FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2019/04/018378 [Registered on: 02/04/2019] Trial Registered Prospectively
Last Modified On: 31/07/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus 
Scientific Title of Study   A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients with systemic lupus erythematosus (SLE). 
Trial Acronym  BRAVE II 
Secondary IDs if Any  
Secondary ID  Identifier 
I4V-MC-JAIA Protocol Version 1.0 Addendum dated 01Feb2019  Other 
I4V-MC-JAIA Version 1.0 dated 26Apr2018  Protocol Number 
NCT03616912  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Rashmi Chitgupi 
Designation  Associate Director - Clinical Management 
Affiliation  PPD Pharmaceutical Development India Private Limited 
Address  101, A Wing, Fulcrum building, Hiranandani Business Park Sahar Road, Andheri East

Mumbai
MAHARASHTRA
400099
India 
Phone  912266022900  
Fax  912266022999  
Email  Rashmi.Chitgupi@ppdi.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Rashmi Chitgupi 
Designation  Associate Director - Clinical Management 
Affiliation  PPD Pharmaceutical Development India Private Limited 
Address  101, A Wing, Fulcrum Building, Hiranandani Business Park Sahar Road, Andheri East

Mumbai
MAHARASHTRA
400099
India 
Phone  912266022900  
Fax  91226602999  
Email  Rashmi.Chitgupi@ppdi.com  
 
Source of Monetary or Material Support  
Eli Lilly and Company Indianapolis, Indiana USA 46285 
 
Primary Sponsor  
Name  Eli Lilly and Company 
Address  Indianapolis, Indiana USA 46285 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
PPD Pharmaceuticals India Private Limited  101, A Wing, Fulcrum, Hiranandani Business Park, Sahar Road, Andheri East, Mumbai 400099, Maharashtra, India 
 
Countries of Recruitment     France
Argentina
Chile
Colombia
India
Italy
Japan
Philippines
Poland
Republic of Korea
Romania
Serbia
South Africa
Spain
United States of America  
Sites of Study
Modification(s)  
No of Sites = 15  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Reena Sharma  Care Institute of Medical Science CIMS Hospital   Basement, Clinical Research Department, Near Shukan Mall, Off Science City Road, Sola-380060
Ahmadabad
GUJARAT 		 919978662400

reena141@gmail.com 
Dr Srikantiah Chandrashekara  ChanRe Rheumatology & Immunology Center & Research  3rd Floor, Clinical Research Department, No.414/65, 20th Main, West of Chord Road, 1st Block, Rajajinagara-560010
Bangalore
KARNATAKA 		 080-23238080

chandrashekara_s@yahoo.com 
Dr Amit Sharma  Fortis Escorts Hospital  First Floor, Clinical Research Department, Service Lane, Girdhar Marg, Malviya Nagar - 302017
Jaipur
RAJASTHAN 		 919950123654

amit.sharma4@fortishealthcare.com 
Dr Smruti Ramteke  Jasleen Hospital  First floor,First floor, Clinical Research Room,Opposite to big bazar,Panchsheel square,Wardha Road, Godhni, Dhantoli-440012
Nagpur
MAHARASHTRA 		 919823514680

sramteke@rediffmail.com 
Dr Mukhyaprana Prabhu  Kasturba Medical College and Hospital  B, 2nd Floor , Medicine Dept, Madhav Nagar, Manipal-576104
Udupi
KARNATAKA 		 919449592986

mmukhyaprana@yahoo.com 
Dr Sarath Chandra Mauli Veeravalli  Krishna Institute of Medical Sciences ( KIMS Hospital )  2nd Floor, Dept. of Rheumatology, 1-8-31/1, Minister Road , Secunderabad-500003
Hyderabad
TELANGANA 		 919866000685

