A clinical study to evaluate the tolerability of repeated doses of CEP-33457 administered in patients with a chronic autoimmune disease (Lupus)

Conditions: Patients With Systemic Lupus Erythematosus (SLE)
MedDRA version: 14.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Registration Number: EUCTR2010-019293-32-PT

Lead Sponsor: Cephalon, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 130

Inclusion Criteria

Patients are included in the study if all of the following criteria are met:
(a1) The patient previously participated in and completed at least visit 8 (week 24) in the Cephalon-sponsored clinical study with CEP-33457 (study C33457/2047) and, in the investigator's opinion, would benefit from continued participation in a clinical study.
(b) The patient is a man or woman between 18 and 70 years of age who has an established diagnosis of SLE as defined by ACR Classification Revised Criteria. The diagnosis is fulfilled provided that at least 4 criteria are met.
(c) Written informed consent is obtained.
(d) 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, intrauterine device (IUD), or steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction with a barrier method.
(e) The patient must be willing and able to comply with study restrictions, to remain at the clinic for the required duration during the study period, and to return to the clinic for the final assessment as specified in this protocol.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 126
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion Criteria

Patients are excluded from participating in this study if 1 or more of the following criteria are met:
(a) The patient has New York Heart Association (NYHA) Class III or IV
congestive heart failure
(b) The patient has an estimated glomerular filtration rate (eGFR) of less than 30 mL/min/1.73m2 (via Modification of Diet in Renal Disease [MDRD] equation).
(c) 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 value of greater than or equal to 1.5 times the ULN.
(d) The patient has a planned immunization with a live or live attenuated vaccine within 3 months prior to the 1st dose of study drug and for 3 months after administration of the last dose of study drug is administered.
(e) The patient has clinically significant abnormalities on the 12 lead EGG 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.
(f) 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. Patients with a history of less severe infections in the 3 months prior to administration of the 1st dose of study drug are permitted to participate in the study at the discretion of the investigator and medical monitor.
(g) 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.
(h1) The patient has a history of a positive test result for hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody (HCV Ab).
(i) The patient has a known positive history of antibodies to human immunodeficiency virus (HIV) or HIV disease.
(j) 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 for study C33457/2047, or current substance abuse.
(k) The patient has a history of severe allergic reactions to or hypersensitivity to any component of the study drug.
(l) The patient is a pregnant or lactating woman. (Any women becoming pregnant during the study will be withdrawn from the study.)
(m) 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 30 days prior to the 1st dose of study drug, except for treatment with CEP-33457 or placebo in study 33457/2047.
(n1) The patient has a known history of antibodies to CEP-33457.
(o) 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