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

NCT03287414 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-06-18

Study results available
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Summary

The purpose of this study was to investigate the safety, tolerability and efficacy of VAY736 as potential therapy for the treatment of idiopathic pulmonary fibrosis (IPF).

Conditions

Interventions

DRUG

VAY736

300 mg VAY736 administered subcutaneously every 4 weeks for 48 weeks

DRUG

Placebo

Placebo administered subcutaneously every 4 weeks for 48 weeks

DRUG

Standard of Care (SoC)

Background standard-of-care treatment for IPF: nintedanib, pirfenidone, or no background therapy

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-20
Primary Completion
2020-11-25
Completion
2022-02-14
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Germany
  • Ireland
  • Italy
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03287414 on ClinicalTrials.gov