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

INTERVENTION: Product Code: IPP‐201101 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: IPP‐201101 Current Sponsor code: IPP‐201101 Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 200‐ Pharmaceutical form of the placebo: Concentrate for solution for infusion Route of administration of the placebo: Subcutaneous use CONDITION: Systemic Lupus Erythematosus ; MedDRA version: 19.0 Level: PT Classification code 10042945 Term: Systemic lupus erythematosus System Organ Class: 10028395 ‐ Musculoskeletal and connective tissue disorders Therapeutic area: Body processes [G] ‐ Immune system processes [G12] PRIMARY OUTCOME: Main Objective: The primary objective of this study is to evaluate the efficacy of a 200‐mcg dose every 4 weeks for 48 weeks of IPP‐201101 compared with placebo in patients with active systemic lupus erythematosus (SLE) as assessed by the SLE responder index (SRI) at week 52. Primary end point(s): Assessed by the SLE responder index (SRI) at week 52. Secondary Objective: •the SRI response at each visit during the study; •the reduction of the SLEDAI‐2K total score by at least 4 points at each visit during the treatment period; •the effect of IPP‐201101 on disease activity ; •the effect of IPP‐201101 on the status of disease ; ; Assessed at each visit during the treatment period, the following:; ; •the reduction of the SLEDAI‐2K total score by at least 5 points ; •the reduction of the SLEDAI‐2K total score by at least 6 points; •the SRI‐5 response ; •the SRI‐6 response ; •the effect of IPP‐201101 on arthritis, as assessed by the 28‐joint count examination for pain and tenderness ; •the effect of IPP‐201101 on the incidence of disease flares ; •the effect of IPP‐201101 on the occurrence of SLE–induced organ damage at visits at weeks 24 and 52 or final assessment; •the effect of IPP‐201101 on health‐related quality of life, ; •the effect of IPP‐201101 on steroid dose over time throughout the study Timepoint(s) of evaluation of this end point: week 52 SECONDARY OUTCOME: Secondary end point(s): the SRI response at each visit during the study; •the reduction of the SLEDAI‐2K total score by at least 4 points at each visit during the treatment period; •the effect of IPP‐201101 on disease activity ; •the effect of IPP‐201101 on the status of disease (PhGA scale) ; •the reduction of the SLEDAI‐2K total score by at least 5 points at each visit during the treatment period; •the reduction of the SLEDAI‐2K total score by at least 6 points at each visit during the treatment period; •the SRI‐5 response at each visit during the treatment period; •the SRI‐6 response at each visit during the treatment period; •the effect of IPP‐201101 on arthritis, as assessed by the 28‐joint count examination for pain and tenderness at each visit during the treatment period; •the effect of IPP‐201101 on the incidence of disease flares ; •the effect of IPP‐201101 on the occurrence of SLE–induced organ damage at visits at weeks 24 and 52 or final assessment; •the effect of IPP‐201101 on health‐related quality of life, ; •the effect of IPP‐201101 on steroid dose over time throughout the study Timepoint(s) of evaluation of this end point: weeks 12, 24, 36, and 52 (or final assessment) INCLUSION CRITERIA: (a)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. (b)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]). (c)Written informed consent is obtained. (d)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, intrauterine device(IUD), or steroidal c