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

NCT02504645 | Completed Phase 3 Results

• 1 other identifier: IPP-201101/005
• Study Type: interventional
• Target: 202
• Locations: 8 countries
• Sites: 30

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

Outcome Measures

Primary Outcomes (1)

• Assessment of Systemic Lupus Erythematosus Responder Index (SRI) at Week 52

  A Systemic lupus erythematosus Responder Index (SRI) response is defined as a reduction from baseline in the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score of at least 4 points, no worsening in Physician's Global Assessment (PhGA) (with worsening defined as an increase in PhGA of more than 0.30 point from baseline), no new British Isles Lupus Assessment Group A (BILAG A) body system score, and no more than 1 new BILAG B body system score from baseline. The decrease of 4 points of the SRI is considered as better ouctome.

  At week 52

Study Arms (2)

IPP-201101 200-mcg plus SOC

ACTIVE COMPARATOR

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).

Drug: IPP-201101; Other: Standard of Care

PLACEBO plus SOC

PLACEBO COMPARATOR

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).

Drug: Placebo; Other: Standard of Care

Interventions

IPP-201101 DRUG

Also known as: Lupuzor, regiremod

IPP-201101 200-mcg plus SOC

Placebo DRUG

PLACEBO plus SOC

Standard of Care OTHER

IPP-201101 200-mcg plus SOC; PLACEBO plus SOC

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• ImmuPharma: lead

Study Sites (30)

WALLACE

Los Angeles, California, United States

Location

East Bay Rheumatology Medical

San Leandro, California, United States

Location

Denver Arthritis Clinic

Denver, Colorado, United States

Location

Arthritis and Rheumatic Disease Specialties

Aventura, Florida, United States

Location

McILwain Medical Group

Tampa, Florida, 33614, United States

Location

Arthritis Research & Treatment Center

Stockbridge, Georgia, United States

Location

Innovative Health Research

Las Vegas, Nevada, United States

Location

Thurston Arthritis Research Center

Chapel Hill, North Carolina, United States

Location

DJL Clinical Research, PLLC

Charlotte, North Carolina, United States

Location

Revmatologie s.r.o.

Brno, Czechia

Location

Revmatologický ústav v Praze

Prague, 128 50, Czechia

Location

CHU Felix Guyon

Saint-Denis, La Réunion, France

Location

Hopital Haut Lévêque

Bordeaux, France

Location

Hôpital européen

Marseille, France

Location

GHR Mulhouse Sud-Alsace

Mulhouse, France

Location

Hôpital Cochin

Paris, France

Location

CHU Strasbourg Hôpital de Hautepierre

Strasbourg, France

Location

CHU Strasbourg Nouvel Hôpital Civil

Strasbourg, France

Location

Schlosspark-Klinik Berlin

Berlin, Germany

Location

Clinic for Rheumatology and Internal Medicine

Freiburg im Breisgau, Germany

Location

Egyesitett Szt.István és Szt. László Kórház

Budapest, 1097, Hungary

Location

University of Debrecen Medical Center Department of Clinical Immunology

Debrecen, Hungary

Location

Synexus Gyula AS

Gyula, 5700, Hungary

Location

Mentaház Magánorvosi Központ Kft.

Székesfehérvár, 8000, Hungary

Location

Cap Research

Phoenix, Mauritius

Location

Centrum Medyczne Plejady

Krakow, Poland

Location

Krakowskie Centrum Medyczne

Krakow, Poland

Location

Centrum Medyczne Hetmańska

Poznan, Poland

Location

Centrum Medyczne Oporow

Wroclaw, Poland

Location

Latin Clinical Trial Center

San Juan, PR, 00909, Puerto Rico

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

spliceosomal peptide P140; Standard of Care

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: CEO
• Organization: ImmuPharma

robert.zimmer@immupharma.com

+33 6 18 22 16 50

Study Officials

• Daniel WALLACE

  Wallace Rheumatic Studies Center LLC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2015
• First Posted: July 22, 2015
• Study Start: March 1, 2015
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: April 11, 2019
• Results First Posted: April 11, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (2); DE (2); MA (1); PL (4); HU (4); PR (1); US (9); FR (7)