Confirmatory Study of PRGN-2012 in Patients With RRP

Phase 3

Recruiting

• Conditions: Recurrent Respiratory Papillomatosis; Papillomaviridae; Papillomavirus Infection
• Interventions: Drug: PRGN-2012

• Registration Number: NCT06538480
• Lead Sponsor: Precigen, Inc

Brief Summary

The purpose of this confirmatory study is to provide further demonstration of the efficacy of PRGN-2012 for the treatment of RRP in adults.

Detailed Description

This is a single-arm, open-label confirmatory study of PRGN-2012 in RRP patients with a history of repeated surgical debulking for the management of their disease. Patients will be treated with PRGN-2012 and followed for at least 12 months to evaluate for efficacy and safety endpoints.

Study Timeline

• Study Start: 2024-07-11
• Status Verified: 2024-08
• Study First Submitted: 2024-08-01
• Study First Submitted QC: 2024-08-01
• Study First Posted: 2024-08-05
• Last Update Submitted: 2024-08-16
• Last Update Posted: 2024-08-19
• Primary Completion: 2027-03-01
• Study Completion: 2029-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 42

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All participants	PRGN-2012	-

Primary Outcome Measures

Name	Time	Method
Determine the percentage of subjects with a complete response following treatment with PRGN-2012	1 year	A complete response is defined as no requirement for surgical intervention in the 12 months after treatment

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability	1 year	Incidence and severity of adverse events will be assessed through capture of adverse events, lab assessments and vital signs. Adverse events will be evaluated for causality, grade (Common Terminology Criteria for Adverse Events (CTCAE) v 5.0) and seriousness.

Trial Locations

Locations (2)

National Institute of Health; 🇺🇸 Bethesda, Maryland, United States

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States