PEARL-SC Trial: A Study of the Efficacy, Safety, and Tolerability of A 623 Administration in Subjects With Systemic Lupus Erythematosus (PEARL-SC)
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| ClinicalTrials.gov Identifier: NCT01162681 |
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Recruitment Status :
Completed
First Posted : July 15, 2010
Last Update Posted : March 4, 2014
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Sponsor:
Anthera Pharmaceuticals
Information provided by (Responsible Party):
Anthera Pharmaceuticals
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Brief Summary:
The purpose of this study is to evaluate the efficacy, safety and tolerability of three different doses of A-623 administered in addition to standard therapy in subjects with active SLE disease
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Systemic Lupus Erythematosus | Drug: A-623 Other: Placebo Comparator | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 547 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Double-Blind Phase 2b Study to Evaluate the Efficacy, Safety, and Tolerability of A 623 Administration in Subjects With Systemic Lupus Erythematosus |
| Study Start Date : | July 2010 |
| Actual Primary Completion Date : | April 2012 |
| Actual Study Completion Date : | April 2012 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Systemic lupus erythematosus
MedlinePlus related topics:
Lupus
| Arm | Intervention/treatment |
|---|---|
| Experimental: A-623 high dose weekly |
Drug: A-623
High dose given subcutaneously once a week for up to 52 weeks |
| Experimental: A-623 low dose weekly |
Drug: A-623
Low dose given subcutaneously once a week for up to 52 weeks |
| Experimental: A-623 high dose every 4 weeks |
Drug: A-623
High dose given subcutaneously once every 4 weeks for up to 52 weeks |
| Placebo Comparator: Placebo |
Other: Placebo Comparator
Placebo comparator is a matched volume given subcutaneously once a week or once every 4 weeks for up to 52 weeks |
Primary Outcome Measures :
- SLE response [ Time Frame: Various timepoints through Week 52 ]The % of subjects with SLE response compared with baseline at the time of assessment
Secondary Outcome Measures :
- B cell reduction [ Time Frame: Various timepoints through Week 52 ]
- Time to first flare [ Time Frame: Various timepoints through Week 52 ]
- FACIT-fatigue score [ Time Frame: Various timepoints through Week 52 ]
- Reduction in prednisone dose [ Time Frame: Various timepoints through Week 52 ]
- Change in IgG, IgM,C3 and C4 [ Time Frame: Various timepoints through Week 52 ]
- Flare rates [ Time Frame: Various timepoints through Week 52 ]
- SRI, using improvements of SELENA-SLEDAI of 5, 6, 7, 8 and 9 [ Time Frame: Various timepoints through Week 52 ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of SLE by American College of Rheumatology guidelines.
- On stable SLE treatment
- Active SLE disease
- Serologically active
- 18 years of age or older
- Receiving stable doses of prednisone between 7.5 mg and 40 mg per day
Exclusion Criteria:
- Severe active vasculitis, active central nervous system lupus, active lupus nephritis, uncontrolled hypertension, or uncontrolled diabetes.
- Known to be positive for HIV and/or positive at the screening visit for hepatitis B, or hepatitis C.
- Liver disease.
- Anemia, neutropenia, or thrombocytopenia.
- Malignancy within past 5 years
- Active infection requiring hospitalization or treatment with parenteral antibiotics within the past 60 days or history of repeated herpetic viral infections.
- History of active tuberculosis or a history of tuberculosis infection.
- Participation in the active treatment arm of any Phase 2 or Phase 3 clinical trial for a molecule that primarily targets the B cell pathway in the past 18 months.
- Prior administration of any B cell depleting therapy in the past 18 months.
- Pregnant or nursing
- History of congenital immunodeficiency
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01162681
Locations
Show 74 study locations
Sponsors and Collaborators
Anthera Pharmaceuticals
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Anthera Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01162681 |
| Other Study ID Numbers: |
AN-SLE3321 |
| First Posted: | July 15, 2010 Key Record Dates |
| Last Update Posted: | March 4, 2014 |
| Last Verified: | January 2014 |
Keywords provided by Anthera Pharmaceuticals:
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SLE Lupus Lupus Erythematosus, Systemic |
Autoimmune Diseases A-623 Blisibimod |
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |