Zephyrus II: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
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- STATUS
- Recruiting
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- days left to enroll
- 64
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- participants needed
- 340
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- 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 participants with Idiopathic Pulmonary Fibrosis (IPF). There is a 48-week randomized treatment phase followed by an optional, open-label extension phase.
Description
The intent of this study is to evaluate the efficacy and safety profile of pamrevlumab as monotherapy in participants with IPF who were previously treated with an approved therapy but who discontinued that therapy (possible reasons for discontinuation of approved therapy could include, but are not limited to, intolerance or disease progression), unless neither treatment is available in the host country.
During the 48-week treatment phase of the study, co-administration of an approved IPF therapy (such as, pirfenidone or nintedanib) is acceptable if clinically indicated in the Investigator's opinion, after assessment of potential risks/benefits of such combination with blinded study treatment. However, since participants either tried and stopped treatment with an approved IPF therapy, or have no such treatment available, it is not expected that many participants will resume treatment with an approved IPF therapy during this study.
Participants who complete the 48-week study will be eligible for an optional, open-label extension phase with continued access to pamrevlumab, regardless of their randomized assignment.
Details
| Condition | Idiopathic Pulmonary Fibrosis |
|---|---|
| Treatment | Placebo, Pamrevlumab |
| Clinical Study Identifier | NCT04419558 |
| Sponsor | FibroGen |
| Last Modified on | 18 October 2022 |
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