| CTRI Number |
CTRI/2025/03/083043 [Registered on: 21/03/2025] Trial Registered Prospectively |
| Last Modified On: |
07/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
This study is to learn if continued treatment with the medicine VAY736 ianalumab can help patients with systemic lupus erythematosus also called SLE. |
|
Scientific Title of Study
|
A randomized, double-blind, placebo-controlled extension study to assess the long-term safety and tolerability of ianalumab in patients with systemic lupus erythematosus (SIRIUS-SLE extension) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 2023-505929-14 |
EudraCT |
| CVAY736F12301E1 Version 01 dated 15 Sep 2023 |
Protocol Number |
| NCT06133972 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Murugananthan K |
| Designation |
SSO Country Head |
| Affiliation |
Novartis Healthcare Private Limited |
| Address |
Novartis Healthcare Private Limited 7 floor Inspire BKC G Block BKC Main Road Bandra Kurla Complex Bandra (East) Mumbai
Mumbai
MAHARASHTRA
400051
India
Mumbai
MAHARASHTRA
400051
India |
| Phone |
912250243544 |
| Fax |
|
| Email |
murugananthan.k@novartis.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Murugananthan K |
| Designation |
SSO Country Head |
| Affiliation |
Novartis Healthcare Private Limited |
| Address |
Novartis Healthcare Private Limited 7 floor Inspire BKC G Block BKC Main Road Bandra Kurla Complex Bandra (East) Mumbai
Mumbai
MAHARASHTRA
400051
India
Mumbai
MAHARASHTRA
400051
India |
| Phone |
912250243544 |
| Fax |
|
| Email |
murugananthan.k@novartis.com |
|
Details of Contact Person
Public Query
|
| Name |
Murugananthan K |
| Designation |
SSO Country Head |
| Affiliation |
Novartis Healthcare Private Limited |
| Address |
Novartis Healthcare Private Limited 7 floor Inspire BKC G Block BKC Main Road Bandra Kurla Complex Bandra (East) Mumbai
Mumbai
MAHARASHTRA
400051
India
Mumbai
MAHARASHTRA
400051
India |
| Phone |
912250243544 |
| Fax |
|
| Email |
murugananthan.k@novartis.com |
|
|
Source of Monetary or Material Support
|
| Novartis Pharma AG, Novartis Campus 4056 - Basel, Switzerland |
|
|
Primary Sponsor
|
| Name |
Novartis Healthcare Pvt Ltd |
| Address |
7 floor, Inspire BKC, G Block, BKC Main Road, Bandra Kurla Complex, Bandra (East), Mumbai - 400051,lndia |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Argentina
Australia
Brazil
Bulgaria
Canada
Chile
China
Colombia
Czech Republic
France
Germany
Guatemala
Hungary
India
Israel
Italy
Japan
Malaysia
Mexico
Poland
Portugal
Romania
Singapore
Slovakia
South Africa
Spain
Taiwan
Thailand
Turkey
United Kingdom
United States of America |
Sites of Study
Modification(s)
|
| No of Sites = 12 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Uma Kumar |
All India Institiute of Medical Sciences |
All India Institiute of Medical Sciences, Room No-4067, 4th Floor, Teaching Block, Ansari Nagar, New Delhi- 110029, Delhi, India
New Delhi
DELHI |
9868217040
umaakumar@yahoo.co.in |
| Dr Rajashree Sanjay Khot |
All India Institute of Medical Sciences |
All India Institute of Medical Sciences, MIHAN, Sumthana,Nagpur-441108, Maharashtra, India
Nagpur
MAHARASHTRA |
91-9823134598
rajashree.s.khot@gmail.com |
| Dr Praveen Jadhav |
Assured Care Plus Hospital |
Assured Care Plus Hospital, 4th & 5th floor, Star Plus Complex, Lam Road, Near Muktidham Temple, Opp. NMC Divisional Office, Nashik Road
Nashik
MAHARASHTRA |
9822055612
drpraveenjadhav@rediffmail.com |
| Dr Rojith Balakrishnan |
Government Medical College, Medical College P.O, |
Government Medical College, Medical College P.O
Kozhikode
KERALA |
9746006050
drrojith@gmail.com |
| Dr Ajit Nalawade |
Grant Medical Foundation Ruby Hall |
Grant Medical Foundation Ruby Hall Clinic, 40, Sassoon Road, Pune- 411001, Maharashtra, India
Pune
MAHARASHTRA |
9822746248
dr.ajitnalawade@gmail.com |
| Dr Wasim Saleem Kazi |
Kolhapur Institute of Orthopaedic & Trauma |
Kolhapur Institute of Orthopaedic & Trauma, Near Royal Tourist Hub New Shahupuri Central ST Stand Kolhapur- 416001
Kolhapur
MAHARASHTRA |
9158184488
wasimk12@gmail.com |
| Dr Girish Kakade |
Medipoint Hospitals Pvt. Ltd |
Medipoint Hospitals Pvt. Ltd., 241/1, New D.P. Road, Aundh, Pune-411007
Pune
MAHARASHTRA |
9529151910
drgirishk.medipoint@gmail.com |
| Dr Vishnu Sharma |
Navneet Memorial Hospital Sushrusha |
Navneet Memorial Hospital Sushrusha, Opp Sardar Patel Seva Samaj Hall, In the lane, Opp Tele Exchange, Navrangpura, Ahmedabad-380006
Ahmadabad
GUJARAT |
85115555477
drvishnusharma@yahoo.co.in |
| Dr Reena Sharma |
Shalby Hospital |
Shalby Hospital, Opp. Karnavati Club, SG Highway, Ahmedabad-380015
Ahmadabad
GUJARAT |
7940203000
reena141@gmail.com |
| Dr Subodh Gururani |
Shri Guru Ram Rai Institute of Medical and Health Sciences And Shri Mahant Indiresh Hospital |
Shri Guru Ram Rai Institute of Medical and Health Sciences And Shri Mahant Indiresh Hospital, Patel Nagar, Dehradun- 248001, Uttaranchal, India
