Lupus Erythematosus, SystemicPhase 4NCT03543839
Trial of Belimumab in Early Lupus
A Phase 4 study testing Belimumab in people with Lupus Erythematosus, Systemic and Lupus Erythematosus, run by Northwell Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lupus Erythematosus, Systemic, Lupus Erythematosus
- What is being tested?
- Belimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2020to Mar 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 11Show fewer
- 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
Who cannot join
- 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
Show all 34Show fewer
- 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
- Currently on any suppressive therapy for a chronic infection (such as tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster and atypical mycobacteria)
- Hospitalization for treatment of infection within 60 days of Day 0.
- Use of parenteral (IV or IM) antibiotics (antibacterials, antivirals, anti-fungals, or anti parasitic agents) within 60 days of Day 0
- History of serious recurrent or chronic infection
- Lack of peripheral venous access
- History of drug, alcohol, or chemical abuse within 365 days prior to Day 0
- Pregnancy (a negative serum pregnancy test must be obtained for all women of childbearing potential at screening; a urine pregnancy test must be negative < 7 days prior to first dose and monthly)
- Lactation
- History of psychiatric disorder that would interfere with normal participation in this protocol
- Significant cardiac or pulmonary disease (including obstructive pulmonary disease)
- Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications
- History of malignant neoplasm within the last 5 years with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
- Evidence of serious suicide risk including any history of suicidal behaviour in the last 6 months and/or any suicidal ideation in the last 2 months or who in the investigator's judgment, pose a significant suicide risk
- History of a primary immunodeficiency
- Have a significant IgG deficiency (IgG level < 400 mg/dL)
- Have an IgA deficiency (IgA level < 10 mg/dL)
- Have any other clinically significant abnormal laboratory value in the opinion of the investigator
- Comorbidities requiring corticosteroid therapy, including those which have required two or more courses of systemic courses of systemic corticosteroids within the previous 12 months
- Inability to comply with study and follow-up procedures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Feinstein Institute
Manhasset, New York, 11030
Sanita Kandasami, 516-562-2401, skandasami@northwell.edu
Cynthia Aranow, M.D.
About this study
Official title: Pilot Trial of Belimumab in Early Lupus
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.
Read the detailed description
This protocol proposes that early treatment of Systemic Lupus Erythematous (SLE) may prevent tissue damage and may even lead to long-term remission of disease. This concept is supported by reports of SLE-associated autoimmunity that are detected serologically many years prior to any constitutional symptoms or specific tissue inflammation and immune dysregulation precedes the development of clinically apparent SLE. Belimumab (Benlysta) is an FDA approved medication and is a monoclonal antibody directed against B cell-activating factor (BAFF)/ B Lymphocyte Stimulator (BLyS). B cells maturing in environments with high BAFF levels are more likely to be autoreactive B cells. This is a double-blind placebo controlled trial of belimumab, in patients with early lupus, ie lupus diagnosed within 2 years. Thirty subjects will be randomized (2:1) to receive subcutaneous belimumab weekly or placebo. After a year of treatment, subjects receiving belimumab will be rerandomized (1:1) to receive belimumab or placebo. The primary outcome is B cell autoreactivity. Clinical efficacy including disease activity, flares, attainment of low disease activity or remission as well as surrogate cardiovascular biomarkers will also be assessed.
- Conditions
- Lupus Erythematosus, Systemic, Lupus Erythematosus
- Being tested
- Belimumab, Belimumab/Placebo, Placebo
- Keywords
- lupus, early lupus, belimumab, autoreactivity
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BelimumabBiological
Subjects in this arm will receive 200mg belimumab subcutaneously weekly for 2 years
Belimumab/PlaceboBiological
Subjects in this arm will receive weekly subcutaneous injections of 200mg belimumab for 1 year and then placebo subcutaneous injections for 1 year.
PlaceboOther
Subjects in this arm will receive weekly subcutaneous injections of placebo for 2 years
| Study group | Role | What they receive |
|---|---|---|
| Belimumab | Active comparator | Subjects in this arm will receive 200mg belimumab for self administration subcutaneously weekly for 2 years Receives: 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. Receives: Biological: Belimumab/Placebo |
| Placebo | Placebo comparator | Subjects in this arm will receive placebo for self administration subcutaneously weekly for 2 years Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of anergic autoreactive naïve B cells
The frequency of autoreactive B cells in the naïve subset will be identified by flow cytometry.
Measured: Assessment at year 1
Secondary outcomes (35)
Frequency of anergic autoreactive naïve B cells
The frequency of autoreactive B cells in the naïve subset will be identified by flow cytometry.
Measured: Assessment at year 2
Frequency of autoreactivity in transitional B cells
The frequency of autoreactive B cells in the transitional B cell subset will be identified by flow cytometry.
Measured: Year 1
Frequency of autoreactivity in transitional B cells
The frequency of autoreactive B cells in the transitional B cell subset will be identified by flow cytometry.
