Study of Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of VAY736 in Patients With Idiopathic Pulmonary Fibrosis
NCT ID: NCT03287414
Last Updated: 2024-06-18
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
30 participants
INTERVENTIONAL
2017-12-20
2022-02-14
Brief Summary
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Detailed Description
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Participants were randomized in a 1:1 ratio on top of local standard of care (SOC), to receive VAY736 or placebo. Randomized subjects entered the treatment epoch (for up to 48 weeks), followed by two follow-up epochs: the PK/safety follow-up epoch and the PD/safety follow-up epoch. The PK/safety follow-up epoch lasted for 20 weeks. When the PK/safety follow-up epoch was completed, participants in the placebo arm were discharged from the study; but participants in the active arm (those who had received VAY736) continued into the PD/safety follow-up epoch. Participants in the PD/safety follow-up epoch were followed until B-cell recovery (in the peripheral blood), defined as: B cells \>=50/μL or B cells \>= 80% of baseline (whichever occurred first). If a participant had not recovered his/her B-cells after a period of 2 years from the last dose of VAY736, then this participant was discharged from the study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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VAY736
Participants received 300 mg VAY736 administered subcutaneously every 4 weeks for 48 weeks on top of current standard-of-care therapy
VAY736
300 mg VAY736 administered subcutaneously every 4 weeks for 48 weeks
Standard of Care (SoC)
Background standard-of-care treatment for IPF: nintedanib, pirfenidone, or no background therapy
Placebo
Participants received placebo administered subcutaneously every 4 weeks for 48 weeks on top of current standard-of-care therapy
Placebo
Placebo administered subcutaneously every 4 weeks for 48 weeks
Standard of Care (SoC)
Background standard-of-care treatment for IPF: nintedanib, pirfenidone, or no background therapy
Interventions
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VAY736
300 mg VAY736 administered subcutaneously every 4 weeks for 48 weeks
Placebo
Placebo administered subcutaneously every 4 weeks for 48 weeks
Standard of Care (SoC)
Background standard-of-care treatment for IPF: nintedanib, pirfenidone, or no background therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Forced Vital Capacity (FVC) 40-90% predicted (inclusive)
* Diffusing Capacity of the Lungs (DLCO), corrected for hemoglobin, 25-79% predicted (inclusive)
* Forced Expiratory Volume in first second (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
* History of major organ, hematopoietic stem cell or bone marrow transplant
* Clinically diagnosed acute exacerbation of idiopathic pulmonary fibrosis (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)
40 Years
80 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Birmingham, Alabama, United States
Novartis Investigative Site
Aurora, Colorado, United States
Novartis Investigative Site
Miami, Florida, United States
Novartis Investigative Site
Durham, North Carolina, United States
Novartis Investigative Site
Pittsburgh, Pennsylvania, United States
Novartis Investigative Site
Nashville, Tennessee, United States
Novartis Investigative Site
Salt Lake City, Utah, United States
Novartis Investigative Site
Calgary, Alberta, Canada
Novartis Investigative Site
Coswig, , Germany
Novartis Investigative Site
Hanover, , Germany
Novartis Investigative Site
Dublin, , Ireland
Novartis Investigative Site
Forlì, FC, Italy
Novartis Investigative Site
Modena, MO, Italy
Novartis Investigative Site
Siena, SI, Italy
Novartis Investigative Site
Cambridge, Cambridgeshire, United Kingdom
Novartis Investigative Site
High Heaton, Newcastle Upon Tyne, United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2017 002667 17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CVAY736X2207
Identifier Type: -
Identifier Source: org_study_id
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