Trial of Belimumab in Early Lupus

NCT03543839 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 17-0861
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This two year study will evaluate the effects of giving belimumab (Benlysta) to patients with Early Lupus. Early lupus is a diagnosis of lupus within 2 years. Subjects will be randomized to receive belimumab or placebo during the first year. During the second year, subjects who were randomized to belimumab will be rerandomized to continue to receive belimumab or to receive placebo. The study will look at clinical effects as well as effects on the immune system.

Conditions

Lupus Erythematosus, Systemic; Lupus Erythematosus

Keywords

lupus; early lupus; belimumab; autoreactivity

Outcome Measures

Primary Outcomes (1)

• Frequency of anergic autoreactive naïve B cells

  The frequency of autoreactive B cells in the naïve subset will be identified by flow cytometry.

  Assessment at year 1

Secondary Outcomes (35)

• Frequency of anergic autoreactive naïve B cells

  Assessment at year 2

• Frequency of autoreactivity in transitional B cells

  Year 1

• Frequency of autoreactivity in transitional B cells

  Year 2

• Time to reconstitution of B cell subsets in subjects in belimumab/placebo arm randomized to receive placebo after 1 year of belimumab therapy

  Year 2

• SRI (SLE Response Index) modified

  Year 1

Study Arms (3)

Belimumab

ACTIVE COMPARATOR

Subjects in this arm will receive 200mg belimumab for self administration subcutaneously weekly for 2 years

Biological: Belimumab

Belimumab/Placebo

EXPERIMENTAL

Subjects in this arm will receive 200mg belimumab for self administration subcutaneously weekly for 1 year and then placebo injections subcutaneously for 1 year.

Biological: Belimumab/Placebo

Placebo

PLACEBO COMPARATOR

Subjects in this arm will receive placebo for self administration subcutaneously weekly for 2 years

Other: Placebo

Interventions

Belimumab BIOLOGICAL

Subjects in this arm will receive 200mg belimumab subcutaneously weekly for 2 years

Belimumab

Belimumab/Placebo BIOLOGICAL

Subjects in this arm will receive weekly subcutaneous injections of 200mg belimumab for 1 year and then placebo subcutaneous injections for 1 year.

Belimumab/Placebo

Placebo OTHER

Subjects in this arm will receive weekly subcutaneous injections of placebo for 2 years

Placebo

Eligibility Criteria

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

You may qualify if:

• Diagnosis of SLE per current ACR classification criteria
• Date of SLE diagnosis within 2 years of screening
• ANA positive (with a titer ≥ 80)
• anti-ds DNA antibody positive
• Mild to moderate disease activity define by a SLEDAI-2K ≥4
• Stable corticosteroid dose in the 4 weeks prior to screening ≤ 30mg/day.
• If on methotrexate, dose must be stable for 4 weeks
• Concomitant treatment with hydroxychloroquine unless documented inability to tolerate
• Able and willing to give written informed consent and comply with the requirements of the study protocol
• Negative serum pregnancy test (for women of child bearing potential)
• Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for 16 weeks after completion of treatment

You may not qualify if:

• Previous exposure to disease modifying drugs such as azathioprine, mycophenolate mofetil, cyclophosphamide, or cyclosporine.
• Previous exposure to biologic therapies including rituximab, belimumab or other agents that have been investigated for SLE.
• Active renal or nervous system disease or disease activity fulfilling BILAG A criteria
• Use of high dose steroids (\>0.5 mg/kg/ day) within the 4 weeks prior to screening
• Expectation (by the investigator) that the subject will require treatment with a disease modifying drug within the first 52 weeks of the study
• Hemoglobin: \< 8.0 gm/dL
• Platelets: \< 50,000/mm
• ANC \< 1.0 x 103/mm
• AST or ALT \>2.5 x Upper Limit of Normal unless related to primary disease.
• Creatinine clearance ≤ 25ml/min per 1.73 m2
• Positive Hepatitis B or C serology (Hep B Surface antigen, Hep B core Ab or Hepatitis C antibody)
• History of positive HIV (HIV conducted during screening if applicable)
• Treatment with any investigational agent within 4 weeks of screening or 5 half-lives of the investigational drug (whichever is longer)
• Receipt of a live vaccine within 30 days prior to baseline or concurrently with belimumab
• Have a history of an anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins or monoclonal antibodies

Sponsors & Collaborators

• Northwell Health: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Feinstein Institute

Manhasset, New York, 11030, United States

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

belimumab

Condition Hierarchy (Ancestors)

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

Study Officials

• Cynthia Aranow, MD

  Feinstein Institute for Medical Research, Northwell Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sanita Kandasami, BS

CONTACT

516 562-2401; skandasami@northwell.edu

Cynthia Aranow, MD

CONTACT

516 562-3845; caranow@northwell.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study drug or placebo look identical.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is not a true cross-over study. Subjects are randomized to receive true drug or placebo in the initial phase and then those patients who were randomized to receive belimumab will be rerandomized to receive either study drug or placebo. Subjects randomized at baseline to receive placebo continue to receive placebo through the study.

Study Record Dates

• First Submitted: April 12, 2018
• First Posted: June 1, 2018
• Study Start: September 15, 2020
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 14, 2024

Record last verified: 2024-02

Locations

US (1)