Zephyrus II: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
Zephyrus II: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
This is a Phase 3 trial to evaluate the efficacy and safety of 30 milligrams (mg)/kilogram (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.
The intent of this study is to evaluate the efficacy and safety of pamrevlumab as monotherapy in participants with IPF. Participants who are not being treated with approved IPF therapies (that is, nintedanib or pirfenidone) may be eligible for screening. Examples of reasons participants may not be treated with approved IPF therapies include but are not limited to:
NOTE: No participant should discontinue an approved IPF therapy for the purpose of enrolling in this study.
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.
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.
Key Inclusion Criteria:
Key Exclusion Criteria:
Boston, Massachusetts 02114, United States
Belo Horizonte, Minas Gerais 30130-100, Brazil
Porto Alegre, Rio Grande do Sul 90020-090, Brazil
Porto Alegre, Rio Grande do Sul 90610-000, Brazil
Botucatu, São Paulo 18618-686, Brazil
São Bernardo do Campo, São Paulo 09715-090, Brazil
São Paulo, 05403-000, Brazil
Wuhan, China
Forlì, 47121, Italy
Monterrey, 64460, Mexico
Katowice, 40-635, Poland
Dnipro, 49069, Ukraine
Ivano-Frankivsk, 76018, Ukraine
Kyiv, 03680, Ukraine
Birmingham, B15 2TH, United Kingdom
Cambridge, CB2 0AY, United Kingdom