Zephyrus I: Evaluation of Efficacy and Safety of Pamrevlumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)

Summary

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 IPF.

Timeline

Start

2019-06-18

Primary completion

2023-03-20

Completion

2023-08-28

Outcome

Missed primary endpoint

Stopped: “Study did not meet its primary endpoint.”

paper There was no statistically significant between-group difference for the primary outcome of absolute change in FVC from baseline to week 48. PMID 38762797 ↗

registry p = 0.2926; LS Mean Difference 0.07 (95% CI -0.06 to 0.19) NCT03955146 ↗

Publications

• Raghu G, Richeldi L, Fernandez Perez ER, De Salvo MC, Silva RS, Song JW, Ogura T, Xu ZJ, Belloli EA, Zhang X, Seid LL, Poole L; ZEPHYRUS-1 Study Investigators. Pamrevlumab for Idiopathic Pulmonary Fibrosis: The ZEPHYRUS-1 Randomized Clinical Trial. JAMA. 2024 Aug 6;332(5):380-389. doi: 10.1001/jama.2024.8693.
• Rayego-Mateos S, Morgado-Pascual JL, Lavoz C, Rodrigues-Diez RR, Marquez-Exposito L, Tejera-Munoz A, Tejedor-Santamaria L, Rubio-Soto I, Marchant V, Ruiz-Ortega M. CCN2 Binds to Tubular Epithelial Cells in the Kidney. Biomolecules. 2022 Feb 3;12(2):252. doi: 10.3390/biom12020252.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pamrevlumab	Monoclonal antibody	30 mg/kg	Intravenous

Indications