Belimumab In Early Systemic Lupus Erythematosus

Sponsor

Peking Union Medical College Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04956484

Collaborator

(none)

Enrollment

Location

Arm

7.2

Actual Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To investigate the efficacy of belimumab in early SLE patients (disease duration less than 6 months).

Condition or Disease	Intervention/Treatment	Phase
Lupus Erythematosus, Systemic	Biological: Belimumab Drug: Standard of care	Phase 4

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

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Single Arm, 24 Weeks, Pilot Study of Belimumab In Treatment of Early Systemic Lupus Erythematosus

Actual Study Start Date :

Sep 1, 2021

Actual Primary Completion Date :

Apr 8, 2022

Actual Study Completion Date :

Apr 8, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Belimumab 10 mg/kg plus standard of care 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	Biological: Belimumab Belimumab 10 mg/kg Other Names: BENLYSTA™ Drug: Standard of care Steroid(≤1mg/kg/d) with or without proper immunosuppressants：CTX, MMF, AZA, CsA, FK 506, HCQ, MTX, LEF, SASP etc.

Arm

Intervention/Treatment

Experimental: Belimumab 10 mg/kg plus standard of care

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

Biological: Belimumab

Belimumab 10 mg/kg

Other Names:

BENLYSTA™

Drug: Standard of care

Steroid(≤1mg/kg/d) with or without proper immunosuppressants：CTX, MMF, AZA, CsA, FK 506, HCQ, MTX, LEF, SASP etc.

Outcome Measures

Primary Outcome Measures

LLDAS [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

Secondary Outcome Measures

Serologies [week 12, week 24]
Changes in titers of anti-DNA antibody levels
Complement levels [week 12, week 24]
Changes in measures of C3, C4
Dynamics of immune cell subsets [week 12, week 24]
T cell and B cell subsets
Glucocorticoid tapering [week 12, week 24]
A prednisone dose that was decreased≤ 7.5mg/d
Remission [week 12, week 24]
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
LLDAS [week 12]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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)
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking Union Medical College hospital	Beijing	Dongcheng	China	100730

Sponsors and Collaborators

Peking Union Medical College Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Peking Union Medical College Hospital

ClinicalTrials.gov Identifier:

NCT04956484

Other Study ID Numbers:

LXM-210622

First Posted:

Jul 9, 2021

Last Update Posted:

Jul 8, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Peking Union Medical College Hospital

SLE

Belimumab

Additional relevant MeSH terms:

Lupus Erythematosus, Systemic

Belimumab

Study Results

No Results Posted as of Jul 8, 2022