Lupus Erythematosus, SystemicPhase 4NCT04956484
Belimumab In Early Systemic Lupus Erythematosus
A Phase 4 study testing Belimumab in people with Lupus Erythematosus, Systemic, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
To investigate the efficacy of belimumab in early SLE patients (disease duration less than 6 months). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lupus Erythematosus, Systemic
- What is being tested?
- Belimumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2021to 8 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of SLE according to the 1997 American College of Rheumatology (ACR) classification criteria or 2019 EULAR/ACR classification criteria within three months, which is autoantibody-positive (antinuclear antibody titers ≥1:80, anti-double-stranded DNA antibodies, or both)
- 18-75 years of age
- body weight 45-80kg
- Disease duration of SLE ≤ 6months
- SELENA-2K score ≥6 scores
- Negative pregnancy test for child-bearing women at screening and baseline
- Provide written informed consent
Who cannot join
- Known to be allergic to Prednisone Acetate, Meprednisone, Hydroxychloroquine, and Immunosuppressants including Mycophenolate Mofetil, Cyclophosphamide,et al
- Active serious neuropsychiatric systemic lupus erythematosus or other severe situations of SLE who need pulse steroid treatment
- Abnormal liver function (ALT or AST is 2 times higher than normal)
- Pregnancy or breastfeeding women;
- Have a history of malignant tumors;
- Have any serious acute, chronic or recurrent infectious disease (such as pneumonia or active stage of pyelitis, recurrent pneumonia, chronic bronchiectasis and tuberculosis)
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- Chronic infections, such as Hepatitis B virus or hepatitis B and C and HIV;
- Previous visual obstruction, monocular dysfunction and cataract;
- Cardiac insufficiency with metabolic imbalance or severe high blood pressure (systolic pressure > 160mmHg or diastolic pressure > 100mmHg) or diabetics;
- Active hemorrhage or peptic ulcer;
- With other concommitant autoimmune disease;
- Receipt of B-cell-targeted therapy (including belimumab) within 1 year before randomization.
- Participated in other drugs clinical trials within 4 weeks.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Arm, 24 Weeks, Pilot Study of Belimumab In Treatment of Early Systemic Lupus Erythematosus
To investigate the efficacy of belimumab in early SLE patients (disease duration less than 6 months).
Read the detailed description
This is a single arm, 24 weeks, pilot trial. All patients will be treated with standard of care plus Belimumab (at a dose of 10 mg per kilogram of body weight) .
The primary endpoint is the proportion of LLDAS in week 24.
- Conditions
- Lupus Erythematosus, Systemic
- Being tested
- Belimumab, Standard of care
- Keywords
- SLE, Belimumab
- 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 10 mg/kg
Standard of careDrug
Steroid(≤1mg/kg/d) with or without proper immunosuppressants：CTX, MMF, AZA, CsA, FK 506, HCQ, MTX, LEF, SASP etc.
