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

NCT ID: NCT03951259

Last Updated: 2023-10-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-24
• Study Completion Date: 2023-10-19

Brief Summary

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.

Conditions

Systemic Lupus Erythematosus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

SM934 10mg

SM934 10mg（1 tablet）+Placebo（4 tablets）p.o. qd in combination with steroids

Group Type: EXPERIMENTAL

SM934

Intervention Type: DRUG

In this study, the investigating intervention is oral administration of SM934. SM934 is a water-soluble derivative of arteminisin, which exerts immunosuppressive functions in vitro and in vivo.

SM934 30mg

SM934 10mg（3 tablet）+ Placebo（2 tablets）p.o. qd in combination with steroids

Group Type: EXPERIMENTAL

SM934

Intervention Type: DRUG

In this study, the investigating intervention is oral administration of SM934. SM934 is a water-soluble derivative of arteminisin, which exerts immunosuppressive functions in vitro and in vivo.

SM934 50mg

SM934 10mg（5 tablet）p.o. qd in combination with steroids

Group Type: EXPERIMENTAL

SM934

Intervention Type: DRUG

In this study, the investigating intervention is oral administration of SM934. SM934 is a water-soluble derivative of arteminisin, which exerts immunosuppressive functions in vitro and in vivo.

Placebo

Placebo（5 tablets）p.o. qd in combination with steroids

Group Type: PLACEBO_COMPARATOR

Placebos

Intervention Type: DRUG

The placebo pills are made identical to the investigating SM934 in appearance.

Interventions

SM934

In this study, the investigating intervention is oral administration of SM934. SM934 is a water-soluble derivative of arteminisin, which exerts immunosuppressive functions in vitro and in vivo.

Intervention Type: DRUG

Placebos

The placebo pills are made identical to the investigating SM934 in appearance.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu ZuoYou Medicine Co., Ltd.

UNKNOWN

Sponsor Role: collaborator

RenJi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nan Shen, MD & PhD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Jiao Tong University School of Medicine affiliated Renji Hospital

Locations

Department of Rheumatology, RenJi Hospital, School of Medicine, Shanghai JiaoTong University

Shanghai, Shanghai Municipality, China

Countries

China

References

Hou LF, He SJ, Wang JX, Yang Y, Zhu FH, Zhou Y, He PL, Zhang Y, Yang YF, Li Y, Tang W, Zuo JP. SM934, a water-soluble derivative of arteminisin, exerts immunosuppressive functions in vitro and in vivo. Int Immunopharmacol. 2009 Dec;9(13-14):1509-17. doi: 10.1016/j.intimp.2009.09.003. Epub 2009 Sep 19.

Reference Type: BACKGROUND

PMID: 19772931 (View on PubMed)

Other Identifiers

SM934

Identifier Type: -

Identifier Source: org_study_id