NCT01632241 (EMBRACE) is a Phase 4 clinical trial of Belimumab 10 mg/kg plus standard therapy in Systemic Lupus Erythematosus, sponsored by Human Genome Sciences Inc., a GSK Company.

Who is sponsoring NCT01632241?

NCT01632241 is sponsored by Human Genome Sciences Inc., a GSK Company.

What drugs are being tested in NCT01632241?

Interventions in NCT01632241: Placebo plus standard therapy, Belimumab 10 mg/kg plus standard therapy, Standard therapy.

What condition does NCT01632241 study?

NCT01632241 studies Systemic Lupus Erythematosus.

Is NCT01632241 still recruiting?

NCT01632241 is currently completed. Last updated 8 September 2021.

Are results published for NCT01632241?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-09-08 · How we verify

NCT01632241: EMBRACE

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 4 Results posted Last updated 8 September 2021

What this trial tests

Phase 4 trial testing Placebo plus standard therapy in Systemic Lupus Erythematosus in 503 participants. Completed in 28 January 2019.

Timeline

19 February 2013

Primary endpoint
18 June 2018

28 January 2019

Quick facts

Lead sponsor	Human Genome Sciences Inc., a GSK Company
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	503
Start date	19 February 2013
Primary completion	18 June 2018
Estimated completion	28 January 2019
Sites	96 locations across France, Colombia, South Africa, United Kingdom, United States, Brazil

Drugs / interventions tested

Placebo plus standard therapy — full drug profile →
Belimumab 10 mg/kg plus standard therapy — full drug profile →
Standard therapy — full drug profile →

Conditions studied

Systemic Lupus Erythematosus — all drugs for Systemic Lupus Erythematosus →

Sponsor

Human Genome Sciences Inc., a GSK Company — full company profile →

Who can join

18 and older, any sex, with Systemic Lupus Erythematosus. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index (SRI) Response Rate With the Modified Systemic Lupus Erythematosus Disease Activity Index- 2K (SLEDAI-2K) Scoring for Proteinuria at Week 52 [DB Phase] Primary · Week 52

SRI response is defined as \>=4 point reduction, from Baseline in safety of estrogen in Lupus National Assessment(SELENA)SLEDAI\[SS\] score (with modified SLEDAI-2K scoring for proteinuria \[PU\]), no worsening (increase of \<0.30 points from Baseline) in Physician's Global Assessment (PGA) and no new British Isles Lupus Assessment Group of SLE clinics(BILAG)A organ domain score \[ODS\] or 2 new BILAG B ODS compared with Baseline. Drop-outs and treatment failures were set to non-responders. Analysis performed using a logistic regression model for comparison between belimumab and placebo with c

Group	Value	95% CI
Placebo (DB Phase)	41.6
Belimumab 10 mg/kg (DB Phase)	48.7

Percentage of Participants Achieving a SRI Response Rate With the Modified SLEDAI-2K Scoring for Proteinuria at Week 24 of OL Phase Primary · Week 24 of OL phase (Week 76)

SRI response is defined as \>=4 point reduction, from OL Baseline in SS score (with the modified SLEDAI-2K scoring for PU), no worsening (increase of \<0.30 points from OL Baseline) in PGA and no new BILAG A ODS or 2 new BILAG B ODS compared with OL Baseline. For participants switching from placebo to belimumab 10 mg/kg IV in the OL phase, Baseline was defined as the last assessment at the end of the double-blind phase (i.e. Week 52) pre-OL treatment. For participants that received belimumab 10 mg/kg IV during the double-blind phase and continued to receive belimumab 10 mg/kg IV during the OL

Group	Value	95% CI
Placebo to Belimumab 10 mg/kg (OL Phase)	18.8
Belimumab 10 mg/kg to Belimumab 10 mg/kg (OL Phase)	73.6

Number of Participants With Non-serious Adverse Events (nSAEs) and Serious Adverse Event (SAEs) [OL Phase] Primary · Week 52 to Week 84

An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician, is associated with liver injury and impaired liver function. Number of participants who had common nSAEs (\>

nSAEs

Group	Value	95% CI
Placebo to Belimumab 10 mg/kg (OL Phase)	23
Belimumab 10 mg/kg to Belimumab 10 mg/kg (OL Phase)	49

SAEs

Group	Value	95% CI
Placebo to Belimumab 10 mg/kg (OL Phase)	6
Belimumab 10 mg/kg to Belimumab 10 mg/kg (OL Phase)	13

Number of Participants With Severe AEs [OL Phase] Primary · Week 52 to Week 84

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants with severe AEs have been presented. For Safety, participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84).