Measured: 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
B cell numbers decrease following belimumab; the time for B cell reconstituion will be determined
Measured: Year 2
SRI (SLE Response Index) modified
Systemic lupus response index
Measured: Year 1
SRI modified
Systemic lupus response index
Measured: Year 2
Low lupus disease activity state (LLDAS)
LLDAS as defined by the Asia-Pacific Lupus Association
Measured: Year 1
Low lupus disease activity state
LLDAS as defined by the Asia-Pacific Lupus Association
Measured: Year 2
Remission
Remission defined by DORIS (Definition of Remission in SLE)
Measured: Year 1
Remission
Remission defined by DORIS (Definition of Remission in SLE)
Measured: Year 2
Flare of lupus disease
Lupus flare will be measure using the SELENA-SLEDAI (Safety of Estrogens in Lupus Erythematosus National Assessment --Systemic Lupus Erythematosus Disease Activity Index) flare instrument or British Isles Lupus Assessment Group (BILAG) disease activity index
Measured: Through year 2
New Classification Criteria for SLE.
Accumulation of new American College of Rheumatology (ACR) Classification criteria or Systemic Lupus International Cooperative Clinics (SLICC) criteria
Measured: Through year 2
Serologies
Changes in titers of anti-DNA antibody levels
Measured: Through year 2
Complement levels
Changes in measures of C3 and C4 (mg/dL)
Measured: Through year 2
Complement levels
Changes in measures of C3, C4 (mg/dL)
Measured: Through year 2
Serum immunoglobulin levels
Change from baseline of serum IgG, IgM and IgA (mg/dL)
Measured: Through year 2
Damage
Damage accrual assessed using a SLE damage index
Measured: Through year 2
Cardiovascular biomarkers
IgM phosphocholine antibody titers and proinflammatory HDL
Measured: Through year 2
Safety and tolerability (adverse events)
All adverse events and serious adverse events will be collected
Measured: Through year 2
Frequency of autoreactivity in CD27+, IgD+ memory B cells
The frequency of autoreactive B cells in the CD27+, IgD+ B cell subset will be identified by flow cytometry.
Measured: Year 1
Frequency of autoreactivity in CD27+, IgD+ memory B cells
The frequency of autoreactive B cells in the CD27+, IgD+ B cell subset will be identified by flow cytometry.
Measured: Year 2
Frequency of autoreactivity in CD27+, IgD- B cells
The frequency of autoreactive B cells in the CD27+, IgD- B cell subset will be identified by flow cytometry.
Measured: Year 1
Frequency of autoreactivity in CD27+, IgD- B cells
The frequency of autoreactive B cells in the CD27+, IgD- B cell subset will be identified by flow cytometry.
Measured: Year 2
Frequency of autoreactivity in CD27-, IgD- B cells
The frequency of autoreactive B cells in the CD27-, IgD- B cell subset will be identified by flow cytometry.
Measured: Year 1
Frequency of autoreactivity in CD27-, IgD- B cells
The frequency of autoreactive B cells in the CD27-, IgD- B cell subset will be identified by flow cytometry.
Measured: Year 2
The absolute numbers of transitional B cells
The number of transitional B cells will be determined by flow cytometry.
Measured: Year 1
The absolute numbers of transitional B cells
The number of transitional B cells will be determined by flow cytometry.
Measured: Year 2
The absolute numbers of naïve B cells
The number of transitional B cells will be determined by flow cytometry.
Measured: Year 1
The absolute numbers of naïve B cells
The number of naïve B cells will be determined by flow cytometry.
Measured: Year 2
The absolute numbers of memory B cells
The number of memory B cells will be determined by flow cytometry.
Measured: Year 1
The absolute numbers of memory B cells
The number of memory B cells will be determined by flow cytometry.
Measured: Year 2
The absolute number of plasmablasts
The number of plasmablasts will be determined by flow cytometry.
Measured: Year 1
The absolute number of plasmablasts
The number of plasmablasts will be determined by flow cytometry.
Measured: Year 2
The absolute number of plasma cells
The number of plasma cells will be determined by flow cytometry.
Measured: Year 1
The absolute number of plasma cells
The number of plasma cells will be determined by flow cytometry.
