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

• Register: ClinicalTrials.gov
• Last refreshed on: 9 January 2023
• Main ID: NCT01240694
• Date of registration: 15/10/2010
• Prospective Registration: Yes
• Primary sponsor: Cephalon, Inc.
• Public title: A Long-Term Study of the Safety and Tolerability of Repeated Administration of CEP-33457 in Participants With Systemic Lupus Erythematosus
• Scientific title: An Open-Label Long-Term Study of the Safety and Tolerability of Repeated Administration of CEP-33457 in Patients With Systemic Lupus Erythematosus
• Date of first enrolment: December 9, 2010
• Target sample size: 136
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01240694
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Belgium, Czech Republic, Czechia, France, Germany, Hungary, Poland, Portugal, Spain, Ukraine, United Kingdom, United States

Contacts

• Name: Teva Medical Expert
• Affiliation: Teva Branded Pharmaceutical Products R&D, Inc.

Key inclusion & exclusion 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.

- 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.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Intervention(s)

Drug: CEP-33457

Primary Outcome(s)

Number of Participants With Adverse Events (AEs) [Time Frame: Baseline up to Week 72]

Number of Participants Who Received Concomitant Medications [Time Frame: Baseline up to Week 72]

Secondary Outcome(s)

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 [Time Frame: 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])]

Change From Baseline in Short-Form 36 (SF-36) Domain Scores [Time Frame: Baseline, Week 12, 24, 36, 48, 60 and final assessment (or early termination [up to Week 72])]

Number of Participants Achieving a Clinical Response Using the Systemic Lupus Erythematosus (SLE) Responder Index (SRI) [Time Frame: Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 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 [Time Frame: Baseline, Week 24, 48 and Final Assessment (or Early Termination [up to Week 72])]

Number of Participants Achieving Remission of Disease [Time Frame: 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])]

Change From Baseline in the Biomarker: C-Reactive Protein (CRP) [Time Frame: 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 [Time Frame: Week 12, 24, 36, 48, 60, and 72]

Number of Participants With Change in Steroid Dose [Time Frame: From Baseline up to Final Assessment (or Early Termination [up to Week 72])]

Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Total Score [Time Frame: 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 Reactive and Non-Reactive Anti-CEP-33457 Antibodies [Time Frame: Week 24, 48 and Final Assessment (or Early Termination [up to Week 72])]

Change From Baseline in the Biomarker: Anti-U1 Ribonucleoprotein Antibody (Anti-UI RNP Ab) [Time Frame: Baseline, Week 12, 24, 36, 48, 60 and final assessment (or early termination [up to Week 72])]

Number of Participants With Anti-nuclear Antibodies (ANA) [Time Frame: Week 12, 24, 36, 48, 60, and Final Assessment (or Early Termination [up to Week 72])]

Number of Participants Showing No Worsening on Physician's Global Assessment (PhGA) Scale [Time Frame: Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72]

Number of Participants With British Isles Lupus Assessment Group 2004 (BILAG-2004) Response [Time Frame: Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72]

Secondary ID(s)

C33457/3075

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 30/12/2022
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01240694