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

See if you pre-qualify

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.

Condition 
Idiopathic Pulmonary Fibrosis
Phase 
Phase 2
Overall status 
Recruiting
Enrollment count 
84 participants
Start date 
Dec 20, 2017
Completion date 
Apr 05, 2024
Gender 
All
Age(s)
40 Years - 80 Years (Adult, Older Adult)

Interventions

Drug
VAY736
VAY736 administered subcutaneously (s.c.) every 4 weeks
Drug
Placebo
Placebo administered s.c. every 4 weeks

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

United States
Novartis Investigative Site
Recruiting
Birmingham, 35294-0007
Alabama
United States
Novartis Investigative Site
Recruiting
Los Angeles, 90095
California
United States
Novartis Investigative Site
Recruiting
Aurora, 80045
Colorado
United States
Novartis Investigative Site
Recruiting
Miami, 33136
Florida
United States
Novartis Investigative Site
Recruiting
Chicago, 60637
Illinois
United States
Novartis Investigative Site
Recruiting
Baltimore, 21224
Maryland
United States
Novartis Investigative Site
Recruiting
Boston, 02115
Massachusetts
United States
Novartis Investigative Site
Recruiting
Saint Louis, 63110
Missouri
United States
Novartis Investigative Site
Recruiting
Lebanon, 03756
New Hampshire
United States
Novartis Investigative Site
Recruiting
Durham, 27710
North Carolina
United States
Novartis Investigative Site
Recruiting
Pittsburgh, 15213
Pennsylvania
United States
Novartis Investigative Site
Recruiting
Nashville, 37203
Tennessee
United States
Novartis Investigative Site
Recruiting
Salt Lake City, 84108
Utah
United States
Canada
Novartis Investigative Site
Recruiting
Calgary, T2N 2T9
Alberta
Canada
Novartis Investigative Site
Recruiting
Quebec, GIV 4G5
-
Canada
France
Novartis Investigative Site
Recruiting
Besancon Cedex, 25030
Doubs
France
Novartis Investigative Site
Recruiting
Montpellier cedex 5, 34059
Herault
France
Novartis Investigative Site
Recruiting
Bobigny cedex, 93009
Seine Saint Denis
France
Novartis Investigative Site
Recruiting
Marseille, 13015
-
France
Novartis Investigative Site
Recruiting
Paris, 75018
-
France
Germany
Novartis Investigative Site
Recruiting
Gauting, 82131
Bayern
Germany
Novartis Investigative Site
Recruiting
Coswig, 01640
-
Germany
Novartis Investigative Site
Recruiting
Essen, 45147
-
Germany
Novartis Investigative Site
Recruiting
Hannover, 30625
-
Germany
Novartis Investigative Site
Recruiting
Leipzig, 04103
-
Germany
Ireland
Novartis Investigative Site
Recruiting
Dublin, D04
-
Ireland
Italy
Novartis Investigative Site
Recruiting
Forli, 47100
Forli - Cesena
Italy
Novartis Investigative Site
Recruiting
Milano, 20123
MI
Italy
Novartis Investigative Site
Recruiting
Catania, 95123
-
Italy
Novartis Investigative Site
Recruiting
Modena, 41124
-
Italy
Novartis Investigative Site
Recruiting
Roma, 00168
-
Italy
Novartis Investigative Site
Recruiting
Siena, 53100
-
Italy
United Kingdom
Novartis Investigative Site
Recruiting
Cambridge, CB23 3RE
Cambridgeshire
United Kingdom
Novartis Investigative Site
Recruiting
High Heaton, NE7 7DN
Newcastle Upon Tyne
United Kingdom
Novartis Investigative Site
Recruiting
Edinburgh,
-
United Kingdom
Novartis Investigative Site
Recruiting
Nottingham, NG5 1PB
-
United Kingdom

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
1-888-669-6682
Email: 
Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]