Belimumab In Early Systemic Lupus Erythematosus

NCT04956484 | Completed Phase 4 FDA Drug

• 1 other identifier: LXM-210622
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lupus Erythematosus, Systemic

Keywords

SLE; Belimumab

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Serologies

  week 12, week 24

• Complement levels

  week 12, week 24

• Dynamics of immune cell subsets

  week 12, week 24

• Glucocorticoid tapering

  week 12, week 24

• Remission

  week 12, week 24

Study Arms (1)

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

Biological: Belimumab; Drug: Standard of care

Interventions

Belimumab BIOLOGICAL

Belimumab 10 mg/kg

Also known as: BENLYSTA™

Belimumab 10 mg/kg plus standard of care

Standard of care DRUG

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

Belimumab 10 mg/kg plus standard of care

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College hospital

Beijing, Dongcheng, 100730, China

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

belimumab; Standard of Care

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2021
• First Posted: July 9, 2021
• Study Start: September 1, 2021
• Primary Completion: April 8, 2022
• Study Completion: April 8, 2022
• Last Updated: July 8, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)