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Systemic Lupus ErythematosusPhase 1NCT01381536

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

A Phase 1 study testing GSK1550188 1mg/kg or 10mg/kg in people with Systemic Lupus Erythematosus, run by GlaxoSmithKline at 2 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Systemic Lupus Erythematosus
What is being tested?
GSK1550188 1mg/kg or 10mg/kg
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
2 sitesJapan
Study dates
20 Jul 2010to 27 Nov 2010
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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

Who cannot join

  • 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
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  • 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 locations and contacts

2 sites in 1 country.

Japan2 sites

  • GSK Investigational Site

    Fukuoka, 812-0025

  • GSK Investigational Site

    Miyagi, 982-0032

Other trials in Japan

About this study

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)

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).

Being tested
GSK1550188 1mg/kg or 10mg/kg
Keywords
Anti Blys Antibody
Medical subject headings
Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GSK1550188 1mg/kg or 10mg/kgDrug

    IV one shot

Study groups in NCT01381536
Study groupRoleWhat they receive
GSK1550188 1mg/kg or 10mg/kgExperimentalone shot IV
Receives: Drug: GSK1550188 1mg/kg or 10mg/kg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To evaluate the safety, tolerability

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

    Measured: For 84 days

Secondary outcomes (1)

  1. To evaluate pharmacokinetics and pharmacodynamics

    Serum concentrations of GSK1550188 and derived PK parameters for phamacokinetics, Immunoglobulins (IgG, IgM and IgA), complement (C3, C4), CH50, autoantibodies (anti-double stranded deoxyribonucleic acid [dsDNA] and anti-nuclear antibody [ANA]), B cell subsets (CD20+, CD20+/27+ memory, CD20+/27-naïve, CD20+/69+ activated, CD20+/138+ plasmacytoid, CD19+/27BRIGHT/38BRIGHT SLE subset and CD20-/138+ plasma cells), anti-belimumab antibody, BLyS protein, and Safety of Estrogen in Lupus National Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA SLEDAI) score

    Measured: 84days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2011 (estimated)
  2. Study start20 Jul 2010
  3. Primary completion27 Nov 2010
  4. Study completion27 Nov 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Participant
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01381536
Sponsor's protocol ID
114243
Status last verified
Jun 2017
First submitted
21 Apr 2011
Last updated
12 Jun 2017
Results posted
No
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

  • 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.

    PubMed 27536436

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GSK1550188 1mg/kg or 10mg/kg in people with Systemic Lupus Erythematosus, run by GlaxoSmithKline at 2 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate the safety, tolerability (time frame: For 84 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01381536, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2017.

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