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Systemic Lupus ErythematosusPhase 2NCT03951259

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

A Phase 2 study testing SM934 in people with Systemic Lupus Erythematosus, run by RenJi Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Systemic Lupus Erythematosus
What is being tested?
SM934
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
32 participants
Where
1 siteChina
Study dates
24 Jul 2019to 19 Oct 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

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

    Shanghai, Shanghai Municipality, 200001

Other trials in China

About this study

Official 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

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.

Being tested
SM934, Placebos
Medical subject headings
Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SM934Drug

    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.

  • PlacebosDrug

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

Study groups in NCT03951259
Study groupRoleWhat they receive
SM934 10mgExperimentalSM934 10mg（1 tablet）+Placebo（4 tablets）p.o. qd in combination with steroids
Receives: Drug: SM934
SM934 30mgExperimentalSM934 10mg（3 tablet）+ Placebo（2 tablets）p.o. qd in combination with steroids
Receives: Drug: SM934
SM934 50mgExperimentalSM934 10mg（5 tablet）p.o. qd in combination with steroids
Receives: Drug: SM934
PlaceboPlacebo comparatorPlacebo（5 tablets）p.o. qd in combination with steroids
Receives: Drug: Placebos

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Week 12

  2. 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).

    Measured: Week 12

  3. Percentage of Subjects with Treatment-Emergent Adverse Events (TEAEs) in each group

    Percentage of Subjects with TEAEs in each group

    Measured: Baseline through Week 13

Secondary outcomes (8)

  1. 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

    Measured: Week 12

  2. 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.

    Measured: Week 12

  3. Change of SLICC/ACR from baseline

    Change of SLICC/ACR score from baseline

    Measured: Week 12

  4. 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

    Measured: Week 12

  5. 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

    Measured: Week 12

  6. 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

    Measured: Week 12

  7. Percentage change of anti-dsDNA level from baseline in each group

    Percentage change of anti-dsDNA level from baseline in each group

    Measured: Week 12

  8. 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.

    Measured: Baseline through week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2019
  2. Study start24 Jul 2019
  3. Primary completion13 Oct 2023
  4. Study completion19 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03951259
Sponsor's protocol ID
SM934
Status last verified
Oct 2023
First submitted
14 May 2019
Last updated
27 Oct 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 19772931

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SM934 in people with Systemic Lupus Erythematosus, run by RenJi Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Subjects with Lupus Low Disease Activity Score (LLDAS) in each group (time frame: Week 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03951259, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2023.

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