Clinical trial NCT02504645: 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: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lupus Erythematosus, Systemic
Lead sponsor: ImmuPharma
Sponsor class: INDUSTRY
First posted: 2015-07-22
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Assessment of Systemic Lupus Erythematosus Responder Index (SRI) at Week 52
timeFrame: At week 52
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: WALLACE
state: California
city: San Leandro
country: United States
facility: East Bay Rheumatology Medical
state: California
city: Denver
country: United States
facility: Denver Arthritis Clinic
state: Colorado
city: Aventura
country: United States
facility: Arthritis and Rheumatic Disease Specialties
state: Florida
city: Tampa
country: United States
facility: McILwain Medical Group
state: Florida
city: Stockbridge
country: United States
facility: Arthritis Research & Treatment Center
state: Georgia
city: Las Vegas
country: United States
facility: Innovative Health Research
state: Nevada
city: Chapel Hill
country: United States
facility: Thurston Arthritis Research Center
state: North Carolina
city: Charlotte
country: United States
facility: DJL Clinical Research, PLLC
state: North Carolina
city: Brno
country: Czechia
facility: Revmatologie s.r.o.
city: Praha
country: Czechia
facility: Revmatologický ústav v Praze
city: Saint-Denis
country: France
facility: CHU Felix Guyon
state: La Réunion
city: Bordeaux
country: France
facility: Hopital Haut Lévêque
city: Marseille
country: France
facility: Hôpital européen
city: Mulhouse
country: France
facility: GHR Mulhouse Sud-Alsace
city: Paris
country: France
facility: Hôpital Cochin
city: Strasbourg
country: France
facility: CHU Strasbourg Hôpital de Hautepierre
city: Strasbourg
country: France
facility: CHU Strasbourg Nouvel Hôpital Civil
city: Berlin
country: Germany
facility: Schlosspark-Klinik Berlin
city: Freiburg
country: Germany
facility: Clinic for Rheumatology and Internal Medicine
city: Budapest
country: Hungary
facility: Egyesitett Szt.István és Szt. László Kórház
city: Debrecen
country: Hungary
facility: University of Debrecen Medical Center Department of Clinical Immunology
city: Gyula
country: Hungary
facility: Synexus Gyula AS
city: Székesfehérvár
country: Hungary
facility: Mentaház Magánorvosi Központ Kft.
city: Phoenix
country: Mauritius
facility: Cap Research
city: Krakow
country: Poland
facility: Centrum Medyczne Plejady
city: Kraków
country: Poland
facility: Krakowskie Centrum Medyczne
city: Poznan
country: Poland
facility: Centrum Medyczne Hetmańska
city: Wroclaw
country: Poland
facility: Centrum Medyczne Oporow
city: San Juan
country: Puerto Rico
facility: Latin Clinical Trial Center
Study officials:
affiliation: Wallace Rheumatic Studies Center LLC
name: Daniel WALLACE
role: PRINCIPAL_INVESTIGATOR
References: