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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
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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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 Phase 2

Study Design
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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

Resource links provided by the National Library of Medicine


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


Outcome Measures
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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


Eligibility Criteria
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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.

Contacts and Locations
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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


Contacts
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Contact: Novartis Pharmaceuticals 1-888-669-6682 Novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111

Locations
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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
Sponsors and Collaborators
Novartis Pharmaceuticals
More Information
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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

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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:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Fibrosis
Pathologic Processes
 Lung Diseases
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial