Safety and Efficacy of SM934 Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus

• Register: ClinicalTrials.gov
• Last refreshed on: 6 November 2023
• Main ID: NCT03951259
• Date of registration: 14/05/2019
• Prospective Registration: Yes
• Primary sponsor: RenJi Hospital
• Public title: Safety and Efficacy of SM934 Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus
• Scientific title: A Randomised, Double-blind, Placebo-controlled, Phase 2 Study Evaluating the Safety and Efficacy of SM934 in Adult Subjects With Active Systemic Lupus Erythematosus
• Date of first enrolment: July 24, 2019
• Target sample size: 32
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT03951259
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

China

Contacts

• Name: Nan Shen, MD & PhD
• Affiliation: Shanghai Jiao Tong University School of Medicine affiliated Renji Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- Age: 18 to 70;

- Have a clinical diagnosis of SLE according to SLICC-2012 classification criteria;

- Have active SLE with SLEDAI-2k = 6;

- Have positive anti-nuclear antibody (ANA) test results;

- Are on a stable steroids treatment (equals to prednison more than 7.5mg daily but no
more than 0.5mg/kg/d) for SLE for at least 30 days prior to first dose of study agent;

- Females of childbearing age are willing to use appropriate contraception;

- Are voluntary to to provide and sign voluntary informed consent is given;

Exclusion Criteria:

- Have any unstable or progressive manifestation of SLE, including but not limited to
Central nervous system (CNS) involvement, transverse myelitis, systemic vasculitis,
vasculitis with GI involvement, severe or rapidly progressive lupus nephritis, lupus
nephritis with proteinuria > 3g/24h, pulmonary hemorrhage, myocarditis;

- Have abnormal liver function test or renal function test: Alanine
aminotransferase(ALT)or aspartate aminotransferase (AST) >2 upper limit of normal
(ULN); Gamma-glutamyl transferase (GGT) >1.5 ULN; Creatinine or Blood urea nitrogen
(BUN) >1.5 ULN;

- Have a history of acute myocardiac infarction, unstable angina, severe arrhythmias
within 6 months prior to first dose of study agent;

- Have any major illness/condition or evidence of an unstable clinical condition not due
to SLE (eg, cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal,
psychiatric), which, in the Investigator's judgment, will substantially increase the
risk to the participant if he or she participates in the study;

- Have any acute or chronic infectious disease, which requires medical intervention;

- Have a history of cancer within the last 5 years, except for adequately treated skin
cancer, or carcinoma in situ of the uterine cervix;

- Have a planned surgical procedure;

- Have received a biologic investigational agent in the past one year;

- Have received the following treatment within 30 days prior to first dose of study
agent: live vaccine; change of glucocorticoids dose; IV, intra-muscular (IM),
intra-articular (IA) administration of glucocorticoids; other
immunosuppressants/immunomodulators; anti-malarial drugs; traditional medicines which
has proved to be effective in SLE;

- Have had a major organ transplant;

- Have a history of HIV, or test positive at screening for HIV;

- Test positive for Hepatitis B virus (HBV)-DNA or Hepatitis C virus (HCV)-RNA;

- Have or have had a substance abuse (drug, alcohol) problem in the past one year;

- Are currently using or planned to use estrogen-containing contraceptive methods;

- Have enrolled in an investigational study within 3 months prior to first dose of study
agent;

- Investigator considers candidates not appropriating for the study.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Intervention(s)

Drug: Placebos

Drug: SM934

Primary Outcome(s)

Percentage of Subjects with Systemic Lupus Erythematosus Responder Index - 4 (SRI-4) response in each group [Time Frame: Week 12]

Percentage of Subjects with Lupus Low Disease Activity Score (LLDAS) in each group [Time Frame: Week 12]

Percentage of Subjects with Treatment-Emergent Adverse Events (TEAEs) in each group [Time Frame: Baseline through Week 13]

Secondary Outcome(s)

Percentage of subjects and number of days with steroids dose equal or less to prednisone 7.5mg per day [Time Frame: Week 12]

Percentage change of complement 3 (C3) and complement 4 (C4) from baseline in each group [Time Frame: Week 12]

Change of SLICC/ACR from baseline [Time Frame: Week 12]

Percentage change of anti-dsDNA level from baseline in each group [Time Frame: Week 12]

Percentage change of SLEDAI-2000 and Physician Global Assessment (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 [Time Frame: Week 12]

Percentage of subjects with Proteinuria < 0.5g/24h in each group [Time Frame: Week 12]

Time to SLE flare and Percentage of subjects with SLE flare [Time Frame: Baseline through week 12]

Secondary ID(s)

SM934

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Jiangsu ZuoYou Medicine Co., Ltd.