sarath10@hotmail.com 
Dr Bankim Desai  Nirmal Hospitals Pvt. Ltd  Clinical Research Room, Fifth Floor, Nirmal Hospitals Pvt. Ltd,Ring Rd, Sagrampura, Surat, Gujarat 395002
Surat
GUJARAT 		 919979530073

drbankim.desai@gmail.com 
Dr Vishnu Sharma  Panchshil Hospital  2nd floor, Research department, Near Sabarmati Police Station, Highway, Ramnagar, Sabarmati-380005
Ahmadabad
GUJARAT 		 918511555477

drvishnusharma@yahoo.co.in 
Dr Shefali Sharma  Post Graduate Institute of Medical Education and Research (PGIMER)  4th floor, Department of rheumatology, F block, Sector 12 - 160012
Chandigarh
CHANDIGARH 		 917087183518

anitarathore98@yahoo.in 
Dr Manish Bavaliya  Shree Giriraj Multispeciality Hospital  CRC Chamber,Shree Giriraj Multispeciality Hospital,27,Navjyot Park,150 Ft Ring Road,Rajkot, Gujarat 360004
Rajkot
GUJARAT 		 919879222625

dr.manishkb@gmail.com 
Dr Sapan Pandya  SMT. NHL Municipal Medical College and VS General Hospital  First Floor, Research Department,Ellise Bridge 380006
Ahmadabad
GUJARAT 		 919824094749

ali.bohra@synexus.in 
Dr Vineeta Shobha  St. Johns Medical College Hospital  Dept. of Clinical Immunology and Rheumatology Sarjapur Road - 560034
Bangalore
KARNATAKA 		 919845021146

vineeta_shobha@yahoo.co.in 
Dr Ripal Shah  Sterling Hospital  Room # 14, Ground Floor, OPD wing, Opp. Inox Multiplex Race course Circle (West), Hari Nagar–390007
Vadodara
GUJARAT 		 919825114686

drripalshah@gmail.com 
Dr Praveen Jadhav  Sujata Birla Hospital & Medical Research Center  Clinical Research Room,3rd Floor,Sujata Birla Hospital & Medical Research Center,Opposite Bytco College,Nashik_Pune Rd, Nashik, Maharashtra -422101
Nashik
MAHARASHTRA 		 919822055612

drpraveenjadhav@rediffmail.com 
Dr Vikram Haridas  Sushruta Multispeciality Hospital & Research Center Pvt Ltd  Old Bldg, 3rd floor, Room No. 314, P.B Road, Vidyanagar, Hubli-580021
Dharwad
KARNATAKA 		 919343649883

drvikramharidas@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 15  
Name of Committee  Approval Status 
Ethics Committee of Care Institute of Medical Science  Approved 
Institutional Ethics Committee Fortis Escorts Hospital  Approved 
Institutional Ethics Committee, ChanRe Rheumatology & Immunology Center & Research  Approved 
Institutional Ethics Committee, Jasleen Hospital  Approved 
Institutional Ethics Committee, Post Graduate Institute of Medical Education and Research   Approved 
Institutional Ethics Committee, SMT. NHL Municipal Medical College and VS General Hospital  Approved 
Institutional Ethics Committee, St. Johns Medical College Hospital  Approved 
KIMS Ethics Committee  Approved 
MAHE Ethics Committee, Kasturba Medical College and Hospital  Approved 
Nirmal Hospital PVT LTD Ethics Committee  Approved 
Panchshil Institutional Ethics Committee, Panchshil Hospital   Approved 
Shree Giriraj research Ethics committee  Approved 
Sterling Ethics Committee, Sterling Hospital  Approved 
Sushruta Hospital Ethics Committee  Approved 
Yash Societys Sujata Birla Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M321||Systemic lupus erythematosus withorgan or system involvement,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Baricitinib Tablets  2-mg or 4-mg Once daily for up to 52 weeks treatment Period 
Comparator Agent  Placebo Tablets   Once daily for up to 52 weeks treatment period 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Have a clinical diagnosis of SLE at least 24 weeks prior to screening.
2. 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.
3. Have a positive antinuclear antibody (ANA) (titer grater than or equal to 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.
4. Have a total Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score grater than or equal to 6 during screening.
5. Have a clinical SLEDAI-2K score grater than or equal to 4 at randomization.
6. Have at least 1 British Isles Lupus Assessment Group (BILAG) A score or 2 BILAG B scores during screening.
7. Are receiving at least one of the following standard of care medications for SLE:

a. A single antimalarial at a stable dose for at least 8 weeks prior to screening
b. A single immunosuppressant at a stable dose for at least 8 weeks prior to screening
c. An oral corticosteroid, initiated at least 4 weeks prior to screening, at a stable dose less than or equal to 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 grater than or equal to 7.5 milligrams/day prednisone (or equivalent) 
 
ExclusionCriteria 
Details  1. Have severe active lupus nephritis.
2. Have active central nervous system lupus.
3. Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, haematological, 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.
4. Have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection.
5. Have received cyclophosphamide (or any other cytotoxic agent) within 12 weeks prior to screening.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
To evaluate the effect of baricitinib 4 mg QD and background standard of care therapy compared with placebo and background standard of care therapy on SLE disease activity.  Proportion of patients achieving an SRI 4 response at Week 52, defined as:
- Reduction of grater than or equal to 4 points from baseline in SLEDAI 2K score; and
- No new British Isles Lupus Assessment Group (BILAG) A or no more than 1 new BILAG B disease activity score; and
- No worsening (defined as an increase of grater than or equal to 0.3 points [10 mm] from baseline) in the Physician’s Global Assessment of Disease Activity.
 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the effect of baricitinib 4 mg QD compared to placebo on SLE disease activity.  - Proportion of patients achieving an SRI 4 response at Week 24.
- Proportion of patients achieving a lupus low disease activity state (LLDAS) response at Week 52
 
To evaluate the corticosteroid sparing effect of baricitinib 4 mg QD compared to placebo.  - Proportion of patients receiving 7.5 mg prednisone (or equivalent) at baseline able to decrease dose by grater than equal to 25% to a prednisone equivalent dose of less than or equal to 7.5 mg/day maintained between Week 40 and Week 52. 
To evaluate the effect of baricitinib 4 mg QD compared to placebo on SLE flares.  - Time to first severe flare over 52 weeks. 
To evaluate the effect of baricitinib 4 mg QD compared to placebo on patient reported outcomes (PROs).  - Change from baseline in Worst Pain NRS at Week 52.
- Change from baseline in FACIT Fatigue total score at Week 52.
 
To evaluate the effect of baricitinib 2 mg QD compared to placebo on SLE disease activity.  - Proportion of patients achieving an SRI 4 response at Week 52.
- Proportion of patients achieving an SRI 4 response at Week 24.
- Proportion of patients achieving a lupus low disease activity state (LLDAS) response at Week 52
 
To evaluate the corticosteroid sparing effect of baricitinib 2 mg QD compared to placebo.  - Proportion of patients receiving 7.5 mg prednisone (or equivalent) at baseline able to decrease dose by grater than or equal to 25% to a prednisone equivalent dose of less than or equal to 7.5 mg/day maintained between Week 40 and Week 52. 
To evaluate the effect of baricitinib 2 mg QD compared to placebo on SLE flares.  - Time to first severe flare over 52 weeks. 
To evaluate the effect of baricitinib 2 mg QD compared to placebo on patient reported outcomes (PROs).  - Change from baseline in Worst Pain NRS at Week 52.
- Change from baseline in FACIT-Fatigue total score at Week 52
 
 
Target Sample Size   Total Sample Size="750"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)
Modification(s)  		 11/07/2019 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  30/08/2018 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="2"
Days="18" 
Recruitment Status of Trial (Global)
Modification(s)  		 Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

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). 
Close