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A Study to Evaluate the Efficacy and Safety of CEP-33457 in Participants With Systemic Lupus Erythematosus (SLE)

Primary Purpose

Systemic Lupus Erythematosus

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CEP-33457
Placebo
Sponsored by
Cephalon, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring Lupus

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The participant has an established diagnosis of systemic lupus erythematosus (SLE) as defined by ACR Classification Revised Criteria. The diagnosis is fulfilled provided that at least 4 criteria are met.
  • The participant has a positive test for antinuclear antibody (ANA) at screening and/or a positive test for anti-double-stranded deoxyribonucleic acid antibody (anti-dsDNA Ab) at screening.
  • 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.
  • The participant has a clinical SLEDAI-2K score of at least 6 points during screening.
  • The participant 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 first dose of study drug.
  • If the participant is using antimalarials, methotrexate, leflunomide, mycophenolate mofetil, or azathioprine, the start date must be at least 3 months prior to the first dose of study drug, and the daily dose must be stable over the 4 weeks preceding the first dose of study drug.
  • If the participant is not currently using corticosteroids, antimalarials, methotrexate, mycophenolate mofetil, or azathioprine, the last dose (in case of previous use) must be at least 4 weeks prior to the first dose of study drug. For leflunomide, the stop date must be at least 8 weeks before the first dose of study drug, unless an adequate cholestyramine washout has been completed.

Exclusion Criteria:

  • The participant has been treated with intramuscular or intravenous (iv) pulse steroids (ie, 250 to 1000 milligrams [mg] iv total daily dose of methylprednisolone) within 4 weeks of the first dose of study drug. The use of intra-articular steroids may be allowed after consultation with the medical expert.
  • The participant has received tacrolimus, cyclosporine A, or iv immunoglobulins (IVIG) within 3 months of the first dose of study drug.
  • The participant has received cyclophosphamide within 12 months prior to the first dose of study drug.
  • The participant has been treated for SLE with agents such as fusion proteins, therapeutic proteins, or monoclonal antibodies or antibody fragments, within 12 months of the first dose of study drug.
  • The participant has received B-cell depleting agents such as rituximab and has not yet normalized the B-cell count (ie, CD20+ B-cell count is less than 200 and the absolute lymphocyte count [ALC] is less than 1500/μL).
  • The participant has New York Heart Association (NYHA) Class III or IV congestive heart failure.
  • The participant has severe active lupus nephritis or cerebritis.
  • 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. Participant 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 medical condition other than SLE that has required treatment with steroids in excess of 80 mg of prednisone equivalent/week within 6 months of the first dose of study drug.
  • The participant has a positive test result for hepatitis B surface antigen (HBsAg) or antibodies to hepatitis C (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 or has current substance abuse.
  • The participant has a history of severe allergic reactions to or hypersensitivity to any component of the study drug or placebo.
  • 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.
  • The participant has previously participated in a Cephalon- or ImmuPharma-sponsored clinical study with CEP-33457.
  • The participant is a pregnant or lactating woman. (Any women becoming pregnant during the study will be withdrawn from the study.)
  • 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.

