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A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus (LUPUZOR)

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ClinicalTrials.gov Identifier: NCT02504645
Recruitment Status : Completed
First Posted : July 22, 2015
Results First Posted : April 11, 2019
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
ImmuPharma

Tracking Information
First Submitted Date  ICMJE July 17, 2015
First Posted Date  ICMJE July 22, 2015
Results First Submitted Date  ICMJE February 12, 2019
Results First Posted Date  ICMJE April 11, 2019
Last Update Posted Date April 11, 2019
Actual Study Start Date  ICMJE March 2015
Actual Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2019)
Assessment of Systemic Lupus Erythematosus Responder Index (SRI) at Week 52 [ Time Frame: At week 52 ]
A Systemic lupus erythematosus Responder Index (SRI) response is defined as a reduction from baseline in the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score of at least 4 points, no worsening in Physician's Global Assessment (PhGA) (with worsening defined as an increase in PhGA of more than 0.30 point from baseline), no new British Isles Lupus Assessment Group A (BILAG A) body system score, and no more than 1 new BILAG B body system score from baseline. The decrease of 4 points of the SRI is considered as better ouctome.
Original Primary Outcome Measures  ICMJE
 (submitted: July 21, 2015)
Assessment of Systemic Lupus Erythematosus Responder Index (SRI) at Week 52 [ Time Frame: baseline and week 52 ]
A SRI response is defined as a reduction from baseline in the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score of at least 4 points, no worsening in Physician's Global Assessment (PhGA) (with worsening defined as an increase in PhGA of more than 0.30 point from baseline), no new British Isles Lupus Assessment Group A (BILAG A) body system score, and no more than 1 new BILAG B body system score from baseline.
Change History Complete list of historical versions of study NCT02504645 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: July 21, 2015)
  • Systemic Lupus Erythematosus Responder Index (SRI) response at each visit during the study [ Time Frame: baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 ]
  • the reduction in the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score by at least 4 points at each visit during the treatment period [ Time Frame: baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 ]
  • assessment of the British Isles Lupus Assessment Group (BILAG-2004) disease activity index, at each visit during the treatment period [ Time Frame: baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 ]
  • status of disease by Physician's Global Assessment (PhGA scale) at each visit during the treatment period [ Time Frame: baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 ]
  • the reduction of the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score by at least 5 points at each visit during the treatment period [ Time Frame: baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 ]
  • the reduction of the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score by at least 6 points at each visit during the treatment period [ Time Frame: baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 ]
  • the Systemic Lupus Erythematosus Responder Index (SRI-5) response at each visit during the treatment period [ Time Frame: baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 ]
  • the Systemic Lupus Erythematosus Responder Index (SRI-6) response at each visit during the treatment period [ Time Frame: baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 ]
  • assessment by the 28-joint count examination for pain and tenderness at each visit during the treatment period [ Time Frame: baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 ]
  • incidence of disease flares at each visit during the treatment period [ Time Frame: baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 ]
    ie, Safety of Estrogens in Lupus Erythematosus: National Assessment [SELENA] Flare Index [SFI] and Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score of greater than 15
  • occurrence of Systemic Lupus Erythematosus (SLE)-induced organ damage at visits at weeks 24 and 52 (or final assessment) [ Time Frame: baseline, weeks 24 and 52 ]
    eg, Systemic Lupus International Collaborative Clinics/American College of Rheumatology [SLICC/ACR] Damage Index (SDI) and adverse event inquiry
  • assessment of health-related quality of life by completion of the Medical Outcome Survey Short Form 36 (SF-36) at visits at weeks 12, 24, 36, and 52 (or final assessment) [ Time Frame: baseline, weeks 12, 24, 36 and 52 ]
  • steroid dose over time throughout the study. [ Time Frame: baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 ]
  • biologic markers of disease activity assessment at each visit during the treatment period [ Time Frame: baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 ]
    anti-double-stranded deoxyribonucleic acid antibody (anti-dsDNA Ab) complement components (C3 and C4)
  • biologic markers of disease activity assessment at visits at weeks 4, 12, 24, 36, and 52 (or final assessment) [ Time Frame: baseline, weeks 4, 12, 24, 36 and 52 ]
    antinuclear antibody (ANA)
  • biologic markers of disease activity assessment at visits at weeks 4, 12, 24, 36, and 52 (or final assessment) [ Time Frame: baseline, weeks 4, 12, 24, 36 and 52 ]
    anti-uridine rich 70 kilodalton small nuclear ribonucleoprotein particle Ab (anti-U1-70K snRNP Ab)
  • biologic markers of disease activity assessment at visits at weeks 4, 12, 24, 36, and 52 (or final assessment) [ Time Frame: baseline, weeks 4, 12, 24, 36 and 52 ]
    anti-Smith antibody (anti-Sm Ab)
  • biologic markers of disease activity assessment at visits at weeks 4, 12, 24, 36, and 52 (or final assessment) [ Time Frame: baseline, weeks 4, 12, 24, 36 and 52 ]
