Efficacy and Safety of Belimumab in Black Race Patients With Systemic Lupus Erythematosus (SLE) (EMBRACE)

• Register: EUCTR
• Last refreshed on: 27 July 2020
• Main ID: EUCTR2011-005672-42-GB
• Date of registration: 27/03/2013
• Prospective Registration: Yes
• Primary sponsor: Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)
• Public title: Efficacy and Safety of Belimumab in Black Race Patients With Systemic Lupus Erythematosus (SLE) (EMBRACE)
• Scientific title: A Phase 3/4, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) in Adult Subjects of Black Race With Systemic Lupus Erythematosus (SLE) - EMBRACE
• Date of first enrolment: 11/06/2013
• Target sample size: 501
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-005672-42
• 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): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): yes

Countries of recruitment

Brazil, Colombia, France, Martinique, South Africa, United Kingdom, United States

Contacts

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

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

Key inclusion & exclusion criteria

Inclusion criteria:
• Black race.
• Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria.
• Active SLE disease.
• Autoantibody-positive.
• On stable SLE treatment regimen which may include corticosteroids (for example, prednisone), antimalarial (for example, hydroxychloroquine) and/or immunosuppressants (for example, azathioprine, methotrexate, mycophenolate).
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 491
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion criteria:
• Pregnant or nursing.
• Have received treatment with belimumab at any time
• Have received treatment with any other B cell targeted therapy (for example, rituximab) in the past year.
• Have received treatment with an investigational biological agent in the past year.
• Have received intravenous (IV) cyclophosphamide within the past 90 days.
• Have severe active lupus kidney disease.
• Have severe active central nervous system (CNS) lupus.
• Have required management of acute or chronic infections within the past 60 days.
• Have current drug or alcohol abuse or dependence.
• Tested positive for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
• Have a 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

Systemic Lupus Erythematosus (SLE)
MedDRA version: 19.1 Level: LLT Classification code 10025134 Term: Lupus erythematosus System Organ Class: 100000004859

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

Intervention(s)

Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion
Product Name: Belimumab
Product Code: L04AA26
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)

Main Objective: • To evaluate the efficacy of belimumab in adult SLE subjects of black race.
• To evaluate the safety and tolerability of belimumab in adult SLE subjects of black race.

Secondary Objective: N/A

Timepoint(s) of evaluation of this end point: 52 weeks

Primary end point(s): The primary efficacy endpoint is the systemic lupus erythematosus
responder index (SRI) response rate with the modified SLEDAI-2K
scoring for proteinuria at Week 52
A participant that has an SRI response has all 3 of the following:
• =4 point reduction from baseline in Safety of Estrogen in Lupus National Assessment SLE Disease Activity Index (SELENA SLEDAI) score (with the modified SLEDAI-2K scoring for proteinuria), AND
• No worsening (increase of <0.30 points from baseline) in Physician's Global Assessment (PGA), AND
• No new British Isles Lupus Assessment Group (BILAG) A organ domain score or 2 new BILAG B organ domain scores compared with baseline at the time of assessment (ie, at Week 52).

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Baseline to 52 weeks
Baseline, weeks 40 to 52
Up to 84 weeks

Secondary end point(s): • SRI response rate with the SELENA SLEDAI for scoring of proteinuria at
Week 52.
• Time to first severe flare (SLE Flare Index) with SLEDAI-2K and
SELENA SLEDAI as the SLEDAI criterion of the SFI.
• Reduction in prednisone
• Number of participants who experienced adverse events

Secondary ID(s)

HGS1006-C1112

NCT01632241

Source(s) of Monetary Support

Human Genome Sciences, Inc

GlaxoSmithKline Research & Development Ltd

Ethics review

Status: Approved
Approval date: 11/06/2013
Contact:

Results

• Results available: Yes
• Date Posted: 03/07/2019
• Date Completed: 28/01/2019
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2011-005672-42/results