Sites / Locations

  • Teva Investigational Site 27
  • Teva Investigational Site 20
  • Teva Investigational Site 16
  • Teva Investigational Site 5
  • Teva Investigational Site 7
  • Teva Investigational Site 14
  • Teva Investigational Site 17
  • Teva Investigational Site 30
  • Teva Investigational Site 4
  • Teva Investigational Site 32
  • Teva Investigational Site 35
  • Teva Investigational Site 1
  • Teva Investigational Site 11
  • Teva Investigational Site 8
  • Teva Investigational Site 31
  • Teva Investigational Site 38
  • Teva Investigational Site 23
  • Teva Investigational Site 37
  • Teva Investigational Site 36
  • Teva Investigational Site 10
  • Teva Investigational Site 22
  • Teva Investigational Site 9
  • Teva Investigational Site 3
  • Teva Investigational Site 28
  • Teva Investigational Site 18
  • Teva Investigational Site 2
  • Teva Investigational Site 21
  • Teva Investigational Site 13
  • Teva Investigational Site 25
  • Teva Investigational Site 26
  • Teva Investigational Site 15
  • Teva Investigational Site 29
  • Teva Investigational Site 40
  • Teva Investigational Site 6
  • Teva Investigational Site 39
  • Teva Investigational Site 34
  • Teva Investigational Site 24
  • Teva Investigational Site 19
  • Teva Investigational Site 12
  • Teva Investigational Site 33
  • Teva Investigational Site 102
  • Teva Investigational Site 101
  • Teva Investigational Site 100
  • Teva Investigational Site 201
  • Teva Investigational Site 200
  • Teva Investigational Site 202
  • Teva Investigational Site 203
  • Teva Investigational Site 301
  • Teva Investigational Site 302
  • Teva Investigational Site 300
  • Teva Investigational Site 303
  • Teva Investigational Site 304
  • Teva Investigational Site 402
  • Teva Investigational Site 403
  • Teva Investigational Site 401
  • Teva Investigational Site 404
  • Teva Investigational Site 406
  • Teva Investigational Site 405
  • Teva Investigational Site 400
  • Teva Investigational Site 501
  • Teva Investigational Site 502
  • Teva Investigational Site 500
  • Teva Investigational Site 603
  • Teva Investigational Site 600
  • Teva Investigational Site 602
  • Teva Investigational Site 604
  • Teva Investigational Site 601
  • Teva Investigational Site 606
  • Teva Investigational Site 605
  • Teva Investigational Site 701
  • Teva Investigational Site 702
  • Teva Investigational Site 703
  • Teva Investigational Site 700
  • Teva Investigational Site 751
  • Teva Investigational Site 752
  • Teva Investigational Site 750
  • Teva Investigational Site 901
  • Teva Investigational Site 905
  • Teva Investigational Site 900
  • Teva Investigational Site 902
  • Teva Investigational Site 903
  • Teva Investigational Site 904
  • Teva Investigational Site 803
  • Teva Investigational Site 801
  • Teva Investigational Site 800
  • Teva Investigational Site 802

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CEP-33457

Placebo

Arm Description

Participants will receive CEP-33457 200 mcg SC every 4 weeks for 20 weeks (Day 1, Weeks 4, 8, 12, 16, and 20).

Participants will receive placebo matching to CEP-33457 SC every 4 weeks for 20 weeks (Day 1, Weeks 4, 8, 12, 16, and 20).

Outcomes

Primary Outcome Measures

Number of Participants Achieving a Combined Clinical Response Using the Systemic Lupus Erythematosus (SLE) Responder Index (SRI) at Week 24
An SRI response was defined as a reduction from baseline in SLE Disease Activity Index 2000 (SLEDAI-2K) score of ≥4 points, no worsening in Physician Global Assessment (PhGA), no new British Isles Lupus Assessment Group (BILAG) A body system score, and ≤1 new BILAG B body system score from baseline. SLEDAI-2K includes 24 weighted clinical and laboratory variables. Total score = 0 to 105. A score of 6 to 10 = moderate disease activity, and a reduction of >3 points = improvement. PhGA was completed by physician using a visual analog scale (VAS) from 0=none to 3=severe. A change of >0.3 points = worsening. BILAG includes 97 clinical and laboratory items. Each organ system is assigned a score displayed as a grade from A to E: A=very active disease; B=patient needs increase in treatment for moderately active disease; C=stable or mild disease; D=previous organ involvement but no current disease activity; and E=no current disease activity and organ system has never been involved.

