| CTRI Number |
CTRI/2025/11/097906 [Registered on: 24/11/2025] Trial Registered Prospectively |
| Last Modified On: |
14/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
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Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
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A study to evaluate the safety of belumosudil in patients of 12 years and above, with chronic graft versus-host disease (cGVHD) after failure of at least two prior lines of therapy. |
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Scientific Title of Study
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A multi-center, single-arm phase IV clinical trial to evaluate the safety of Belumosudil in Indian participants, 12 years and above, with chronic graft-versus-host disease (cGVHD) |
| Trial Acronym |
Phase IV Belumosudil study in Indian patients |
|
Secondary IDs if Any
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| Secondary ID |
Identifier |
| LPS18471, Version number: Final version 1.0, 12th Sep 2024 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
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| Designation |
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| Affiliation |
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| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
|
| Name |
Dr Godhuli Chatterjee |
| Designation |
Senior Medical Advisor |
| Affiliation |
Sanofi Healthcare India Pvt Limited (SHIPL) |
| Address |
Sanofi House, C.T.S. No. 117/B, L&T Business Park, Saki
Vihar Road, Powai, Mumbai, Maharashtra
Mumbai
MAHARASHTRA
400 072
India |
| Phone |
919930151289 |
| Fax |
|
| Email |
Godhuli.Chatterjee@sanofi.com |
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Details of Contact Person
Public Query
|
| Name |
Mr Swapnil Sonje |
| Designation |
Clinical Project Leader |
| Affiliation |
Sanofi Healthcare India Pvt Limited (SHIPL) |
| Address |
Sanofi House, C.T.S. No. 117/B, L&T Business Park, Saki
Vihar Road, Powai, Mumbai
Mumbai
MAHARASHTRA
400 072
India |
| Phone |
919967836410 |
| Fax |
|
| Email |
swapnil.sonje@saniofi.com |
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Source of Monetary or Material Support
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| Sanofi Healthcare India Pvt Limited (SHIPL), Sanofi House, C.T.S No.117/B, L&T Business park, Saki Vihar Road, Powai, Mumbai -400072 |
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Primary Sponsor
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| Name |
Sanofi Healthcare India Pvt Limited (SHIPL) |
| Address |
Sanofi House, C.T.S. No. 117/B, L&T Business Park, Saki
Vihar Road, Powai, Mumbai, Maharashtra, 400 072
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| Type of Sponsor |
Pharmaceutical industry-Global |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Joseph John |
Christian Medical College & Hospital |
Department of Clinical Hematology,BMT Office, 4th floor,
Christian Medical College & Hospital,
Brown Road, Ludhiana, 141008
Ludhiana
PUNJAB |
9878659525
mjosephjohn@gmail.com |
| Dr Sameer Melinkari |
Deenanath Mangeshkar Hospital & Research Center, |
Department of Clinical Haematology, Room no. 7, Ground floor, Annex building, Near Mhatre Bridge,
Erandwane, Pune 411004
Pune
MAHARASHTRA |
912040151000
info@dmhospital.org |
| Dr Rahul Bhargava |
Fortis Memorial Research Institute |
Department of Hematology & BMT, UG Floor,
Sector-44, Opposite Millenium city Centre
Gurugram-122002 Haryana
Gurgaon
HARYANA |
9958174994
bhargava777@gmail.com |
| Dr Sunil Bhat |
Mazumdar Shaw Medical Center |
Department of Pediatric Hematology,Room no
#258 /A ,7th Floor, A Block, Narayana Health City Anekal, 258/A, Hosur Rd, Bommasandra Industrial Area, Bengaluru, Bommasandra, Karnataka 560099
Bangalore
KARNATAKA |
9538965968
sunilbhat_9@hotmail.com |
| Dr Arijit Nag |
TMC |
Kolkata 4, Major Arterial Road(South-East), DH Block, Action Area I, Newtown, Kolkata, Chakpachuria, West Bengal 700160
Kolkata
WEST BENGAL |
9051121161
arijit.nag@tmckolkata.com |
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Details of Ethics Committee
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| IEC, Fortis Memorial Research Institute, Gurugram |
Submittted/Under Review |
| Institutional Ethics Committee (IEC) - Christian Medical College and Hospital, Ludhiane |
Approved |
| Institutional Ethics committee Deenanath Mangeshkar Hospital And Research Centre, Pune |
Submittted/Under Review |
| INSTITUTIONAL REVIEW BOARD TATA MEDICAL CENTER, Kolkata |
Submittted/Under Review |
| NARAYANA HEALTH MEDICAL ETHICS COMMITTEE, Bengaluru |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D811||Severe combined immunodeficiency [SCID] with low T- and B-cell numbers, |
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
REZUROCK™ /belumosudil
|
200 mg tablet taken orally once daily with food for 24 weeks |
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Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
I 01 Male or female patients at least 12 years of age inclusive, at the time of signing the informed consent
Type of participant and disease characteristics
I 02 Participants who had an allogeneic hematopoietic cell transplantation (HCT)
Sex, contraceptive/barrier method and pregnancy testing requirements/breastfeeding
