A Study to Investigate Safety of Belumosudil in Participants Aged 12 Years and Above, With Chronic Graft-versus-host Disease (cGVHD)

Sanofi

Status and phase

Not yet enrolling

Phase 4

Conditions

Chronic Graft Versus Host Disease

Treatments

Drug: Belumosudil

Study type

Interventional

Funder types

Industry

Identifiers

NCT07135973

LPS18471

Details and patient eligibility

About

This is an interventional phase IV clinical study which is single-arm study for assessing the safety of belumosudil in Indian patients who are12 years and older.

Study details include:

The study duration will be up to 12 months per participant.
The treatment duration will be up to 24 weeks.
The number of visits will be 7.

Enrollment

26 estimated patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: Male or female patients at least 12 years of age inclusive, at the time of signing the informed consent Participants who had an allogeneic hematopoietic cell transplantation (HCT) Previously received at least 2 prior lines of systemic therapy for cGVHD Received glucocorticoid therapy with a stable dose over the 2 weeks prior to screening Had persistent cGVHD manifestations and systemic therapy was indicated Karnofsky (if aged ≥ 16 years)/Lansky (if aged <16 years) Performance Score of ≥ 60

Capable of giving signed informed consent as described in the protocol Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply:

Absolute neutrophil count ≤1.5 X 109/L Platelet count ≤ 50 X 109/L Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≥ 3 X upper limit of normal (ULN) (>5 × ULN if due to cGVHD) Total bilirubin ≥ 1.5 X ULN Glomerular filtration rate (GFR) ≤ 30 mL/min/1.73m3 Positive hepatitis B surface antigen, or hepatitis C antibody or HIV antibody at screening FEV1 ≤39% or has lung score of 3