NCT06538480

Zopa Retreatment and Vector Shedding in Adults With RRP

Open-Label Study of Zopapogene Imadenovec Retreatment and Vector Shedding Evaluation in Adult Patients With Recurrent Respiratory Papillomatosis

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Precigen, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This open-label study evaluates safety, vector shedding, and retreatment efficacy of Zopapogene imadenovec (Zopa) in adults with recurrent respiratory papillomatosis (RRP). Two cohorts will be enrolled (n=30): Cohort 1 to assess the magnitude and duration of adenoviral vector shedding in urine, feces, skin, and nasal tissue; Cohort 2 to assess the complete response rate following retreatment.

Conditions

• Recurrent Respiratory Papillomatosis
• Papillomavirus Infection
• Papillomaviridae

Interventions

Type	Name	Description
DRUG	Zopapogene imadenovec (Zopa)	Zopa will be administered as 4 subcutaneous administrations over a 12-week interval.

Timeline

• Start date: 2024-07-11
• Primary completion: 2027-12-02
• Completion: 2028-12-02
• First posted: 2024-08-05
• Last updated: 2025-12-15

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study