Secondary Outcome Measures

Number of Participants Achieving an SRI Response at Each Visit During the Treatment Period
An SRI response was defined as a reduction from baseline in SLEDAI-2K score of ≥4 points, no worsening in PhGA, no new BILAG A body system score, and ≤1 new BILAG B body system score from baseline. SLEDAI-2K includes 24 weighted clinical and laboratory variables. Total score = 0 to 105. A score of 6 to 10 = moderate disease activity, and a reduction of >3 points = improvement. PhGA was completed by physician using a VAS from 0=none to 3=severe. A change of >0.3 points = worsening. BILAG includes 97 clinical and laboratory items. Each organ system is assigned a score displayed as a grade from A to E: A=very active disease; B=participant needs increase in treatment for moderately active disease; C=stable or mild disease; D=previous organ involvement but no current disease activity; and E=no current disease activity and organ system has never been involved.
Number of Participants Achieving a Reduction of at Least 4 Points in the SLEDAI-2K Total Score
The SLEDAI-2K is a global index and includes 24 weighted clinical and laboratory variables. The total score (sum of all 24 scores) ranges from 0 to 105. A SLEDAI-2K score of 6 to 10 is indicative of moderate disease activity, and improvement is defined as a reduction of more than 3 points.
Number of Participants Achieving a British Isles Lupus Assessment Group (BILAG) 2004 Response
The BILAG 2004 is a validated objective and subjective global measure of the disease activity of SLE based on the physician intention to treat. It includes 97 clinical and laboratory items to evaluate SLE disease activity in 9 organ systems; each organ system is assigned a score displayed as a grade from A to E, as follows: A=very active disease; B=participant needs increase in treatment for moderately active disease; C=stable or mild disease; D=previous organ involvement but no current disease activity; and E=no current disease activity and the organ system has never been involved. BILAG 2004 response was defined as no new A body system score and no more than 1 new BILAG B body system score from baseline.
Number of Participants Achieving a BILAG 2004 Clinical Response
The BILAG 2004 is a validated objective and subjective global measure of the disease activity of SLE based on the physician intention to treat. It includes 97 clinical and laboratory items to evaluate SLE disease activity in 9 organ systems; each organ system is assigned a score displayed as a grade from A to E, as follows: A=very active disease; B=participant needs increase in treatment for moderately active disease; C=stable or mild disease; D=previous organ involvement but no current disease activity; and E=no current disease activity and the organ system has never been involved. BILAG 2004 clinical response was defined as having an improvement in at least 1 category from a B score at baseline to a C or D score with no worsening in any other category from baseline.
Number of Participants Achieving a Physician Global Assessment (PhGA) Response
The PhGA was completed by the physician using a 3 inch VAS labeled from 0=none to 3=severe. The PhGA response was defined as having no worsening in PhGA (with worsening defined as an increase in PhGA of more than 0.30 inch from baseline).
Number of Participants Achieving a Patient's Global Assessment (PtGA) Response
The PhGA was completed by the participant using a 3 inch VAS labeled from 0=none to 3=severe. The PtGA response was defined as having no worsening in PtGA (with worsening defined as an increase in PtGA of more than 0.30 inch from baseline).
Change From Baseline in the Medical Outcome Survey Short-Form 36 (SF-36) Patient-Reported Questionnaire For Physical Component Summary (PCS) Score at Weeks 12 and 24
The SF-36 questionnaire has 36 questions composing the scale that represent 8 domains: 1) physical functioning, role physical, 2) bodily pain, 3) general health, 4) vitality, 5) social functioning, 6) role, 7) emotional, and 8) mental health. The scores for the 8 domains were combined into two summary scores: the physical component summary (PCS) score and the mental component summary (MCS) score. Items 1 to 4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. Scores on each item were summed and averaged (range: 0=worst to 100=best). Higher scores represent better health status and functional ability.
Change From Baseline in the Medical Outcome Survey SF-36 Patient-Reported Questionnaire For Mental Component Summary (MCS) Score at Weeks 12 and 24
The SF-36 questionnaire has 36 questions composing the scale that represent 8 domains: 1) physical functioning, role physical, 2) bodily pain, 3) general health, 4) vitality, 5) social functioning, 6) role, 7) emotional, and 8) mental health. The scores for the 8 domains were combined into two summary scores: the physical component summary (PCS) score and the mental component summary (MCS) score. Items 1 to 4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. Scores on each item were summed and averaged (range: 0=worst to 100=best). Higher scores represent better health status and functional ability.
Systemic Lupus International Collaborative Clinics/American College of Rheumatology (SLICC/ACR) Damage Index
SLICC/ACR score or damage index is a measure of cumulative damage due to SLE. Damage is defined as nonreversible change (not related to active inflammation) occurring since onset of lupus, ascertained by clinical assessment and present for at least 6 months. Damage is defined for 12 separate organ systems: ocular (range 0-2), neuropsychiatric (0-6), renal (0-3), pulmonary (0-5), cardiovascular (0-6), peripheral vascular (0-5), gastrointestinal (0-6), musculoskeletal (0-7), skin (0-3), endocrine (diabetes) (0-1), gonadal (0-1) and malignancies (0-2). A score of 0=no damage, early damage is defined as ≥1. The total maximum score is 47, and increasing score indicates increasing disease damage severity.
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. 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.

