NCT04398433

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

An Open-label Multi-center Study of INO-3107 With Electroporation (EP) in Subjects With HPV-6- and/or HPV-11-associated Recurrent Respiratory Papillomatosis (RRP)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Inovio Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1/2 open-label, multicenter trial to evaluate the safety, tolerability, immunogenicity, and efficacy of INO-3107 in participants with human papilloma virus type 6 (HPV-6) and/or type 11 (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) as defined by age at first diagnosis \<12 years or with Adult- Onset RRP (A-O RRP) as defined by age at first diagnosis ≥12 years. A safety run-in will be performed with up to six participants with a one week waiting period between each enrolled participant.

Conditions

• Respiratory Papillomatosis

Interventions

Type	Name	Description
DRUG	INO-3107	INO-3107 administered by IM injection.
DEVICE	CELLECTRA® 2000	CELLECTRA® 2000 device used for EP following IM delivery of INO-3107.

Timeline

• Start date: 2020-10-07
• Primary completion: 2022-12-15
• Completion: 2022-12-15
• First posted: 2020-05-21
• Last updated: 2026-04-14
• Results posted: 2026-04-14

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study