An Open-Label Long-Term Study of the Safety and Tolerability of Repeated Administration of CEP-33457 in Patients With Systemic Lupus Erythematosus

Cephalon, Inc.85 sites in 4 countries136 target enrollmentDecember 9, 2010

ConditionsSystemic Lupus Erythematosus

InterventionsCEP-33457

Overview

Phase: Phase 3
Intervention: CEP-33457
Conditions: Systemic Lupus Erythematosus
Sponsor: Cephalon, Inc.
Enrollment: 136
Locations: 85
Primary Endpoint: Number of Participants With Adverse Events (AEs)
Status: Terminated
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective of this study is to evaluate the long term safety and tolerability of repeated administration of subcutaneous (SC) CEP-33457 for injection every 4 weeks over 72 weeks (18 doses) in participants with systemic lupus erythematosus (SLE) who have participated in a previous Cephalon sponsored clinical study of CEP-33457, and completed at least Visit 8 (Week 24 of that study).

Registry

clinicaltrials.gov

Start Date

December 9, 2010

End Date

June 14, 2012

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Cephalon, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•The participant 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.
•The participant previously participated in and completed at least Visit 8 (Week 24) 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.
•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.

Exclusion Criteria

•The participant has New York Heart Association (NYHA) Class III or IV congestive heart failure.
•The participant has an estimated glomerular filtration rate (eGFR) of less than 30 milliliters (mL)/minute (min)/1.73 square meter (m\^2) (via Modification of Diet in Renal Disease \[MDRD\] equation).
•The participant has an aspartate aminotransferase (AST) or alanine aminotransferase (ALT) value greater than 2 times the upper limit of normal (ULN) or a total bilirubin level greater than 1.5 times ULN.
•The participant has a planned immunization with a live or live attenuated vaccine within 3 months prior to administration of the first dose of study drug and for 3 months after administration of the last dose of study drug.
•The participant has any clinically significant abnormalities on electrocardiogram (ECG) that are not related to SLE, as determined by the investigator. Participants with stable ECG changes without evidence of active cardiovascular disease may participate at the discretion of the investigator and medical monitor.
•The participant 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 first dose of study drug. Less severe infections in the 3 months prior to administration of the first dose of study drug are permitted at the discretion of the investigator and medical monitor.
•The participant 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 participant has a history of a positive test result for hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody (HCV Ab).
•The participant has a known positive history of antibodies to human immunodeficiency virus (HIV) or HIV disease.
•The participant 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 has current substance abuse.

Arms & Interventions

CEP-33457

Participants will receive 200 micrograms (mcg) of CEP-33457

Intervention: CEP-33457

Outcomes

Primary Outcomes

Number of Participants With Adverse Events (AEs)

Time Frame: Baseline up to Week 72

An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs included clinically significant vitals, labs, and physical examination findings. Serious adverse events (SAEs) were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

Number of Participants Who Received Concomitant Medications

Time Frame: Baseline up to Week 72

Any concomitant therapy or medication taken while the participant received study drug.

Secondary Outcomes

Number of Participants Achieving a Clinical Response Using the Systemic Lupus Erythematosus (SLE) Responder Index (SRI)(Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72)
Number of Participants With Anti-nuclear Antibodies (ANA)(Week 12, 24, 36, 48, 60, and Final Assessment (or Early Termination [up to Week 72]))
Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index(Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64 and Final Assessment (or Early Termination [up to Week 72]))
Number of Participants With British Isles Lupus Assessment Group 2004 (BILAG-2004) Response(Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72)
Number of Participants With Reactive and Non-Reactive Anti-CEP-33457 Antibodies(Week 24, 48 and Final Assessment (or Early Termination [up to Week 72]))
Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Total Score(Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64 and Final Assessment (or Early Termination [up to Week 72]))
Number of Participants Showing No Worsening on Physician's Global Assessment (PhGA) Scale(Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72)
Change From Baseline in Short-Form 36 (SF-36) Domain Scores(Baseline, Week 12, 24, 36, 48, 60 and final assessment (or early termination [up to Week 72]))
Change From Baseline in the Biomarker: Anti-U1 Ribonucleoprotein Antibody (Anti-UI RNP Ab)(Baseline, Week 12, 24, 36, 48, 60 and final assessment (or early termination [up to Week 72]))
Number of Participants Showing No Worsening on Patient's Global Assessment (PtGA) Scale(Week 12, 24, 36, 48, 60, and 72)
Change From Baseline in the Biomarker: C-Reactive Protein (CRP)(Baseline, Week 12, 24, 36, 48, 60, and Final Assessment (or Early Termination [up to Week 72]))
Number of Participants With Change in Steroid Dose(From Baseline up to Final Assessment (or Early Termination [up to Week 72]))
Change From Baseline in Total Damage Score as Assessed by the Systemic Lupus International Collaborative Clinics/American College of Rheumatology (SLICC/ACR) Damage Index(Baseline, Week 24, 48 and Final Assessment (or Early Termination [up to Week 72]))
Number of Participants Achieving Remission of Disease(Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64 and Final Assessment (or Early Termination [up to Week 72]))