Full Information

First Posted
June 1, 2010
Last Updated
November 18, 2022
Sponsor
Cephalon, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01135459
Brief Title
A Study to Evaluate the Efficacy and Safety of CEP-33457 in Participants With Systemic Lupus Erythematosus (SLE)
Official Title
A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
June 24, 2010 (Actual)
Primary Completion Date
January 31, 2012 (Actual)
Study Completion Date
June 30, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cephalon, Inc.

4. Oversight

5. Study Description

Brief Summary
The primary objective of this study is to evaluate the efficacy of a 200 micrograms (mcg) dose of CEP-33457 compared with placebo in participants with active systemic lupus erythematosus (SLE) as assessed by the proportion of participants achieving a combined clinical response using the SLE responder index (SRI) at Week 24.
Detailed Description
The study consisted of a 2-week screening period (visit 1), a 20-week treatment period beginning with a baseline visit in which randomization was completed and study drug treatment began (visits 2 through 7), and a final assessment was performed 4 weeks after the last dose of study drug (visit 8 [week 24 or early termination]). Participants were randomized to receive either CEP-33457 or placebo subcutaneously (SC) every 4 weeks. Plasma samples for measurement of study drug concentration were collected in a subset of participants and study drug was administered at each study visit until the final visit. The dose of background steroid medication may have been increased, if needed, to treat the participant for minor fluctuations in lupus disease activity. One interim analysis was conducted when at least 80 participants completed Week 12 or had been withdrawn from the study. Participants who completed the treatment period returned to the study center 4 weeks after the last dose had been administered for final procedures and assessments. Final procedures and assessments for participants who withdrew from the study before 20 weeks of treatment were performed at the last visit. Final procedures and assessments for participants who participated in the study beyond week 24 were to be performed at the next regularly scheduled visit. Participants who complete the study will be eligible for participation in the 12-month open-label study (study C33457/3075; herein referred to as study 3075) to assess continued effectiveness and safety of the CEP-33457 treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
Keywords
Lupus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
183 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CEP-33457
Arm Type
Experimental
Arm Description
Participants will receive CEP-33457 200 mcg SC every 4 weeks for 20 weeks (Day 1, Weeks 4, 8, 12, 16, and 20).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo matching to CEP-33457 SC every 4 weeks for 20 weeks (Day 1, Weeks 4, 8, 12, 16, and 20).
Intervention Type
Drug
Intervention Name(s)
CEP-33457
Other Intervention Name(s)
Lupuzor
Intervention Description
CEP-33457 will be administered per dose and schedule specified in the arm description.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matching to CEP-33457 will be administered per schedule specified in the arm description.
Primary Outcome Measure Information:
Title
Number of Participants Achieving a Combined Clinical Response Using the Systemic Lupus Erythematosus (SLE) Responder Index (SRI) at Week 24
Description
An SRI response was defined as a reduction from baseline in SLE Disease Activity Index 2000 (SLEDAI-2K) score of ≥4 points, no worsening in Physician Global Assessment (PhGA), no new British Isles Lupus Assessment Group (BILAG) A body system score, and ≤1 new BILAG B body system score from baseline. SLEDAI-2K includes 24 weighted clinical and laboratory variables. Total score = 0 to 105. A score of 6 to 10 = moderate disease activity, and a reduction of >3 points = improvement. PhGA was completed by physician using a visual analog scale (VAS) from 0=none to 3=severe. A change of >0.3 points = worsening. BILAG includes 97 clinical and laboratory items. Each organ system is assigned a score displayed as a grade from A to E: A=very active disease; B=patient needs increase in treatment for moderately active disease; C=stable or mild disease; D=previous organ involvement but no current disease activity; and E=no current disease activity and organ system has never been involved.
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Number of Participants Achieving an SRI Response at Each Visit During the Treatment Period
