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Belimumab In Early Systemic Lupus Erythematosus

Primary Purpose

Lupus Erythematosus, Systemic

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Belimumab
Standard of care
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lupus Erythematosus, Systemic focused on measuring SLE, Belimumab

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Peking Union Medical College hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Belimumab 10 mg/kg plus standard of care

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 8, 2021
Last Updated
July 5, 2022
Sponsor
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04956484
Brief Title
Belimumab In Early Systemic Lupus Erythematosus
Official Title
A Single Arm, 24 Weeks, Pilot Study of Belimumab In Treatment of Early Systemic Lupus Erythematosus
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
April 8, 2022 (Actual)
Study Completion Date
April 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital

4. Oversight

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

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Erythematosus, Systemic
Keywords
SLE, Belimumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Belimumab 10 mg/kg plus standard of care
Arm Type
Experimental
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
Belimumab
Other Intervention Name(s)
BENLYSTA™
Intervention Description
Belimumab 10 mg/kg
Intervention Type
Drug
Intervention Name(s)
Standard of care
Intervention Description
Steroid(≤1mg/kg/d) with or without proper immunosuppressants：CTX, MMF, AZA, CsA, FK 506, HCQ, MTX, LEF, SASP etc.
Primary Outcome Measure Information:
Title
LLDAS
Description
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
Time Frame
week 24
Secondary Outcome Measure Information:
Title
Serologies
Description
Changes in titers of anti-DNA antibody levels
Time Frame
week 12, week 24
Title
Complement levels
Description
Changes in measures of C3, C4
Time Frame
week 12, week 24
Title
Dynamics of immune cell subsets
Description
T cell and B cell subsets
Time Frame
week 12, week 24
Title
Glucocorticoid tapering
Description
A prednisone dose that was decreased≤ 7.5mg/d
Time Frame
week 12, week 24
Title
Remission
Description
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
Time Frame
week 12, week 24
Title
LLDAS
Description
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
Time Frame
week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Peking Union Medical College hospital
City
Beijing
State/Province
Dongcheng
ZIP/Postal Code
100730
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Belimumab In Early Systemic Lupus Erythematosus

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