Evaluation of Efficacy and Safety of Pamrevlumab in Patients With Idiopathic Pulmonary Fibrosis
-
- STATUS
- Recruiting
-
- End date
- Jan 31, 2023
-
- participants needed
- 340
-
- sponsor
- FibroGen
Summary
This is a Phase 3 trial to evaluate the efficacy and safety of 30 mg/kg intravenous (IV) infusions of pamrevlumab administered every 3 weeks as compared to placebo in subjects with Idiopathic Pulmonary Fibrosis
Description
This is a Phase 3, randomized, double-blind, placebo-controlled, multi-center trial to evaluate the efficacy and safety of pamrevlumab in subjects with idiopathic pulmonary fibrosis (IPF).
Subjects who are not being treated with approved IPF therapies (i.e., nintedanib or pirfenidone) may be eligible for screening. Examples of reasons subjects may not be treated with approved IPF therapies include but are not limited to:
- Intolerant or not responsive to approved IPF therapies
- Ineligible to receive these therapies
- Subject voluntarily declines to receive approved IPF therapies after being fully informed of the potential benefits/risks
NOTE: No subject should discontinue an approved IPF therapy for the purpose of enrolling in this study.
Approximately 340 eligible subjects will be randomized at a 1:1 ratio to Arm A or Arm B,
- respectively
Arm A: pamrevlumab, 30 mg/kg IV, Day 1 and every 3 weeks thereafter
Arm B: Matching placebo IV, Day 1 and every 3 weeks thereafter
The study consists of the following study periods:
- Main (double blind, placebo-controlled) phase:
- Screening period: Up to 6 weeks
- Treatment period: 48 weeks
- Optional, open label extension (OLE) phase of pamrevlumab:
- Access to pamrevlumab will be available until the last subject completes 48 weeks of treatment in the OLE phase, or pamrevlumab is commercially available for the indication of IPF, or the Sponsor decides to end the OLE phase, whichever occurs first.
- Follow-up period/final safety assessments:
- 28 days after last dose
- 60 days after last dose: follow-up phone call, for a final safety assessment
During the treatment period, co-administration of an approved IPF therapy (i.e., pirfenidone or nintedanib) is acceptable if clinically indicated in the Investigator's opinion, provided that the Investigator assesses the potential risks/benefits of combining approved IPF therapies with blinded study treatment.
Subjects who discontinue study treatment for any reason should be encouraged to remain in the study and be followed for all study visits and assessments.
Subjects who complete the study will be eligible for an open-label, extension with pamrevlumab.
Details
| Condition | Idiopathic Pulmonary Fibrosis |
|---|---|
| Treatment | Placebo, Pamrevlumab |
| Clinical Study Identifier | NCT03955146 |
| Sponsor | FibroGen |
| Last Modified on | 24 May 2022 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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