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NCT01663623 · ClinicalTrials.gov registry record · Phase 3

Belimumab in Remission of VASculitis

A Phase 3 study, sponsored by Human Genome Sciences Inc., a GSK Company.

Completed
Registry status
Phase 3
Development phase
106
Enrollment target

NCT01663623 is a Phase 3 study that has completed, run by Human Genome Sciences Inc., a GSK Company. The registered enrollment target is 106 participants.

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The verdict

NCT01663623, a Phase 3 study, has completed, sponsored by Human Genome Sciences Inc., a GSK Company.

COMPLETED
Registry status
Phase 3
Development phase
106 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the efficacy and safety of belimumab, in combination with azathioprine, for the maintenance of remission following a standard induction regimen in patients with Wegener's granulomatosis or microscopic polyangiitis. The random assignment in this study is "1 to 1" which means that participants have an equal chance of receiving belimumab or placebo.

Interventions

  • BIOLOGICAL Placebo
  • DRUG Azathioprine
  • BIOLOGICAL Belimumab 10 mg/kg

Trial Details

FieldValue
Enrollment Target 106 participants
Start Date 2013-03-20
Est. Completion 2017-02-06
Phase Phase 3

What the Registry Record Tells You About NCT01663623

The ClinicalTrials.gov registry entry for NCT01663623 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 106 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Human Genome Sciences Inc., a GSK Company, which has 9 total studies on file at ClinicalTrials.gov.

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

NCT01663623 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01663623 about?

NCT01663623 is a clinical study titled "Belimumab in Remission of VASculitis". The purpose of this study is to evaluate the efficacy and safety of belimumab, in combination with azathioprine, for the maintenance of remission following a standard induction regimen in patients with Wegener's granulomatosis or microscopic polyangiitis. The random assignment in this study is "1 to...

What is the current status of trial NCT01663623?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 106 participants. The study started on 2013-03-20. Estimated completion is 2017-02-06.

What interventions are being tested in trial NCT01663623?

The interventions under investigation include: Placebo (BIOLOGICAL), Azathioprine (DRUG), Belimumab 10 mg/kg (BIOLOGICAL).

Who is sponsoring clinical trial NCT01663623?

This trial is sponsored by Human Genome Sciences Inc., a GSK Company, which has 9 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.