DRKS00003248Not yet recruitingPhase 2
Phase IIa, 2:2:1 randomised, double-blind, placebo-controlled, parallel group, multi-centre clinical trial to investigate the safety, efficacy and pharmacokinetics of recombinant human soluble Fc-gamma receptor IIb (SM101) for intravenous application in the treatment of systemic lupus erythematosus (SLE) patients with or without a history of lupus nephritis - SMILE - SM101 in Lupus Erythematosus
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- SuppreMol GmbH
- Enrollment
- 50
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized controlled study
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 18 Years to one (—)
- Sex
- All
Inclusion Criteria
- •1. Patient has provided written informed consent prior to any study-related procedure
- •2. Male or female adult patients aged 18 years or older
- •3. Diagnosis of SLE meeting at least four revised main classification criteria of the ACR with or without a history of glomerulonephritis
- •4. Clinically active patients with a SELENA-SLEDAI score of = 6
- •5. Patients with a current serological active status (anti-dsDNA or C3)
- •6. Concurrent maintenance immunosuppressant SLE treatment (if any) with prednisone alone or in combination with either azathioprine or mycophenolate mofetil
- •7. Adequate liver function
Exclusion Criteria
- •1. Patient is intended to receive immunosuppressive SLE treatment other than listed in the inclusion criteria
- •2. Patients with proteinuria > 3.5 g/day at baseline or glomerular filtration rate (GFR) < 60 mL/min/1.73 m2
- •3. Patients with active SLE neurological disorders
- •4. Patients with an acute BILAG score defined as = 1 BILAG A score or = 2 BILAG B scores
- •5. History of class VI glomerulonephritis
- •6. Patients with non-lupus related renal disease such as microthrombotic disease associated with antiphospholipid syndrome
- •7. Patients with other acute infections
- •8. Patient received any B cell depleting therapy
Investigators
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