Group	Value	95% CI
Placebo to Belimumab 10 mg/kg (OL Phase)	10
Belimumab 10 mg/kg to Belimumab 10 mg/kg (OL Phase)	9

Number of Participants With AEs Leading to Treatment Discontinuation [OL Phase] Primary · Week 52 to Week 84

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants with AEs leading to treatment discontinuation have been presented. For Safety, participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84).

Group	Value	95% CI
Placebo to Belimumab 10 mg/kg (OL Phase)	1
Belimumab 10 mg/kg to Belimumab 10 mg/kg (OL Phase)	0

Number of Participants With Worst Toxicity Grade 3 or 4 for Hematology Parameters [OL Phase] Primary · Week 52 to Week 84

Blood samples were collected for the assessment of hematology parameters. The parameters assessed were activated partial thromboplastin time (APTT), hemoglobin, leukocytes, neutrophils, platelets and prothrombin time. Grading was assigned as mild (Grade 1), moderate (grade 2), severe (Grade 3) and potentially life-threatening (Grade 4) according to Division of Microbiology and Infectious Diseases (DMID \[Modified from DMID Adult Toxicity Tables, 2001\]) AE Severity Grading. Number of participants with worst toxicity Grade 3 or 4 for hematology parameters have been presented. For Safety, partic

APTT, Grade 3, n=93,203

Group	Value	95% CI
Placebo to Belimumab 10 mg/kg (OL Phase)	0
Belimumab 10 mg/kg to Belimumab 10 mg/kg (OL Phase)	1

APTT, Grade 4, n=93,203

Group	Value	95% CI
Placebo to Belimumab 10 mg/kg (OL Phase)	0
Belimumab 10 mg/kg to Belimumab 10 mg/kg (OL Phase)	0

Hemoglobin, Grade 3, n=115,235

Group	Value	95% CI
Placebo to Belimumab 10 mg/kg (OL Phase)	4
Belimumab 10 mg/kg to Belimumab 10 mg/kg (OL Phase)	6

Hemoglobin, Grade 4, n=115,235

Group	Value	95% CI
Placebo to Belimumab 10 mg/kg (OL Phase)	0
Belimumab 10 mg/kg to Belimumab 10 mg/kg (OL Phase)	0

Leukocytes, Grade 3, n=114,235

Group	Value	95% CI
Placebo to Belimumab 10 mg/kg (OL Phase)	0
Belimumab 10 mg/kg to Belimumab 10 mg/kg (OL Phase)	6

Leukocytes, Grade 4, n=114,235

Group	Value	95% CI
Placebo to Belimumab 10 mg/kg (OL Phase)	0
Belimumab 10 mg/kg to Belimumab 10 mg/kg (OL Phase)	0

Neutrophils, Grade 3, n=114,234

Group	Value	95% CI
Placebo to Belimumab 10 mg/kg (OL Phase)	2
Belimumab 10 mg/kg to Belimumab 10 mg/kg (OL Phase)	6

Neutrophils, Grade 4, n=114,234

Group	Value	95% CI
Placebo to Belimumab 10 mg/kg (OL Phase)	0
Belimumab 10 mg/kg to Belimumab 10 mg/kg (OL Phase)	1

Number of Participants With Worst Toxicity Grade of 3 or 4 for Clinical Chemistry Parameters [OL Phase] Primary · Week 52 to Week 84

Blood samples were collected for the assessment of liver function and other chemistry parameters. The parameters assessed were alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma glutamyl transferase (GGT), bilirubin, albumin, creatinine, hyperglycemia, hypoglycemia and urate. Grading was assigned as mild (Grade 1), moderate (grade 2), severe (Grade 3) and potentially life-threatening (Grade 4) according to DMID AE Severity Grading. Number of participants with worst toxicity Grade of 3 or 4 for liver function and other chemistry parameters have b

ALP, Grade 3

Group	Value	95% CI
Placebo to Belimumab 10 mg/kg (OL Phase)	0
Belimumab 10 mg/kg to Belimumab 10 mg/kg (OL Phase)	0

ALP, Grade 4

Group	Value	95% CI
Placebo to Belimumab 10 mg/kg (OL Phase)	0
Belimumab 10 mg/kg to Belimumab 10 mg/kg (OL Phase)	0

