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Status unknownNCT02854761Updated Aug 3, 2016

Safety Study of EF-022 in Adults With Recurrent Respiratory Papillomatosis (RRP)

A Phase 1 interventional study of EF-022 (Modified Vitamin D Binding Protein Macrophage Activator) in Recurrent Respiratory Papillomatosis, sponsored by Efranat Ltd.. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-08-03.

Sponsored by Efranat Ltd. · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2016), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
6
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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
02

Conditions studied

  • Recurrent Respiratory Papillomatosis
03

In context

Respiratory Tract Infections

1,031 studies on the registry are indexed under Respiratory Tract Infections; 144 are open to participants now.

This study's planned enrollment of 6 is below the median of 199 across 698 interventional studies indexed under Respiratory Tract Infections.

Browse Respiratory Tract Infections studies →

Lead sponsor

Efranat Ltd. is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patients with documented diagnosis of recurrent respiratory papillomatosis
  2. Patients with measurable disease
  3. Patients presenting at least one of the following severity criteria: Derkay score ≥ 8 , Voice handicap index (VHI) ≥11
  4. Adult male and female subjects, age of 18 and above (≥18 yrs)
  5. Patients with documentation on number of debulking procedures done during past 12 months
  6. Estimated expectancy time for next debulking procedure must be at least 3 months.
  7. Must be at least 4 weeks (>4 weeks) since last treatment including cytotoxic therapy, biological or immunotherapy, anti-viral therapy, molecularly targeted therapy or steroid treatment.
  8. Must be at least 2 weeks (>2weeks) since last NSAID treatment.
  9. Must have adequately recovered (to at least Grade 1 level) from adverse effects of prior therapies.
  10. Female of child bearing potential must have a negative pregnancy test and must be practicing an effective method of birth control
  11. Patients or their guardians must sign an informed consent indicating that they are aware of the investigational nature of this study

Exclusion criteria

Exclusion Criteria:

  1. Patient on concurrent steroids or anti-inflammatory non steroid treatment.
  2. Active autoimmune disease
  3. Known major immunodeficiency
  4. Known to be Positive for HIV, Hepatitis B surface antigen, Hepatitis C antibody
  5. Have absolute neutrophil counts below 1.5X 10\^9/L
  6. Hemoglobin below 10.0 g/dL
  7. White blood cell counts below 3.5X10\^9/L.
  8. Granulocytes below 1.5X10\^9/L.
  9. Have Platelets below 100 X 10\^9/L
  10. Abnormal renal function with creatinine above 1.5X the upper limit of normal (ULN)
  11. Abnormal liver function tests with bilirubin above 1.5X the ULN, AST and ALT above 2.5 X ULN.
  12. Patients with active cardiovascular disease under continuous treatment
  13. Patients with associated malignancy currently receiving chemotherapy and/or radiation.
  14. Female adult patients that are pregnant, nursing or plan to nurse during and up to 12 months of treatment period.
  15. Subjects receiving another investigational drug.
  16. Patients with concurrent or history of malignancy within 5 years.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
6 participants (estimated)

Study arms

  • Experimental
    SC administration

    Subcutaneous (SC) administration of 500 ng of EF-022 (Modified Vitamin D Binding Protein Macrophage Activator) once weekly, for 6 months

    Drug: EF-022 (Modified Vitamin D Binding Protein Macrophage Activator)

  • Experimental
    IM administration

    Intramuscular (IM) adminstration of 500 ng EF-022 (Modified Vitamin D Binding Protein Macrophage Activator) once weekly for 6 months

    Drug: EF-022 (Modified Vitamin D Binding Protein Macrophage Activator)

Interventions

  • DrugEF-022 (Modified Vitamin D Binding Protein Macrophage Activator)
06

What researchers measure

Primary outcomes

  1. CTCAE v.4.03 criteria will constitute the primary safety endpoints to be monitored throughout this study

    Time frame: 6 months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 3, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02854761
Lead sponsor
Efranat Ltd.
Responsible party
Sponsor
First posted
Aug 3, 2016
Start date
Sep 2016
Primary completion
Sep 2018 (estimated)
Last update
Aug 3, 2016

Study contacts

Myriam Golembo, PhD
Contact
myriam.golembo@efranat.com
972-8-9724972
Uri Yogev
Contact
uri.yogev@efranat.com
972-8-9724972
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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