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

NCT ID: NCT02504645

Last Updated: 2019-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 202 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2018-01-31

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.

Conditions

Lupus Erythematosus, Systemic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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).

Group Type: ACTIVE_COMPARATOR

IPP-201101

Intervention Type: DRUG

Standard of Care

Intervention Type: OTHER

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).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Standard of Care

Intervention Type: OTHER

Interventions

IPP-201101

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Standard of Care

Intervention Type: OTHER

Other Intervention Names

Lupuzor, regiremod

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ImmuPharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel WALLACE

Role: PRINCIPAL_INVESTIGATOR

Wallace Rheumatic Studies Center LLC

Locations

WALLACE

Los Angeles, California, United States

East Bay Rheumatology Medical

San Leandro, California, United States

Denver Arthritis Clinic

Denver, Colorado, United States

Arthritis and Rheumatic Disease Specialties

Aventura, Florida, United States

McILwain Medical Group

Tampa, Florida, United States

Arthritis Research & Treatment Center

Stockbridge, Georgia, United States

Innovative Health Research

Las Vegas, Nevada, United States

Thurston Arthritis Research Center

Chapel Hill, North Carolina, United States

DJL Clinical Research, PLLC

Charlotte, North Carolina, United States

Revmatologie s.r.o.

Brno, , Czechia

Revmatologický ústav v Praze

Prague, , Czechia

CHU Felix Guyon

Saint-Denis, La Réunion, France

Hopital Haut Lévêque

Bordeaux, , France

Hôpital européen

Marseille, , France

GHR Mulhouse Sud-Alsace

Mulhouse, , France

Hôpital Cochin

Paris, , France

CHU Strasbourg Hôpital de Hautepierre

Strasbourg, , France

CHU Strasbourg Nouvel Hôpital Civil

Strasbourg, , France

Schlosspark-Klinik Berlin

Berlin, , Germany

Clinic for Rheumatology and Internal Medicine

Freiburg im Breisgau, , Germany

Egyesitett Szt.István és Szt. László Kórház

Budapest, , Hungary

University of Debrecen Medical Center Department of Clinical Immunology

Debrecen, , Hungary

Synexus Gyula AS

Gyula, , Hungary

Mentaház Magánorvosi Központ Kft.

Székesfehérvár, , Hungary

Cap Research

Phoenix, , Mauritius

Centrum Medyczne Plejady

Krakow, , Poland

Krakowskie Centrum Medyczne

Krakow, , Poland

Centrum Medyczne Hetmańska

Poznan, , Poland

Centrum Medyczne Oporow

Wroclaw, , Poland

Latin Clinical Trial Center

San Juan, PR, Puerto Rico

Countries

United States; Czechia; France; Germany; Hungary; Mauritius; Poland; Puerto Rico

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

IPP-201101/005

Identifier Type: -

Identifier Source: org_study_id