Dehradun
UTTARANCHAL |
7906318412
subodh.aqua@gmail.com |
| Dr Ved Prakash Chaturvedi |
Sir Ganga Ram Hospital |
Sir Ganga Ram Hospital,
Sir Ganga Ram Hospital Marg, Rajinder Nagar, New Delhi-110060
New Delhi
DELHI |
9560001969
vedchaturvedi@hotmail.com |
| Dr Sakshi Mittal |
Venkateshwar Hospital |
Venkateshwar Hospital, Sector 18A, Dwarka, Delhi 110075
New Delhi
DELHI |
011-48555555
sakshi.mittal@vankateshwarhospitals.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 12 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, All India Institute of Medical Sciences |
Approved |
| Institutional Ethics Committee All India Institute of Medical Sciences Nagpur Dr Rajashree Khot |
Approved |
| Institutional Ethics Committee Poona Medical Research Foundation Dr Ajit Nalawade |
Approved |
| Institutional Ethics Committee, Assured Care Plus Hospital |
Approved |
| Institutional Ethics Committee, Govt. Medical College, Kozhikode |
Approved |
| Institutional Ethics Committee, Venkateshwar Hospital |
Approved |
| Institutional Ethics Committee- Ethics Committe Shalby Limited |
Approved |
| Institutional Ethics Committee-SCRR Institute Of Medical Health Sciences |
Submittted/Under Review |
| Penta-Med Ethics Committee, Medipoint Hospitals Pvt. Ltd |
Submittted/Under Review |
| Sangini Hospital Ethics Committee Sangini Hospital Dr Vishnu Sharma |
Approved |
| Sir Ganga Ram Hospital Ethics Committee, Sir Ganga Ram Hospital |
Submittted/Under Review |
| Zenith Institutional Ethics Committee, Kolhapur Institute of Orthopaedic And Trauma |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
Ianalumab (VAY736) |
3mg monthly or quaterly upto 3 years through veins |
| Intervention |
Matching Placebo |
Matching Placebo given monthly through veins |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Adults and adolescents (where allowed) aged 12 years or older who are diagnosed with SLE and had previously completed the treatment period in one of the SIRIUS-SLE core studies without treatment discontinuation |
|
| ExclusionCriteria |
| Details |
Use of prohibited therapies.
Active viral, bacterial or other infections requiring intravenous or intramuscular treatment for clinically significant infection which in the opinion of the investigator will place the participant at risk for participation.
Plans for administration of live vaccines during the study period.
Pregnant or nursing (lactating) women.
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, refusing or unable to use highly effective methods of contraception while on study treatment and for 6 months after stopping of study drug (or longer if required by concomitant medications).
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| What adverse events do participants have during the trial? |
What adverse events do participants have during the trial? |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
What is the long-term effect of ianalumab on disease activity?
|
Every 12 weeks from week 72 until week 216 |
| What is the long-term effect of ianalumab on organ damage? |
Every 20 weeks from week 84 until week 180 |
|
|
Target Sample Size
|
Total Sample Size="550"
Sample Size from India="45"
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)
|
17/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
21/05/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="5"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The purpose of this trial is to learn if continued treatment with the trial drug VAY736 (ianalumab) can help adolescent and adult patients with systemic lupus erythematosus (also called SLE). This is an extension study offered to participants who have completed the treatment period in one of the SIRIUS-SLE core trials (CVAY736F12301/CVAY736F12302). Ianalumab belongs to a class of drugs called monoclonal antibodies which are able to recognize and stick to specific proteins on specific cells. By attaching to a protein on B cells, ianalumab causes the elimination of the B cell. B cells are a group of white blood cells which play a role in the development of SLE. By removing such B cells, ianalumab may be able to improve SLE disease activity. This trial is designed to find out if longer treatment with ianalumab improves participants’ lupus symptoms over time, and if it does better than the standard of care (SoC) treatment. This trial is also designed to learn more about the safety of ianalumab. A treatment duration of three years in this extension study will allow for an overall assessment of four-year safety and efficacy data when taking into account the data from the two SIRIUS-SLE core studies (SIRIUS-SLE 1 and SIRIUS-SLE 2). This is to learn more about how ianalumab affects patient’s well-being and how effective is ianalumab in reducing SLE disease activity. |