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Activity, Safety and Pharmacokinetics in Pediatric Subjects With Moderate and Severe Chronic Graft vs. Host Disease After Allogeneic Stem Cell Transplant

NCT03774082 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2025-12-11

Study results available
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Summary

This open-label, single-arm, Phase II multi-center study enrolled 46 participants and investigated the activity, pharmacokinetics and safety of ruxolitinib added to the subject's immunosuppressive regimen among infants, children, and adolescents aged ≥28 days to \<18 years old with either moderate to severe treatment-naive cGvHD or SR-cGvHD.

Although 46 participants were enrolled,1 participant (enrolled in the ≥6y to \<12y age group) received study treatment beyond protocol requirements and was excluded from analyses.

Conditions

  • Graft vs Host Disease

Interventions

DRUG

INC424

Ruxolitinib was taken orally based on age groups as follows: Group 1 (\>=12y to \<18y): 10mg bid as tablet Group 2 (\>=6y to \<12y): 5mg bid as tablet or liquid Group 3 (\>=2y to \<6y): 4mg/m2 bid as liquid

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
28 Days
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-20
Primary Completion
2022-02-25
Completion
2024-08-26

Countries

  • Brazil
  • Canada
  • Czechia
  • India
  • Italy
  • Japan
  • Russia
  • Slovakia
  • South Korea
  • Spain
  • Switzerland
  • Taiwan
  • Thailand
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03774082 on ClinicalTrials.gov