Study of Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of VAY736 in Patients With Idiopathic Pulmonary Fibrosis

Summary

The purpose of this study was to investigate the safety, tolerability and efficacy of VAY736 as potential therapy for the treatment of idiopathic pulmonary fibrosis (IPF).

Timeline

Start

2017-12-20

Primary completion

2020-11-25

Completion

2022-02-14

Outcome

Missed primary endpoint

Stopped (Business): “Sponsor decision”

registry analysis (superiority test); VAY736 vs Placebo; p = 0.3248; Least Squares Mean Difference 0.063 (80% CI -0.115 to 0.241) NCT03287414 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ianalumab	Monoclonal antibody	300 mg	Subcutaneous
Background	Nintedanib	Small molecule	—	—
Background	Pirfenidone	Small molecule	—	—

Indications