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Study of BOS161721 in Systemic Lupus Erythematosus (SLE) Patients on a Background of Limited Standard of Care

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ClinicalTrials.gov Identifier: NCT03371251
Recruitment Status : Recruiting
First Posted : December 13, 2017
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
Boston Pharmaceuticals

Brief Summary:

This study will be conducted to assess the safety, tolerability, and immunogenicity of repeat doses of BOS161721 (20 milligrams [mg], 60 mg, and 120 mg) administered subcutaneously in adult participants with moderately to severely active Systemic Lupus Erythematosus (SLE) on limited background standard of care treatment, in order to estimate the optimal dose.

BOS161721 at the chosen dose will be compared to placebo for response on the SLE Responder Index 4, with sustained reduction of oral corticosteroids, in the same participant population.


Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: BOS161721 Drug: Placebo Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 186 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Double-Blind Phase 1b/2 Combined Staggered Multiple Dose Escalation Study of BOS161721 in Systemic Lupus Erythematosus (SLE) Patients on a Background of Limited Standard of Care
Actual Study Start Date : February 7, 2018
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arm Intervention/treatment
Experimental: Phase 1b: BOS161721 20, 60, 120 mg
Participants will be randomized to receive a 20 milligram (mg), 60 mg, or 120 mg subcutaneous (SC) dose of BOS161721. Participants may receive a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.
Drug: BOS161721
SC administration

Placebo Comparator: Phase 1b: Placebo 20, 60, 120 mg
Participants will be randomized to receive a 20 mg, 60 mg, or 120 mg SC dose of placebo. Participants may receive a total of 7 SC monthly doses of placebo on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.
Drug: Placebo
SC administration

Experimental: Phase 2: BOS161721
Participants will be randomized to receive a SC dose of BOS161721 as determined from Phase 1b of the study. Participants may receive a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.
Drug: BOS161721
SC administration

Placebo Comparator: Phase 2: Placebo
Participants will be randomized to receive a SC dose of placebo as determined from Phase 1b of the study. Participants may receive a total of 7 SC monthly doses of placebo on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.
Drug: Placebo
SC administration




Primary Outcome Measures :
  1. Phase 1b: Incidence of adverse events (AEs) [ Time Frame: up to Day 270 ]
    An AE is defined as any untoward medical occurrence experienced by a study participant, whether or not considered drug related by the principal investigator. AEs are unfavorable changes in a general condition, subjective or objective signs or symptoms, worsening of pre-existing concomitant disease, and clinically significant abnormality in laboratory parameters observed in a participant in the course of a clinical study. Non-serious Systemic Lupus Erythematosus (SLE) manifestations or abnormal laboratory results related to SLE disease activity will not be recorded as AEs unless they meet the definition of serious AEs (SAEs).

  2. Phase 1b: Number of participants with a dose-limiting toxicity (DLT) [ Time Frame: up to Day 270 ]
    For the purpose of dose escalation, pre-defined AEs occurring after study drug administration, which are attributable to the study drug, will be considered DLTs.

  3. Phase 2: Number of participants with an SLE Responder Index 4 (SRI-4) response at Day 210 [ Time Frame: Day 210 ]
    The SRI-4 is a composite index of SLE disease improvement that consists of scores derived from the SLE Disease Activity Index 2000 (SLEDAI-2K) and the British Isles Lupus Assessment Group (BILAG) 2004 Index. Response based on the SRI-4 is defined by: 1) ≥ 4-point reduction in the SLEDAI-2K global score; 2) no new severe disease activity (BILAG A organ score) or more than 1 new moderate organ score (BILAG B); and 3) no deterioration from baseline in the Physician's Global Assessment (PGA) by ≥ 30 millimeters. The SRI-4 response in participants with moderate to severe SLE is associated with broad improvements in clinical and participant-reported outcomes.