Description
An SRI response was defined as a reduction from baseline in SLEDAI-2K score of ≥4 points, no worsening in PhGA, no new BILAG A body system score, and ≤1 new BILAG B body system score from baseline. SLEDAI-2K includes 24 weighted clinical and laboratory variables. Total score = 0 to 105. A score of 6 to 10 = moderate disease activity, and a reduction of >3 points = improvement. PhGA was completed by physician using a VAS from 0=none to 3=severe. A change of >0.3 points = worsening. BILAG includes 97 clinical and laboratory items. Each organ system is assigned a score displayed as a grade from A to E: A=very active disease; B=participant needs increase in treatment for moderately active disease; C=stable or mild disease; D=previous organ involvement but no current disease activity; and E=no current disease activity and organ system has never been involved.
Time Frame
Weeks 4, 8, 12, 16, and 20
Title
Number of Participants Achieving a Reduction of at Least 4 Points in the SLEDAI-2K Total Score
Description
The SLEDAI-2K is a global index and includes 24 weighted clinical and laboratory variables. The total score (sum of all 24 scores) ranges from 0 to 105. A SLEDAI-2K score of 6 to 10 is indicative of moderate disease activity, and improvement is defined as a reduction of more than 3 points.
Time Frame
Week 24
Title
Number of Participants Achieving a British Isles Lupus Assessment Group (BILAG) 2004 Response
Description
The BILAG 2004 is a validated objective and subjective global measure of the disease activity of SLE based on the physician intention to treat. It includes 97 clinical and laboratory items to evaluate SLE disease activity in 9 organ systems; each organ system is assigned a score displayed as a grade from A to E, as follows: A=very active disease; B=participant needs increase in treatment for moderately active disease; C=stable or mild disease; D=previous organ involvement but no current disease activity; and E=no current disease activity and the organ system has never been involved. BILAG 2004 response was defined as no new A body system score and no more than 1 new BILAG B body system score from baseline.
Time Frame
Weeks 4, 8, 12, 16, 20, and 24
Title
Number of Participants Achieving a BILAG 2004 Clinical Response
Description
The BILAG 2004 is a validated objective and subjective global measure of the disease activity of SLE based on the physician intention to treat. It includes 97 clinical and laboratory items to evaluate SLE disease activity in 9 organ systems; each organ system is assigned a score displayed as a grade from A to E, as follows: A=very active disease; B=participant needs increase in treatment for moderately active disease; C=stable or mild disease; D=previous organ involvement but no current disease activity; and E=no current disease activity and the organ system has never been involved. BILAG 2004 clinical response was defined as having an improvement in at least 1 category from a B score at baseline to a C or D score with no worsening in any other category from baseline.
Time Frame
Weeks 4, 8, 12, 16, 20, and 24
Title
Number of Participants Achieving a Physician Global Assessment (PhGA) Response
Description
The PhGA was completed by the physician using a 3 inch VAS labeled from 0=none to 3=severe. The PhGA response was defined as having no worsening in PhGA (with worsening defined as an increase in PhGA of more than 0.30 inch from baseline).
Time Frame
Weeks 4, 8, 12, 16, 20, and 24
Title
Number of Participants Achieving a Patient's Global Assessment (PtGA) Response
Description
The PhGA was completed by the participant using a 3 inch VAS labeled from 0=none to 3=severe. The PtGA response was defined as having no worsening in PtGA (with worsening defined as an increase in PtGA of more than 0.30 inch from baseline).
Time Frame
Weeks 4, 8, 12, 16, 20, and 24
Title
Change From Baseline in the Medical Outcome Survey Short-Form 36 (SF-36) Patient-Reported Questionnaire For Physical Component Summary (PCS) Score at Weeks 12 and 24
Description
The SF-36 questionnaire has 36 questions composing the scale that represent 8 domains: 1) physical functioning, role physical, 2) bodily pain, 3) general health, 4) vitality, 5) social functioning, 6) role, 7) emotional, and 8) mental health. The scores for the 8 domains were combined into two summary scores: the physical component summary (PCS) score and the mental component summary (MCS) score. Items 1 to 4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. Scores on each item were summed and averaged (range: 0=worst to 100=best). Higher scores represent better health status and functional ability.
Time Frame
Baseline, Week 12, Week 24
Title
Change From Baseline in the Medical Outcome Survey SF-36 Patient-Reported Questionnaire For Mental Component Summary (MCS) Score at Weeks 12 and 24
Description
The SF-36 questionnaire has 36 questions composing the scale that represent 8 domains: 1) physical functioning, role physical, 2) bodily pain, 3) general health, 4) vitality, 5) social functioning, 6) role, 7) emotional, and 8) mental health. The scores for the 8 domains were combined into two summary scores: the physical component summary (PCS) score and the mental component summary (MCS) score. Items 1 to 4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. Scores on each item were summed and averaged (range: 0=worst to 100=best). Higher scores represent better health status and functional ability.
Time Frame
Baseline, Week 12, Week 24
Title
Systemic Lupus International Collaborative Clinics/American College of Rheumatology (SLICC/ACR) Damage Index
Description
SLICC/ACR score or damage index is a measure of cumulative damage due to SLE. Damage is defined as nonreversible change (not related to active inflammation) occurring since onset of lupus, ascertained by clinical assessment and present for at least 6 months. Damage is defined for 12 separate organ systems: ocular (range 0-2), neuropsychiatric (0-6), renal (0-3), pulmonary (0-5), cardiovascular (0-6), peripheral vascular (0-5), gastrointestinal (0-6), musculoskeletal (0-7), skin (0-3), endocrine (diabetes) (0-1), gonadal (0-1) and malignancies (0-2). A score of 0=no damage, early damage is defined as ≥1. The total maximum score is 47, and increasing score indicates increasing disease damage severity.
Time Frame
Baseline, Week 24
Title
Number of Participants With Adverse Events (AEs)
Description
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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.
Time Frame
Baseline up to Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The participant has an established diagnosis of systemic lupus erythematosus (SLE) as defined by ACR Classification Revised Criteria. The diagnosis is fulfilled provided that at least 4 criteria are met. The participant has a positive test for antinuclear antibody (ANA) at screening and/or a positive test for anti-double-stranded deoxyribonucleic acid antibody (anti-dsDNA Ab) at screening. 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. The participant has a clinical SLEDAI-2K score of at least 6 points during screening. The participant 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 first dose of study drug. If the participant is using antimalarials, methotrexate, leflunomide, mycophenolate mofetil, or azathioprine, the start date must be at least 3 months prior to the first dose of study drug, and the daily dose must be stable over the 4 weeks preceding the first dose of study drug. If the participant is not currently using corticosteroids, antimalarials, methotrexate, mycophenolate mofetil, or azathioprine, the last dose (in case of previous use) must be at least 4 weeks prior to the first dose of study drug. For leflunomide, the stop date must be at least 8 weeks before the first dose of study drug, unless an adequate cholestyramine washout has been completed. Exclusion Criteria: The participant has been treated with intramuscular or intravenous (iv) pulse steroids (ie, 250 to 1000 milligrams [mg] iv total daily dose of methylprednisolone) within 4 weeks of the first dose of study drug. The use of intra-articular steroids may be allowed after consultation with the medical expert. The participant has received tacrolimus, cyclosporine A, or iv immunoglobulins (IVIG) within 3 months of the first dose of study drug. The participant has received cyclophosphamide within 12 months prior to the first dose of study drug. The participant has been treated for SLE with agents such as fusion proteins, therapeutic proteins, or monoclonal antibodies or antibody fragments, within 12 months of the first dose of study drug. The participant has received B-cell depleting agents such as rituximab and has not yet normalized the B-cell count (ie, CD20+ B-cell count is less than 200 and the absolute lymphocyte count [ALC] is less than 1500/μL). The participant has New York Heart Association (NYHA) Class III or IV congestive heart failure. The participant has severe active lupus nephritis or cerebritis. 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. Participant 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 medical condition other than SLE that has required treatment with steroids in excess of 80 mg of prednisone equivalent/week within 6 months of the first dose of study drug. The participant has a positive test result for hepatitis B surface antigen (HBsAg) or antibodies to hepatitis C (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 or has current substance abuse. The participant has a history of severe allergic reactions to or hypersensitivity to any component of the study drug or placebo. 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. The participant has previously participated in a Cephalon- or ImmuPharma-sponsored clinical study with CEP-33457. The participant is a pregnant or lactating woman. (Any women becoming pregnant during the study will be withdrawn from the study.) 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teva Medical Expert
Organizational Affiliation
Teva Branded Pharmaceutical Products R&D, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Teva Investigational Site 27
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Teva Investigational Site 20
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85715
Country
United States
Facility Name
Teva Investigational Site 16
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Teva Investigational Site 5
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1769
Country
United States
Facility Name
Teva Investigational Site 7
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
Facility Name
Teva Investigational Site 14
City
San Leandro
State/Province
California
ZIP/Postal Code
94578
Country
United States
Facility Name
Teva Investigational Site 17
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Teva Investigational Site 30
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Teva Investigational Site 4
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Teva Investigational Site 32
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Teva Investigational Site 35
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33334
Country
United States
Facility Name
Teva Investigational Site 1
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Teva Investigational Site 11
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Teva Investigational Site 8
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Teva Investigational Site 31
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Teva Investigational Site 38
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
Teva Investigational Site 23
City
Coeur d'Alene
State/Province
Idaho
ZIP/Postal Code
83814
Country
United States
Facility Name
Teva Investigational Site 37
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
Facility Name
Teva Investigational Site 36
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
Teva Investigational Site 10
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Teva Investigational Site 22
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Teva Investigational Site 9
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Teva Investigational Site 3
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7600
Country
United States
Facility Name
Teva Investigational Site 28
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Teva Investigational Site 18
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Teva Investigational Site 2
City
Monroe
State/Province
North Carolina
ZIP/Postal Code
28112
Country
United States
Facility Name
Teva Investigational Site 21
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Teva Investigational Site 13
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Teva Investigational Site 25
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Teva Investigational Site 26
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Teva Investigational Site 15
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Teva Investigational Site 29
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Teva Investigational Site 40
City
Houston
State/Province
Texas
ZIP/Postal Code
77034
Country
United States
Facility Name
Teva Investigational Site 6
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Teva Investigational Site 39
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75150
Country
United States
Facility Name
Teva Investigational Site 34
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Teva Investigational Site 24
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Teva Investigational Site 19
City
Arlington
State/Province
Virginia
ZIP/Postal Code
22205
Country
