A study to evaluate the effectiveness and safety of the study drug, when patients are given a 200-mcg dosage of IPP-201101 plus standard of care in patients with systemic lupus erythematosus.

• Register: EUCTR
• Last refreshed on: 18 June 2018
• Main ID: EUCTR2015-003341-25-HU
• Date of registration: 07/03/2016
• Prospective Registration: Yes
• Primary sponsor: ImmuPharma SA
• Public title: A study to evaluate the effectiveness and safety of the study drug, when patients are given a 200-mcg dosage of IPP-201101 plus standard of care in patients with systemic lupus erythematosus.
• Scientific title: 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 - A study to evaluate the effectiveness and safety of the study drug for patients with SLE.
• Date of first enrolment: 02/05/2016
• Target sample size: 200
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-003341-25
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

France, Germany, Hungary, United States

Contacts

• Name: Fanny Valleix
• Affiliation: ImmuPharma SA

• Name: Fanny Valleix
• Affiliation: ImmuPharma SA

Key inclusion & exclusion criteria

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)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].
(e)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.
(f)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.
(g)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.
(h)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.
(i)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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion criteria:
Criteria for Exclusion: Patients are excluded from participating in this study if 1 or more of the following criteria are met:
(a)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.
(b)The patient has received tacrolimus, cyclosporin A, or iv immunoglobulins (IVIG) within 3 months of the 1st dose of study drug.
(c)The patient has received cyclophosphamide within 6 months prior to the 1st dose of study drug.
(d)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.
(e)The patient has received B-cell depleting agents such as rituximab or belimumab and has not yet normalized the B-cell count (ie, CD20+ B-cell count is less than 200 and the absolute lymphocyte count [ALC] is less than 1500/µL).
(f)The patient has New York Heart Association (NYHA) Class III or IV congestive heart failure.
(g)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).
(h)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.
(i)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.
(j)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.
(k)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.
(l)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.
(m)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.
(n)The patient has a positive test result for hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody (HCV Ab).
(o)The patient has a known positive history of antibodies to human immunodeficiency virus (HIV) or HIV disease or other immunosuppressive state (eg, agammaglobulinemia, etc).
(p)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.
(q)The patient has a history of severe all

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus
MedDRA version: 18.1 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]

Intervention(s)

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

Primary Outcome(s)

Primary end point(s): Assessed by the SLE responder index (SRI) at week 52.

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.

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(s)

Timepoint(s) of evaluation of this end point: weeks 12, 24, 36, and 52 (or final assessment)

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

Secondary ID(s)

IPP-201101/005

Source(s) of Monetary Support

ImmuPharma SA