Study of Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of VAY736 in Patients With Idiopathic Pulmonary Fibrosis
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ClinicalTrials.gov Identifier: NCT03287414 |
Recruitment Status :
Recruiting
First Posted : September 19, 2017
Last Update Posted : March 11, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Idiopathic Pulmonary Fibrosis | Drug: VAY736 Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 84 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Masking Description: | A subject-, investigator-, and sponsor-blinded |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | December 20, 2017 |
Actual Primary Completion Date : | December 15, 2020 |
Estimated Study Completion Date : | September 26, 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: VAY736
VAY736 administered subcutaneously (s.c.) every 4 weeks
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Drug: VAY736
VAY736 administered subcutaneously (s.c.) every 4 weeks |
Placebo Comparator: Placebo
Placebo administered subcutaneously (s.c.) every 4 weeks
|
Drug: Placebo
Placebo administered s.c. every 4 weeks |
- Change from baseline to end of treatment epoch (48 weeks of treatment) in Forced Vital Capacity (FVC). [ Time Frame: Baseline, Week 48 ]To assess the efficacy of VAY736 in patients with idiopathic pulmonary fibrosis Change from baseline to end of treatment epoch (48 weeks of treatment) in Forced Vital Capacity (FVC).
- All-Cause mortality [ Time Frame: Week 48 ]To assess the impact of VAY736 on survival: All-cause mortality
- Progression-free survival (PFS) [ Time Frame: Week 48 ]
Progression free survival analysis as defined will be produced at the end of the treatment epoch (week 48) for the following event of interest:
- Events, defined as: death (all-cause mortality) OR "progression" (relative reduction in FVC ≥ 10%)
- Events, defined as: death (IPF-related mortality) OR "progression" (relative reduction in FVC ≥ 10%)
- Disease progression [ Time Frame: Week 48 ]Disease Progression, defined as: a)relative reduction in FVC ≥ 10% b) relative reduction in Diffusing Capacity of the Lungs (DLCO) ≥ 15% c) absolute reduction in Six Minute Walk Distance (6MWD) ≥ 50 m
- Composite Endpoint [ Time Frame: Week 48 ]
Composite Endpoint defined as:
- death (all-cause mortality), OR relative reduction in FVC≥10%, OR relative reduction in DLCO ≥15%, OR relative reduction in 6MWD ≥50m
- death (IPF-related morality), OR relative reduction in FVC≥10%, OR relative reduction in DLCO ≥15%, OR relative reduction in 6MWD ≥50m
- Change from baseline to end of treatment epoch (Week 48) in Diffusing Capacity of the Lungs (DLCO) [ Time Frame: Baseline, Week 48 ]To assess the impact of VAY736 on Pulmonary Physiology: Change from baseline to theend of treatment epoch (week 48) in DLCO
- Change from baseline to the end of treatment epoch (Week 48) in 6-minute walk test and in distance-saturation product [ Time Frame: Baseline, Week 48 ]Change from baseline to the end of treatment epoch (Week 48) in 6-minute walk test and in distance-saturation product to assess the impact of VAY736 on exercise capacity
- Change from baseline to the end of treatment epoch (Week 48) in resting oxygen saturation (on room air) [ Time Frame: Baseline, Week 48 ]Change from baseline to the end of treatment epoch (Week 48) in resting oxygen saturation (on room air) to assess the impact of VAY736 on gas exchange
- Immunogenicity of VAY736 [ Time Frame: Week 48 ]To assess the immunogenicity of VAY736 by measuring Serum anti-VAY736 antibodies
- To assess the pharmacokinetics Cmin,ss of VAY736 after multiple s.c. doses [ Time Frame: Day 1 through Week 69 ]Determine the Cmin,ss from the serum concentration (VAY736)-time data
- Idiopathic Pulmonary Fibrosis (IPF) -related Mortality [ Time Frame: Week 48 ]To assess the impact of VAY736 on survival: IPF-related mortality

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 40 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03287414
Contact: Novartis Pharmaceuticals | 1-888-669-6682 | Novartis.email@novartis.com | |
Contact: Novartis Pharmaceuticals | +41613241111 |
United States, Alabama | |
Novartis Investigative Site | Recruiting |
Birmingham, Alabama, United States, 35294-0007 | |
United States, California | |
Novartis Investigative Site | Recruiting |
Los Angeles, California, United States, 90095 | |
United States, Colorado | |
Novartis Investigative Site | Recruiting |
Aurora, Colorado, United States, 80045 | |
United States, Florida | |
Novartis Investigative Site | Recruiting |
Miami, Florida, United States, 33136 | |
United States, Illinois | |
Novartis Investigative Site | Recruiting |
Chicago, Illinois, United States, 60637 | |
United States, Maryland | |
Novartis Investigative Site | Recruiting |
Baltimore, Maryland, United States, 21224 | |
United States, Massachusetts | |
Novartis Investigative Site | Recruiting |
Boston, Massachusetts, United States, 02115 | |
United States, Missouri | |
Novartis Investigative Site | Recruiting |
Saint Louis, Missouri, United States, 63110 | |
United States, New Hampshire | |
Novartis Investigative Site | Recruiting |
Lebanon, New Hampshire, United States, 03756 | |
United States, North Carolina | |
Novartis Investigative Site | Recruiting |
Durham, North Carolina, United States, 27710 | |
United States, Pennsylvania | |
Novartis Investigative Site | Recruiting |
Pittsburgh, Pennsylvania, United States, 15213 | |
United States, South Carolina | |
Novartis Investigative Site | Recruiting |
Charleston, South Carolina, United States, 29406-7108 | |
United States, Tennessee | |
Novartis Investigative Site | Recruiting |
Nashville, Tennessee, United States, 37203 | |
United States, Utah | |
Novartis Investigative Site | Recruiting |
Salt Lake City, Utah, United States, 84108 | |
Canada, Alberta | |
Novartis Investigative Site | Recruiting |
Calgary, Alberta, Canada, T2N 2T9 | |
Canada | |
Novartis Investigative Site | Recruiting |
Quebec, Canada, GIV 4G5 | |
France | |
Novartis Investigative Site | Recruiting |
Besancon Cedex, Doubs, France, 25030 | |
Novartis Investigative Site | Recruiting |
Montpellier cedex 5, Herault, France, 34059 | |
Novartis Investigative Site | Recruiting |
Bobigny cedex, Seine Saint Denis, France, 93009 | |
Novartis Investigative Site | Recruiting |
Marseille, France, 13015 | |
Novartis Investigative Site | Recruiting |
Paris, France, 75018 | |
Germany | |
Novartis Investigative Site | Recruiting |
Heidelberg, Baden-Württemberg, Germany, 69126 | |
Novartis Investigative Site | Recruiting |
Gauting, Bayern, Germany, 82131 | |
Novartis Investigative Site | Recruiting |
Coswig, Germany, 01640 | |
Novartis Investigative Site | Recruiting |
Essen, Germany, 45147 | |
Novartis Investigative Site | Recruiting |
Hannover, Germany, 30625 | |
Novartis Investigative Site | Recruiting |
Leipzig, Germany, 04103 | |
Ireland | |
Novartis Investigative Site | Recruiting |
Dublin, Ireland, D04 | |
Italy | |
Novartis Investigative Site | Recruiting |
Forli, Forli - Cesena, Italy, 47100 | |
Novartis Investigative Site | Recruiting |
Milano, MI, Italy, 20123 | |
Novartis Investigative Site | Recruiting |
Catania, Italy, 95123 | |
Novartis Investigative Site | Recruiting |
Modena, Italy, 41124 | |
Novartis Investigative Site | Recruiting |
Roma, Italy, 00168 | |
Novartis Investigative Site | Recruiting |
Siena, Italy, 53100 | |
United Kingdom | |
Novartis Investigative Site | Recruiting |
Cambridge, Cambridgeshire, United Kingdom, CB23 3RE | |
Novartis Investigative Site | Recruiting |
High Heaton, Newcastle Upon Tyne, United Kingdom, NE7 7DN | |
Novartis Investigative Site | Recruiting |
Edinburgh, United Kingdom | |
Novartis Investigative Site | Recruiting |
Nottingham, United Kingdom, NG5 1PB |
Responsible Party: | Novartis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT03287414 |
Other Study ID Numbers: |
CVAY736X2207 |
First Posted: | September 19, 2017 Key Record Dates |
Last Update Posted: | March 11, 2021 |
Last Verified: | March 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Plan Description: | Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
idiopathic pulmonary fibrosis VAY736 |
Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis Fibrosis Pathologic Processes |
Lung Diseases Respiratory Tract Diseases Idiopathic Interstitial Pneumonias Lung Diseases, Interstitial |