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Trial Title:
Confirmatory Study of PRGN-2012 in Patients with RRP
NCT ID:
NCT06538480
Condition:
Recurrent Respiratory Papillomatosis
Papillomavirus Infection
Papillomaviridae
Conditions: Official terms:
Papillomavirus Infections
Respiratory Tract Infections
Papilloma
Conditions: Keywords:
Human Papilloma Virus
Confirmatory study
laryngotracheal disease
papillomatous disease
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
PRGN-2012
Description:
PRGN-2012 will be administered as 4 subcutaneous administrations over a 12-week interval.
Arm group label:
All participants
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
National Institute of Health
Address:
City:
Bethesda
Zip:
20892
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Laura Parsons-Wandell, BSN, RN
Email:
laura.parsons-wandell@nih.gov
Contact backup:
Last name:
Scott Norberg, DO
Facility:
Name:
University of Cincinnati
Address:
City:
Cincinnati
Zip:
45267
Country:
United States
Status:
Recruiting
Contact:
Last name:
Rebecca Reinert
Phone:
5135581719
Email:
gibsonrk@ucmail.uc.edu
Contact backup:
Last name:
Aaron Friedman, MD
Start date:
July 11, 2024
Completion date:
March 1, 2029
Lead sponsor:
Agency:
Precigen, Inc
Agency class:
Industry
Source:
Precigen, Inc
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06538480
