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Virus Therapy

PRGN-2012 for Respiratory Papillomatosis

Phase 3
Recruiting
Research Sponsored by Precigen, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 years and older
Clinical diagnosis of RRP requiring surgical intervention
Must not have
Participants receiving any prohibited medications including immunosuppressive medications and other treatments for RRP
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

"This trial aims to show how well PRGN-2012 works to treat RRP in adults."

Who is the study for?
Adults over 18 with RRP (a condition causing wart-like growths in the airways) needing surgery can join. They must be able to consent, use contraception if sexually active, and have a good performance status (able to carry out daily activities). Those with severe health issues or on certain medications for RRP or other investigational drugs within the last month cannot participate.
What is being tested?
The trial is testing PRGN-2012's effectiveness in treating adults with Respiratory Papillomatosis (RRP), which causes wart-like growths due to Human Papillomavirus. The study aims to confirm previous results showing benefits of this treatment.
What are the potential side effects?
While specific side effects of PRGN-2012 are not listed here, similar treatments may cause immune reactions, fatigue, skin changes like rashes or warts, and potential impacts on reproductive health.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I need surgery for my recurrent respiratory papillomatosis.
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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not taking any medications that are not allowed in the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Determine the percentage of subjects with a complete response following treatment with PRGN-2012
Secondary study objectives
Safety and tolerability

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: All participantsExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Precigen, IncLead Sponsor
6 Previous Clinical Trials
258 Total Patients Enrolled
Amy Lankford, PhDStudy DirectorPrecigen, Inc
1 Previous Clinical Trials
38 Total Patients Enrolled
~28 spots leftby Mar 2027
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