| Study group | Role | What they receive |
|---|---|---|
| Belimumab 10 mg/kg plus standard of care | Experimental | Standard of care and Belimumab: 10 mg per kilogram of body weight，days 1 (baseline), 15, and 29 and every 28 days thereafter to week 24 Receives: Biological: Belimumab; Drug: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
LLDAS
Lupus low disease activity status (LLDAS) was defined as SLEDAI-2K ≤4, no activity in any major organ, no new disease activity feature, PGA ≤1, prednisone ≤7.5 mg/day, and allowance for maintenance of IS and antimalarials
Measured: week 24
Secondary outcomes (6)
Serologies
Changes in titers of anti-DNA antibody levels
Measured: week 12, week 24
Complement levels
Changes in measures of C3, C4
Measured: week 12, week 24
Dynamics of immune cell subsets
T cell and B cell subsets
Measured: week 12, week 24
Glucocorticoid tapering
A prednisone dose that was decreased≤ 7.5mg/d
Measured: week 12, week 24
Remission
a clinical SLEDAI-2K of 0 (disregarding the serology, including anti-dsDNA and complements), Physician Global Assessment <0.5 (0-3). The patient may be on antimalarials, low-dose glucocorticoids (prednisolone ≤5 mg/day), and/or stable immunosuppressives including biologics
Measured: week 12, week 24
LLDAS
Lupus low disease activity status (LLDAS) was defined as SLEDAI-2K ≤4, no activity in any major organ, no new disease activity feature, PGA ≤1, prednisone ≤7.5 mg/day, and allowance for maintenance of IS and antimalarials
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2021
- Study start1 Sep 2021
- Primary completion8 Apr 2022
- Study completion8 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus Erythematosus, SystemicStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04956484
- Sponsor's protocol ID
- LXM-210622
- Status last verified
- Apr 2022
- First submitted
- 8 Jul 2021
- Last updated
- 8 Jul 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm, 24 Weeks, Pilot Study of Belimumab In Treatment of Early Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT04956484
- Acronym / sponsor ID
- LXM-210622
- Conditions
- Lupus Erythematosus, Systemic
- Keywords
- SLE, Belimumab
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 8 Apr 2022 (actual)
- Study completion
- 8 Apr 2022 (actual)
- First posted
- 9 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the efficacy of belimumab in early SLE patients (disease duration less than 6 months).
Detailed description
This is a single arm, 24 weeks, pilot trial. All patients will be treated with standard of care plus Belimumab (at a dose of 10 mg per kilogram of body weight) .
The primary endpoint is the proportion of LLDAS in week 24.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Belimumab 10 mg/kg plus standard of care | Experimental | Biological: Belimumab, Drug: Standard of careStandard of care and Belimumab: 10 mg per kilogram of body weight，days 1 (baseline), 15, and 29 and every 28 days thereafter to week 24 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Clinical diagnosis of SLE according to the 1997 American College of Rheumatology (ACR) classification criteria or 2019 EULAR/ACR classification criteria within three months, which is autoantibody-positive (antinuclear antibody titers ≥1:80, anti-double-stranded DNA antibodies, or both)
- 18-75 years of age
- body weight 45-80kg
- Disease duration of SLE ≤ 6months
- SELENA-2K score ≥6 scores
Key exclusion criteria (13 listed)
- Known to be allergic to Prednisone Acetate, Meprednisone, Hydroxychloroquine, and Immunosuppressants including Mycophenolate Mofetil, Cyclophosphamide,et al
- Active serious neuropsychiatric systemic lupus erythematosus or other severe situations of SLE who need pulse steroid treatment
- Abnormal liver function (ALT or AST is 2 times higher than normal)
- Pregnancy or breastfeeding women;
- Have a history of malignant tumors;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BelimumabAlso: BENLYSTA™Belimumab 10 mg/kg | Biological | Belimumab 10 mg/kg plus standard of care |
| Standard of careSteroid(≤1mg/kg/d) with or without proper immunosuppressants：CTX, MMF, AZA, CsA, FK 506, HCQ, MTX, LEF, SASP etc. | Drug | Belimumab 10 mg/kg plus standard of care |
Primary outcome
LLDAS
Time frame: week 24
Lupus low disease activity status (LLDAS) was defined as SLEDAI-2K ≤4, no activity in any major organ, no new disease activity feature, PGA ≤1, prednisone ≤7.5 mg/day, and allowance for maintenance of IS and antimalarials
6 secondary outcomes
Serologies
Time frame: week 12, week 24
Complement levels
Time frame: week 12, week 24
Dynamics of immune cell subsets
Time frame: week 12, week 24
Glucocorticoid tapering
Time frame: week 12, week 24
Remission
Time frame: week 12, week 24
LLDAS
Time frame: week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Belimumab in people with Lupus Erythematosus, Systemic, run by Peking Union Medical College 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 13 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 8 Jul 2022. 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. 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?
LLDAS (time frame: week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jul 2022.