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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 up to week 48
Awards & highlights
Pivotal Trial
Summary
This trial tests pamrevlumab, an IV drug given regularly, in people with IPF who can't use or don't benefit from existing treatments. The drug aims to stop lung scarring.
Eligible Conditions
- Idiopathic Pulmonary Fibrosis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to week 48
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 48
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
DB Period: Change From Baseline in FVC at Week 48
Secondary study objectives
DB Period: Change From Baseline in Quantitative Lung Fibrosis (QLF) Volume at Week 48
DB Period: Time to All-Cause Mortality
DB Period: Time to Disease Progression
+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%
Pain
8%
Headache
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%
Musculoskeletal chest pain
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%
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
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
58 Previous Clinical Trials
14,971 Total Patients Enrolled
4 Trials studying Idiopathic Pulmonary Fibrosis
627 Patients Enrolled for Idiopathic Pulmonary Fibrosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
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.
Idiopathic Pulmonary Fibrosis Patient Testimony for trial: Trial Name: NCT04419558 — Phase 3
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