| CTRI Number |
CTRI/2024/10/075411 [Registered on: 17/10/2024] Trial Registered Prospectively |
| Last Modified On: |
25/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To find out if a new medicine called ianalumab is safe and works well for adults with a condition called diffuse cutaneous systemic sclerosis that involves the hardening and tightening of the skin |
|
Scientific Title of Study
|
A randomized, double-blind, parallel group, placebo-controlled multicenter study to evaluate efficacy, safety and tolerability of ianalumab in participants with diffuse cutaneous systemic sclerosis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 2024-511933-36 |
EudraCT |
| CVAY736S12201 Version 00 Dated 06 March 2024 |
Protocol Number |
|
|
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
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 |
| 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 |
| 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
Belgium
Brazil
Colombia
France
Germany
Greece
Hungary
India
Italy
Mexico
Poland
Republic of Korea
South Africa
Spain
Thailand
Turkey
United Kingdom
United States of America
Viet Nam |
Sites of Study
Modification(s)
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Uma Kumar |
All India Institute of Medical Sciences |
All India Institute of Medical Sciences, Room No. 4076, 4th Floor, Teaching Block, Ansari Nagar, New Delhi- 110029, India
South
DELHI |
9111-26594467
umaakumar@yahoo.co.in |
| Dr Kaushik Bhojani |
Fortis Hospitals Limited |
Clinical Research Department, Next to MRD dept, Merind gate, Mulund Goregaon Link Road, Bhandup west, Mumbai 400078
Mumbai
MAHARASHTRA |
9220961020
kaushik.bhojani@fortishealthcare.com |
| Dr Anjali Rajadhyaksha |
Seth GS Medical College and KEM Hospital |
Department of Medicine, 2nd Floor,
Seth GS Medical College and KEM Hospital,
Acharya Donde Marg, Parel, Mumbai- 400012
Mumbai
MAHARASHTRA |
9821275280
anjalirajadhyaksha@kem.edu |
| Dr Atul Kakar |
Sir Ganga Ram Hospital |
SGRH Marg, Rajinder Nagar, New Delhi 110060 INDIA
New Delhi
DELHI |
911135125600
atulkakar@hotmail.com |
| Dr Aradhana Singh |
SMS Hospital |
Room No 26, First floor, Department of Rheumatology and Clinical Immunology, Dhanvantri, OPD block, SMS Hospital Jaipur, Pincode-302004, State Rajasthan India
Jaipur
RAJASTHAN |
01412619020
aradhanas610@yahoo.com |
| Dr Padmanabha Shenoy D |
Sree Sudheendra medical Mission |
Department of Rheumatology, 1st floor, Annex Building,
Chittoor Road, Kacheripady,
Ernakulam
Kochi – 682018
Ernakulam
KERALA |
9446567000
drdpshenoy@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Ethics Committee- SMS Medical College and Attached Hospital |
Approved |
| Institute Ethics Committee All India Institute of Medical Sciences |
Approved |
| Institutional Ethics Committee, Fortis Hospitals Limited |
Approved |
| Institutional Ethics Committee- Sree Sudheendra medical Mission |
Approved |
| Institutional Ethics Committee-l,Seth GS Medical College and KEM Hospital |
Approved |
| Sir Ganga Ram Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M349||Systemic sclerosis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ianalumab |
300 mg Injections through veins Sub Cutaneous monthly 52 weeks |
| Intervention |
Matching Placebo |
Placebo injections through veins monthly for 52 weeks |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Adults diagnosed with dcSSc are allowed to participate in the study. |
|
| ExclusionCriteria |
| Details |
Participants must not have any chronic infections including hepatitis, tuberculosis, or HIV. To take part in the study, participants cannot be pregnant or breastfeeding. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Do participants that receive ianalumab have less dcSSc disease activity than those who receive placebo? |
The number of participants who can get better in 3 out of 5 dcSSc disease activity measures at Week 52 without worsening. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • Do participants who receive ianalumab show improvement in lung function, assessment of skin thickness and difficulty in performing daily activities compared to placebo at Week 52? |
By measuring the FVC%, mRSS and HAQ-DI at Week 52 |
| Is it safe to use ianalumab as a treatment for a long time? |
every 4 week |
| Are any antibodies produced against ianalumab? |
every 12 week |
| How much ianalumab can be measured over time in the participant’s blood? |
week 4,8,12 week 36 |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="25"
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)
|
30/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
31/07/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
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 goal of this study is to find out if a new medicine called
VAY736 (ianalumab) is safe and works well for adults with a condition called
diffuse cutaneous systemic sclerosis (dcSSc). dcSSc is a disease in which the
immune system mistakenly attacks different parts of a person’s own body causing
swelling and harm to important organs including kidneys, digestive system,
lungs, and heart. This disease gets worse over time and causes the skin to
become thicker. Ianalumab is a monoclonal antibody. This medicine sticks to a
protein found on our B cells which is involved in the development and
progression of dcSSc. By attaching to these B cells, ianalumab might be able to
make the dcSSc condition better by reducing their activity and number. |