Belimumab In Early Systemic Lupus Erythematosus

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).

Study Overview

• Status: Completed
• Conditions: Lupus Erythematosus, Systemic
• Intervention / Treatment: Biological: Belimumab; Drug: Standard of care

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 Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Dongcheng
    • Beijing, Dongcheng, China, 100730
      • Peking Union Medical College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	week 24

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): April 8, 2022
• Study Completion (Actual): April 8, 2022

Study Registration Dates

• First Submitted: July 8, 2021
• First Submitted That Met QC Criteria: July 8, 2021
• First Posted (Actual): July 9, 2021

Study Record Updates

• Last Update Posted (Actual): July 8, 2022
• Last Update Submitted That Met QC Criteria: July 5, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: SLE; Belimumab
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic; Physiological Effects of Drugs; Immunosuppressive Agents; Immunologic Factors; Belimumab
• Other Study ID Numbers: LXM-210622

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes