Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03287414
Recruitment Status : Terminated (Sponsor decision)
First Posted : September 19, 2017
Last Update Posted : March 14, 2022
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
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 or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis Drug: VAY736 Drug: Placebo Drug: Standard of Care (SoC) Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 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 : November 25, 2020
Actual Study Completion Date : October 20, 2021


Arm Intervention/treatment
Experimental: VAY736
VAY736 administered subcutaneously (s.c.) every 4 weeks
Drug: VAY736
VAY736 administered subcutaneously (s.c.) every 4 weeks

Drug: Standard of Care (SoC)
nintedanib, pirfenidone, or neither

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

Drug: Standard of Care (SoC)
nintedanib, pirfenidone, or neither




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. All-Cause mortality [ Time Frame: Week 48 ]
    To assess the impact of VAY736 on survival: All-cause mortality

  2. 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:

    1. Events, defined as: death (all-cause mortality) OR "progression" (relative reduction in FVC ≥ 10%)
    2. Events, defined as: death (IPF-related mortality) OR "progression" (relative reduction in FVC ≥ 10%)

  3. 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

  4. Composite Endpoint [ Time Frame: Week 48 ]

    Composite Endpoint defined as:

    1. death (all-cause mortality), OR relative reduction in FVC≥10%, OR relative reduction in DLCO ≥15%, OR relative reduction in 6MWD ≥50m
    2. death (IPF-related morality), OR relative reduction in FVC≥10%, OR relative reduction in DLCO ≥15%, OR relative reduction in 6MWD ≥50m

  5. 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

  6. 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

  7. 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

  8. Immunogenicity of VAY736 [ Time Frame: Week 48 ]
    To assess the immunogenicity of VAY736 by measuring Serum anti-VAY736 antibodies

  9. 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

  10. Idiopathic Pulmonary Fibrosis (IPF) -related Mortality [ Time Frame: Week 48 ]
    To assess the impact of VAY736 on survival: IPF-related mortality



Information from the National Library of Medicine

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.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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)
  2. FVC 40-90% predicted (inclusive)
  3. DLCO, corrected for hemoglobin, 25-79% predicted (inclusive)
  4. FEV1/FVC >70%
  5. Unlikely to die from cause other than IPF within the next 3 years, in the opinion of the investigator
  6. Unlikely to undergo lung transplantation during this trial

Exclusion Criteria:

  1. Emphysema > fibrosis on screening HRCT (must be confirmed by central reader)
  2. History of major organ, hematopoietic stem cell or bone marrow transplant
  3. Clinically diagnosed AE-IPF or other significant clinical worsening within 3 months of randomization
  4. New York Heart Association (NYHA) class III/IV Congestive Heart Failure (CHF), Ejection Fraction (EF) <25%
  5. Current smoker
  6. 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.


Information from the National Library of Medicine

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


Locations
Layout table for location information
United States, Alabama
Novartis Investigative Site
Birmingham, Alabama, United States, 35294-0007
United States, Colorado
Novartis Investigative Site
Aurora, Colorado, United States, 80045
United States, Florida
Novartis Investigative Site
Miami, Florida, United States, 33136
United States, North Carolina
Novartis Investigative Site
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Novartis Investigative Site
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Novartis Investigative Site
Nashville, Tennessee, United States, 37203
United States, Utah
Novartis Investigative Site
Salt Lake City, Utah, United States, 84108
Canada, Alberta
Novartis Investigative Site
Calgary, Alberta, Canada, T2N 2T9
Germany
Novartis Investigative Site
Coswig, Germany, 01640
Novartis Investigative Site
Hannover, Germany, 30625
Ireland
Novartis Investigative Site
Dublin, Ireland, D04
Italy
Novartis Investigative Site
Forli, Forli - Cesena, Italy, 47100
Novartis Investigative Site
Modena, Italy, 41124
Novartis Investigative Site
Siena, Italy, 53100
United Kingdom
Novartis Investigative Site
Cambridge, Cambridgeshire, United Kingdom, CB23 3RE
Novartis Investigative Site
High Heaton, Newcastle Upon Tyne, United Kingdom, NE7 7DN
Sponsors and Collaborators
Novartis Pharmaceuticals
Layout table for additonal information
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 14, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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


Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
idiopathic pulmonary fibrosis
VAY736
Additional relevant MeSH terms:
Layout table for MeSH terms
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases