Overview

This trial is active, not recruiting.

Condition vasculitis
Treatments placebo, belimumab 10 mg/kg, azathioprine
Phase phase 3
Sponsor Human Genome Sciences Inc., a GSK Company
Collaborator GlaxoSmithKline
Start date March 2013
End date January 2017
Trial size 100 participants
Trial identifier NCT01663623, 115466

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Placebo Comparator)
Placebo IV plus oral azathioprine 2 mg/kg/day; placebo administered on Days 0, 14, 28, and then every 28 days until the end of the study. If the results in the double-blind period show that belimumab is safe and effective, then participants have the option to receive treatment with belimumab in a 6-month open-label extension phase. Placebo patients who opt to participate in the extension will receive belimumab 10 mg/kg IV every 28 days plus oral azathioprine 2 mg/kg/day for an additional 6 months.
placebo
Placebo
azathioprine
Azathioprine
(Experimental)
Belimumab 10 mg/kg IV plus oral azathioprine 2 mg/kg/day; belimumab administered on Days 0, 14, 28, and then every 28 days until the end of the study. If the results in the double-blind period show that belimumab is safe and effective, then participants have the option to continue treatment with belimumab in a 6-month open-label extension phase. Patients who opt to participate in the extension will continue to receive belimumab 10 mg/kg IV every 28 plus oral azathioprine 2 mg/kg/day days for an additional 6 months.
belimumab 10 mg/kg BENLYSTA™
Belimumab 10 mg/kg
azathioprine
Azathioprine

Primary Outcomes

Measure
Time to first relapse
time frame: Approximately 3 years

Secondary Outcomes

Measure
Time to first major relapse
time frame: Approximately 3 years
Number of participants who experienced adverse events
time frame: Approximately 3 years

Eligibility Criteria

Male or female participants at least 18 years old.

Key Inclusion Criteria: - Clinical diagnosis Wegener's granulomatosis or microscopic polyangiitis by Chapel Hill criteria. - Disease flare in the past 26 weeks requiring treatment with high dose corticosteroids and 1 of the following medications: rituximab, oral cyclophosphamide OR IV cyclophosphamide. - Tested positive for anti-proteinase 3 (anti-PR3) or anti-myeloperoxidase (anti-MPO) antibodies at any time prior to enrollment. - Achieve remission no more than 26 weeks after first dose of induction treatment. Remission is defined as a Birmingham Vasculitis Activity (BVAS) score of 0 and receiving less than 10 mg/day of oral prednisone (or equivalent) on 2 consecutive visits 21 to 35 days apart. - Maintenance therapy on this study must start no more than 2 weeks after confirmation of remission. Key Exclusion Criteria: - Pregnant or nursing. - Receipt of a B cell targeted therapy (other than rituximab) at anytime - Receipt of an investigational biological agent within the past 60 days. - Required management of acute or chronic infections within the past 60 days. - Current drug or alcohol abuse or dependence. - Current or past positive test for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C. - History of severe allergic reaction to contrast agents or biological medicines.

Additional Information

Official title A Phase 3, Multi-Center, Multinational, Randomized, Double-Blind, Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) in Combination With Azathioprine for the Maintenance of Remission in Wegener's Granulomatosis and Microscopic Polyangiitis
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by GlaxoSmithKline.