ALT, Grade 3

Group	Value	95% CI
Placebo to Belimumab 10 mg/kg (OL Phase)	0
Belimumab 10 mg/kg to Belimumab 10 mg/kg (OL Phase)	0

ALT, Grade 4

Group	Value	95% CI
Placebo to Belimumab 10 mg/kg (OL Phase)	0
Belimumab 10 mg/kg to Belimumab 10 mg/kg (OL Phase)	0

AST, Grade 3

Group	Value	95% CI
Placebo to Belimumab 10 mg/kg (OL Phase)	0
Belimumab 10 mg/kg to Belimumab 10 mg/kg (OL Phase)	0

AST, Grade 4

Group	Value	95% CI
Placebo to Belimumab 10 mg/kg (OL Phase)	0
Belimumab 10 mg/kg to Belimumab 10 mg/kg (OL Phase)	0

Bilirubin, Grade 3

Group	Value	95% CI
Placebo to Belimumab 10 mg/kg (OL Phase)	0
Belimumab 10 mg/kg to Belimumab 10 mg/kg (OL Phase)	0

Bilirubin, Grade 4

Group	Value	95% CI
Placebo to Belimumab 10 mg/kg (OL Phase)	0
Belimumab 10 mg/kg to Belimumab 10 mg/kg (OL Phase)	0

Number of Participants With Worst Toxicity Grade of 3 or 4 for Urinalysis Parameters [OL Phase] Primary · Week 52 to Week 84

Urinalysis parameters assessed were urine protein and protein/creatinine. Urine samples were collected for the measurement of urinalysis parameters by dipstick method. Grading was assigned as mild (Grade 1), moderate (grade 2), severe (Grade 3) and potentially life-threatening (Grade 4) according to DMID AE Severity Grading. Number of participants with worst toxicity grade of 3 or 4 for urinalysis parameters have been presented. For Safety, participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84).

Protein, Grade 3, n=115, 234

Group	Value	95% CI
Placebo to Belimumab 10 mg/kg (OL Phase)	0
Belimumab 10 mg/kg to Belimumab 10 mg/kg (OL Phase)	0

Protein, Grade 4, n=115,234

Group	Value	95% CI
Placebo to Belimumab 10 mg/kg (OL Phase)	0
Belimumab 10 mg/kg to Belimumab 10 mg/kg (OL Phase)	0

Protein/Creatinine, Grade 3,n=112,227

Group	Value	95% CI
Placebo to Belimumab 10 mg/kg (OL Phase)	5
Belimumab 10 mg/kg to Belimumab 10 mg/kg (OL Phase)	5

Protein/Creatinine, Grade 4, n=112,227

Group	Value	95% CI
Placebo to Belimumab 10 mg/kg (OL Phase)	3
Belimumab 10 mg/kg to Belimumab 10 mg/kg (OL Phase)	0

Number of Participants With Worst Toxicity Grade of 3 or 4 of Immunoglobulins [OL Phase] Primary · Week 52 to Week 84

Serum samples were obtained for the measurement of immunoglobulin G. Grading was assigned as mild (Grade 1), moderate (grade 2), severe (Grade 3) and potentially life threatening (Grade 4) according to DMID AE Severity Grading. Number of participants with worst toxicity grade of 3 or 4 of immunoglobulin G have been presented. For Safety, participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84).

Grade 3

Group	Value	95% CI
Placebo to Belimumab 10 mg/kg (OL Phase)	0
Belimumab 10 mg/kg to Belimumab 10 mg/kg (OL Phase)	1

Grade 4

Group	Value	95% CI
Placebo to Belimumab 10 mg/kg (OL Phase)	0
Belimumab 10 mg/kg to Belimumab 10 mg/kg (OL Phase)	0

Percentage of Participants Achieving SRI-SS Response Rate at Week 52 [DB Phase] Secondary · Week 52

SRI is defined as \>=4 point reduction, from Baseline in SS score, no worsening (increase of \<0.30 points from Baseline) in PGA and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with Baseline. Drop-outs and Treatment failures were set to non-responders. Analysis was performed using a logistic regression model for the comparison between belimumab and placebo with covariates treatment group, Baseline SS score (\<=9 vs. \>=10), Baseline complement levels (low C3 and/or C4 vs. no low C3 or C4) and region (US/Canada vs. Rest of World).

