A PHASE 2B, MULTIDOSE, MULTICENTER, DOUBLE-BLIND, PLACEBOCONTROLLED, 24 WEEK STUDY TO EVALUATE THE EFFICACY AND SAFETY OF INTRAVENOUS INFUSION WITH RECOMBINANT HUMAN SOLUBLE FC-GAMMA IIB RECEPTOR SM101 IN SUBJECTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)
- Conditions
- -M32 Systemic lupus erythematosusSystemic lupus erythematosusM32
- Registration Number
- PER-050-16
- Lead Sponsor
- Baxalta Innovations GmbH,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 0
1.Male or female adult subjects 18-70 years of age at the time of Screening, who provide written informed consent prior to any study-related procedure.
2.Diagnosis of SLE by fulfilling at least 4 criteria of the ACR 1982 revised classification criteria and/or SLICC classification criteria for SLE during the course of their illness confirmed at the Screening visit.
3.Moderate to severe active SLE disease as defined by:
SLEDAI-2K score ≥ 6 and Clinical SLEDAI-2K score ≥ 4 at Screening AND
BILAG 2004 organ domain scores of ≥ 1A or ≥ 2B at Screening AND
Clinical SLEDAI-2K score ≥ 2 at Baseline (Day 1)
4.Positive test results for antinuclear antibodies (ANA) (human epithelial cell [Hep]-2 ANA ≥ 1:80) and at least 1 of the following (as confirmed by a central laboratory) at Screening:
dsDNA antibody OR
low complement C3 OR
positive Ro, La, ribonucleic protein (RNP), or Smith autoantibodies
5.If female of childbearing potential, subject presents with a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline and agrees to employ adequate birth control measures for the duration of the study.
6.Subject is willing and able to comply with the requirements of the protocol.
1. Use of immunosuppressant or antimalarial drugs inconsistent with the following allowance:
subjects are permitted to use only 1 of the immunosuppressive oral therapies at the allowed doses as in addition to an antimalarial (eg, hydroxychloroquine up to 400 mg/day OR chloroquine up to 250 mg/day):
•≤ 2 mg/kg/day AZA
•≤ 3 g/day MMF [or equivalent], or
•≤ 25 mg/week MTX
Doses of permitted immunosuppressant and/or antimalarial, if being used, must have been stable for 8 weeks prior to Screening with plan to remain stable during the study.
2. Subject has received the following immunosuppressive or immunomodulating treatments prior to Screening visit:
•Rituximab or ocrelizumab within 48 weeks
•Immunoglobulins (eg, intravenous immunoglobulin [IVIG]) within 16 weeks
•Belimumab within 12 weeks
•Tumor necrosis factor-alpha (TNF-) inhibitors within 12 weeks (including investigational biosimilars)
• Plasmapheresis within 12 weeks
•Cyclophosphamide and chlorambucil within 12 weeks
•Abatacept within 8 weeks
•Cyclosporine, tacrolimus, and any other immunosuppressant or immunomodulating drug not listed above or in exclusion criterion 1 within 8 weeks
3. Other investigational treatments within the last 3 months or 5 terminal half-lives, whichever is longest, prior to the Screening visit
4. Subjects changing or introducing oral corticosteroids > 20 mg/day within 4 weeks of the Screening visit (IV, IM, and IA corticosteroids are not permitted within 4 weeks of Screening, during Screening, or during the treatment period)
5. Active central nervous system SLE which, in the opinion of the Investigator or Sponsor, is
uncontrolled within 3 months of the Screening visit and/or leading to the incapacity of the subject to comply with consent and protocol requirements
6. Secondary antiphospholipid antibody syndrome associated with a thromboembolic event in the 12 months prior to or during Screening and/or associated with evidence of unstable or inadequate anticoagulation during Screening
7. Presence of other systemic rheumatic disease other than and not related to SLE (secondary Sjogren´s syndrome due to SLE is permitted)
8. Baseline chronic comorbidities (other than SLE) requiring systemic corticosteroid therapy within 6 months prior to the Screening visit, during Screening, and during the course of the study.
9. History of or positive HIV, hepatitis C antibody (unless polymerase chain reaction negative), HBsAg (+), and/or hepatitis B core total antibody (+) (HBV DNA negative which may be done if Hep B core IgG Ab positive and HBsAg negative) at Screening
10. History of incompletely treated or current diagnosis of active TB, or latent TB infection (LTBI), determined by a TB skin test with purified protein derivative as evidenced by induration ≥ 5 mm or a positive Quantiferon centrally or positive or borderline T-SPOT (Elispot) test performed locally, either at Screening or documented with results within 3 months of the Screening visit. Subjects who have previously completed appropriate and documented LTBI treatment will not be required to be tested
•Subjects with current household contacts with active TB will also be excluded unless treated and evidence of household contacts being treated
•Indeterminate Quantiferon or borderline T-SPOT tests may be repeated once, and will be considered positive if retest results ar
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method