Clinical Trials List
Protocol NumberAN-SLE3331
NCT Number(ClinicalTrials.gov Identfier)NCT01395745
2013-05-28 - 2016-09-21
Phase III
Terminated4
Study ended1
ICD-10M32.0
Drug-induced systemic lupus erythematosus
ICD-10M32.10
Systemic lupus erythematosus, organ or system involvement unspecified
ICD-10M32.11
Endocarditis in systemic lupus erythematosus
ICD-10M32.12
Pericarditis in systemic lupus erythematosus
ICD-10M32.13
Lung involvement in systemic lupus erythematosus
ICD-10M32.14
Glomerular disease in systemic lupus erythematosus
ICD-10M32.15
Tubulo-interstitial nephropathy in systemic lupus erythematosus
ICD-10M32.19
Other organ or system involvement in systemic lupus erythematosus
ICD-10M32.8
Other forms of systemic lupus erythematosus
ICD-10M32.9
Systemic lupus erythematosus, unspecified
ICD-9710.0
Systemic lupus erythematosus
A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects with Systemic Lupus Erythematosus
-
Trial Applicant
CHILTERN RESEARCH INTERNATIONAL (SINGAPORE) PTE. LTD.
-
Sponsor
Anthera Pharmaceuticals, Inc
-
Trial scale
Multi-Regional Multi-Center
-
Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Chi-Sheng Chiou 風濕免疫科
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Po-Hao Huang 風濕免疫科
The Actual Total Number of Participants Enrolled
1 Study ended
Co-Principal Investigator
- CHIEH-YU SHEN 風濕免疫科
- PING-NING HSU 風濕免疫科
- KO-JEN LI 風濕免疫科
- CHENG-HAN WU 風濕免疫科
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Systemic Lupus Erythematosus
Objectives
The primary objective of this study is to evaluate the clinical efficacy of
blisibimod as measured by a composite responder index in subjects
who, despite corticosteroid use, continue to have autoantibody positive,
clinically-active systemic lupus erythematosus (SLE) as defined by
SELENA-SLEDAI score ≥10.
Secondary objectives include assessment of the impact of blisibimod on
time to first severe SLE flare, ability to reduce steroid dose to
≤ 7.5 mg/day prednisone (or prednisone equivalent), change in disease
activity within lupus organ domains, and effects of blisibimod on
health-related quality-of-life, biomarker changes, and safety
Test Drug
Blisibimod
Active Ingredient
Blisibimod
Dosage Form
injection
Dosage
100mg/ml
Endpoints
The primary objective of this study is to evaluate the clinical efficacy of
blisibimod as measured by a composite responder index in subjects
who, despite corticosteroid use, continue to have autoantibody positive,
clinically-active systemic lupus erythematosus (SLE) as defined by
SELENA-SLEDAI score ≥10.
Secondary objectives include assessment of the impact of blisibimod on
time to first severe SLE flare, ability to reduce steroid dose to
≤ 7.5 mg/day prednisone (or prednisone equivalent), change in disease
activity within lupus organ domains, and effects of blisibimod on
health-related quality-of-life, biomarker changes, and safety
blisibimod as measured by a composite responder index in subjects
who, despite corticosteroid use, continue to have autoantibody positive,
clinically-active systemic lupus erythematosus (SLE) as defined by
SELENA-SLEDAI score ≥10.
Secondary objectives include assessment of the impact of blisibimod on
time to first severe SLE flare, ability to reduce steroid dose to
≤ 7.5 mg/day prednisone (or prednisone equivalent), change in disease
activity within lupus organ domains, and effects of blisibimod on
health-related quality-of-life, biomarker changes, and safety
Inclution Criteria
Subjects will only be eligible for inclusion in this study if all of the
following criteria are met:
1. Male or female, age ≥18 years.
2. Fulfill at least 4 of the criteria for SLE defined by the American
College of Rheumatology (ACR, Appendix E).
3. Anti-nuclear antibody (ANA) ≥1:80 (IFA titer) and/or anti-double stranded DNA antibody (anti-dsDNA Ab) ≥30 IU/mL. SLE serologies may be re-tested once during the 28-day screening window in subjects who meet all other inclusion/exclusion criteria
but fail to meet only the SLE serologic inclusion criteria.
