Sponsor study identifier
interventional
15
1 country
1
Study Start
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
January 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Recurrent respiratory papillomatosis (RRP) is a rare disease in which wart-like growths caused by human papillomavirus (HPV) types 6 or 11 form in the airway. These growths can affect the voice and breathing and often come back after they are removed, meaning many children will need repeated surgeries to keep their airway open. There is no medicine approved to treat RRP in children. This study is testing zopapogene imadenovec, an investigational immunotherapy designed to help the immune system recognize and control cells infected with HPV 6 and 11. Zopapogene imadenovec is approved in the United States for the treatment of adults with recurrent respiratory papillomatosis. All participants in this study will receive zopapogene imadenovec; there is no placebo group. The study drug is given as four injections under the skin over about three months. Before the first injection, participants have a standard surgical procedure to remove visible growths. Participants are then followed for at least 12 months to see how many need further surgery, and are contacted periodically for up to five years after their last injection. The study will enroll children in two age groups, starting with older children and opening to younger children only after safety has been reviewed.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 21, 2026
Actual (reported)October 28, 2026
Actual (reported)December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
January 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
January 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Complete response rate
Percentage of participants with a complete response, defined as no requirement for any clinically indicated debulking intervention during the 12 months following the last administration of zopapogene imadenovec.
12 months following last administration of study drug
Number of participants with adverse events (AEs) and treatment-related AEs
From first administration through 12 months after the last administration (treatment-related AEs through 28 days after the last administration)
Time to first clinically indicated debulking intervention (duration of response)
From the last administration (Week 12) up to 5 years
Objective response rate (ORR)
12 months before the first administration and 12 months after the last administration
Participants receive four subcutaneous administrations of zopapogene imadenovec on Day 1, Week 2, Week 6, and Week 12, each in a different limb. Participants aged ≥6 to \<18 years receive 5 x 10\^11 particle units per injection; participants aged ≥1 to ≤5 years begin at 2.5 x 10\^11 particle units per injection with sentinel dosing. All participants undergo a standard-of-care debulking procedure on Day -1.
Children's National Hospital
Washington D.C., District of Columbia, 20010, United States
First Submitted
October 21, 2026
First Posted
October 28, 2026
Study Start
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
January 2029
EstimatedContact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 28, 2026
Record last verified: 2026-10
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Source: ClinicalTrials.gov.
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