A Long-Term Study of the Safety and Tolerability of Repeated Administration of CEP-33457 in Participants With Systemic Lupus Erythematosus

NCT01240694 | Terminated Phase 3 Results

• 1 other identifier: C33457/3075
• Study Type: interventional
• Target: 136
• Locations: 11 countries
• Sites: 85

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).

Conditions

Systemic Lupus Erythematosus

Keywords

Lupus; SLE

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Adverse Events (AEs)

  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.

  Baseline up to Week 72

• Number of Participants Who Received Concomitant Medications

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

  Baseline up to Week 72

Secondary Outcomes (14)

• 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

• 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 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 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

• Number of Participants Showing No Worsening on Patient's Global Assessment (PtGA) Scale

  Week 12, 24, 36, 48, 60, and 72

Study Arms (1)

CEP-33457

EXPERIMENTAL

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

Drug: CEP-33457

Interventions

CEP-33457 DRUG

CEP-33457 will be administered subcutaneously per dose specified in the arm description.

Also known as: Lupuzor

CEP-33457

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 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.

You may not qualify if:

• 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.
• The participant has a history of severe allergic reactions to or hypersensitivity to any component of the study drug.
• The participant is a pregnant or lactating woman. (Any women becoming pregnant during the study will be withdrawn from the study.)
• The participant 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 C33457/2047.
• The participant has a known history of antibodies to CEP-33457.
• The participant is unlikely to comply with the study protocol or is unsuitable for any other reason, as judged by the investigator or medical monitor.

Sponsors & Collaborators

• Cephalon, Inc.: lead

Study Sites (85)

Teva Investigational Site 27

Birmingham, Alabama, 35233, United States

Location

Teva Investigational Site 20

Tucson, Arizona, 85715, United States

Location

Teva Investigational Site 16

Los Angeles, California, 90048, United States

Location

Teva Investigational Site 5

Los Angeles, California, 90095-1769, United States

Location

Teva Investigational Site 7

San Diego, California, 92161, United States

Location

Teva Investigational Site 14

San Leandro, California, 94578, United States

Location

Teva Investigational Site 17

Stanford, California, 94305, United States

Location

Teva Investigational Site 30

Aurora, Colorado, 80045, United States

Location

Teva Investigational Site 4

Aventura, Florida, 33180, United States

Location

Teva Investigational Site 32

Clearwater, Florida, 33765, United States

Location

Teva Investigational Site 35

Fort Lauderdale, Florida, 33334, United States

Location

Teva Investigational Site 1

Jupiter, Florida, 33458, United States

Location

Teva Investigational Site 11

Tampa, Florida, 33614, United States

Location

Teva Investigational Site 8

Atlanta, Georgia, 30322, United States

Location

Teva Investigational Site 31

Atlanta, Georgia, 30342, United States

Location

Teva Investigational Site 38

Stockbridge, Georgia, 30281, United States

Location

Teva Investigational Site 23

Coeur d'Alene, Idaho, 83814, United States

Location

Teva Investigational Site 37

Lexington, Kentucky, 40504, United States

Location

Teva Investigational Site 36

Baltimore, Maryland, 21231, United States

Location

Teva Investigational Site 10

Boston, Massachusetts, 02111, United States

Location

Teva Investigational Site 22

Ann Arbor, Michigan, 48109, United States

Location

Teva Investigational Site 9

Manhasset, New York, 11030, United States

Location

Teva Investigational Site 3

Chapel Hill, North Carolina, 27599-7600, United States

Location

Teva Investigational Site 28

Charlotte, North Carolina, 28210, United States

Location

Teva Investigational Site 18

Durham, North Carolina, 27710, United States

Location

Teva Investigational Site 2

Monroe, North Carolina, 28112, United States

Location

Teva Investigational Site 21

Oklahoma City, Oklahoma, 73103, United States

Location

Teva Investigational Site 25

Duncansville, Pennsylvania, 16635, United States

Location

Teva Investigational Site 26

Pittsburgh, Pennsylvania, 15213, United States

Location

Teva Investigational Site 15

Charleston, South Carolina, 29425, United States

Location

Teva Investigational Site 29

Dallas, Texas, 75231, United States

Location

Teva Investigational Site 40

Houston, Texas, 77034, United States

Location

Teva Investigational Site 6

Houston, Texas, 77074, United States

Location

Teva Investigational Site 39

Mesquite, Texas, 75150, United States

Location

Teva Investigational Site 34

San Antonio, Texas, 78229, United States

Location

Teva Investigational Site 24

Temple, Texas, 76508, United States

Location

Teva Investigational Site 19

Arlington, Virginia, 22205, United States

Location

Teva Investigational Site 12

Seattle, Washington, 98104, United States

Location

Teva Investigational Site 33

Milwaukee, Wisconsin, 53226, United States

Location

Teva Investigational Site 102

Brussels, 1090, Belgium

Location

Teva Investigational Site 101

Liège, 4000, Belgium

Location

Teva Investigational Site 100

Yvoir, 5530, Belgium

Location

Teva Investigational Site 201

Brno, 638 00, Czechia

Location

Teva Investigational Site 200

Olomouc, 775 20, Czechia

Location

Teva Investigational Site 202

Prague, 128 08, Czechia

Location

Teva Investigational Site 203

Prague, 128 50, Czechia

Location

Teva Investigational Site 301

Lille, 59000, France

Location

Teva Investigational Site 302

Nantes, 44093, France

Location

Teva Investigational Site 300

Paris, 75013, France

Location

Teva Investigational Site 303

Paris, 75674, France

Location

Teva Investigational Site 304

Strasbourg, 67098, France

Location

Teva Investigational Site 402

Aachen, 52074, Germany

Location

Teva Investigational Site 403

Berlin, 12200, Germany

Location

Teva Investigational Site 401

Dresden, 01307, Germany

Location

Teva Investigational Site 404

Düsseldorf, 40225, Germany

Location

Teva Investigational Site 406

Hamburg, 22081, Germany

Location

Teva Investigational Site 405

Mainz, 55131, Germany

Location

Teva Investigational Site 400

München, 80336, Germany

Location

Teva Investigational Site 501

Budapest, 1023, Hungary

Location

Teva Investigational Site 502

Debrecen, 4032, Hungary

Location

Teva Investigational Site 500

Zalaegerszeg, 8900, Hungary

Location

Teva Investigational Site 603

Dąbrówka, 62-069, Poland

Location

Teva Investigational Site 600

Elblag, 82-300, Poland

Location

Teva Investigational Site 602

Gmina Końskie, 26-200, Poland

Location

Teva Investigational Site 604

Lublin, 20-090, Poland

Location

Teva Investigational Site 601

Lublin, 20-607, Poland

Location

Teva Investigational Site 606

Warsaw, 00-235, Poland

Location

Teva Investigational Site 605

Wroclaw, 50-556, Poland

Location

Teva Investigational Site 701

Amadora, 2720-276, Portugal

Location

Teva Investigational Site 702

Coimbra, 3000-075, Portugal

Location

Teva Investigational Site 703

Porto, 4099-001, Portugal

Location

Teva Investigational Site 700

Porto, 4200-319, Portugal

Location

Teva Investigational Site 751

Dresden, 01307, Spain

Location

Teva Investigational Site 752

Santander, 39008, Spain

Location

Teva Investigational Site 750

Seville, 41013, Spain

Location

Teva Investigational Site 901

Donetsk, 83059, Ukraine

Location

Teva Investigational Site 905

Ivano-Frankivsk, 76018, Ukraine

Location

Teva Investigational Site 900

Kyiv, 01601, Ukraine

Location

Teva Investigational Site 902

Kyiv, 03151, Ukraine

Location

Teva Investigational Site 903

Kyiv, 04107, Ukraine

Location

Teva Investigational Site 904

Lviv, 79035, Ukraine

Location

Teva Investigational Site 803

Bath, BA1 1RL, United Kingdom

Location

Teva Investigational Site 801

Leeds, LS7 4SA, United Kingdom

Location

Teva Investigational Site 800

London, SE1 7EH, United Kingdom

Location

Teva Investigational Site 802

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

spliceosomal peptide P140

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

The study was terminated early due to business decision; there were no safety issues.

Results Point of Contact

• Title: Director, Clinical Research
• Organization: Teva Branded Pharmaceutical Products R&D, Inc.

USMedInfo@tevapharm.com

1-888-483-8279

Study Officials

• Teva Medical Expert

  Teva Branded Pharmaceutical Products R&D, Inc.

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2010
• First Posted: November 15, 2010
• Study Start: December 9, 2010
• Primary Completion: June 14, 2012
• Study Completion: June 14, 2012
• Last Updated: December 30, 2022
• Results First Posted: December 30, 2022

Record last verified: 2022-11

Locations

HU (3); PL (7); BE (3); DE (7); PT (4); ES (3); GB (4); FR (5); CZ (4); UA (6); US (39)