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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
Diagnosis of IPF as defined by American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association (ATS/ERS/JRS/ALAT) guidelines within the past 7 years prior to study participation
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 48
Awards & highlights

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.

Eligible Conditions
  • Idiopathic Pulmonary Fibrosis

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have been diagnosed with IPF according to specific guidelines from lung health organizations in the past 7 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 48
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 48 for reporting.

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 to Week 48 in Quantitative Lung Fibrosis (QLF) Volume
Time to All-Cause Mortality
Time to Any Component of the Clinical Composite Endpoint, Whichever Occurs First: Acute IPF Exacerbation, Respiratory Hospitalization, or Death
+3 more

Side effects data

From 2017 Phase 2 trial • 160 Patients • NCT01890265
30%
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%
Upper-airway cough syndrome
8%
Abdominal pain upper
8%
Chest pain
8%
Oedema peripheral
8%
Pain
8%
Dizziness
8%
Insomnia
6%
Myalgia
6%
Chest discomfort
6%
Heart sounds abnormal
6%
Decreased appetite
6%
Musculoskeletal pain
6%
Anxiety
6%
Pulmonary hypertension
6%
Sinus congestion
6%
Sleep apnoea syndrome
6%
Flushing
6%
Hypertension
4%
Bronchitis
4%
Constipation
4%
Interstitial lung disease
4%
Pulmonary embolism
4%
Contusion
2%
Autoimmune haemolytic anaemia
2%
Non-cardiac chest pain
2%
Acute respiratory failure
2%
Respiratory failure
2%
Immune thrombocytopenic purpura
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
Pamrevlumab-matching placebo administered by IV infusion every 3 weeks for a total of up to 17 infusions over 48 weeks
Group II: PamrevlumabExperimental Treatment1 Intervention
Treatment phase: Pamrevlumab 30 mg/kg administered by IV infusion, every 3 weeks, for a total of up to 17 infusions over 48 weeks. Open-label extension phase: Pamrevlumab 30 mg/kg administered by intravenous infusion, every 3 weeks for up to 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
14,932 Total Patients Enrolled
4 Trials studying Idiopathic Pulmonary Fibrosis
627 Patients Enrolled for Idiopathic Pulmonary Fibrosis

Media Library

Pamrevlumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04419558 — Phase 3
Idiopathic Pulmonary Fibrosis Research Study Groups: Placebo, Pamrevlumab
Idiopathic Pulmonary Fibrosis Clinical Trial 2023: Pamrevlumab Highlights & Side Effects. Trial Name: NCT04419558 — Phase 3
Pamrevlumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04419558 — Phase 3
Idiopathic Pulmonary Fibrosis Patient Testimony for trial: Trial Name: NCT04419558 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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.."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
New York
Minnesota
Other
Wisconsin
How old are they?
65+
18 - 65
What site did they apply to?
UC San Francisco
UAB Lung Health Center
University of Wisconsin Clinical Research
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

i want to help science and gain $$ so others do not have to suffer.
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Email
Most responsive sites:
  1. University of Wisconsin Clinical Research: < 24 hours
Average response time
  • < 2 Days
~84 spots leftby Mar 2025