Group	Value	95% CI
Placebo (DB Phase)	41.6
Belimumab 10 mg/kg (DB Phase)	49.0

Percentage of Participants Achieving SRI-SS Response Rate With the SELENA SLEDAI for Scoring of Proteinuria at Week 24 of OL Phase Secondary · Week 24 of OL phase (Week 76)

SRI response is defined as \>=4 point reduction, from OL Baseline in SS scoring for PU, no worsening (increase of \<0.30 points from OL Baseline) in PGA and no new BILAG A ODS or 2 new BILAG B ODS compared with OL Baseline. For participants switching from placebo to belimumab 10 mg/kg IV in the open-label phase, Baseline was defined as the last assessment at the end of the double-blind phase (i.e. Week 52) pre-OL treatment. For participants that received belimumab 10 mg/kg IV during the double-blind phase and continued to receive belimumab 10 mg/kg IV during the open-label phase, Baseline was

Group	Value	95% CI
Placebo to Belimumab 10 mg/kg (OL Phase)	19.4
Belimumab 10 mg/kg to Belimumab 10 mg/kg (OL Phase)	73.1

Time to First Severe Flare (as Measured by the Modified SLE Flare Index) up to 52 Weeks [DB Phase] Secondary · Up to 52 Weeks

Time to first severe SLE flare is defined as the number of days from treatment start date until the participant met an event (event date - treatment start date +1). Analyses of severe SLE flare was performed on modified SS SLE flare index that excludes severe flares (SF) that were triggered only by an increase in SS score to \>12 (this may only represent a modest increase in disease activity). Treatment failures were imputed as SF. For participants who died, data were censored at date of death if no SF occurred before death. Only post-Baseline SF were considered. Analysis was performed using C

Group	Value	95% CI
Placebo (DB Phase)	NA	346 – NA
Belimumab 10 mg/kg (DB Phase)	NA	NA – NA

Adverse events — posted to ClinicalTrials.gov

Time frame: nSAEs and SAEs were collected from the start of study treatment up to Week 52 for Double Blind phase and from Week 52 to Week 84 for the Open Label phase. Participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo (DB Phase)

Serious: 31/165 (19%)

Deaths: 0/165

Belimumab 10 mg/kg (DB Phase)

Serious: 36/331 (11%)

Deaths: 2/331

Placebo to Belimumab 10 mg/kg (OL Phase)

Serious: 6/117 (5%)

Deaths: 0/117

Belimumab 10 mg/kg to Belimumab 10 mg/kg (OL Phase)

Serious: 13/242 (5%)

Deaths: 0/242

Serious adverse events (107 terms)

Reaction	System	Placebo (DB Phase)	Belimumab 10 mg/kg (DB Pha…	Placebo to Belimumab 10 mg…	Belimumab 10 mg/kg to Beli…
Pneumonia	Infections and infestations	—	—	—	—
Systemic lupus erythematosus	Musculoskeletal and connective tissue disorders	—	—	—	—
Pericarditis	Cardiac disorders	—	—	—	—
Lupus nephritis	Renal and urinary disorders	—	—	—	—
SLE arthritis	Musculoskeletal and connective tissue disorders	—	—	—	—
Costochondritis	Musculoskeletal and connective tissue disorders	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Muscular weakness	Musculoskeletal and connective tissue disorders	—	—	—	—
Non-cardiac chest pain	General disorders	—	—	—	—
Pleurisy	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	—	—	—	—
Asthma	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Cellulitis	Infections and infestations	—	—	—	—
Lupus pneumonitis	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Pyrexia	General disorders	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—
Accidental overdose	Injury, poisoning and procedural complications	—	—	—	—
Acute kidney injury	Renal and urinary disorders	—	—	—	—
Acute myocardial infarction	Cardiac disorders	—	—	—	—
Amoebic colitis	Infections and infestations	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—
Appendicitis	Infections and infestations	—	—	—	—
Arthritis	Musculoskeletal and connective tissue disorders	—	—	—	—
Arthritis gonococcal	Infections and infestations	—	—	—	—

Other adverse events (13 terms — click to expand)

Reaction	System	Placebo (DB Phase)	Belimumab 10 mg/kg (DB Pha…	Placebo to Belimumab 10 mg…	Belimumab 10 mg/kg to Beli…
Upper respiratory tract infection	Infections and infestations	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—
Headache	Nervous system disorders	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—
Influenza	Infections and infestations	—	—	—	—
Sinusitis	Infections and infestations	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—
Insomnia	Psychiatric disorders	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—
Depression	Psychiatric disorders	—	—	—	—

Most-reported serious reactions: Pneumonia, Systemic lupus erythematosus, Pericarditis, Lupus nephritis, SLE arthritis, Costochondritis, Dyspnoea, Muscular weakness.