4. Clinically active disease defined by SELENA-SLEDAI score ≥10 (Appendix B).
5. Receiving prednisone or prednisone equivalent for at least 28 days prior to randomization. The total daily dose must not exceed the greater of either 0.5 mg/kg or 40 mg. Other allowed oral standard-of-care medications include:
• Methotrexate up to 25 mg weekly
• Azathioprine up to 300 mg daily
• Mycophenolate (mofetil or sodium salt) up to 3 grams daily
• Leflunomide up to 40 mg daily
• Hydroxychloroquine up to 400 mg per day or antimalarial equivalent
• Non-steroidal anti-inflammatory drugs (NSAIDS) within locally-approved dose ranges
following criteria are met:
1. Male or female, age ≥18 years.
2. Fulfill at least 4 of the criteria for SLE defined by the American
College of Rheumatology (ACR, Appendix E).
3. Anti-nuclear antibody (ANA) ≥1:80 (IFA titer) and/or anti-double stranded DNA antibody (anti-dsDNA Ab) ≥30 IU/mL. SLE serologies may be re-tested once during the 28-day screening window in subjects who meet all other inclusion/exclusion criteria
but fail to meet only the SLE serologic inclusion criteria.
4. Clinically active disease defined by SELENA-SLEDAI score ≥10 (Appendix B).
5. Receiving prednisone or prednisone equivalent for at least 28 days prior to randomization. The total daily dose must not exceed the greater of either 0.5 mg/kg or 40 mg. Other allowed oral standard-of-care medications include:
• Methotrexate up to 25 mg weekly
• Azathioprine up to 300 mg daily
• Mycophenolate (mofetil or sodium salt) up to 3 grams daily
• Leflunomide up to 40 mg daily
• Hydroxychloroquine up to 400 mg per day or antimalarial equivalent
• Non-steroidal anti-inflammatory drugs (NSAIDS) within locally-approved dose ranges
Exclusion Criteria
Subjects must NOT meet any of the following exclusion criteria:
1. A disorder (including psychiatric), condition or clinically significant disease (other than a diagnosis of SLE) that would interfere with the study evaluation, completion and/or procedures per the Investigator’s discretion. This includes any co-morbidities like
presence of congestive heart failure, angina, and chronic obstructive pulmonary disease, or diseases for which treatment with systemic steroid is likely (e.g. severe asthma).
2. Active vasculitis that may result in gangrene, acute ischemic infarction, present or likely open wounds giving rise to increased infection risk, or a condition that prompts the Investigator to consider escalation of immunosuppressive therapy or further diagnostic workup because of worsening or persistence of vasculitis.
3. Severe active central nervous system (CNS) lupus. This includes recently active cerebrovascular accidents, transient ischemic attacks, psychosis, or seizures due to lupus, or a condition that prompts the Investigator to consider escalation of immunosuppressive therapy or further diagnostic workup because of worsening or persistence of SLE-related CNS symptoms.
4. Severe active lupus nephritis that prompts the Investigator to consider escalation of immunosuppressive therapy or further diagnostic workup because of worsening or persistence of inflammatory renal signs or symptoms.
5. Proteinuria >6 grams/24 hours or equivalent using spot urinary protein/creatinine ratio, serum creatinine >2.5 mg/dL, or requirement for dialysis.
6. Poorly controlled hypertension (≥160/90 mmHg) or poorly controlled diabetes (hemoglobin A1C ≥10%).
7. Known to be positive for human immunodeficiency virus (HIV) and/or positive at the screening visit for hepatitis B surface antigen, or hepatitis C virus antibody.
8. Liver disease defined as serum alanine aminotransferase [ALT] or aspartate aminotransferase [AST] >3 x upper limit of normal [ULN] confirmed by repeat testing.
9. Anemia (Hgb <8 g/dL), neutropenia (≤1500 cells/µL), or thrombocytopenia (<50,000 platelets/µL). If the condition is considered to be due to active SLE, the subject may be enrolled.
10. Malignancy within the past 5 years (other than a squamous or basal cell carcinoma of the skin which has been excised and considered cured). Those with history of malignancy greater than 5 years ago should provide evidence of remission or cure. Subjects with a history of cervical cancer are allowed if they have documented evidence of conization or cure within last 3 years.
