Status:
TERMINATED
Study of Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of VAY736 in Patients With Idiopathic Pulmonary Fibrosis
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Idiopathic Pulmonary Fibrosis
Eligibility:
All Genders
40-80 years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
December 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 14 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03287414
Start Date
December 20 2017
End Date
February 14 2022
Last Update
June 18 2024
Active Locations (16)
Enter a location and click search to find clinical trials sorted by distance.
1
Novartis Investigative Site
Birmingham, Alabama, United States, 35294-0007
2
Novartis Investigative Site
Aurora, Colorado, United States, 80045
3
Novartis Investigative Site
Miami, Florida, United States, 33136
4
Novartis Investigative Site
Durham, North Carolina, United States, 27710