Last updated: 11/07/2018 07:30:28
Phase I study of GSK1550188 in Japanese subjects with Systemic Lupus Erythematosus (SLE)
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: GSK1550188, A randomised, single-blind, placebo controlled, dose ascending, single dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamic of GSK1550188 in Japanese subjects with Systemic Lupus Erythematosus (SLE)
Trial description: 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).
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
Single (Participant)
Allocation:
Randomized
Primary outcomes:
To evaluate the safety, tolerability
Timeframe: For 84 days
Secondary outcomes:
To evaluate pharmacokinetics and pharmacodynamics
Timeframe: 84days
Interventions:
Enrollment:
12
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Masanori Yamada, Mikio Akita, Tomofumi Nakagawa, Naoki Takahashi, Akira Endo and Pascal Yoshida. Safety, tolerability, pharmacokinetics and pharmacodynamics of belimumab in Japanese patients with systemic lupus erythematosus. J Drug Asses. 2013;
Medical condition
Systemic Lupus Erythematosus
Product
belimumab
Collaborators
Not applicable
Study date(s)
July 2010 to November 2010
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
20+ years
Accepts healthy volunteers
No
- 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.
- 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.
Inclusion and exclusion criteria
Inclusion criteria:
- 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)
- Double barrier method with vaginal spermicidal agent: Condom and an occlusive cap (cervical cap/vault or diaphragm) with a vaginal spermicidal agent (foam/gel/film/cream/suppository)
- Percutaneous contraceptive patch
- The subject is positive test for anti-nuclear antibody (ANA) or anti-dsDNA antibody in serum
Exclusion criteria:
- 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%).
- Have a historically positive HIV test or test positive at screening for HIV.
- History of, or positive test at Screening visit for any of HBsAg, anti-HBcAb or anti-HCVAb. If only anti-HBcAb result is positive, HBV-DNA test will be performed. If HBV-DNA results in negative, the patient is eligible.
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2010-27-11
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Participate in clinical trial
Additional information
Results for study 114243 can be found on the GSK Clinical Study Register.
Click hereResearchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Click hereAccess to clinical trial data by researchers
Visit website