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NCT03287414 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by Novartis Pharmaceuticals.

Terminated
Registry status
Phase 2
Development phase
30
Enrollment target

NCT03287414: Clinical Trial Phase 2 study, sponsored by Novartis Pharmaceuticals.

NCT03287414 is a Phase 2 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 30 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03287414, a Phase 2 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.

TERMINATED
Registry status
Phase 2
Development phase
30 participants
Enrollment target

Study 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).

Primary Outcome

FVC was defined as the maximum amount of air that an individual was able to forcibly exhale from his / her lungs after taking the deepest breath they could. Change from baseline to end of treatment epoch (48 weeks of treatment) in Forced Vital Capacity (FVC) was analyzed using a Mixed Effects Model for Repeated Measures (MMRM) and considering all assessments collected during the treatment epoch. The model included treatment and visit as fixed effects, standard of care treatment (Nintedanib, Pirf

Interventions

  • DRUG Placebo
  • DRUG VAY736
  • DRUG Standard of Care (SoC)

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2017-12-20
Est. Completion 2022-02-14
Phase Phase 2
Novartis Pharmaceuticals

1,375 total trials

Why NCT03287414 stopped before completion

NCT03287414 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT03287414 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03287414 about?

NCT03287414 is a clinical study titled "Study of Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of VAY736 in Patients With Idiopathic Pulmonary Fibrosis". 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).

What is the current status of trial NCT03287414?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2017-12-20. Estimated completion is 2022-02-14.

What interventions are being tested in trial NCT03287414?

The interventions under investigation include: Placebo (DRUG), VAY736 (DRUG), Standard of Care (SoC) (DRUG).

Who is sponsoring clinical trial NCT03287414?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03287414's enrollment target sits among peer trials

30 1582nd of 2000 higher than 332 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03287414, the US trial registry maintained by the National Library of Medicine. NCT03287414 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.