Data from ClinicalTrials.gov NCT01632241 adverse events section.

Sponsor's own description

The purpose of this study is to evaluate the efficacy, safety, and tolerability of belimumab in adult patients of black race with systemic lupus erythematosus (SLE; lupus).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

The BAFF/APRIL system: emerging functions beyond B cell biology and autoimmunity.
Vincent FB, Saulep-Easton D, Figgett WA, Fairfax KA, et al · · 2013 · cited 333× · PMID 23684423 · DOI 10.1016/j.cytogfr.2013.04.003
Phase III/IV, Randomized, Fifty-Two-Week Study of the Efficacy and Safety of Belimumab in Patients of Black African Ancestry With Systemic Lupus Erythematosus.
Ginzler E, Guedes Barbosa LS, D'Cruz D, Furie R, et al · · 2022 · cited 80× · PMID 34164944 · DOI 10.1002/art.41900
B-cell targeted therapeutics in clinical development.
Blüml S, McKeever K, Ettinger R, Smolen J, et al · · 2013 · cited 74× · PMID 23566679 · DOI 10.1186/ar3906
A critical review of clinical trials in systemic lupus erythematosus.
Mahieu MA, Strand V, Simon LS, Lipsky PE, et al · · 2016 · cited 57× · PMID 27497257 · DOI 10.1177/0961203316652492
Systemic lupus erythematosus biomarkers: the challenging quest.
Arriens C, Wren JD, Munroe ME, Mohan C. · · 2017 · cited 52× · PMID 28013203 · DOI 10.1093/rheumatology/kew407
Research and therapeutics-traditional and emerging therapies in systemic lupus erythematosus.
Davis LS, Reimold AM. · · 2017 · cited 37× · PMID 28375452 · DOI 10.1093/rheumatology/kew417
Current and emerging treatment options for ANCA-associated vasculitis: potential role of belimumab and other BAFF/APRIL targeting agents.
Lenert A, Lenert P. · · 2015 · cited 28× · PMID 25609919 · DOI 10.2147/dddt.s67264
Belimumab in systemic lupus erythematosus (SLE): evidence-to-date and clinical usefulness.
Guerreiro Castro S, Isenberg DA. · · 2017 · cited 26× · PMID 28344669 · DOI 10.1177/1759720x17690474

Verify or expand the search:

Other trials of Belimumab 10 mg/kg plus standard therapy

Trials testing the same drug.

NCT01705977 — Belimumab Assessment of Safety in SLE · Phase 4 · completed
NCT01639339 — Efficacy and Safety of Belimumab in Patients With Active Lupus Nephritis · Phase 3 · completed

Other recruiting trials for Systemic Lupus Erythematosus

Currently open trials in the same condition.

NCT06984341 — A Study to Evaluate the Safety, Tolerability, Cellular Kinetics, Pharmacodynamics, and Efficacy of P-CD19CD20-ALLO1 in P · Phase 1 · recruiting
NCT07526350 — MTS109 in Patients With Refractory Autoimmune Diseases · EARLY_PHASE1 · recruiting
NCT07246096 — Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19/BCMA U CAR-T Cell Injection for the Treatment of Rel · EARLY_PHASE1 · recruiting
NCT07363590 — A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004) · Phase 1 · recruiting
NCT07371468 — A Study of GSK5926371 in Participants With B-cell Driven Autoimmune Rheumatic Diseases (ARD) · Phase 1 · recruiting

Other Human Genome Sciences Inc., a GSK Company trials

Trials by the same sponsor.

NCT01663623 — Belimumab in Remission of VASculitis · Phase 3 · completed
NCT01639339 — Efficacy and Safety of Belimumab in Patients With Active Lupus Nephritis · Phase 3 · completed
NCT01597492 — A Study to Evaluate the Effect of Belimumab on Vaccine Responses in Subjects With Systemic Lupus Erythematosus (SLE) · Phase 4 · completed
NCT01484496 — A Study of Belimumab Administered Subcutaneously in Subjects With Systemic Lupus Erythematosus (SLE) · Phase 3 · completed
NCT01258608 — Study of Mapatumumab in Combination With Sorafenib in Subjects With Advanced Hepatocellular Carcinoma · Phase 1, PHASE2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01632241 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Human Genome Sciences Inc., a GSK Company
Last refreshed: 8 September 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01632241.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing