMS-986165 Dose 1 oral administration -

Experimental: BMS-986165 Dose 2 oral administration -

Experimental: BMS-986165 Dose 3 oral administration -

Placebo Comparator: Placebo oral administration -


Treatment: Drugs: BMS-986165
administered orally

Other interventions: Placebo
administered orally

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
Number of participants who meet response criteria for SLE Responder Index [SRI(4)]
Timepoint [1] 0 0
32 weeks
Secondary outcome [1] 0 0
Number of participants with a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score = 10 at baseline achieving a CLASI response, defined as a decrease of = 50% from baseline CLASI activity score
Timepoint [1] 0 0
32 weeks
Secondary outcome [2] 0 0
Change from baseline in the 40-joint count for tender, swollen, and tender + swollen joints
Timepoint [2] 0 0
32 weeks
Secondary outcome [3] 0 0
Number of participants who achieve British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response
Timepoint [3] 0 0
32 weeks
Secondary outcome [4] 0 0
Distribution of participants experiencing serious adverse events (SAEs)
Timepoint [4] 0 0
32 weeks
Secondary outcome [5] 0 0
Distribution of participants experiencing adverse events (AEs)
Timepoint [5] 0 0
32 weeks
Secondary outcome [6] 0 0
Distribution of participants experiencing abnormalities in laboratory testing
Timepoint [6] 0 0
48 weeks
Secondary outcome [7] 0 0
Distribution of participants experiencing abnormalities in vital signs
Timepoint [7] 0 0
48 weeks
Secondary outcome [8] 0 0
Distribution of participants experiencing abnormalities in electrocardiograms (ECGs)
Timepoint [8] 0 0
48 weeks
Secondary outcome [9] 0 0
Maximum observed plasma concentration (Cmax)
Timepoint [9] 0 0
48 weeks
Secondary outcome [10] 0 0
Time of maximum observed plasma concentration (Tmax)
Timepoint [10] 0 0
48 weeks
Secondary outcome [11] 0 0
Trough observed plasma concentration (Ctrough)
Timepoint [11] 0 0
48 weeks

Eligibility
Key inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com



- Meets the Systemic Lupus International Collaborating Clinics (SLICC) classification
criteria for SLE and diagnosed = 24 weeks before the screening visit

- One of the following: antinuclear antibody (ANA) = 1:80 or positive
anti-double-stranded DNA (dsDNA) or positive anti-Smith (Sm)

- Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score = 6 points
and clinical SLEDAI-2K score = 4 points
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Subjects with drug-induced SLE, certain other autoimmune diseases, and active, severe
lupus nephritis

- SLE overlap syndromes such as scleroderma and mixed connective tissue disease

- Clinically significant abnormalities on chest x-ray or ECG

- History of any significant drug allergy

Other protocol defined inclusion/exclusion criteria could 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 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
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Actual
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Actual
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Actual
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Final
Recruitment in Australia
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QLD,VIC
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Local Institution - Maroochydore
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Local Institution - Clayton
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Local Institution - Heidelberg West
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4558 - Maroochydore
Recruitment postcode(s) [2] 0 0
- Clayton
Recruitment postcode(s) [3] 0 0
3081 - Heidelberg West
Recruitment outside Australia
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Zhytomyr

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

Ethics approval
Ethics application status

Summary
Brief summary
This study will investigate BMS-986165 to assess its effects in patients with systemic lupus
erythematosus (SLE).
Trial website
https://clinicaltrials.gov/show/NCT03252587
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
Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,
Address 0 0
Country 0 0
Phone 0 0
please email:
Fax 0 0
Email 0 0
Clinical.Trials@bms.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03252587