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NCT06538480 | RECRUITING | Recurrent Respiratory Papillomatosis

Confirmatory Study of PRGN-2012 in Patients with RRP
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.

Condition or disease

Recurrent Respiratory Papillomatosis

Papillomavirus Infection

Papillomaviridae

Intervention/treatment

PRGN-2012

Phase

PHASE3

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 Type : INTERVENTIONAL
Estimated Enrollment : 42 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase 3 Trial of PRGN-2012 for the Treatment of Recurrent Respiratory Papillomatosis in Adult Patients
Actual Study Start Date : 2024-07-11
Estimated Primary Completion Date : 2027-03-01
Estimated Study Completion Date : 2029-03-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Confirmatory Study of PRGN-2012 in Patients with RRP

Location Details

NCT06538480

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

NOT YET RECRUITING

United States, Maryland

National Institute of Health

Bethesda, Maryland, United States, 20892

RECRUITING

United States, Ohio

University of Cincinnati

Cincinnati, Ohio, United States, 45267