11. Active infection requiring hospitalization or treatment with parenteral antibiotics within the past 60 days, or history of repeated herpetic viral infections (Herpes simplex and Herpes zoster) having more than 2 episodes in the year prior to screening). Other chronic infectious history should be discussed with the Medical Monitor.
12. History of active tuberculosis (TB), or evidence of prior TB infection. History of latent TB infection is also excluded unless there is documentation demonstrating completion of appropriate anti-TB therapy per CDC guidelines or local regulations prior to screening.
In addition, the subject must not have any clinical signs/symptoms of active TB.
13. Any prior administration of blisibimod.
14. Participation in any clinical trial for a molecule that primarily targets
the B-cell pathway, interferon pathway, or Toll-like receptors (e.g., LY2127399, TACI-Ig, anti-CD22, anti-interferon therapies, anti-IL-6 therapies, or Toll-like receptor inhibitors) in the past 12 months.
15. Administration of cyclophosphamide, systemic corticosteroid (>40 mg oral prednisone per day), cyclosporine, anti-TNFα therapies, B-cell modulating therapies, transfusion, plasmapheresis or plasma exchange, IV immunoglobulin, or live vaccines within the listed wash-out periods:
• Cyclophosphamide or other alkylating agent – 90 days prior to randomization
• Cyclosporine or other calcineurin inhibitor – 60 days prior to randomization. Topical calcineurin inhibitors are allowed at any time.
• Anti-TNF alpha, abatacept, anakinra – 90 days prior to randomization
• Transfusion, IV immunoglobulin, plasmapheresis, Prosorba column, or plasma exchange – 120 days prior to randomization
• Live vaccines – 30 days prior to randomization
• High dose systemic corticosteroid, >40 mg oral prednisone per day, including administration as pulse IV – 30 days prior to randomization
• B-cell modulating therapy (e.g., belimumab, rituximab, tocilizumab, anti-CD20, anti-IL-6) – 12 months prior to randomization
• Intramuscular or intra-articular injections of corticosteroids - 30 days prior to randomization. Topical and inhaled steroids are allowed at any time.
16. Females who are nursing, pregnant, intending to become pregnant or intending to nurse during the time of the study, or who have a positive pregnancy test at baseline. All sexually-active subjects of reproductive potential are required to use a reliable method of birth control. Females and males are required to use or start using a reliable method of birth control at least 2 weeks prior to randomization, throughout the study, and for at least 3 months following completion of study therapy. A reliable method of birth control is defined as one of the following: oral or injectable contraceptives, intrauterine device, contraceptive implants, tubal ligation, hysterectomy, or a double-barrier method (diaphragm with spermicidal foam or jelly, or a condom), abstinence or vasectomy.
17. General
• Subject has not yet achieved at least 3 months or 5 half-lives (whichever is longer) since ending other investigational device or drug study not already mentioned.
• Subject has known sensitivity to any of the products to be administered during dosing.
• Subject previously has been randomized into this study.
• Subject will not be available for follow-up assessment.
• History of clinically evident immunodeficiency.
• Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures.
• With the exception of the allowed re-screening of SLE serologies, subjects who fail to meet the inclusion and exclusion criteria may not be re-screened for this study.
1. A disorder (including psychiatric), condition or clinically significant disease (other than a diagnosis of SLE) that would interfere with the study evaluation, completion and/or procedures per the Investigator’s discretion. This includes any co-morbidities like
presence of congestive heart failure, angina, and chronic obstructive pulmonary disease, or diseases for which treatment with systemic steroid is likely (e.g. severe asthma).
2. Active vasculitis that may result in gangrene, acute ischemic infarction, present or likely open wounds giving rise to increased infection risk, or a condition that prompts the Investigator to consider escalation of immunosuppressive therapy or further diagnostic workup because of worsening or persistence of vasculitis.
3. Severe active central nervous system (CNS) lupus. This includes recently active cerebrovascular accidents, transient ischemic attacks, psychosis, or seizures due to lupus, or a condition that prompts the Investigator to consider escalation of immunosuppressive therapy or further diagnostic workup because of worsening or persistence of SLE-related CNS symptoms.
4. Severe active lupus nephritis that prompts the Investigator to consider escalation of immunosuppressive therapy or further diagnostic workup because of worsening or persistence of inflammatory renal signs or symptoms.
5. Proteinuria >6 grams/24 hours or equivalent using spot urinary protein/creatinine ratio, serum creatinine >2.5 mg/dL, or requirement for dialysis.
