Confirmatory Study of PRGN-2012 in Patients With RRP

Launched by PRECIGEN, INC · Aug 1, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called PRGN-2012 for adults with Recurrent Respiratory Papillomatosis (RRP), a condition caused by the papillomavirus that leads to the growth of warts in the respiratory tract. The goal of this Phase 3 study is to see how well this treatment works in helping patients who have RRP that requires surgery. The trial is currently looking for participants who are 18 years or older, have been diagnosed with RRP, and are in good enough health to participate. It’s important that participants are willing to use contraception if they are sexually active and can understand the information provided to them.

If you decide to join the study, you can expect to undergo treatment with PRGN-2012, and your progress will be closely monitored by the research team. However, some individuals may not be eligible, especially if they have serious health conditions, are taking certain medications, or are pregnant. This trial aims to provide more evidence about how effective PRGN-2012 is, which could lead to better treatment options for those suffering from RRP in the future.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • Age 18 years and older
• • Clinical diagnosis of RRP requiring surgical intervention
• • Performance status of ECOG of 0-1
• • Sexually active participants (men and women) of reproductive potential must agree to use contraception.
• • All participants must have the ability to understand and willingness to sign a written informed consent
• Key Exclusion Criteria:
• • Severe acute or chronic medical or psychiatric conditions that, in the opinion of the investigators, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results and in the judgment of the investigator, would make the participant inappropriate for entry into this study.
• • Participants receiving any prohibited medications including immunosuppressive medications and other treatments for RRP.
• • Participants who had received any other investigational agents within the past 30 days.
• • Pregnant women are excluded from this study