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
ClinicalTrials.gov Identifier: NCT03287414
Novartis Reference Number: CVAY736X2207
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.
Study Description
This study will investigate the safety and efficacy of VAY736 administered subcutaneously (s.c.) every 4 weeks for 48 weeks. Approximately, 84 subjects will be randomized in a 1:1 ratio on top of local standard of care (SOC), to receive VAY736 or placebo.
Interventions
Eligibility Criteria
Inclusion Criteria:
A diagnosis of definite or probable IPF within 5 years of the screening visit, as defined by Figure 3, Tables 4-6 of the ATS/ERS/JRS/ALAT Diagnostic Guidelines (Raghu et al 2011)
FVC 40-90% predicted (inclusive)
DLCO, corrected for hemoglobin, 25-79% predicted (inclusive)
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 Criteria:
Emphysema > fibrosis on screening HRCT (must be confirmed by central reader)
History of major organ, hematopoietic stem cell or bone marrow transplant
Clinically diagnosed 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)
Other protocol-defined inclusion/exclusion criteria may apply.
Study Locations
Contacts
Have a question?
Call 1-999-669-6682 or email [email protected]