NCT03287414

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

A Subject-, Investigator-, and Sponsor-blinded, Randomized, Placebo-controlled, Multicenter Study to Investigate Efficacy, Safety, and Tolerability of VAY736 in Patients With Idiopathic Pulmonary Fibrosis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This was an exploratory (non-confirmatory) randomized, patient-, investigator-, sponsor- blinded, placebo controlled study of VAY736 in IPF patients. This study investigated the safety and efficacy of 300 mg VAY736 administered subcutaneously (s.c.) every 4 weeks for 48 weeks. Participants were randomized in a 1:1 ratio on top of local standard of care (SOC), to receive VAY736 or placebo. Randomized subjects entered the treatment epoch (for up to 48 weeks), followed by two follow-up epochs: the PK/safety follow-up epoch and the PD/safety follow-up epoch. The PK/safety follow-up epoch lasted for 20 weeks. When the PK/safety follow-up epoch was completed, participants in the placebo arm were discharged from the study; but participants in the active arm (those who had received VAY736) continued into the PD/safety follow-up epoch. Participants in the PD/safety follow-up epoch were followed until B-cell recovery (in the peripheral blood), defined as: B cells \>=50/μL or B cells \>= 80% of baseline (whichever occurred first). If a participant had not recovered his/her B-cells after a period of 2 years from the last dose of VAY736, then this participant was discharged from the study.

Conditions

• Idiopathic Pulmonary Fibrosis

Interventions

Type	Name	Description
DRUG	VAY736	300 mg VAY736 administered subcutaneously every 4 weeks for 48 weeks
DRUG	Placebo	Placebo administered subcutaneously every 4 weeks for 48 weeks
DRUG	Standard of Care (SoC)	Background standard-of-care treatment for IPF: nintedanib, pirfenidone, or no background therapy

Timeline

• Start date: 2017-12-20
• Primary completion: 2020-11-25
• Completion: 2022-02-14
• First posted: 2017-09-19
• Last updated: 2024-06-18
• Results posted: 2023-03-10

Locations

16 sites across 6 countries: United States, Canada, Germany, Ireland, Italy, United Kingdom

Regulatory

• FDA-regulated drug study