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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03616912




Registration number
NCT03616912
Ethics application status
Date submitted
1/08/2018
Date registered
6/08/2018
Date last updated
18/06/2020

Titles & IDs
Public title
A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus
Scientific title
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients With Systemic Lupus Erythematosus
Secondary ID [1] 0 0
I4V-MC-JAHZ
Secondary ID [2] 0 0
16676
Universal Trial Number (UTN)
Trial acronym
BRAVE I
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 - Baricitinib
Treatment: Drugs - Placebo

Experimental: Baricitinib High Dose - Baricitinib administered orally. Placebo administered orally to maintain the blind.

Experimental: Baricitinib Low Dose - Baricitinib administered orally. Placebo administered orally to maintain the blind.

Placebo Comparator: Placebo - Placebo administered orally.


Treatment: Drugs: Baricitinib
Administered orally.

Treatment: Drugs: Placebo
Administered orally.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response (High Dose) - Percentage of participants achieving SRI-4 response (high dose).
Timepoint [1] 0 0
Week 52
Secondary outcome [1] 0 0
Percentage of Participants Achieving SRI-4 Response (Low Dose) - Percentage of participants achieving SRI-4 response (low dose).
Timepoint [1] 0 0
Week 52
Secondary outcome [2] 0 0
Percentage of Participants Achieving a Lupus Low Disease Activity State (LLDAS) - Percentage of Participants Achieving a LLDAS.
Timepoint [2] 0 0
Week 52
Secondary outcome [3] 0 0
Time to First Severe Flare - Time to first severe flare.
Timepoint [3] 0 0
Baseline to Week 52
Secondary outcome [4] 0 0
Change from Baseline in Prednisone Dose - Change from baseline in prednisone dose.
Timepoint [4] 0 0
Baseline, Week 52
Secondary outcome [5] 0 0
Change from Baseline in Worst Pain Numeric Rating Scale (NRS) - Change from baseline in worst pain NRS.
Timepoint [5] 0 0
Baseline, Week 52
Secondary outcome [6] 0 0
Change from Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Total Score - Change from baseline on FACIT-Fatigue total score.
Timepoint [6] 0 0
Baseline, Week 52
Secondary outcome [7] 0 0
Percentage of Participants with Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Total Activity Score =10 at Baseline with =50% Reduction in CLASI Total Activity Score - Percentage of participants with CLASI total activity score =10 at baseline with =50% reduction in CLASI total activity score.
Timepoint [7] 0 0
Week 52
Secondary outcome [8] 0 0
Change from Baseline in Tender Joint Count - Change from baseline in tender joint count.
Timepoint [8] 0 0
Baseline, Week 52
Secondary outcome [9] 0 0
Change from Baseline in Swollen Joint Count - Change from baseline in swollen joint count.
Timepoint [9] 0 0
Baseline, Week 52
Secondary outcome [10] 0 0
Population Pharmacokinetics (PK): Area Under the Concentration-Time Curve of Baricitinib at Steady State (AUCt, ss) - PK: Area Under the Concentration-Time Curve of Baricitinib at Steady State (AUCt, ss).
Timepoint [10] 0 0
Baseline through Week 16
Secondary outcome [11] 0 0
Population PK: Maximum Observed Drug Concentration at Steady State (Cmax,ss) - Population PK: Maximum Observed Drug Concentration at Steady State (Cmax,ss).
Timepoint [11] 0 0
Baseline through Week 16

Eligibility
Key inclusion criteria
- Have a clinical diagnosis of SLE at least 24 weeks prior to screening.

- Have documentation of having met at least 4 of 11 Revised Criteria for Classification
of Systemic Lupus Erythematosus according to the 1997 Update of the 1982 American
College of Rheumatology (ACR) criteria for classification of SLE prior to
randomization.

- Have a positive antinuclear antibody (ANA) (titer =1:80) and/or a positive
anti-double-stranded deoxyribonucleic acid (dsDNA), and/or a positive anti-Smith
(anti-Sm) as assessed by a central laboratory during screening.

- Have a total Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)
score =6 during screening.

- Have a clinical SLEDAI-2K score =4 at randomization.

- Have at least 1 British Isles Lupus Assessment Group (BILAG) A score or 2 BILAG B
scores during screening.

- Are receiving at least one of the following standard of care medications for SLE:

- A single antimalarial at a stable dose for at least 8 weeks prior to screening

- A single immunosuppressant at a stable dose for at least 8 weeks prior to
screening

- An oral corticosteroid, initiated at least 4 weeks prior to screening, at a
stable dose =40 milligrams/day prednisone (or equivalent) for at least 2 weeks
prior to screening. If the participant is not receiving an antimalarial or
immunosuppressant, the dose of corticosteroid must be =7.5 milligrams/day
prednisone (or equivalent)
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Have severe active lupus nephritis.

- Have active central nervous system (CNS) lupus.

- Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal,
endocrine, hematological, neurological, or neuropsychiatric disorders or any other
serious and/or unstable illness that, in the opinion of the investigator, could
constitute an unacceptable risk when taking investigational product or interfere with
the interpretation of data.

- Have a current or recent clinically serious viral, bacterial, fungal, or parasitic
infection.

- Have received cyclophosphamide (or any other cytotoxic agent) within 12 weeks prior to
screening.

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 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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Optimus Clinical Research - Kogarah
Recruitment hospital [2] 0 0
The Rheumatology Research Unit Sunshine Coast - Maroochydore
Recruitment hospital [3] 0 0
Emeritus Research - Camberwell
Recruitment hospital [4] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [5] 0 0
St Vincents Hospital Melbourne - Fitzroy
Recruitment hospital [6] 0 0
Griffith University - Southport
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
4558 - Maroochydore
Recruitment postcode(s) [3] 0 0
3124 - Camberwell
Recruitment postcode(s) [4] 0 0
3168 - Clayton
Recruitment postcode(s) [5] 0 0
3065 - Fitzroy
Recruitment postcode(s) [6] 0 0
4215 - Southport
Recruitment outside Australia
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Ufa
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Switzerland
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Switzerland
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Taoyuan Hsien
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Dalin Township
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Kaohsiung City
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Kaohsiung
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Taichung
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Taipei City
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Taipei
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Kent
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Surrey
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Doncaster
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Leeds
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London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Eli Lilly and Company
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Incyte Corporation
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The reason for this study is to see how effective and safe the study drug known as
baricitinib is in participants with systemic lupus erythematosus (SLE).
Trial website
https://clinicaltrials.gov/show/NCT03616912
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Address 0 0
Country 0 0
Phone 0 0
1-317-615-4559
Fax 0 0
Email 0 0
clinicaltrials.gov@lilly.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03616912