Secondary Outcome Measures :
  1. Phase 1b: Plasma concentration of BOS161721 [ Time Frame: Pre-dose: Days 0, 30, 60, 90, 120, 150, and 180. Post-dose: Days 0, 7, 15, 30, 180, 187, 195, 210, 240, and 270. Postdose samples will be collected at 4, 8, and 24 hours after study drug administration on Days 0, 30, and 180. ]
  2. Phase 1b: Maximum observed concentration (Cmax) [ Time Frame: Pre-dose: Days 0, 30, 60, 90, 120, 150, and 180. Post-dose: Days 0, 7, 15, 30, 180, 187, 195, 210, 240, and 270. Postdose samples will be collected at 4, 8, and 24 hours after study drug administration on Days 0, 30, and 180. ]
  3. Phase 1b: First time to maximum concentration (Tmax) [ Time Frame: Pre-dose: Days 0, 30, 60, 90, 120, 150, and 180. Post-dose: Days 0, 7, 15, 30, 180, 187, 195, 210, 240, and 270. Postdose samples will be collected at 4, 8, and 24 hours after study drug administration on Days 0, 30, and 180. ]
  4. Phase 1b: Area under the concentration-time curve (AUC) [ Time Frame: Pre-dose: Days 0, 30, 60, 90, 120, 150, and 180. Post-dose: Days 0, 7, 15, 30, 180, 187, 195, 210, 240, and 270. Postdose samples will be collected at 4, 8, and 24 hours after study drug administration on Days 0, 30, and 180. ]
  5. Phase 1b: Terminal elimination half-life (t1/2) [ Time Frame: Pre-dose: Days 0, 30, 60, 90, 120, 150, and 180. Post-dose: Days 0, 7, 15, 30, 180, 187, 195, 210, 240, and 270. Postdose samples will be collected at 4, 8, and 24 hours after study drug administration on Days 0, 30, and 180. ]
  6. Phase 1b: Systematic clearance (CL) [ Time Frame: Pre-dose: Days 0, 30, 60, 90, 120, 150, and 180. Post-dose: Days 0, 7, 15, 30, 180, 187, 195, 210, 240, and 270. Postdose samples will be collected at 4, 8, and 24 hours after study drug administration on Days 0, 30, and 180. ]
  7. Phase 1b: Volume of distribution (Vd) [ Time Frame: Pre-dose: Days 0, 30, 60, 90, 120, 150, and 180. Post-dose: Days 0, 7, 15, 30, 180, 187, 195, 210, 240, and 270. Postdose samples will be collected at 4, 8, and 24 hours after study drug administration on Days 0, 30, and 180. ]
  8. Phase 1b: Mean change from Baseline in phosphorylated signal transducer and activator of transcription 3 (pSTAT3) [ Time Frame: Baseline (Day 0); Days 30, 44, 60, and 90 (pre-dose [trough] samples only) ]
  9. Phase 1b: Mean change from Baseline in C3 and C4 levels [ Time Frame: Baseline (Day 0); Days 30, 60, 90, 120, 150, 180, 210, 240, and 270 ]
  10. Phase 1b: Mean change from Baseline in leukocyte immunophenotype [ Time Frame: Baseline (Day 0); Days 15, 30, 60, 90, and 180 ]
  11. Phase 1b: Mean change from Baseline in anti-double-stranded DNA (dsDNA) at each visit [ Time Frame: Baseline (Day 0); Days 30, 60, 90, 120, 150, 180, 210, 240, and 270 ]
  12. Phase 1b: Mean change from Baseline in autoantibodies at each visit [ Time Frame: Baseline (Day 0); Days 30, 60, 90, 120, 150, and 180 ]
  13. Phase 1b: Mean change from Baseline in abrogation of IL-21 gene signature [ Time Frame: Baseline (Day 0); Days 15, 90, 180, and 270 ]
  14. Phase 2: Number of participants with an SRI-4, SRI-5, and SRI-6 response at each visit [ Time Frame: Time frame: Days 30, 60, 90, 120, 150, 180, 210, 240, and 270 ]
    The SRI-4 is a composite index of SLE disease improvement that consists of scores derived from the SLE Disease Activity Index 2000 (SLEDAI-2K) and the British Isles Lupus Assessment Group (BILAG) 2004 Index. Response based on the SRI-4 is defined by: 1) ≥ 4-point reduction in the SLEDAI-2K global score; 2) no new severe disease activity (BILAG A organ score) or more than 1 new moderate organ score (BILAG B); and 3) no deterioration from baseline in the Physician's Global Assessment (PGA) by ≥ 30 millimeters. The SRI-4 response in participants with moderate to severe SLE is associated with broad improvements in clinical and participant-reported outcomes. SRI-5 and SRI-6 are composite indices of SLE disease improvement that consist of scores derived from the SLEDAI-2K and the BILAG 2004 Index. The SRI-5 and SRI-6 are computed with a minimal five-point or six-point improvement in SLEDAI-2K being required, respectively.

  15. Phase 2: Mean change from baseline in SLEDAI-2K at Day 210 [ Time Frame: Baseline, Day 210 ]
    The SLEDAI-2K is a validated instrument that measures disease activity in SLE participants at the time of the visit and in the previous 30 days. Change from baseline will be calculated as the post-baseline value minus the baseline value.

  16. Phase 2: Time to BILAG A flare or > 1 BILAG B flare compared to baseline through Day 210 [ Time Frame: Baseline; Day 210 ]
    The BILAG-2004 index is an organ-specific 97-question assessment based on the principle of the doctor's intent to treat. Only clinical features attributable to SLE disease activity are recorded and based on the participant's condition in the last 4 weeks compared with the previous 4 weeks. BILAG A is the score for severe arthritis manifested by observed active synovitis in ≥ 2 joints with marked loss of functional range of movements and significant impairment of basic activities of daily living that has been present on several days cumulatively over the past 4 weeks, including at the time of the screening visit. BILAG B is the score for moderate arthritis, tendonitis or tenosynovitis in ≥ 1 joint, (observed or throughout history), with some loss of functional range of movements which lead to some loss of functional range of motion as manifested by effects on instrumental activities of daily living.

  17. Phase 2: Mean change from baseline in the Cutaneous Lupus Erythematosus Area and Severity Index (CLASI) at Day 210 [ Time Frame: Baseline, Day 210 ]
    The CLASI is a comprehensive tool for the assessment of disease activity and damage in cutaneous lupus, shown to be valid, reliable, and sensitive to changes in disease activity. Response is defined as 50% improvement from baseline in "A" or "B" scores. This assessment will be applied to all participants as all are required to have cutaneous disease activity. Change from baseline will be calculated as the post-baseline value minus the baseline value.

  18. Phase 2: Number of participants with a BILAG-based Composite Lupus Assessment (BICLA) response at Day 210 [ Time Frame: Baseline, Day 210 ]
    BICLA response is defined as: 1) at least 1 gradation of improvement in baseline BILAG 2004 scores in all body systems with moderate disease activity at entry (eg, all B [moderate disease] scores falling to C [mild], or D [no activity]); 2) no new BILAG A or more than 1 new BILAG B scores; 3) no worsening of total SLEDAI-2K score from baseline; 4) ≤ 10% deterioration in PGA score; and 5) no treatment failure.

  19. Phase 2: Number of participants with a CLASI response at Day 210 [ Time Frame: Baseline, Day 210 ]
    The CLASI is a comprehensive tool for assessment of disease activity and damage in cutaneous lupus, shown to be valid, reliable, and sensitive to changes in disease activity. Response is defined as 50% improvement from baseline in "A" or "B" scores. This assessment will be applied to all participants as all are required to have cutaneous disease activity.

  20. Phase 2: Mean change from baseline in swollen joints and tender joints American College of Rheumatology-28 (ACR-28) joint count [ Time Frame: Baseline, up to 180 days ]
    The ACR-28 joint count will evaluate the number of tender and swollen joints in the shoulder, elbow, wrist, hand, and knee joints. Joints of the feet are excluded. Percentage change from baseline will be calculated using the following formula: ([post-baseline value - baseline value]/baseline value) x 100.

  21. Phase 2: Incidence of AEs [ Time Frame: up to Day 270 ]
    An AE is defined as any untoward medical occurrence experienced by a study participant, whether or not considered drug related by the principal investigator. AEs are unfavorable changes in a general condition, subjective or objective signs or symptoms, worsening of pre-existing concomitant disease, and clinically significant abnormality in laboratory parameters observed in a participant in the course of a clinical study. Non-serious SLE manifestations or abnormal laboratory results related to SLE disease activity will not be recorded as AEs unless they meet the definition of SAEs.

  22. Phase 2: Number of participants with a DLT [ Time Frame: up to Day 270 ]
    For the purpose of dose escalation, pre-defined AEs occurring after study drug administration, which are attributable to the study drug, will be considered DLTs

  23. Phase 2: Number of participants with a sustained reduction of oral corticosteroid (CS) (≤ 10 mg/day and ≤ Day 0 dose) between Day 120 and Day 210 [ Time Frame: Day 120 to Day 210 ]
  24. Phase 2: Number of participants with a new BILAG A flare or > 1 BILAG B flares relative to Baseline through Day 210 [ Time Frame: Baseline; Day 210 ]
  25. Phase 2: Number of participants with Physician's Global Assessment (PGA) worsening [ Time Frame: Days 30, 60, 90, 120, 150, 180, 210, 240, and 270 ]
  26. Phase 2: Number of participants with medication failures [ Time Frame: Up to Day 270 ]
  27. Phase 2: Mean change from Baseline in Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) damage index [ Time Frame: Baseline; Day 180 ]
  28. Phase 2: Time to medication failure [ Time Frame: Up to Day 270 ]
  29. Phase 2: Duration of longest SRI-4 response [ Time Frame: Up to Day 270 ]
  30. Phase 2: Time to first SRI-4 response [ Time Frame: Up to Day 270 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women, ages 18 to 70 years, inclusive
  • Participants must be mentally capable of giving consent and there must be evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study
  • Participants must have Systemic Lupus Erythematosus (SLE) as defined by meeting 4 of the Systemic Lupus International Collaborating Clinics classification criteria for SLE (with at least 1 clinical and 1 immunologic criterion OR Lupus nephritis as the sole clinical criterion in the presence of anti-nuclear antibodies (ANA) or anti-double stranded DNA (dsDNA) antibodies), either sequentially or simultaneously
  • At screening, participants must have at least 1 of the following:

    1. Elevated ANA ≥ 1:80 via immunofluorescent assay at the central laboratory
    2. Positive anti-dsDNA or anti-Smith (anti-Sm) above the normal level as determined by the central laboratory
    3. C3 or C4 levels below normal as determined by the central laboratory
  • At screening, the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) must be ≥ 6, including points from at least 1 of the following clinical components: Arthritis, rash, myositis, mucosal ulcers, pleurisy, pericarditis, and vasculitis

    1. Excluding parameters which require central laboratory results: (hematuria, pyuria, urinary casts, proteinuria, positive anti-dsDNA, decreased complement, thrombocytopenia, and leukopenia)
    2. Points from lupus headache and organic brain syndrome will also be excluded.
  • On Day 0, the SLEDAI-2K must be ≥ 6, including points from at least 1 of the following clinical components: Arthritis, rash, myositis, mucosal ulcers, pleurisy, pericarditis, and vasculitis

    1. Excluding parameters which require central laboratory results: hematuria, pyuria, urinary casts, proteinuria, positive anti-dsDNA, decreased complement, thrombocytopenia and leukopenia
    2. Points from lupus headache and organic brain syndrome will also be excluded.
  • Participants must have at least 1A or 2Bs from the following manifestations of SLE, as defined by the British Isles Lupus Assessment Group (BILAG) criteria as modified for use in this study, which must be confirmed by the central data reviewer:

    1. BILAG A or B score in the mucocutaneous body system
    2. BILAG A or B score in the musculoskeletal body system due to active polyarthritis

If only one "B" and no "A" score is present in the mucocutaneous body system or in the musculoskeletal body system due to arthritis, then at least 1 "B" must be present in the other body systems for a total of 2 "B" BILAG body system scores

  • Participants must be currently receiving at least 1 of the following:

    1. Administration for a minimum of 12 weeks, and a stable dose for at least 56 days (8 weeks prior to signing consent) of the following permitted steroid sparing agents: Azathioprine, mycophenolate mofetil or mycophenolic acid, chloroquine, hydroxychloroquine, or methotrexate
    2. Prednisone (or prednisone-equivalent) cannot exceed 30 milligrams per day (mg/day) at screening for a participant to be eligible and must be stable at a maximum of 10 mg/day for at least 5 days prior to Day 0 (randomization)
  • Women of childbearing potential (WOCBP):

    1. Must have a negative serum pregnancy test at screening. Urine pregnancy test must be negative prior to first dose
    2. Must not be breastfeeding
    3. Must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug plus 5 half-lives of study drug BOS1617219 plus 30 days (duration of ovulatory cycle) for a total of 36 weeks after treatment completion
  • Men who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug plus 5 half lives of BOS161721 plus 90 days (duration of sperm turnover) for a total of 44 weeks after treatment completion
  • Participants must demonstrate willingness and ability to comply with the scheduled study visits, treatment plans, laboratory tests, and other procedures

Exclusion Criteria:

Participants presenting with any of the following will not be included in this study:

  • Drug-induced SLE, rather than "idiopathic" SLE
  • Other systemic autoimmune disease (eg, erosive arthritis, rheumatoid arthritis [RA], multiple sclerosis [MS], systemic scleroderma, or vasculitis not related to SLE). RA-Lupus overlap (Rupus), and secondary Sjogren syndrome are allowed.
  • Any major surgery within 6 weeks of study drug administration (Day 0) or any elective surgery planned during the course of the study
  • Any history or risk for tuberculosis (TB), specifically those with:

    1. Current clinical, radiographic, or laboratory evidence of active TB
    2. History of active TB
    3. Latent TB defined as positive QuantiFERON-TB Gold In Tube or other diagnostic test in the absence of clinical manifestations. Latent TB is not excluded if the participant has documented completion of adequate course of prophylactic treatment with regimen recommended by local health authority guideline, or the participant has started treatment with isoniazid, or other regimen recommended by local health authority guidelines for at least 1 month before Day 0 and continues to receive the prophylactic treatment during study until the treatment course is completed
  • Active or unstable lupus neuropsychiatric manifestations, including but not limited to any condition defined by BILAG A criteria, with the exception of mononeuritis multiplex and polyneuropathy, which are allowed
  • Severe proliferative lupus nephritis (World Health Organization Class III, IV), which requires or may require induction treatment with cytotoxic agents or high dose corticosteroids
  • Concomitant illness that, in the opinion of the investigator, is likely to require additional systemic glucocorticosteroid therapy during the study, (eg, asthma), is exclusionary. However, treatment for asthma with inhalational corticosteroids therapy is allowed.
  • Use or planned use of concomitant medication outside of standard of baseline treatment for SLE from Day -1 or for any time during the study
  • Active and clinically significant infection (bacterial, fungal, viral, or other) within 60 days prior to first dose of study drug. Clinically significant is defined as requiring systemic parenteral antibiotics or hospitalization
  • A history of opportunistic infection, or a history of recurrent or severe disseminated herpes zoster or disseminated herpes simplex within the last 3 years
  • Chronic viral hepatitis B (HBV) and hepatitis C (HCV), unless participant received curative treatment for HCV and has a documented negative viral load, known human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS)-related illness
  • Cryptosporidium in the stool sample at screening
  • White blood cells < 1,200/millimeters cubed (mm^3) (1.2 × 10^9/Liter [L]) at screening
  • Absolute neutrophil count < 500/mm^3 at screening
  • CD4+ count < 350/microliter (µL) at screening
  • Platelets < 50,000/mm^3 (50 × 10^9/L) or < 35,000/mm^3 (35 × 10^9/L) if related to SLE, at screening
  • Hemoglobin < 8 grams per deciliter (g/dL) or < 7 g/dL at screening if related to SLE
  • Proteinuria > 3.0 g/day (3000 milligrams per day [mg/day]) at screening or equivalent level of proteinuria as assessed by protein/creatinine ratio (3 mg/mg or 339 milligrams per millimole [mg/mmol])
  • Serum creatinine > 2.0 mg/dL at screening or creatinine clearance < 40 milliliters per minute (mL/minute) based on Cockcroft-Gault calculation
  • Serum alanine aminotransferase and/or serum aspartate aminotransferase > 2 × the upper limit of normal (ULN) at screening, unless explicitly related to lupus based on the investigator's judgment
  • Creatinine kinase > 3.0 × ULN at screening unless related to lupus myositis
  • Direct bilirubin > 1.5 × ULN at screening (unless related to Gilbert's syndrome)
  • Any other laboratory test results that, in the opinion of the Investigator, might place a participant at unacceptable risk for participating in this study
  • History of allergic or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibodies (mAb) (eg, IgG protein) or molecules made of components of mAbs
  • History substance and/or alcohol abuse, or dependence within the past 1 year, at the investigator's judgment
  • History of cancer within the last 5 years (except for cutaneous basal cell or squamous cell cancer, or cervical cancer in situ resolved by excision)
  • Any other severe acute or chronic medical or psychiatric condition, including recent (within the past year) medical conditions (eg, cardiovascular conditions, respiratory illnesses) that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study
  • Investigational site staff members directly involved in the conduct of the trial and their family members, site staff members otherwise supervised by the investigator, or participants who are employees of the sponsor or directly involved in the conduct of the trial
  • Currently participating in, or who have participated in other interventional (drug or device) clinical study within 30 days or 5 half-lives of baseline, whichever is longer
  • Recent (within the past 12 months) or active suicidal ideation or behavior based on participant responding "yes" to question 3, 4, or 5 on the Columbia Suicide severity Rating Scale
  • Current or pending incarceration
  • Current or pending compulsory detainment for treatment of either a psychiatric or physical (eg, infectious disease) illness

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03371251


Contacts
Contact: Jeremy Perkins +1 214 566 2368 jeremy.perkins@syneoshealth.com

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Sponsors and Collaborators
Boston Pharmaceuticals

Responsible Party: Boston Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03371251     History of Changes
Other Study ID Numbers: BOS161721-02
First Posted: December 13, 2017    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Boston Pharmaceuticals:
Adults
BOS161721
standard of care
moderately to severely active Systemic Lupus Erythematosus

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases