Ignite Creation Date:
2025-12-24 @ 12:05 PM
Ignite Modification Date:
2025-12-25 @ 2:06 PM
Study NCT ID:
NCT02854761
Status:
UNKNOWN
Last Update Posted:
2016-08-03
First Post:
2016-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Study of EF-022 in Adults With Recurrent Respiratory Papillomatosis (RRP)
Sponsor:
Efranat Ltd.
Organization:
Study Overview
Official Title:
Phase I Safety and Tolerability Study of EF-022 in Adult Subjects With Recurrent Respiratory Papillomatosis
Status:
UNKNOWN
Status Verified Date:
2016-08
Last Known Status:
NOT_YET_RECRUITING
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:
This study evaluates the safety and tolerability of the investigational drug EF-022 in the treatment of adult patients with Recurrent Respiratory Papillomatosis (RRP). Patients will be administered EF-022, either intramuscular or subcutaneous, for a period of 6 months. Preliminary effect of the drug on the disease will be evaluated by following the number and severity of the lesions in the respiratory tract and the effect on voice changes.
Detailed Description:
The etiology of RRP is associated with local immune suppression at disease-involved sites.
EF-022, a Vitamin D-Binding protein Macrophage Activating Factor, modulates the innate arm of the immune system to alleviate immune suppression. The investigators hypothesize that EF-022 may modulate the immune response in a manner that might slow down or even prevent disease progression.
Adult subjects will be treated weekly with EF-022 for a period of 6 months by either intramuscular or subcutaneous administration.
The primary objective of the study is to evaluate the safety and tolerability of EF-022 administered to adult subjects with recurrent respiratory papillomatosis either IM or SC.
The main response assessment will be performed over the 6 months period by:
* Evaluating lesion size and/or number of disease-involved sites by Coltera-Derkay score
* Assessment of degree of voice disorder using the VHI-10 score
* Symptomatic assessment of dyspnea/stridor
EF-022, a Vitamin D-Binding protein Macrophage Activating Factor, modulates the innate arm of the immune system to alleviate immune suppression. The investigators hypothesize that EF-022 may modulate the immune response in a manner that might slow down or even prevent disease progression.
Adult subjects will be treated weekly with EF-022 for a period of 6 months by either intramuscular or subcutaneous administration.
The primary objective of the study is to evaluate the safety and tolerability of EF-022 administered to adult subjects with recurrent respiratory papillomatosis either IM or SC.
The main response assessment will be performed over the 6 months period by:
* Evaluating lesion size and/or number of disease-involved sites by Coltera-Derkay score
* Assessment of degree of voice disorder using the VHI-10 score
* Symptomatic assessment of dyspnea/stridor
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: