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Study of Repeated Administration of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus (IP-006)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03427151
Recruitment Status : Completed
First Posted : February 9, 2018
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
ImmuPharma

Tracking Information
First Submitted Date  ICMJE December 8, 2017
First Posted Date  ICMJE February 9, 2018
Last Update Posted Date April 11, 2019
Actual Study Start Date  ICMJE February 27, 2018
Actual Primary Completion Date February 5, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2018)
  • Occurrence of adverse events throughout the study [ Time Frame: 7 months ]
    all adverse events will be coded using MedDRA and the sverity will be graded according to the modified WHO toxicity Criteria and they will be determined by the Investigator to be treatment related. The incidence of adverse events will be summarized using descriptive statistics by system organ classe and preferred term.
  • Clinical laboratory test results at each visit during the treatment extension period [ Time Frame: 7 months ]
    Summary statistics for laboratory tests will be presented at baseline and at each visit.The severity of select laboratory resuts will be graded accroding the Modified WHO Toxicity Criteria.
  • Body weight measurements at each visit during the treatment period [ Time Frame: 7 months ]
    The incidence of clinically significant abonormal values will be summarized using descriptive statistics.
  • Temperature measurements at each visit during the treatment period [ Time Frame: 7 months ]
    The incidence of clinically significant abonormal values will be summarized using descriptive statistics.
  • Pulse measurements at each visit during the treatment period [ Time Frame: 7 months ]
    The incidence of clinically significant abonormal values will be summarized using descriptive statistics.
  • Systolic and diastolic blood pressures measurements at each visit during the treatment period [ Time Frame: 7 months ]
    The incidence of clinically significant abonormal values will be summarized using descriptive statistics.
  • 2-lead electrocardiogram (ECG) findings at week 28 (or final assessment) [ Time Frame: 7 months ]
    Any ECG finding that is judged by the investigator as a clinically significant change (worsening) compared to a baseline value will be considered an adverse event coded using MedDRA
  • Physical examination findings, at specified time points at each visit during the treatment extension period [ Time Frame: 7 months ]
    Body system (General appearance, Skin, HEENT (Head, eyes, ears, nose, throat), Lymph Nodes, Thyroïd, Musculo-skeletal / Extremities, Cardiovascular, Lungs, Abdomen, Neurological) findings that is judged by the investigator as a clinically significant change (worsening) compared to a baseline value will be considered an adverse event coded using MedDRA
  • Concomitant medication usage throughout the study extension [ Time Frame: 7 months ]
    All concomittant medication will be coded using the WHO Drug dictionnary. The incidence of concomittant medications will be sumamrized using descriptive statistics by therapeutic class and preferred terms category.
Original Primary Outcome Measures  ICMJE
 (submitted: February 2, 2018)
  • Occurrence of adverse events throughout the study [ Time Frame: 7 months ]
    all adverse events will be coded using MedDRA and the sverity will be graded according to the modified WHO toxicity Criteria and they will be determined by the Investigator to be treatment related. The incidence of adverse events will be summarized using descriptive statistics by system organ classe and preferred term.
  • Clinical laboratory test results at each visit during the treatment extension period [ Time Frame: 7 months ]
    Summary statistics for laboratory tests will be presented at baseline and at each visit.The severity of select laboratory resuts will be graded accroding the Modified WHO Toxicity Criteria.
  • Body weight measurements at each visit during the treatment period [ Time Frame: 7 months ]
    The incidence of clinically significant abonormal values will be summarized using descriptive statistics.
  • Temperature measurements at each visit during the treatment period [ Time Frame: 7 months ]
    The incidence of clinically significant abonormal values will be summarized using descriptive statistics.
  • Pulse measurements at each visit during the treatment period [ Time Frame: 7 months ]
    The incidence of clinically significant abonormal values will be summarized using descriptive statistics.
  • Systolic and diastolic blood pressures measurements at each visit during the treatment period [ Time Frame: 7 months ]
    The incidence of clinically significant abonormal values will be summarized using descriptive statistics.
  • 2-lead electrocardiogram (ECG) findings at week 28 (or final assessment) [ Time Frame: 7 months ]
    Any ECG finding that is judged by the investigator as a clinically significant change (worsening) compared to a baseline value will be considered an adverse event coded using MedDRA
  • Physical examination findings, at specified time points at each visit during the treatment extension period [ Time Frame: 7 months ]
    Any physical examination indings that is judged by the investigator as a clinically significant change (worsening) compared to a baseline value will be considered an adverse event coded using MedDRA
  • Concomitant medication usage throughout the study extension [ Time Frame: 7 months ]
    All concomittant medication will be coded using the WHO Drug dictionnary. The incidence of concomittant medications will be sumamrized using descriptive statistics by therapeutic class and preferred terms category.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2018)
  • the effect in the Clinical SLEDAI-2K total score by at final visit compared to initial visit [ Time Frame: at week 28 ]
    The SLEDAI 2K is a validated objective measure that assesses disease activity within the last 28 days before completion of the index. It is a global index and includes 24 weighted clinical and laboratory variables. The SLEDAI-2K clinical score is the calculated score without inclusion of the points that may be contributed by having a psoitive titer fr anti-dsdna Ab or decreased serum complement level. The SLEDAI-2K clinical score (sum of 22 scores) ranges from 0 to 101.
  • remission of the disease (i.e reduction of clinical SLEDAI-2K score to 0) [ Time Frame: at week 28 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Repeated Administration of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus
Official Title  ICMJE An Open-label Study of the Safety and Tolerability of Repeated Administration of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus
Brief Summary this study extension objective is to evaluate the safety and tolerability of a 200-mcg dose every 4 weeks for 24 weeks of IPP-201101 in patients with active systemic lupus erythematosus (SLE) who had participated in the main study IP-005.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
open label
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lupus Erythematosus, Systemic
Intervention  ICMJE Drug: IPP-201101
200 mcg of IPP-201101 will be administered subcutaneously every 4 weeks for 24 weeks.
Study Arms  ICMJE Experimental: IPP-201101
every 4 weeks
Intervention: Drug: IPP-201101
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: November 28, 2018)
62
Original Estimated Enrollment  ICMJE
 (submitted: February 2, 2018)
100
Actual Study Completion Date  ICMJE February 5, 2019
Actual Primary Completion Date February 5, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient had participated previously to study IP-005
  • Written informed consent is obtained.
  • Female and males receiving IPP-201101 and their female partners must use a highly effective contraceptive during treatment and for 30 days after discontinuation of study drug treatment.
  • Women must be surgically sterile, 2 years postmenopausal, or, if of childbearing potential, use a highly effective method of contraception, Men and their partner must have highly effective accepted method of contraception. Single barrier/Double barrier and spermicides are not acceptable methods of contraception. Highly effective methods of contraception include, true abstinence, intrauterine device (IUD), or hormonal contraception associated with inhibition of ovulation (oral, transdermal, implanted, and injected), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomised partner. True abstinence is defined when this is in line with the preferred and usual lifestyle of the subject." [Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration of a trial, and withdrawal are not acceptable methods of contraception]
  • 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.

Criteria for Exclusion: Patients are excluded from participating in this study if 1 or more of the following criteria are met:

  • 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 or 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.
  • 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 except for 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 and older   (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,   Puerto Rico,   United States
Removed Location Countries Poland
 
Administrative Information
NCT Number  ICMJE NCT03427151
Other Study ID Numbers  ICMJE IPP-201101/006
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party ImmuPharma
Study Sponsor  ICMJE ImmuPharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
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