Pamrevlumab for Idiopathic Pulmonary Fibrosis
Recruiting at120 trial locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: FibroGen
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
This study is evaluating whether a drug may help treat Idiopathic Pulmonary Fibrosis.
Research Team
Eligibility Criteria
Inclusion 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 been diagnosed with IPF within the last 7 years according to specific medical guidelines.
See 3 more
Exclusion Criteria
Smoking within 3 months of screening and/or unwilling to avoid smoking throughout the study
Female participants who are pregnant or nursing
You have taken pamrevlumab before.
See 8 more
Treatment Details
Interventions
- Pamrevlumab (Monoclonal Antibodies)
Participant Groups
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
FibroGen
Lead Sponsor
Trials
60
Recruited
15,400+
Thane Wettig
FibroGen
Chief Executive Officer since 2023
Bachelor's degree in Mechanical Engineering from Case Western Reserve University, MBA from Duke University
Dr. Mark Eisner
FibroGen
Chief Medical Officer since 2020
MD from Harvard Medical School