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Safety and Clinical Activity of Itolizumab in aGVHD

NCT05823675 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2023-05-25

No results posted yet for this study

Summary

To evaluate the safety, tolerability, PK, PD, and clinical activity of Itolizumab in subjects with Newly diagnosed Acute Graft Versus Host Disease(aGVHD).

Conditions

  • Acute Graft Versus Host Disease

Interventions

DRUG

Itolizumab

Subjects will receive Itolizumab concomitant within 72 hours of systematic Corticosteroids.

DRUG

Methylprednisolone

Methylprednisolone will be taperred as required

Sponsors & Collaborators

  • Biotech Pharmaceutical Co., Ltd.

    lead OTHER

Principal Investigators

  • Erlie Jiang · Chinese Academy of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-19
Primary Completion
2024-10-31
Completion
2025-02-28

Countries

  • China

Study Locations

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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 NCT05823675 on ClinicalTrials.gov