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CTRI Number  CTRI/2011/04/001667 [Registered on: 06/04/2011] Trial Registered Prospectively
Last Modified On: 16/06/2011
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A Study of the Efficacy, Safety, and Tolerability of A 623 (A-623 is a potential therapeutic agent for B cell-mediated autoimmune and inflammatory diseases) Administration in Subjects With Systemic Lupus Erythematosus 
Scientific Title of Study   AN-SLE3321: A Randomized, Double-Blind Phase 2b Study to Evaluate the Efficacy, Safety, and Tolerability of A-623 Administration in Subjects with Systemic Lupus Erythematosus  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
AN-SLE3321  Protocol Number 
NCT01162681  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ataali shaikh 
Designation  General Manager 
Affiliation  Kendle India 
Address  General Manager, India Asia Pacific, Kendle Unit 002, Ground Floor, Tower C, Unitech Cyber Park, Sector- 39,

Gurgaon
HARYANA
122001
India 
Phone  01244536357  
Fax    
Email  shaikh.ataali@kendle.com  
 
Details of Contact Person
Scientific Query  
Name  vivek malhotra 
Designation  Regulatory specialist 
Affiliation  Kendle India 
Address  Regulatory specialist, Kendle India Pvt Ltd. Unit 002, Ground Floor,Tower C, Unitech Cyber Park, Sector- 39,
Kendle India Pvt Ltd. Unit 002, Ground Floor,Tower C, Unitech Cyber Park, Sector- 39, Haryana, India
Gurgaon
HARYANA
122001
India 
Phone  01244536357  
Fax    
Email  malhotra.vivek@kendle.com  
 
Details of Contact Person
Public Query  
Name  Anuraag Priyadarshini 
Designation  Senior CRA 
Affiliation  Kendle India 
Address  Senior CRA, Kendle India Pvt Ltd. Unit 002, Ground Floor, Tower C, Unitech Cyber Park, Sector- 39,
Kendle India Pvt Ltd. Unit 002, Ground Floor, Tower C, Unitech Cyber Park, Sector- 39, Haryana, India
Gurgaon
HARYANA
122001
India 
Phone  01244536357  
Fax    
Email  Priyadarshi.Anuraag@KENDLE.com  
 
Source of Monetary or Material Support  
"Anthera Pharmaceuticals, Inc. 25801 Industrial Boulevard, Suite B Hayward, CA 94545, USA "  
 
Primary Sponsor  
Name  Anthera Pharmaceuticals Inc  
Address  25801 Industrial Boulevard, Suite B Hayward, CA 94545, USA 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
Kendle India Private Limited  Kendle India Pvt Ltd. Unit 002, Ground Floor, Tower C, Cyber Park, Sector 39, Gurgaon-122001 Haryana, India Tel: +91-124-4536 300 
 
Countries of Recruitment     India
Brazil
Chile
Colombia
Mexico
Peru
Philippines
United States of America  
Sites of Study  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Srikant Wagh  Department Of Rheumatology Jehangir Clinical Development Centre Pvt.ltd  32, Sassoon Road, Pune- 411001, Maharastra, India
Pune
MAHARASHTRA 		 9325668979
02026059319
sywagh@yahoo.co.in 
Dr Mathew Thomas   Health and Research Centre, T.C. 1/907, 1st Floor,  Devis Scans Building, Kumarapuram, Medical College, P.O, Trivandrum - 695011, Kerala, India
Thiruvananthapuram
KERALA 		 914712554911
914712554913
amnavita@gmail.com 
Dr Sarath C Veeravalli   Krishna Institute of Medical Sciences, Department of Rheumatology,  1-8-31/1, Minister Road, Hyderabad - 500003, AndhraPradesh, India
Hyderabad
ANDHRA PRADESH 		 914044885153
914027840773
sarath10@hotmail.com 
Dr Liza Rajasekhar  Nizams Institute of Medical Scieces Department of Rheumatology Millenium Block, 4th Floor  Nizams Institute of Medical Sciences, Hyderabad 500082
Hyderabad
ANDHRA PRADESH 		 914023310625
914066465086
lizarajasekhar@yahoo.com 
Dr Anjali G Rajadhyaksha  Seth GS Medical College and KEM Hospital, Department of Medicine,  Acharya Dhonde Marg, Parel, Mumbai - 400012, Maharashtra, India
Mumbai
MAHARASHTRA 		 912224107616
912224126766
anjalirajadhyaksha@kem.edu 
Dr Vineeta Shobha  St. John Medical College Hospital, Department of Medicine  Sarjapura Road, Koramangala, Bangalore - 560034, Karnataka, India
Bangalore
KARNATAKA 		 918022065354
918025503697
vineeta_shobha@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
Ethics committee for Dr Liza Rajasekhars site, Nizams Institute of Medical Scieces, Hyderabad 500082, AP  Approved 
Ethics committee for Dr Srikant Waghs site, Jehangir Clinical Development Centre Pvt. Ltd. 32, Sassoon Road, Pune- 411001, Maharastra, India  Approved 
Ethics committee, Seth GS Medical College and KEM Hospital, Department of Medicine, Acharya Dhonde Marg, Parel, Mumbai - 400012, Maharashtra, India   Submittted/Under Review 
Independent Ethics Committee, Dr Mathew Thomas Site, Health and Research Centre, T.C. 1/907, 1st Floor, Devi Scans Building, Kumarapuram Medical College P.O., Trivandrum - 695011, Kerala   Approved 
Institutional ethical review board for Dr Vineeta Shobas site, St. Johns Medical College Hospital, Sarjapura Road, Koramangala, Bangalore - 560034, Karnataka   Approved 
Institutional ethics committee, For Dr Sarath C Veeravallis site, Krishna Institute of Medical Sciences, Department of Rheumatology, 1-8-31/1, Minister Road, Hyderabad - 500003, AndhraPradesh, India   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Systemic Lupus Erythematosus. ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  A-623  High dose given subcutaneously once every 4 weeks for up to 52 weeks 
Intervention  A-623  Low dose given subcutaneously once a week for up to 52 weeks 
Intervention  A623  High dose given subcutaneously once a week for up to 52 weeks 
Comparator Agent  Placebo  Placebo comparator is a matched volume given subcutaneously once a week or once every 4 weeks for up to 52 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  0.00 Year(s)
Gender  Both 
Details  Diagnosis of SLE by American College of Rheumatology guidelines.
On stable SLE treatment
Active SLE disease
Serologically active
18 years of age or older
Receiving stable doses of prednisone between 7.5 mg and 40 mg per day

