Search / Trial NCT06616415

A Clinical Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Belumosudil in Chinese Adolescents With cGVHD Who Have Had an Inadequate Response to Glucocorticoids or Other Systemic Therapies

Launched by SANOFI · Sep 24, 2024

Trial Information

Current as of December 21, 2024

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a medication called belumosudil to see how well it works and how safe it is for Chinese adolescents aged 12 to under 18 who have chronic graft-versus-host disease (cGVHD). cGVHD is a condition that can happen after a stem cell transplant, where the donated cells attack the patient’s body. This study is for young people who have not responded well to previous treatments, such as steroids or other therapies. Participants will take belumosudil tablets once a day for 28 days at a time.

To join the study, participants need to have had a stem cell transplant and currently have moderate to severe cGVHD. They should also be stable on corticosteroid treatment for at least two weeks before starting the trial. It’s important that participants have a good chance of living for more than six months and weigh at least 30 kg. The study is currently recruiting participants, and those who join can expect regular check-ups to monitor their health while they take the medication.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Participant must be 12 to less than 18 years of age at the time of signing the informed consent.
  • Participant has undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT).
  • Has active moderate to severe cGVHD.
  • Has received at least one line of prior systemic therapy for cGVHD.
  • Participant must receive a corticosteroid therapy for cGVHD with a stable dose for at least 2 weeks prior to the first dose of the IMP.
  • Has a Lansky-Play performance score of ≥60.
  • Participants should have an expected survival of longer than 6 months.
  • Body weight of 30 kg and above.
  • Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  • The participant or their legally authorized representative (LAR) must be capable of giving signed informed consent.
  • Exclusion Criteria:
  • Participants are excluded from the study if any of the following criteria apply:
  • Recurrence of hematologic neoplasms (according to the corresponding criteria for recurrence of primary hematologic neoplasms) or post-transplant lymphoproliferative disease at screening.
  • Received investigational systemic therapy for cGVHD within 28 days prior to enrollment, unless the prior treatment had been washed out for at least 28 days or 5 half-lives prior to enrollment, whichever is shorter.
  • Absolute neutrophil count (ANC) \<1.0 × 10\^9/L.
  • Platelet count \<50 × 10\^9/L.
  • Alanine aminotransferase (ALT) \>3× the upper limit of normal (ULN), aspartate aminotransferase (AST) \>3 × ULN.
  • Total bilirubin (TBIL) \>1.5 × ULN (\>3 ULN if Gilbert's syndrome).
  • Estimated Glomerular Filtration Rate (eGFR) \<30 mL/min/1.73 m\^2 using the revised Bedside Schwartz formula . Revised Schwartz equation: CrCl (mL/min/1.73 m\^2) = 0.413 × (height \[in cm\])/Creatinine (in mg/dL) at screening visit.
  • 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.

Trial Officials

Clinical Sciences & Operations

Study Director

Sanofi

About Sanofi

Sanofi is a global healthcare leader dedicated to empowering life through innovation in pharmaceuticals and vaccines. With a strong commitment to research and development, Sanofi focuses on addressing complex health challenges across various therapeutic areas, including diabetes, oncology, immunology, and rare diseases. The company leverages advanced science and technology to develop transformative therapies that improve patient outcomes. Through collaborative partnerships and a patient-centric approach, Sanofi strives to enhance global health and deliver sustainable solutions that meet the evolving needs of healthcare systems and communities worldwide.

Locations

Beijing, , China

Shanghai, , China

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0