United States
Facility Name
Teva Investigational Site 12
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Teva Investigational Site 33
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Teva Investigational Site 102
City
Brussel
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Teva Investigational Site 101
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Teva Investigational Site 100
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
Facility Name
Teva Investigational Site 201
City
Brno
ZIP/Postal Code
638 00
Country
Czechia
Facility Name
Teva Investigational Site 200
City
Olomouc
ZIP/Postal Code
775 20
Country
Czechia
Facility Name
Teva Investigational Site 202
City
Prague 2
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Teva Investigational Site 203
City
Prague 2
ZIP/Postal Code
128 50
Country
Czechia
Facility Name
Teva Investigational Site 301
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Teva Investigational Site 302
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Teva Investigational Site 300
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Teva Investigational Site 303
City
Paris
ZIP/Postal Code
75674
Country
France
Facility Name
Teva Investigational Site 304
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
Teva Investigational Site 402
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Teva Investigational Site 403
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Facility Name
Teva Investigational Site 401
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Teva Investigational Site 404
City
Dusseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Teva Investigational Site 406
City
Hamburg
ZIP/Postal Code
22081
Country
Germany
Facility Name
Teva Investigational Site 405
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Teva Investigational Site 400
City
Munchen
ZIP/Postal Code
80336
Country
Germany
Facility Name
Teva Investigational Site 501
City
Budapest
ZIP/Postal Code
1023
Country
Hungary
Facility Name
Teva Investigational Site 502
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Teva Investigational Site 500
City
Zalaegerszeg
ZIP/Postal Code
8900
Country
Hungary
Facility Name
Teva Investigational Site 603
City
Dabrowka
ZIP/Postal Code
62-069
Country
Poland
Facility Name
Teva Investigational Site 600
City
Elblag
ZIP/Postal Code
82-300
Country
Poland
Facility Name
Teva Investigational Site 602
City
Konskie
ZIP/Postal Code
26-200
Country
Poland
Facility Name
Teva Investigational Site 604
City
Lublin
ZIP/Postal Code
20-090
Country
Poland
Facility Name
Teva Investigational Site 601
City
Lublin
ZIP/Postal Code
20-607
Country
Poland
Facility Name
Teva Investigational Site 606
City
Warszawa
ZIP/Postal Code
00-235
Country
Poland
Facility Name
Teva Investigational Site 605
City
Wroclaw
ZIP/Postal Code
50-556
Country
Poland
Facility Name
Teva Investigational Site 701
City
Amadora
ZIP/Postal Code
2720-276
Country
Portugal
Facility Name
Teva Investigational Site 702
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
Teva Investigational Site 703
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
Teva Investigational Site 700
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
Teva Investigational Site 751
City
Dresden
ZIP/Postal Code
01307
Country
Spain
Facility Name
Teva Investigational Site 752
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Teva Investigational Site 750
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Teva Investigational Site 901
City
Donetsk
ZIP/Postal Code
83059
Country
Ukraine
Facility Name
Teva Investigational Site 905
City
Ivano-Frankivsk
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
Teva Investigational Site 900
City
Kyiv
ZIP/Postal Code
01601
Country
Ukraine
Facility Name
Teva Investigational Site 902
City
Kyiv
ZIP/Postal Code
03151
Country
Ukraine
Facility Name
Teva Investigational Site 903
City
Kyiv
ZIP/Postal Code
04107
Country
Ukraine
Facility Name
Teva Investigational Site 904
City
Lviv
ZIP/Postal Code
79035
Country
Ukraine
Facility Name
Teva Investigational Site 803
City
Bath
ZIP/Postal Code
BA1 1RL
Country
United Kingdom
Facility Name
Teva Investigational Site 801
City
Leeds
ZIP/Postal Code
LS7 4SA
Country
United Kingdom
Facility Name
Teva Investigational Site 800
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Facility Name
Teva Investigational Site 802
City
Newcastle Upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

A Study to Evaluate the Efficacy and Safety of CEP-33457 in Participants With Systemic Lupus Erythematosus (SLE)

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