 
 
ExclusionCriteria 
Details  Severe active vasculitis, active central nervous system lupus, active lupus nephritis, uncontrolled hypertension, or uncontrolled diabetes.
Known to be positive for HIV and/or positive at the screening visit for hepatitis B, or hepatitis C.
Liver disease.
Anemia, neutropenia, or thrombocytopenia.
Malignancy within past 5 years
Active infection requiring hospitalization or treatment with parenteral antibiotics within the past 60 days or history of repeated herpetic viral infections.
History of active tuberculosis or a history of tuberculosis infection.
Participation in the active treatment arm of any Phase 2 or Phase 3 clinical trial for a molecule that primarily targets the B cell pathway in the past 18 months.
Prior administration of any B cell depleting therapy in the past 18 months.
Pregnant or nursing
History of congenital immunodeficiency 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
SLE response
The % of subjects with SLE response compared with baseline at the time of assessment 		 Various timepoints through Week 52 
 
Secondary Outcome  
Outcome  TimePoints 
B cell reduction  Various timepoints through Week 52 
Time to first flare  Various timepoints through Week 52 
FACIT-fatigue score  Various timepoints through Week 52 
Reduction in prednisone dose  Various timepoints through Week 52 
Change in IgG, IgM,C3 and C4  Various timepoints through Week 52 
Flare rates  Various timepoints through Week 52 
SRI, using improvements of SELENA-SLEDAI of 5, 6, 7, 8 and 9  Various timepoints through Week 52 
 
Target Sample Size   Total Sample Size="600"
Sample Size from India="75" 
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 2 
Date of First Enrollment (India)   20/04/2011 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  30/07/2010 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
A-623 is an Fc-conjugated peptide that is being developed as a treatment for SLE based on its ability to bind to and antagonize the action of human B cell activating factor (BAFF). BAFF is a protein that is a critical survival factor for B cells and is required for B cell development and maintenance. Its involvement in B cell survival has been demonstrated in animal studies. Therefore, A-623 is a potential therapeutic agent for B cell-mediated autoimmune and inflammatory diseases.

This is a double-blind, placebo-controlled study that will enroll serologically active systemic lupus erythematosus (SLE) subjects. Randomization will be stratified by: Safety of Estrogen in Lupus Erythematosus National Assessment SLE Disease Activity Index (SELENA-SLEDAI) score 6t o 9 vs. ≥10 
African descent or indigenous American vs. other.
Up to 600 subjects will be randomized 1:1:1:3 to receive either 100 mg every week, 200 mg every week, 200 mg every 4 weeks or placebo for up to 52 weeks of treatment.
A-623 or placebo will be administered subcutaneously (SC).
Prednisone dose should be stable if possible until Week 12. Efforts to taper dose below the baseline dose should be employed from Week 12 on. If this is not possible, efforts should be made to keep the dose either at the baseline level or at no more than 25% above the baseline level.
Other immunosuppressive doses should be kept stable if possible and doses should be tapered if possible.
 
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