Measured: Year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2018
- Study start15 Sep 2020
- Primary completionSep 2028 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus Erythematosus, SystemicStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Principal investigator, Cynthia Aranow, MD, Northwell Health
- Investigators
- Cynthia Aranow, MD, Principal investigator, Feinstein Institute for Medical Research, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03543839
- Sponsor's protocol ID
- 17-0861
- Status last verified
- Jun 2026
- First submitted
- 12 Apr 2018
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial of Belimumab in Early Lupus
- ClinicalTrials.gov ID
- NCT03543839
- Acronym / sponsor ID
- 17-0861
- Conditions
- Lupus Erythematosus, Systemic, Lupus Erythematosus
- Keywords
- lupus, early lupus, belimumab, autoreactivity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 1 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This protocol proposes that early treatment of Systemic Lupus Erythematous (SLE) may prevent tissue damage and may even lead to long-term remission of disease. This concept is supported by reports of SLE-associated autoimmunity that are detected serologically many years prior to any constitutional symptoms or specific tissue inflammation and immune dysregulation precedes the development of clinically apparent SLE. Belimumab (Benlysta) is an FDA approved medication and is a monoclonal antibody directed against B cell-activating factor (BAFF)/ B Lymphocyte Stimulator (BLyS). B cells maturing in environments with high BAFF levels are more likely to be autoreactive B cells. This is a double-blind placebo controlled trial of belimumab, in patients with early lupus, ie lupus diagnosed within 2 years. Thirty subjects will be randomized (2:1) to receive subcutaneous belimumab weekly or placebo. After a year of treatment, subjects receiving belimumab will be rerandomized (1:1) to receive belimumab or placebo. The primary outcome is B cell autoreactivity. Clinical efficacy including disease activity, flares, attainment of low disease activity or remission as well as surrogate cardiovascular biomarkers will also be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Belimumab | Active comparator | Biological: BelimumabSubjects in this arm will receive 200mg belimumab for self administration subcutaneously weekly for 2 years |
| Belimumab/Placebo | Experimental | Biological: Belimumab/PlaceboSubjects in this arm will receive 200mg belimumab for self administration subcutaneously weekly for 1 year and then placebo injections subcutaneously for 1 year. |
| Placebo | Placebo comparator | Other: PlaceboSubjects in this arm will receive placebo for self administration subcutaneously weekly for 2 years |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (34 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BelimumabSubjects in this arm will receive 200mg belimumab subcutaneously weekly for 2 years | Biological | Belimumab |
| Belimumab/PlaceboSubjects in this arm will receive weekly subcutaneous injections of 200mg belimumab for 1 year and then placebo subcutaneous injections for 1 year. | Biological | Belimumab/Placebo |
| PlaceboSubjects in this arm will receive weekly subcutaneous injections of placebo for 2 years | Other | Placebo |
Primary outcome
Frequency of anergic autoreactive naïve B cells
Time frame: Assessment at year 1
The frequency of autoreactive B cells in the naïve subset will be identified by flow cytometry.
35 secondary outcomes
Frequency of anergic autoreactive naïve B cells
Time frame: Assessment at year 2
Frequency of autoreactivity in transitional B cells
Time frame: Year 1
Frequency of autoreactivity in transitional B cells
Time frame: 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
Time frame: Year 2
SRI (SLE Response Index) modified
Time frame: Year 1
SRI modified
Time frame: Year 2
Low lupus disease activity state (LLDAS)
Time frame: Year 1
Low lupus disease activity state
Time frame: Year 2
Remission
Time frame: Year 1
Remission
Time frame: Year 2
Flare of lupus disease
Time frame: Through year 2
New Classification Criteria for SLE.
Time frame: Through year 2
Serologies
Time frame: Through year 2
Complement levels
Time frame: Through year 2
Complement levels
Time frame: Through year 2
Serum immunoglobulin levels
Time frame: Through year 2
Damage
Time frame: Through year 2
Cardiovascular biomarkers
Time frame: Through year 2
Safety and tolerability (adverse events)
Time frame: Through year 2
Frequency of autoreactivity in CD27+, IgD+ memory B cells
Time frame: Year 1
Frequency of autoreactivity in CD27+, IgD+ memory B cells
Time frame: Year 2
Frequency of autoreactivity in CD27+, IgD- B cells
Time frame: Year 1
Frequency of autoreactivity in CD27+, IgD- B cells
Time frame: Year 2
Frequency of autoreactivity in CD27-, IgD- B cells
Time frame: Year 1
Frequency of autoreactivity in CD27-, IgD- B cells
Time frame: Year 2
The absolute numbers of transitional B cells
Time frame: Year 1
The absolute numbers of transitional B cells
Time frame: Year 2
The absolute numbers of naïve B cells
Time frame: Year 1
The absolute numbers of naïve B cells
Time frame: Year 2
The absolute numbers of memory B cells
Time frame: Year 1
The absolute numbers of memory B cells
Time frame: Year 2
The absolute number of plasmablasts
Time frame: Year 1
The absolute number of plasmablasts
Time frame: Year 2
The absolute number of plasma cells
Time frame: Year 1
The absolute number of plasma cells
Time frame: Year 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Lupus Erythematosus, Systemic
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
RecruitingPhase 4
Dapagliflozin in Active Lupus Nephritis
Lupus Nephritis (LN)
RecruitingObservational study
Electroencephalogram Recording in Patients With Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
RecruitingObservational study
Deciphering the Genetic Architecture of Autoimmune Diseases
Autoimmune Diseases
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cynthia Aranow, MD principal investigator
Feinstein Institute for Medical Research, Northwell Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Belimumab in people with Lupus Erythematosus, Systemic and Lupus Erythematosus, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sanita Kandasami, BS (516 562-2401, skandasami@northwell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of anergic autoreactive naïve B cells (time frame: Assessment at year 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.