NCT02694770

A Study Evaluating the Efficacy and Safety of Neihulizumab vs "Conventional Treatment" to Treat Sr-aGvHD

A Phase II Study of Neihulizumab vs "Conventional Treatment" to Treat Steroid-refractory Acute Graft-vs-host Disease (Sr-aGvHD) in Patients Undergoing Allogeneic Hematopoietic Cell Transplantation

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: AbGenomics B.V Taiwan Branch · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is to assess the efficacy of Neihulizumab versus "conventional therapy" and to evaluate safety, pharmacokinetics and immunogenicity in treating steroid-refractory acute Graft-vs-Host Disease

Detailed description

This current Phase II trial is a randomized, open label, controlled, multiple dose, multi-centre study to study the clinical efficacy and safety of Neihulizumab vs "Conventional Treatment" to treat steroid-refractory acute graft-vs-host disease (sr-aGvHD) in patients undergoing allogeneic hematopoietic cell transplantation. This study will enroll a minimum of 90 patients, approximately 60 in Neihulizumab treatment arm and 30 in Conventional treatment control arm. The primary objectives is to evaluate the efficacy of Neihulizumab treatment in patients with steroid-refractory acute GvHD compared to "conventional treatment." The secondary objectives are to investigate safety, pharmacokinetics, and immunogenicity of Neihulizumab administration in subjects with steroid-refractory acute GvHD. For safety evaluation, the parameters to be assessed are adverse events (AEs), discontinuation of therapy due to AEs, safety laboratory analysis, ECG, vital signs, physical examination, and immunogenicity.

Conditions

• Steroid-refractory aGvHD Subsequent to Allogeneic Hematopoietic Cell Transplantation

Interventions

Type	Name	Description
BIOLOGICAL	Neihulizumab Treatment	Monoclonal antibody
BIOLOGICAL	Conventional Treatment	2nd line therapy for aGvHD at the discretion of attending physician, including but not limited to biologics such as ATG, TNF-alpha inhibitors, pentostatin, sirolimus, mycophenolate mofetil and extracorporeal photopheresis.

Timeline

• Start date: 2016-07-01
• Primary completion: 2017-09-01
• Completion: 2018-02-01
• First posted: 2016-03-01
• Last updated: 2016-04-25

Locations

2 sites across 1 country: United States