Phase I Study of GSK1550188 in Japanese Subjects With Systemic Lupus Erythematosus (SLE)

NCT01381536 | Completed Phase 1

• 1 other identifier: 114243
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of GSK1550188 in Japanese subjects with Systemic Lupus Erythematosus (SLE).

Conditions

Systemic Lupus Erythematosus

Keywords

Anti Blys Antibody

Outcome Measures

Primary Outcomes (1)

• To evaluate the safety, tolerability

  Number of subjects with adverse events (AE) as meaasure of safety and tolerability

  For 84 days

Secondary Outcomes (1)

• To evaluate pharmacokinetics and pharmacodynamics

  84days

Study Arms (1)

GSK1550188 1mg/kg or 10mg/kg

EXPERIMENTAL

one shot IV

Drug: GSK1550188 1mg/kg or 10mg/kg

Interventions

GSK1550188 1mg/kg or 10mg/kg DRUG

IV one shot

GSK1550188 1mg/kg or 10mg/kg

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who gave consent to this study participation and signed into informed consent form.
• Subjects who are at least 20 years of age at Screening visit.
• Have a clinical diagnosis of Systemic Lupus Erythematosus (SLE) according to the American College of Rheumatology (ACR) classification criteria, with 4 or more of the 11 ACR criteria present, serially or simultaneously during any interval or observation.
• Be on either no SLE medication or a stable SLE treatment regimen of any medication (e.g., low-dose prednisone, NSAIDs; alone or in combination) for a period of at least 2 months prior to the Screening visit.
• Males and females. A female subject is eligible to enter the study if at least one of the following conditions apply:
• Not pregnant or nursing;
• Of non-childbearing potential (ie, women who had a hysterectomy, are postmenopausal which is defined as 1 year without menses, have both ovaries surgically removed or have current documented tubal ligation); or
• Of childbearing potential (ie, women with functional ovaries and no documented impairment of oviductal or uterine function that would cause sterility). This category includes women with oligomenorrhoea \[even severe\], women who are perimenopausal or have just begun to menstruate. These women must have a negative serum pregnancy test at screening, and agree to 1 of the following:
• Complete abstinence from penile-vaginal intercourse, when this is the female's preferred and usual lifestyle, from 2 weeks prior to administration of the 1st dose of investigational product until 8 weeks after the last dose of investigational product; or
• Consistent and correct use of 1 of the following acceptable methods of birth control for 1 month prior to the start of the investigational product and for 8 weeks after the last dose of investigational product:
• Implants of etonogestrel or levonorgestrel;
• Estrogenic vaginal ring
• Injectable progesterone
• Any intrauterine device (IUD) or intrauterine system (IUS) with a documented failure rate of less than 1% per year
• Oral contraceptives (either combined or progesterone only)

You may not qualify if:

• Active lupus nephritis requiring hemodialysis, intravenous cyclophosphamide (Cytoxan),or high-dose prednisone (\>60 mg/day) within 6 months prior to the Screening visit
• The subject has severe lupus kidney disease (defined by proteinuria \> 6 g/day) within 6 months prior to the Screening visit.
• Received IVIG or plasmapheresis within 6 months prior to Screening visit
• Active CNS lupus \[including seizures, psychosis, organic brain syndrome, cerebrovascular accident (CVA), motor neuropathy, vasculitis\] requiring medical intervention within 6 months prior to Screening visit
• The subject has hypogammaglobulinemia or IgA deficiency (IgA level \< 10 mg/dL)
• History of renal transplant
• History or clinical evidence of active significant acute or chronic diseases (i.e., cardiovascular, pulmonary, untreated hypertension, anemia, gastrointestinal, hepatic, renal, neurological, cancer, or infectious diseases) which, in the opinion of the investigator, could confound the results of the study or put the subject at undue risk
• History of any other medical disease, laboratory abnormalities, or conditions which would make the subject (in the opinion of the Investigator) unsuitable for the study
• History of any infection requiring hospitalization or parenteral antibiotics within 4 weeks prior to Screening visit
• The subject has an abnormality on 12-lead ECG at screening which is clinically significant in the opinion of the investigator.
• The subject is currently participating in another clinical study or post-marketing study in which the subject is or will be exposed to an investigational agent.
• The subject has received a biologic investigational and non-investigational agent within 12 months prior to the dosing day.
• The subject has received a non-biologic investigational agent within 2 months prior to the dosing day.
• Have evidence of current drug or alcohol abuse or dependence.
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) 2x upper limit of normal (ULN); alkaline phosphatase and bilirubin \>1.5xULN (isolated bilirubin \>1.5ULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%).

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (2)

GSK Investigational Site

Fukuoka, 812-0025, Japan

Location

GSK Investigational Site

Miyagi, 982-0032, Japan

Location

Related Publications (1)

• Yamada M, Akita M, Nakagawa T, Takahashi N, Endo A, Yoshida P. Safety, tolerability, pharmacokinetics and pharmacodynamics of belimumab in Japanese patients with mild-to-moderate systemic lupus erythematosus. J Drug Assess. 2013 Apr 12;2(1):40-8. doi: 10.3109/21556660.2013.792823. eCollection 2013.

  PMID: 27536436 BACKGROUND

Related Links

• Results for study 114243 can be found on the GSK Clinical Study Register.
• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

belimumab

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2011
• First Posted: June 27, 2011
• Study Start: July 20, 2010
• Primary Completion: November 27, 2010
• Study Completion: November 27, 2010
• Last Updated: June 12, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share

Locations

JP (2)