I 03. Male or Female
-Female: A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies-
--Not a woman of childbearing potential (WOCBP). OR
--WOCBP who agrees to follow the contraceptive guidance which is highly effective (as described in Section XX) during the study intervention period and for at least 90 days after the last administration of study intervention
- Male participants are eligible to participate if they agree during the study intervention period and for at least 90 days after the last administration of study intervention:
--Either to be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent;
OR must agree to use contraception/barrier (a male condom and an additional highly effective contraceptive method (as described in Section XX) when having sexual intercourse with a WOCBP who is not currently pregnant and capable of giving signed informed consent (including compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol)
Informed Consent
I 04. Capable of giving signed informed consent as described in Appendix 1 of the protocol which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Other inclusion criteria
I 05. Previously received at least 2 prior lines of systemic therapy for cGVHD;
I 06. Received glucocorticoid therapy with a stable dose over the 2 weeks prior to screening.
Note: Concomitant corticosteroids, calcineurin inhibitors, sirolimus, MMF, methotrexate, rituximab, and extracorporeal photopheresis (ECP) are acceptable. Systemic investigational GVHD treatments are not permitted;
I 07. Had persistent cGVHD manifestations and systemic therapy was indicated;
I 08. Karnofsky (if aged more than equal to 16 years)/Lansky (if aged more than equal to 16 years)/Lansky (if aged less than 16 years) Performance Score of more than equal to 60
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| ExclusionCriteria |
| Details |
Participants are excluded from the study if any of the following criteria apply-
Diagnostic assessments
E 01. Absolute neutrophil count less than equal to 1.5 X 109/L;
E 02. Platelet count less than equal to 50 X 109/L;
E 03. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) more than equal to 3 X upper limit of normal (ULN) (more than 5 × ULN if due to cGVHD).;
E 04. Total bilirubin more than equal to 1.5 X ULN;
E 05. Glomerular filtration rate (GFR) less than equal to 30 mL/min/1.73m3
E 06. Positive hepatitis B surface antigen, or hepatitis C antibody or HIV antibody at screening
E 07. FEV1 less than equal to 39percent or has lung score of 3
Other exclusion criteria
E 08. Diagnosed with another malignancy (other than malignancy for which transplant was performed) within 3 years of enrolment
E 09. Current enrolment or past participation within the last 30 days before signing of informed consent in any other clinical study involving an investigational study treatment or any other type of medical research
E 10. Participation in a prior belumosudil clinical trial or any prior use of belumosudil
E 11. Has a history of or ongoing drug or alcohol abuse
E 12. Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study
E 13. Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized
E 14. Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures
E 15. Participants are employees of the clinical study site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals
E 16. Any specific situation during study implementation/course that may raise ethical concerns. |
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Method of Generating Random Sequence
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Not Applicable |
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Method of Concealment
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Not Applicable |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| • To evaluate the safety of belumosudil in Indian patients, 12 years and older, with chronic graft versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy. |
24 weeks |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| • To describe the efficacy of belumosudil in Indian patients, 12 years and older, with chronic graft versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy. |
12 months |
|
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Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 4 |
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Date of First Enrollment (India)
|
11/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
|
Years="3"
Months="6"
Days="0" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
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N/A |
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
This is an interventional,
multicenter, single group, prospective phase IV clinical study which is
single-arm study for assessing the safety of belumosudil in Indian patients.
Participants who are at
least 12 years of age and who have had an allogeneic hematopoietic cell
transplantation (HCT) and have previously received at least 2 prior lines of
systemic therapy for cGVHD will be screened for this study if they consent for
the study.
Duration of study
intervention
Total duration of study
participation for each participant would be:
· Screening: 1 week
· Treatment duration: 24 weeks
Post treatment safety
follow up: 12 months after the first dose of IMP |