    C-reactive protein (CRP)
  • biologic markers of disease activity assessment at visits at weeks 4, 12, 24, 36, and 52 (or final assessment) [ Time Frame: baseline, weeks 4, 12, 24, 36 and 52 ]
    immunoglobulin G (IgG), immunoglobulin M (IgM), and immunoglobulin E (IgE), immunoglobulin A (Ig A)
  • assessment of fatigue using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale at visits at weeks 12, 24, 36, and 52 (or final assessment) [ Time Frame: baseline, weeks 4, 12, 24, 36 and 52 ]
  • in vitro intracellular and cytokine response [ Time Frame: baseline, weeks 4, 24 and 52 ]
  • occurrence of adverse events throughout the study [ Time Frame: baseline, weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 ]
  • clinical laboratory test results at each visit during the treatment period [ Time Frame: baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 ]
    serum chemistry, hematology, and urinalysis
  • vital signs assessment at each visit [ Time Frame: baseline, weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 ]
    systolic and diastolic blood pressures, pulse, temperature, and body weight
  • 12-lead electrocardiogram (ECG) findings at week 52 (or final assessment) [ Time Frame: baselie and week 52 ]
  • physical examination findings [ Time Frame: baseline, weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 ]
    including physical examination symptom directed findings, at specified time points at each visit during the treatment period evaluation for suicidality at each visit during the treatment period using the Columbia-Suicide Severity Rating Scale (C-SSRS) concomitant medication usage throughout the study
  • evaluation for suicidality at each visit during the treatment period using the Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 ]
    concomitant medication usage throughout the study
  • concomitant medication usage throughout the study [ Time Frame: baseline, weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus
Official Title  ICMJE A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus
Brief Summary This current Phase 3 study will evaluate the efficacy and safety of administration of subcutaneous (sc) IPP-201101 in patients with active SLE.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Lupus Erythematosus, Systemic
Intervention  ICMJE
  • Drug: IPP-201101
    Other Name: Lupuzor, regiremod
  • Drug: Placebo
  • Other: Standard of Care
Study Arms  ICMJE
  • Active Comparator: IPP-201101 200-mcg plus SOC
    Patients randomly assigned to IPP-201101 will be administered a dosage of 200 mcg subcutaneously (sc) every 4 weeks for 48 weeks (a total of 13 doses will be administered).
    Interventions:
    • Drug: IPP-201101
    • Other: Standard of Care
  • Placebo Comparator: PLACEBO plus SOC
    Patients randomly assigned to placebo will be administered placebo subcutaneously (sc) every 4 weeks for 48 weeks (a total of 13 doses will be administered).
    Interventions:
    • Drug: Placebo
    • Other: Standard of Care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 10, 2019)
202
Original Estimated Enrollment  ICMJE
 (submitted: July 21, 2015)
200
Actual Study Completion Date  ICMJE January 2018
Actual Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • The patient is a man or woman between 18 and 70 years of age with an established diagnosis of SLE as defined by ACR Classification Revised Criteria. The diagnosis is fulfilled provided that at least 4 criteria are met.
  • The patient has a positive test result for ANA at screening (titer must be at least 1:80 [by human epithelial cell tumor line (HEp-2) ANA assay]) and/or a positive test result for anti-dsDNA Ab at screening (value must be 30 IU/mL or more by enzyme-linked immunosorbent assay [ELISA]).
  • Written informed consent is obtained.
  • Women must be surgically sterile, 2 years postmenopausal, or, if of childbearing potential, using a medically accepted method of contraception, and must agree to continued use of this method for the duration of the study and for 30 days after discontinuation of study drug treatment. Acceptable methods of contraception include barrier method with spermicide, abstinence (when this is in line with the preferred and usual lifestyle of the subject), intrauterine device (IUD), or steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction with a barrier method.
  • The patient has a SLEDAI-2K clinical score of at least 6 points during screening. A SLEDAI-2K clinical score is the calculated score without inclusion of the points that may be contributed by having a positive titer for anti-dsDNA Ab or decreased serum complement levels.
  • The patient does not have an "A" score on the BILAG-2004 scale. If the patient is using oral corticosteroids, the weekly cumulative dose must not exceed 80 mg of prednisone equivalent; the weekly dose must be stable over the 4 weeks preceding the 1st dose of study drug.
  • If the patient is using antimalarials, methotrexate, leflunomide, mycophenolate mofetil (MMF), or azathioprine, the start date must be at least 3 months prior to the 1st dose of study drug, and the daily dose must be stable over the 4 weeks preceding the 1st dose of study drug.
  • If the patient is not currently using corticosteroids, antimalarials, methotrexate, MMF, or azathioprine, the last dose (in case of previous use) must be at least 4 weeks prior to the 1st dose of study drug. For leflunomide, the stop date must be at least 8 weeks before the 1st dose of study drug unless an adequate cholestryamine washout has been performed. If cholestyramine washout is performed, the last use of leflunomide must be at least 4 weeks before the 1st dose of study drug.
  • The patient must be willing and able to comply with study restrictions, to remain at the study center for the required duration during each study visit, and to return to the study center for the final assessment as specified in this protocol.

