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Pamrevlumab for Idiopathic Pulmonary Fibrosis
Study Summary
This trial is testing a new treatment for idiopathic pulmonary fibrosis (IPF). The treatment is given as an IV infusion every 3 weeks. The trial has a 48-week treatment phase, followed by an optional extension phase.
- Idiopathic Pulmonary Fibrosis
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2017 Phase 2 trial • 160 Patients • NCT01890265Trial Design
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Who is running the clinical trial?
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- You have other respiratory diseases that could affect the main goal of the study or prevent you from participating. This includes diseases in different parts of the respiratory system like the lungs, chest wall, or airways.You are not currently taking approved medication for idiopathic pulmonary fibrosis (IPF) or have chosen to stop taking it after discussing the risks and benefits with the investigator.You have smoked in the past 3 months or are not willing to stop smoking during the study.You have already received pamrevlumab treatment in the past.Your condition of idiopathic pulmonary fibrosis (IPF) has been getting better for at least a year before the screening.You have a lung disease that is not idiopathic pulmonary fibrosis (IPF).You recently had a severe worsening of your IPF (a lung disease) and had to go to the hospital because of it.You have experienced severe allergic reactions to certain types of antibodies or their ingredients.You have been diagnosed with IPF according to specific guidelines from lung health organizations in the past 7 years.
- Group 1: Placebo
- Group 2: Pamrevlumab
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is this research novel in any way?
"Pamrevlumab has been under clinical investigation since 2016. The first set of trials, sponsored by FibroGen, studied 21 patients back in 2016. After the initial study showed positive results, Pamrevlumab received Phase 2 drug approval and is now being trialed in 35 different countries across 173 cities."
If this study were to take place in an urban area, would there be a lot of places available to participate?
"There are 27 centres where this research is taking place. They are situated in Jacksonville, Kansas City, Hershey and 24 other cities. By picking the location nearest to you, it will minimize the amount of travel required if you decide to participate."
Has Pamrevlumab received regulatory approval from the FDA?
"Pamrevlumab has undergone extensive safety testing and, as a result, our team rates it as a 3."
Is this study still enrolling participants?
"That is right, the online information on clinicaltrials.gov affirms that this study is still searching for volunteers. The trial was first announced on 9/30/2020 and has since been updated as recently as 9/15/2022. In total, they are looking for 340 patients from 27 different locations."
Could I possibly take part in this research?
"Up to 340 people, aged 40-85 and diagnosed with usual interstitial pneumonia will be enrolled in this clinical trial. Additionally, all patients must have tried an approved therapy for IPF in the past (e.g. pirfenidone or nintedanib) but stopped using it at least a week before screening. Exceptions can be made if neither treatment is available where the patient lives.."
Does this research require participants to be of a certain age?
"The target demographic for this study are individuals who fall between 40 to 85 years old."
What is the treatment capacity for this research?
"In order to have an adequate sample size, 340 patients that meet the inclusion criteria are needed. The sponsor, FibroGen, has various locations where the trial will be conducted including Mayo Clinic in Jacksonville, Florida and The University of Kansas Medical Center in Kansas City, Kansas."
What prior research exists on Pamrevlumab's effects?
"As of now, there are 6 different clinical trials researching pamrevlumab with 5 being in phase 3. Most of the research is concentrated in Goyang and São Paulo; however, Pamrevlumab trials are also running at 553 other locations."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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How responsive is this trial?
Typically responds via
Most responsive sites:
- University of Wisconsin Clinical Research: < 24 hours
Average response time
- < 2 Days
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