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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 study is evaluating whether a drug may help treat Idiopathic Pulmonary Fibrosis.
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 (Japan Extension Cohort): Change From Baseline in FVC at Week 48
DB Period (Main Study Cohort): Change From Baseline in FVC at Week 48
Secondary study objectives
DB Period (Main Study Cohort and Japan Extension Cohort): Change From Baseline in Quantitative Lung Fibrosis (QLF) Volume at Week 48
DB Period (Main Study Cohort): Time to All-Cause Mortality
DB Period (Main Study Cohort): 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
6Treatment groups
Experimental Treatment
Placebo Group
Group I: OLE Period: Placebo/PamrevlumabExperimental Treatment1 Intervention
Participants who receive placebo matching to pamrevlumab in the DB period, will receive pamrevlumab 30 mg/kg by IV infusion every 3 weeks for up to 48 weeks in the OLE period or until pamrevlumab is commercially available for the indication of IPF, or the sponsor decides to end the OLE period, whichever occurrs first.
Group II: OLE Period: Pamrevlumab/PamrevlumabExperimental Treatment1 Intervention
Participants who receive pamrevlumab in the DB period will continue to receive the same dose of pamrevlumab for up to 48 weeks in the OLE period or until pamrevlumab is commercially available for the indication of IPF, or the sponsor decides to end the OLE period, whichever occurrs first.
Group III: Main Study Cohort: PamrevlumabExperimental Treatment1 Intervention
Participants will receive pamrevlumab 30 milligrams (mg)/kilogram (kg) by intravenous (IV) infusion every 3 weeks for up to 48 weeks in the DB period.
Group IV: Japan Extension Cohort: PamrevlumabExperimental Treatment1 Intervention
Participants will receive pamrevlumab 30 mg/kg by IV infusion every 3 weeks for up to 48 weeks.
Group V: Main Study Cohort: PlaceboPlacebo Group1 Intervention
Participants will receive placebo matching to pamrevlumab by IV infusion every 3 weeks for up to 48 weeks in the DB period.
Group VI: Japan Extension Cohort: PlaceboPlacebo Group1 Intervention
Participants will receive placebo matching to pamrevlumab by IV 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
Find a Location
Who is running the clinical trial?
FibroGenLead Sponsor
58 Previous Clinical Trials
14,987 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: Main Study Cohort: Pamrevlumab
- Group 2: Main Study Cohort: Placebo
- Group 3: Japan Extension Cohort: Pamrevlumab
- Group 4: Japan Extension Cohort: Placebo
- Group 5: OLE Period: Pamrevlumab/Pamrevlumab
- Group 6: OLE Period: Placebo/Pamrevlumab
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.
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