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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Idiopathic Pulmonary Fibrosis

In brief

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).

Key facts

Study ID

NCT03287414

Run by

Novartis Pharmaceuticals

People needed

30

Starts

2017-12-20

Expected to finish

2022-02-14

Last updated by the study team

2024-06-18

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A diagnosis of definite or probable IPF within 5 years of the screening visit
• Forced Vital Capacity (FVC) 40-90% predicted (inclusive)
• Diffusing Capacity of the Lungs (DLCO), corrected for hemoglobin, 25-79% predicted (inclusive)
• Forced Expiratory Volume in first second (FEV1)/FVC >70%
• Unlikely to die from cause other than IPF within the next 3 years, in the opinion of the investigator
• Unlikely to undergo lung transplantation during this trial

You may not qualify if…

• Emphysema > fibrosis on screening high-resolution computed tomography (must be confirmed by central reader)
• History of major organ, hematopoietic stem cell or bone marrow transplant
• Clinically diagnosed acute exacerbation of idiopathic pulmonary fibrosis (AE-IPF) or other significant clinical worsening within 3 months of randomization
• New York Heart Association (NYHA) class III/IV Congestive Heart Failure (CHF), Ejection Fraction (EF) <25%
• Current smoker
• Prior use of any B-cell depleting therapy (e.g., rituximab, ofatumumab, or other anti-CD20 mAb, anti-CD40, anti-CD19,anti-CD22 mAb, anti-CD52 mAb, or anti-BAFF mAb)

Where it is running

• Novartis Investigative Site — Birmingham, Alabama, United States
• Novartis Investigative Site — Aurora, Colorado, United States
• Novartis Investigative Site — Miami, Florida, United States
• Novartis Investigative Site — Durham, North Carolina, United States
• Novartis Investigative Site — Pittsburgh, Pennsylvania, United States
• Novartis Investigative Site — Nashville, Tennessee, United States
• Novartis Investigative Site — Salt Lake City, Utah, United States
• Novartis Investigative Site — Calgary, Alberta, Canada
• Novartis Investigative Site — Coswig, Germany
• Novartis Investigative Site — Hanover, Germany
• Novartis Investigative Site — Dublin, Ireland
• Novartis Investigative Site — Forlì, FC, Italy
• Novartis Investigative Site — Modena, MO, Italy
• Novartis Investigative Site — Siena, SI, Italy
• Novartis Investigative Site — Cambridge, Cambridgeshire, United Kingdom
• Novartis Investigative Site — High Heaton, Newcastle Upon Tyne, United Kingdom

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.