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

NCT01135459 | Completed Phase 2 Results

• 1 other identifier: C33457/2047
• Study Type: interventional
• Target: 183
• Locations: 11 countries
• Sites: 86

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.

Conditions

Systemic Lupus Erythematosus

Keywords

Lupus

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 24

Secondary Outcomes (10)

• Number of Participants Achieving an SRI Response at Each Visit During the Treatment Period

  Weeks 4, 8, 12, 16, and 20

• Number of Participants Achieving a Reduction of at Least 4 Points in the SLEDAI-2K Total Score

  Week 24

• Number of Participants Achieving a British Isles Lupus Assessment Group (BILAG) 2004 Response

  Weeks 4, 8, 12, 16, 20, and 24

• Number of Participants Achieving a BILAG 2004 Clinical Response

  Weeks 4, 8, 12, 16, 20, and 24

• Number of Participants Achieving a Physician Global Assessment (PhGA) Response

  Weeks 4, 8, 12, 16, 20, and 24

Study Arms (2)

CEP-33457

EXPERIMENTAL

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

Drug: CEP-33457

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

CEP-33457 DRUG

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

Also known as: Lupuzor

CEP-33457

Placebo DRUG

Placebo matching to CEP-33457 will be administered per schedule specified in the arm description.

Placebo

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 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Cephalon, Inc.: lead

Study Sites (86)

Teva Investigational Site 27

Birmingham, Alabama, 35233, United States

Location

Teva Investigational Site 20

Tucson, Arizona, 85715, United States

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Teva Investigational Site 16

Los Angeles, California, 90048, United States

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Teva Investigational Site 5

Los Angeles, California, 90095-1769, United States

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Teva Investigational Site 7

San Diego, California, 92161, United States

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Teva Investigational Site 14

San Leandro, California, 94578, United States

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Teva Investigational Site 17

Stanford, California, 94305, United States

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Teva Investigational Site 30

Aurora, Colorado, 80045, United States

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Teva Investigational Site 4

Aventura, Florida, 33180, United States

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Teva Investigational Site 32

Clearwater, Florida, 33765, United States

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Teva Investigational Site 35

Fort Lauderdale, Florida, 33334, United States

Location

Teva Investigational Site 1

Jupiter, Florida, 33458, United States

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Teva Investigational Site 11

Tampa, Florida, 33614, United States

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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

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Teva Investigational Site 36

Baltimore, Maryland, 21231, United States

Location

Teva Investigational Site 10

Boston, Massachusetts, 02111, United States

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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 13

Oklahoma City, Oklahoma, 73104, 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

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Teva Investigational Site 201

Brno, 638 00, Czechia

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Teva Investigational Site 200

Olomouc, 775 20, Czechia

Location

Teva Investigational Site 202

Prague, 128 08, Czechia

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Teva Investigational Site 203

Prague, 128 50, Czechia

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Teva Investigational Site 301

Lille, 59000, France

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Teva Investigational Site 302

Nantes, 44093, France

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Teva Investigational Site 300

Paris, 75013, France

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Teva Investigational Site 303

Paris, 75674, France

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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

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Teva Investigational Site 406

Hamburg, 22081, Germany

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Teva Investigational Site 405

Mainz, 55131, Germany

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Teva Investigational Site 400

München, 80336, Germany

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Teva Investigational Site 501

Budapest, 1023, Hungary

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Teva Investigational Site 502

Debrecen, 4032, Hungary

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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

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Teva Investigational Site 602

Gmina Końskie, 26-200, Poland

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Teva Investigational Site 604

Lublin, 20-090, Poland

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Teva Investigational Site 601

Lublin, 20-607, Poland

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Teva Investigational Site 606

Warsaw, 00-235, Poland

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Teva Investigational Site 605

Wroclaw, 50-556, Poland

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Teva Investigational Site 701

Amadora, 2720-276, Portugal

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Teva Investigational Site 702

Coimbra, 3000-075, Portugal

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Teva Investigational Site 703

Porto, 4099-001, Portugal

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Teva Investigational Site 700

Porto, 4200-319, Portugal

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Teva Investigational Site 751

Dresden, 01307, Spain

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Teva Investigational Site 752

Santander, 39008, Spain

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Teva Investigational Site 750

Seville, 41013, Spain

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Teva Investigational Site 901

Donetsk, 83059, Ukraine

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Teva Investigational Site 905

Ivano-Frankivsk, 76018, Ukraine

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Teva Investigational Site 900

Kyiv, 01601, Ukraine

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Teva Investigational Site 902

Kyiv, 03151, Ukraine

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Teva Investigational Site 903

Kyiv, 04107, Ukraine

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Teva Investigational Site 904

Lviv, 79035, Ukraine

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Teva Investigational Site 803

Bath, BA1 1RL, United Kingdom

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Teva Investigational Site 801

Leeds, LS7 4SA, United Kingdom

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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

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 2
• 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: June 1, 2010
• First Posted: June 2, 2010
• Study Start: June 24, 2010
• Primary Completion: January 31, 2012
• Study Completion: June 30, 2012
• Last Updated: December 16, 2022
• Results First Posted: December 16, 2022

Record last verified: 2022-11

Locations

PL (7); DE (7); FR (5); GB (4); UA (6); BE (3); CZ (4); US (40); HU (3); PT (4); ES (3)