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Monoclonal Antibodies
Pamrevlumab for Idiopathic Pulmonary Fibrosis
Phase 3
Waitlist Available
Research Sponsored by FibroGen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 48
Awards & highlights
Study Summary
This trial is testing a new drug to see if it is better than placebo at treating Pulmonary Fibrosis.
Eligible Conditions
- Idiopathic Pulmonary Fibrosis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 48
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 48
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change From Baseline in Forced Vital Capacity (FVC) at Week 48
Secondary outcome measures
Change From Baseline in Quantitative Lung Fibrosis (QLF) Volume at Week 48
Time to All-cause Mortality During Study
Time to Any Component of the Clinical Composite Endpoint, Whichever Occurs First: Acute IPF Exacerbation, Respiratory Hospitalization, or Death
+3 moreSide effects data
From 2017 Phase 2 trial • 160 Patients • NCT0189026530%
Respiratory tract infection
28%
Cough
26%
Dyspnoea
20%
Fatigue
20%
Idiopathic pulmonary fibrosis
20%
Urinary tract infection
18%
Nasopharyngitis
16%
Diarrhoea
16%
Sinusitis
14%
Nausea
10%
Arthralgia
10%
Back pain
8%
Headache
8%
Pain
8%
Upper-airway cough syndrome
8%
Abdominal pain upper
8%
Chest pain
8%
Oedema peripheral
8%
Dizziness
8%
Insomnia
6%
Sleep apnoea syndrome
6%
Myalgia
6%
Chest discomfort
6%
Heart sounds abnormal
6%
Decreased appetite
6%
Musculoskeletal pain
6%
Anxiety
6%
Pulmonary hypertension
6%
Sinus congestion
6%
Flushing
6%
Hypertension
4%
Bronchitis
4%
Constipation
4%
Interstitial lung disease
4%
Pulmonary embolism
4%
Contusion
2%
Autoimmune haemolytic anaemia
2%
Immune thrombocytopenic purpura
2%
Non-cardiac chest pain
2%
Acute respiratory failure
2%
Respiratory failure
2%
Angina pectoris
2%
Sepsis
2%
Femoral neck fracture
2%
Humerus fracture
2%
Musculoskeletal chest pain
2%
Squamous cell carcinoma of the tongue
2%
Peripheral ischaemia
2%
Throat irritation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pamrevlumab
Placebo
Sub-Study: Pamrevlumab+Pirfenidone
Sub-Study: Placebo+Pirfenidone
Sub-Study: Pamrevlumab+Nintedanib
Sub-Study: Placebo+Nintedanib
Trial Design
2Treatment groups
Experimental Treatment
Group I: PlaceboExperimental Treatment1 Intervention
Placebo matching to pamrevlumab by IV infusion every 3 weeks for a total of up to 17 infusions over 48 weeks
Group II: PamrevlumabExperimental Treatment1 Intervention
Pamrevlumab 30 mg/kg by IV infusion every 3 weeks for a total of up to 17 infusions over 48 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pamrevlumab
2013
Completed Phase 3
~210
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
FibroGenLead Sponsor
57 Previous Clinical Trials
14,948 Total Patients Enrolled
4 Trials studying Idiopathic Pulmonary Fibrosis
643 Patients Enrolled for Idiopathic Pulmonary Fibrosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your lung function test shows that your lungs absorb carbon monoxide at a rate between 25% and 90% of what is expected for someone with a similar hemoglobin level.Your FVCpp value should be between 45% and 95% during screening and before starting the study.You have taken pamrevlumab before.You have a serious lung disease that causes breathing problems.You have been diagnosed with IPF within the last 7 years according to specific medical guidelines.Your condition has been getting better over the past year.You have a sudden worsening of your IPF during the screening or randomization process.You have had a serious allergic reaction to a type of medication called monoclonal antibodies.You are currently not taking the approved medication for IPF, such as pirfenidone or nintedanib, for any reason.You have taken any experimental drugs or participated in a clinical trial with a new drug in the last 30 days, or you have used certain approved therapies for pulmonary fibrosis in the last week.You are not currently taking medication for idiopathic pulmonary fibrosis (IPF), even if you've had problems with these medications before or have decided not to take them after talking with the doctor about the risks and benefits.You have lung disease other than IPF.You have a history of other lung or chest-related diseases.A special type of X-ray called HRCT shows that you have some lung scarring, but not too much.
Research Study Groups:
This trial has the following groups:- Group 1: Pamrevlumab
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you explain the risks of Pamrevlumab to patients?
"Pamrevlumab has undergone Phase 3 trials, which suggests that not only is it effective, but also that it is safe."
Answered by AI
Are octogenarians eligible for this research program?
"The aim of this clinical trial is to study the effects of the medication on patients who are in their later years, specifically those over 40 and below 85."
Answered by AI
Might I qualify to join this clinical research?
"Eligibility requirements for this study include a diagnosis of usual interstitial pneumonia and an age between 40-85. Up to 340 patients will be enrolled in the trial."
Answered by AI
Are there any other existing research papers that mention Pamrevlumab?
"There are a total of six studies currently underway for Pamrevlumab. Five of those studies are in Phase 3. The majority of the studies for Pamrevlumab are based in Richmond, Virginia; however, there are 553 locations running trials for this treatment globally."
Answered by AI
Have other clinical trials like this been conducted before?
"Pamrevlumab has been the focus of medical research since 2016 when the first trial, sponsored by FibroGen, was conducted. In total, there have been 6 active studies involving Pamrevlumab which have taken place in 173 different cities across 35 countries."
Answered by AI
Who else is applying?
What state do they live in?
Minnesota
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
What site did they apply to?
UC Davis Medical Center
University of Florida Health, Jacksonville
University of Texas Southwestern Medical Center
Why did patients apply to this trial?
I am currently taking Ofev. Right now I get the medication at no cost. However, my eligibility for financial support may change. I am always looking for an alternative medication.
PatientReceived 1 prior treatment
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