Recurrent Respiratory Papillomatosis Clinical Trial
Official title:
Phase I Safety and Tolerability Study of EF-022 in Adult Subjects With Recurrent Respiratory Papillomatosis
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.
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
;
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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