Ignite Creation Date:
2024-05-06 @ 3:54 AM
Last Modification Date:
2024-10-26 @ 11:40 AM
Study NCT ID:
NCT02406651
Status:
COMPLETED
Last Update Posted:
2021-07-22
First Post:
2015-03-19
Brief Title:
Study of IL-22 IgG2-Fc F-652 for Subjects With Grade II-IV Lower GI aGVHD
Sponsor:
EVIVE Biotechnology
Organization:
EVIVE Biotechnology
Study Overview
Official Title:
A Phase IIa Study of Recombinant Human Interleukin-22 IgG2-Fc F 652 in Combination With Systemic Corticosteroids for the Treatment of Newly Diagnosed Grade II-IV Lower Gastrointestinal Acute Graft-versus-Host Disease aGVHD in Hematopoietic Stem Cell Transplantation Recipients HSCT
Status:
COMPLETED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A Phase IIa single arm open-label study to investigate the safety tolerability and PK of F-652 in combination with systemic corticosteroids in subjects who have undergone Hematopoietic Stem Cell Transplantation HSCT and have newly diagnosed grade II-IV lower GI acute Graft Verses Host Disease aGVHD Treatment with F-652 will be once a week for 4 weeks with post treatment follow up visits on days 28 56 180 and 365
Detailed Description:
This is a Phase IIa single arm open-label study to investigate the safety tolerability and PK of F-652 in combination with systemic corticosteroids in subjects who have undergone HSCT and have newly diagnosed grade II-IV lower GI aGVHD The HSCT may be derived from bone marrow peripheral blood stem cells or cord blood The PK of F-652 in this subject population will be investigated Subjects may be replaced if subject withdrawal is not related to safety or treatment response
F-652 will be administered in conjunction with prednisone or equivalent at the time of the onset of clinical symptoms consistent with GI andor liver aGVHD Prednisone or equivalent will be given at a dose of 2 mgkgday and tapered as per protocol
F-652 will be administered intravenously at a rate of 100 mLhour for one hour once per week for four weeks A total of 4 doses will be administered at a dose of 45 μgkg each Subjects will be followed for safety and efficacy through Day 180 and subject survival status will be collected at Day 365
In the first stage of the trial a total of 16 subjects will be enrolled If six or fewer have a Day 28 treatment response the trial will close due to a lack of efficacy If seven or more have a response an additional 11 subjects will be enrolled into study for a total sample size of 27 During the course of a subjects therapy dose reduction may occur on an individual basis as per protocol
F-652 will be administered in conjunction with prednisone or equivalent at the time of the onset of clinical symptoms consistent with GI andor liver aGVHD Prednisone or equivalent will be given at a dose of 2 mgkgday and tapered as per protocol
F-652 will be administered intravenously at a rate of 100 mLhour for one hour once per week for four weeks A total of 4 doses will be administered at a dose of 45 μgkg each Subjects will be followed for safety and efficacy through Day 180 and subject survival status will be collected at Day 365
In the first stage of the trial a total of 16 subjects will be enrolled If six or fewer have a Day 28 treatment response the trial will close due to a lack of efficacy If seven or more have a response an additional 11 subjects will be enrolled into study for a total sample size of 27 During the course of a subjects therapy dose reduction may occur on an individual basis as per protocol
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None