This is a single-center, randomized, double-blind, placebo-controlled, phase 2 study. The purpose of the study is to initially evaluate the safety and efficacy of SM934 combined with steroids compared to placebo in adult subjects with active systemic lupus erythematosus (SLE) over a 12-week period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
32
Department of Rheumatology, RenJi Hospital, School of Medicine, Shanghai JiaoTong University
Shanghai, Shanghai Municipality, China
Percentage of Subjects with Lupus Low Disease Activity Score (LLDAS) in each group
LLDAS is defined as meeting the following criteria: 1. SLEDAI-2K ≤4, with no activity in major organ systems (renal, CNS, cardiopulmonary, vasculitis), and no reported fever, hemolytic anemia, or gastrointestinal activity) 2. No new disease activity compared with the previous assessment (no new British isles lupus assessment group (BILAG) A domain score or no more than 1 new BILAG B domain score) 3. PGA ≤1 on a 0-3 scale visual visual analogue scale (VAS) 4. A current prednisone (or equivalent) dose of ≤7.5 mg daily 5. Well-tolerated standard maintenance doses of permitted immunosuppressive drugs
Time frame: Week 12
Percentage of Subjects with Systemic Lupus Erythematosus Responder Index - 4 (SRI-4) response in each group
SRI-4 response is defined as: 1. ≥ 4-point reduction from baseline in SLEDAI-2K score 2. No new BILAG A and no more than 1 new BILAG B domain score 3. No worsening from baseline in the PGA (\<10% worsening from baseline).
Time frame: Week 12
Percentage of Subjects with Treatment-Emergent Adverse Events (TEAEs) in each group
Percentage of Subjects with TEAEs in each group
Time frame: Baseline through Week 13
Percentage change of SLEDAI-2000 and Physician Global Assessment (PGA) from baseline in each group
Percentage change of SLEDAI-2000 and PGA from baseline in each group
Time frame: Week 12
Percentage of Subjects with 30% improvement in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) score in each group
Percentage of subjects who have at least 30% improvement in CLASI score compared to baseline.
Time frame: Week 12
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Change of SLICC/ACR from baseline
Change of SLICC/ACR score from baseline
Time frame: Week 12
Percentage of subjects and number of days with steroids dose equal or less to prednisone 7.5mg per day
Percentage of subjects and number of days with steroids dose equal or less to prednisone 7.5mg per day
Time frame: Week 12
Percentage of subjects with Proteinuria < 0.5g/24h in each group
Percentage of subjects with 24hour urine protein level less than 0.5g in each group
Time frame: Week 12
Percentage change of complement 3 (C3) and complement 4 (C4) from baseline in each group
Percentage change of complement 3 (C3) and complement 4 (C4) from baseline in each group
Time frame: Week 12
Percentage change of anti-dsDNA level from baseline in each group
Percentage change of anti-dsDNA level from baseline in each group
Time frame: Week 12
Time to SLE flare and Percentage of subjects with SLE flare
SLE flare is defined as: Compared to baseline, one new BILAG A or more than 1 new BILAG B domain score. Time to SLE flare is defined as the date of SLE flare minus the date of treatment initiation plus one.
Time frame: Baseline through week 12