A Phase 2B Open-Label, Single-Arm, Repeat-Dose Study to Evaluate the Reliability of an Autoinjector
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Intervention: Belimumab autoinjector
Intervention description: Single use, disposable autoinjector assembled with the prefilled syringe containing the drug product belimumab with unit dose strength of 200mg/mL and 1 mL will be given as a once weekly SC dose
Intervention MeSH terms: Belimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 95.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Subcutaneous; Autoinjector; Belimumab; Real-Life Use Study; Reliability

Summary:

      The primary objective of this study is to assess the suitability of the autoinjector for
      self-administration of belimumab by subjects with SLE in real-life conditions. The study will
      assess the use of the autoinjector inside the clinic setting and outside the clinic setting.
      The study will also assess the safety and tolerability of belimumab administered
      subcutaneously (SC) via the autoinjector. Subjects will self-administer belimumab SC into the
      thigh or abdomen using the autoinjector device for 8 weekly doses. Subjects will return for a
      follow-up visit 4 weeks after the last SC dose of belimumab. All injections will be assessed
      by the investigators for success based on direct observation and/or the subject diary. A
      total of 118 subjects (treated with at least one dose of study drug) are planned to be
      enrolled in this study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female aged at least 18 years at the time of signing the informed consent.

          -  Have a clinical diagnosis of SLE according to the American College of Rheumatology
             (ACR) criteria.

          -  Active, autoantibody positive SLE, defined as the presence of anti nuclear antibody
             (ANA) or anti-double strand deoxyribonucleic acid (dsDNA) antibodies (at screening or
             historically).

          -  Are on a SLE treatment regimen including intravenous (IV) belimumab every 28 days for
             at least three 28-day cycles. Day 0 (i.e., day of first dose of study agent) should be
             scheduled about 2 weeks after the last dose IV dose of belimumab but may be scheduled
             1 week and up to 4 weeks after the last IV dose.

          -  A female subject is eligible to participate if she is of: Non-childbearing potential
             defined as pre-menopausal females with a documented tubal ligation or hysterectomy
             (for this definition, "documented" refers to the outcome of the
             investigator's/designee's review of the subject's medical history for study
             eligibility, as obtained via a verbal interview with the subject or from the subject's
             medical records); or postmenopausal defined as 12 months of spontaneous amenorrhea (in
             questionable cases a blood sample with simultaneous follicle stimulating hormone [FSH]
             >40 milli international unit/milliliter [MIU/mL] and estradiol <40 picogram/mL [<147
             picomoles/Liter] is confirmatory). (Females on hormone replacement therapy [HRT] and
             whose menopausal status is in doubt will be required to use one of the contraception
             methods if they wish to continue their HRT during the study. Otherwise, they must
             discontinue HRT to allow confirmation of post-menopausal status prior to study
             enrollment. For most forms of HRT, at least 2 4 weeks will elapse between the
             cessation of therapy and the blood draw; this interval depends on the type and dosage
             of HRT. Following confirmation of their post-menopausal status, they can resume use of
             HRT during the study without use of a contraceptive method.); Child-bearing potential
             with negative pregnancy test as determined by serum human chorionic gonadotropin (hCG)
             test at screening and urine hCG test prior to dosing; Agrees to use one of the
             contraception methods for 2 weeks prior to the day of dosing to sufficiently minimize
             the risk of pregnancy at that point. Female subjects must agree to use contraception
             until Day 112; OR has only same-sex partners, when this is her preferred and usual
             lifestyle

          -  Alanine aminotransferase (ALT) <2x upper limit of normal (ULN), alkaline phosphatase
             and bilirubin <=1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is
             fractionated and direct bilirubin <35%).

          -  Capable of giving written informed consent, which includes compliance with the
             requirements and restrictions listed in the consent form.

        Exclusion Criteria:

          -  Have previously participated in a study of SC belimumab.

          -  Have received a live vaccine within 30 days of Day 0 or anticipate receipt of a live
             vaccine during the study or within 120 days after the last injection of study drug.

          -  Have received a non-biologic investigational agent within 60 days of Day 0.

          -  Have severe active central nervous system (CNS) lupus (including seizures, psychosis,
             organic brain syndrome, cerebrovascular accident (CVA), cerebritis or CNS vasculitis
             requiring therapeutic intervention within 60 days of Day 0.

          -  Have clinical evidence of significant unstable or uncontrolled acute or chronic
             diseases not due to SLE (i.e., cardiovascular, pulmonary, hematologic,
             gastrointestinal, hepatic, renal, neurological, malignancy, or infectious diseases)
             which, in the opinion of the principal investigator, could confound the results of the
             study or put the subject at undue risk.

          -  Have a planned surgical procedure

          -  History of any other medical disease (e.g., cardiopulmonary), laboratory abnormality,
             that, in the opinion of the investigator, makes the subject unsuitable for the study.

          -  Have required management of acute or chronic infections, as follows: Currently on any
             suppressive therapy for a chronic infection (such as tuberculosis, pneumocystis,
             cytomegalovirus, herpes simplex virus, herpes zoster, and atypical mycobacteria);
             Hospitalization for treatment of infection within 60 days of Day 0; Use of parenteral
             (IV or intramascular [IM]) antibiotics (antibacterials, antivirals, anti-fungals, or
             anti-parasitic agents) within 60 days of Day 0.

          -  History of or a positive test for human immuno virus (HIV) at Screening.

          -  A positive Hepatitis B surface antigen or Hepatitis B core antibody, or positive
             Hepatitis C antibody result within 3 months of Screening or positive at Screening.

          -  Have an Immunoglobulin A (IgA) deficiency (IgA level <10 milligrams/deciliter).

          -  Have a Grade 3 or greater laboratory abnormality based on the Adverse Event Severity
             Grading except for the following that are allowed: Stable Grade 3 prothrombin time
             (PT) secondary to warfarin treatment; Stable Grade 3 partial thromboplastin time (PTT)
             due to lupus anticoagulant and not related to liver disease or anti-coagulant therapy;
             Stable Grade 3/4 proteinuria (<=6 grams/24 hour equivalent by spot urine protein to
             creatinine ratio allowed); Stable Grade 3 hypoalbuminemia due to lupus nephritis, and
             not related to liver disease or malnutrition; Stable Grade 3 gamma glutamyl
             transferase (GGT) elevation due to lupus hepatitis, and not related to alcoholic liver
             disease, uncontrolled diabetes, or viral hepatitis. If present, any abnormalities in
             the ALT and/or aspartate aminotransferase (AST) must be<= Grade 2; Stable Grade 3
             neutropenia or stable Grade 3 white blood cell count. Note: All Grade 3 or greater
             laboratory abnormalities will be flagged in the laboratory report. Therefore the above
             exceptions will be determined by the Investigator and Medical Monitor.

          -  Have a history of an anaphylactic reaction to parenteral administration of contrast
             agents, human or murine proteins, or monoclonal antibodies

          -  Have evidence of serious suicide risk including any history of suicidal behavior in
             the last 6 months, or who in the investigator's opinion, pose a significant suicide
             risk

          -  Have current drug or alcohol abuse or dependence, or a history of drug or alcohol
             abuse or dependence within 364 days prior to Day 0

          -  Are unable to administer study agent by SC injection.

          -  In the opinion of the investigator, any subject who is unable to read and/or would not
             be able to complete a patient diary.