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Systemic Lupus ErythematosusPhase 4NCT04515719

Efficacy and Safety of Belimumab in SLE Patients

A Phase 4 study testing Belimumab 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

Systemic lupus erythematosus (SLE) is a chronic inflammatory systemic autoimmune disease. Recurrent relapses of disease and development of long-term organ damage are two key unsolved clinical problems. Belimumab is the only FDA-approved biological agent for SLE. 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?
Belimumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
231 participants
Where
1 siteChina
Study dates
10 Mar 2021to 10 Apr 2022
Phase
Phase 4
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 18-70 years;
  • Patients with low disease activity (score≤ 6 at screening on SLEDAI); no British Isles Lupus Assessment Group (BILAG) A and no more than one B;
  • A stable treatment regimen with fixed doses of prednisone (≤ 20mg/day), antimalarial, or immunosuppressive drugs (azathioprine/mycophenolate mofetil/ methotrexate/ciclosporin/leflunomide/tacrolimus) for at least 30 days.
  • Sign the informed consent;

Who cannot join

  • Alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) > 2 times upper normal limits;
  • Creatinine clearance rate < 60ml/min;
  • Exposure to cyclophosphamide within past 6 months before screening;
  • Exposure to any B cell targeted therapy (Rituximab/belimumab) within past 1 year before screening;
  • History of Malignancy;
  • History of herpes zoster with past 3 months before screening.
  • Chronic HBV/HCV hepatitis；
  • Current infections (HIV/tuberculosis)

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shuang Ye, MD

    Shanghai, Shanghai Municipality

Other trials in China

About this study

Official title: Efficacy and Safety of Belimumab for Prevention of Disease Flares in SLE Patients With Low Disease Activity

Systemic lupus erythematosus (SLE) is a chronic inflammatory systemic autoimmune disease. Recurrent relapses of disease and development of long-term organ damage are two key unsolved clinical problems. Belimumab is the only FDA-approved biological agent for SLE. Data showed that treatment with belimumab on the background of standard therapy was effective in active SLE patients. However, the efficacy of low-dose belimumab for prevention of disease flares in SLE patients with low disease activity is to be explored.

Read the detailed description

Systemic lupus erythematosus (SLE) is a chronic systemic autoimmune disease with the incidence of about 70/100,000 in China. Recurrent relapses of disease and development of long-term organ damage are two key unsolved clinical problems. Its pathogenesis is still unclear, but B cells have been confirmed to play a vital role in it. Belimumab, a B-lymphocyte stimulating factor (Blys) inhibitor, was the only FDA-approved biological agent for SLE. BLISS-52 showed that more active lupus patients had their SELENA-SLEDAI score reduced by at least 4 points during 52 weeks with belimumab 10 mg/kg (58% vs 46%, p=0·0024) than with placebo. But there was limited data about belimumab in SLE patients with low disease activity. Our previous study indicated that even these patients still have an annual flare rate of 30-40%. Therefore, we try to explore whether low-dose of belimumab could prevent the disease flares in SLE patients with low disease activity.

Being tested
Belimumab, Placebo
Keywords
Belimumab, Systemic Lupus Erythematosus, Disease flare
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.

  • BelimumabBiological

    Also called BENLYSTA™

    Belimumab 2mg/kg intravenously

  • PlaceboBiological

    Placebo intravenously

Study groups in NCT04515719
Study groupRoleWhat they receive
Belimumab 2mg/kgExperimentalEligible patients were randomized in a 1:1 ratio to belimumab/placebo on the background of standard therapy. Belimumab 2mg/kg is administered intravenously at week 0, week 2, week 4 and then every 4 weeks until 48 weeks.
Receives: Biological: Belimumab
PlaceboPlacebo comparatorEligible patients were randomized in a 1:1 ratio to belimumab/placebo on the background of standard therapy. Placebo (normal saline) is administered intravenously at week 0, week 2, week 4 and then every 4 weeks until 48 weeks.
Receives: Biological: Placebo

What is being measured

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

  1. Percentage of patients with disease flares

    Disease flare is defined by modified SELENA-SLEDAI SLE flare index (SFI).

    Measured: 52 weeks

Secondary outcomes (8)

  1. Percentage of patients with mild/moderate flares

    Disease flare is defined by modified SELENA-SLEDAI SLE flare index (SFI).

    Measured: 52 weeks

  2. Percentage of patients with major flares

    Disease flare is defined by modified SELENA-SLEDAI SLE flare index (SFI).

    Measured: 52 weeks

  3. Time to first disease flare

    Time to first disease flare

    Measured: 52 weeks

  4. prednisone dose at each visit

    compare the prednisone dose at each visit

    Measured: 52 weeks

  5. SELENA-SLEDAI score at each visit

    compare the disease activity measured by SELENA-SLEDAI score at each visit

    Measured: 52 weeks

  6. BiLAG score at each visit

    compare the disease activity measured by BILAG score at each visit

    Measured: 52 weeks

  7. The percentage of patients achieving prednisone-free successfully

    the percentage of patients achieving prednisone-free successfully

    Measured: 52 weeks

  8. Number of participants with adverse events as assessed by CTCAE v4.0

    the safety of belimumab

    Measured: 52 weeks

Timeline

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

  1. First posted17 Aug 2020
  2. Study start10 Mar 2021
  3. Primary completion10 Apr 2022
  4. Study completion10 Apr 2022

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 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
231 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04515719
Sponsor's protocol ID
Btrial
Status last verified
May 2025
First submitted
13 Aug 2020
Last updated
14 May 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Navarra SV, Guzman RM, Gallacher AE, Hall S, Levy RA, Jimenez RE, Li EK, Thomas M, Kim HY, Leon MG, Tanasescu C, Nasonov E, Lan JL, Pineda L, Zhong ZJ, Freimuth W, Petri MA; BLISS-52 Study Group. Efficacy and safety of belimumab in patients with active systemic lupus erythematosus: a randomised, placebo-controlled, phase 3 trial. Lancet. 2011 Feb 26;377(9767):721-31. doi: 10.1016/S0140-6736(10)61354-2. Epub 2011 Feb 4.

    PubMed 21296403

  • Sun F, Wang H, Zhang D, Shen N, Chen S, Li T, Wan W, Dai SM, Ye S. Low-dose belimumab reduced risk of flares in patients with systemic lupus erythematosus: a multicentre, randomised, double-blind, placebo-controlled trial. Ann Rheum Dis. 2026 Mar;85(3):489-496. doi: 10.1016/j.ard.2025.10.010. Epub 2025 Nov 6.

    PubMed 41203461

  • Sun F, Huang W, Chen J, Zhao L, Zhang D, Wang X, Wan W, Dai SM, Chen S, Li T, Ye S. Low-dose belimumab for patients with systemic lupus erythematosus at low disease activity: protocol for a multicentre, randomised, double-blind, placebo-controlled clinical trial. Lupus Sci Med. 2022 Feb;9(1):e000638. doi: 10.1136/lupus-2021-000638.

    PubMed 35105722

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Belimumab 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 4 inclusion and 8 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 14 May 2025. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 patients with disease flares (time frame: 52 weeks). 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 NCT04515719, which also lists 3 linked publications.

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 14 May 2025.

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