Exclusion Criteria:

  • The patient has been treated with intramuscular or intravenous (iv) pulse steroids (ie, 250 to 1000 mg iv total daily dose of methylprednisolone) within 4 weeks of the 1st dose of study drug. The use of intra-articular steroids may be allowed after consultation with the medical expert.
  • The patient has received tacrolimus, cyclosporin A, or iv immunoglobulins (IVIG) within 3 months of the 1st dose of study drug.
  • The patient has received cyclophosphamide within 6 months prior to the 1st dose of study drug.
  • The patient has been treated for SLE with agents such as fusion proteins, therapeutic proteins, or monoclonal antibodies or antibody fragments, within 6 months of the 1st dose of study drug.
  • The patient has received B-cell depleting agents such as rituximab, belimumab or epratuzumab within one year of the 1st dose and has not yet normalized the B-cell count (ie, CD20+ B-cell count is less than normal range and the absolute lymphocyte count [ALC] is less than normal range).
  • The patient has New York Heart Association (NYHA) Class III or IV congestive heart failure.
  • The patient has an estimated glomerular filtration rate (eGFR) of less than 30 mL/min/1.73 m2 (via Modification of Diet in Renal Disease [MDRD] equation).
  • The patient has an aspartate aminotransferase (AST) or alanine aminotransferase (ALT) value greater than 2 times the upper limit of the normal range (ULN) or a total bilirubin level greater than 1.5 times ULN.
  • The patient has a planned immunization with a live or live attenuated vaccine within 3 months prior to administration of the 1st dose of study drug and for 3 months after administration of the last dose of study drug.
  • The patient has any clinically significant abnormalities on ECG that are not related to SLE, as determined by the investigator. Patients with stable ECG changes without evidence of active cardiovascular disease may participate at the discretion of the investigator and medical monitor.
  • The patient has an ongoing active systemic infection requiring treatment or a history of severe infection, such as hepatitis or pneumonia, in the 3 months prior to administration of the 1st dose of study drug. Less severe infections in the 3 months prior to administration of the 1st dose of study drug are permitted at the discretion of the investigator and medical monitor.
  • The patient has any concomitant medical condition unrelated to SLE that may interfere with his or her safety or with evaluation of the study drug, as determined by the investigator.
  • The patient has a history of a medical condition other than SLE that has required treatment with oral corticosteroids in excess of 80 mg of prednisone equivalent/week within 3 months of the 1st dose of study drug.
  • The patient has a positive test result for hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody (HCV Ab).
  • The patient has a known positive history of antibodies to human immunodeficiency virus (HIV) or HIV disease or other immunosuppressive state (eg, agammaglobulinemia, etc).
  • The patient has a history of alcohol or substance dependence or abuse (with the exception of nicotine),according to the Diagnostic and Statistical Manual of Mental Disorders of the American Psychiatric Association, Fourth Edition, Text Revision (DSM-IV-TR), within 3 months of the screening visit or has current substance abuse.
  • The patient has a history of severe allergic reactions to or hypersensitivity to any component of the study drug or placebo.
  • The patient has undergone or is undergoing treatment with another investigational drug for the treatment of lupus within 6 months prior to the 1st dose of study drug or has received any other investigational drug for any other condition within 4 weeks prior to the 1st dose of study drug.
  • The patient has previously participated in a ImmuPharma- or ImmuPharma-sponsored clinical study with IPP-201101.
  • The patient is a pregnant or lactating woman. (Any women becoming pregnant during the study will be withdrawn from the study.)
  • The patient is unlikely to comply with the study protocol or is unsuitable for any other reason, as judged by the investigator or medical monitor.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czechia,   France,   Germany,   Hungary,   Mauritius,   Poland,   Puerto Rico,   United States
Removed Location Countries Czech Republic,   Italy
 
Administrative Information
NCT Number  ICMJE NCT02504645
Other Study ID Numbers  ICMJE IPP-201101/005
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party ImmuPharma
Study Sponsor  ICMJE ImmuPharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Daniel WALLACE Wallace Rheumatic Studies Center LLC
PRS Account ImmuPharma
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP