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Virus Therapy

INO-3107 for Respiratory Papillomatosis

Phase 1 & 2

Waitlist Available

Research Sponsored by Inovio Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up screening up to week 52 (up to approximately 1 year)

Awards & highlights

Study Summary

This trial is testing a new drug to treat people with HPV-6 and/or HPV-11-associated recurrent respiratory papillomatosis (RRP). The trial population will include participants who have been diagnosed with either Juvenile-Onset RRP (J-O RRP) or with Adult- Onset RRP (A-O RRP). A safety run-in will be performed with up to six participants with a one week waiting period between each enrolled participant.

Eligible Conditions

Recurrent Respiratory Papillomatosis (RRP)

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ screening up to week 52 (up to approximately 1 year)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~screening up to week 52 (up to approximately 1 year)

This trial's timeline: 3 weeks for screening, Varies for treatment, and screening up to week 52 (up to approximately 1 year) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

Secondary outcome measures

Change from Baseline in Flow Cytometry Response Magnitude for T-cell Phenotype and Lytic Potential in PBMCs

Change from Baseline in Interferon-gamma Enzyme-Linked Immunosorbent Spot (IFN-γ ELISpot) Response Magnitude for IFN-γ Secreting Cells in Peripheral Blood Mononuclear Cells (PBMCs)

Change from Baseline in MicroRNA (miRNA) Expression Related to Reduced Frequency of RRP Surgical Intervention

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: INO-3107Experimental Treatment2 Interventions

Participants will be administered one INO-3107 intramuscular (IM) injection followed by electroporation (EP) using CELLECTRA™ 2000 at Day 0, Week 3, Week 6, and Week 9.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

INO-3107

2020

Completed Phase 2

~40

CELLECTRA™ 2000

2020

Completed Phase 2

~480

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Inovio PharmaceuticalsLead Sponsor

53 Previous Clinical Trials

4,807 Total Patients Enrolled

Jeffrey Skolnik, MDStudy DirectorInovio Pharmaceuticals

12 Previous Clinical Trials

662 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many research facilities are coordinating this trial?

"There are 13 enrolling patients for this trial at locations such as Baylor College of Medicine in Houston, NYU Langone Voice Center in New york, and University of Cincinnati Medical Center in Cincinnati."

Answered by AI

Are researchers still looking for participants for this clinical trial?

"Unfortunately, this particular study is no longer enrolling patients. Although the post on clinicaltrials.gov was last updated on October 7th, 2022, the trial originally started on June 15th, 2020. With that said, there are still 204 other trials that could use participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

INO-3107 With Electroporation (EP) in Participants With HPV-6- and/or HPV-11-Associated Recurrent Respiratory Papillomatosis (RRP)

2020. "INO-3107 With Electroporation (EP) in Participants With HPV-6- and/or HPV-11-Associated Recurrent Respiratory Papillomatosis (RRP)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04398433.