Belimumab in Remission of Vasculitis

• Register: EUCTR
• Last refreshed on: 3 April 2017
• Main ID: EUCTR2011-004569-33-BE
• Date of registration: 21/11/2012
• Prospective Registration: Yes
• Primary sponsor: Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)
• Public title: Belimumab in Remission of Vasculitis
• Scientific title: A 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 - BREVAS
• Date of first enrolment: 23/01/2013
• Target sample size: 100
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-004569-33
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Australia, Austria, Belgium, Canada, Czech Republic, Finland, France, Germany, Hungary, India, Ireland, Italy, Mexico, Peru, Poland, Romania, Russian Federation, Spain, Sweden, Switzerland, United Kingdom, United States

Contacts

• Name: Clinical Trials Helpdesk
• Affiliation: GlaxoSmithKline Research & Development Ltd

• Name: Clinical Trials Helpdesk
• Affiliation: GlaxoSmithKline Research & Development Ltd

Key inclusion & exclusion criteria

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 at least 14 days apart, between 6 and 26 weeks after the first dose of introduction therapy.
•Maintenance therapy on this study must start no more than 2 weeks after confirmation of remission.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 75
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

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 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 or abnormal liver function tests.
•History of severe allergic reaction to contrast agents or biological medicines.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Wegener’s granulomatosis (WG) Microscopic polyangiitis (MPA) Vasculitis
MedDRA version: 18.0 Level: LLT Classification code 10047888 Term: Wegener's granulomatosis System Organ Class: 10047065 - Vascular disorders
MedDRA version: 18.0 Level: PT Classification code 10063344 Term: Microscopic polyangiitis System Organ Class: 10047065 - Vascular disorders

Intervention(s)

Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion
Product Name: Belimumab
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: BELIMUMAB
CAS Number: 356547-88-1
Other descriptive name: Benlysta
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 400-
Pharmaceutical form of the placebo: Powder for concentrate for solution for infusion
Route of administration of the placebo: Intravenous use

Primary Outcome(s)

Primary end point(s): The primary efficacy endpoint is time from Day 0 to the first relapse, defined as:
•At least 1 major BVAS item OR
•A minimum total BVAS score of 6 OR
•Receipt of protocol prohibited medications.

Secondary Objective: NA

Main Objective: •To evaluate the efficacy of belimumab in the maintenance of remission following a standard induction regimen in subjects with Wegener’s granulomatosis (WG) or microscopic polyangiitis (MPA).
•To evaluate the safety of belimumab in subjects with WG or MPA.

Timepoint(s) of evaluation of this end point: 12 months have elapsed after the last subject is randomised

Secondary Outcome(s)

Secondary end point(s): Time from Day 0 to the first major relapse (defined as experiencing at least 1 major BVAS item)

Timepoint(s) of evaluation of this end point: 12 months have elapsed after the last subject is randomised

Secondary ID(s)

NCT01663623

HGS1006-C1100

2011-004569-33-GB

Source(s) of Monetary Support

GlaxoSmithKline Research & Development Limited

Human Genome Sciences, Inc. ( a wholly owned subsidiary of GlaxoSmithKline PLC)