6. Poorly controlled hypertension (≥160/90 mmHg) or poorly controlled diabetes (hemoglobin A1C ≥10%).
7. Known to be positive for human immunodeficiency virus (HIV) and/or positive at the screening visit for hepatitis B surface antigen, or hepatitis C virus antibody.
8. Liver disease defined as serum alanine aminotransferase [ALT] or aspartate aminotransferase [AST] >3 x upper limit of normal [ULN] confirmed by repeat testing.
9. Anemia (Hgb <8 g/dL), neutropenia (≤1500 cells/µL), or thrombocytopenia (<50,000 platelets/µL). If the condition is considered to be due to active SLE, the subject may be enrolled.
10. Malignancy within the past 5 years (other than a squamous or basal cell carcinoma of the skin which has been excised and considered cured). Those with history of malignancy greater than 5 years ago should provide evidence of remission or cure. Subjects with a history of cervical cancer are allowed if they have documented evidence of conization or cure within last 3 years.
11. Active infection requiring hospitalization or treatment with parenteral antibiotics within the past 60 days, or history of repeated herpetic viral infections (Herpes simplex and Herpes zoster) having more than 2 episodes in the year prior to screening). Other chronic infectious history should be discussed with the Medical Monitor.
12. History of active tuberculosis (TB), or evidence of prior TB infection. History of latent TB infection is also excluded unless there is documentation demonstrating completion of appropriate anti-TB therapy per CDC guidelines or local regulations prior to screening.
In addition, the subject must not have any clinical signs/symptoms of active TB.
13. Any prior administration of blisibimod.
14. Participation in any clinical trial for a molecule that primarily targets
the B-cell pathway, interferon pathway, or Toll-like receptors (e.g., LY2127399, TACI-Ig, anti-CD22, anti-interferon therapies, anti-IL-6 therapies, or Toll-like receptor inhibitors) in the past 12 months.
15. Administration of cyclophosphamide, systemic corticosteroid (>40 mg oral prednisone per day), cyclosporine, anti-TNFα therapies, B-cell modulating therapies, transfusion, plasmapheresis or plasma exchange, IV immunoglobulin, or live vaccines within the listed wash-out periods:
• Cyclophosphamide or other alkylating agent – 90 days prior to randomization
• Cyclosporine or other calcineurin inhibitor – 60 days prior to randomization. Topical calcineurin inhibitors are allowed at any time.
• Anti-TNF alpha, abatacept, anakinra – 90 days prior to randomization
• Transfusion, IV immunoglobulin, plasmapheresis, Prosorba column, or plasma exchange – 120 days prior to randomization
• Live vaccines – 30 days prior to randomization
• High dose systemic corticosteroid, >40 mg oral prednisone per day, including administration as pulse IV – 30 days prior to randomization
• B-cell modulating therapy (e.g., belimumab, rituximab, tocilizumab, anti-CD20, anti-IL-6) – 12 months prior to randomization
• Intramuscular or intra-articular injections of corticosteroids - 30 days prior to randomization. Topical and inhaled steroids are allowed at any time.
16. Females who are nursing, pregnant, intending to become pregnant or intending to nurse during the time of the study, or who have a positive pregnancy test at baseline. All sexually-active subjects of reproductive potential are required to use a reliable method of birth control. Females and males are required to use or start using a reliable method of birth control at least 2 weeks prior to randomization, throughout the study, and for at least 3 months following completion of study therapy. A reliable method of birth control is defined as one of the following: oral or injectable contraceptives, intrauterine device, contraceptive implants, tubal ligation, hysterectomy, or a double-barrier method (diaphragm with spermicidal foam or jelly, or a condom), abstinence or vasectomy.
17. General
• Subject has not yet achieved at least 3 months or 5 half-lives (whichever is longer) since ending other investigational device or drug study not already mentioned.
• Subject has known sensitivity to any of the products to be administered during dosing.
• Subject previously has been randomized into this study.
• Subject will not be available for follow-up assessment.
• History of clinically evident immunodeficiency.
• Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures.
• With the exception of the allowed re-screening of SLE serologies, subjects who fail to meet the inclusion and exclusion criteria may not be re-screened for this study.
The Estimated Number of Participants
-
Taiwan
23 participants
-
Global
400 participants
