Status:
COMPLETED
Double-Blinded, Randomized, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Biochemical Activity of Intravenous Cpn10 Administration in Subjects With Mild to Moderate SLE.
Lead Sponsor:
Invion, Inc.
Conditions:
Lupus Erythematosus, Systemic
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
The primary objective of the study is to evaluate the safety, tolerability, and efficacy of 4 weeks intravenous treatment with Cpn10 in subjects with mild to moderate active SLE.
Eligibility Criteria
Inclusion
- Inclusion Criteria (ALL must be met):
- To be entered on study, subjects must meet the following criteria:
- Male or female
- Age 18 - 75 years
- Patients fulfilling at least 4 criteria for SLE as defined by the American College of Rheumatology (ACR)
- Laboratory values as follows:
- Documented ANA titer ≥ 1:160 or positive anti-dsDNA antibodies at, or any time prior to screening (verifiable laboratory result)
- Not pregnant or breast-feeding
- If corticosteroids are required for disease stability prior to study entry, able to tolerate a stable dose of ≤ 0.3 mg/kg/day of prednisone or equivalent for the duration of the study.
- Agreement to use an effective form of contraception for the duration of the study.
- Ability to understand and give consent.
- Willing to participate and able to comply with the study requirements, procedures and visits.
- Mild SLE only
- Present with mild active SLE disease
- Moderate SLE only
- Present with active SLE disease based on SLE disease activity score (SLEDAI) ≥4 and ≤10
- MCP-1 urinary level \> 35 pg/ml
- IL-6 serum level \> 10 pg/ml
- Meets the American College of Rheumatology (ACR) conditions for "renal disorder" as one of the diagnostic criteria for SLE i.e.
- Persistent proteinuria between 0.5 and 1.0 grams per day or \> than 3+ by dipstick OR
- Cellular casts--may be red cell, hemoglobin, granular, tubular, or mixed
- OR
- Physician (Pathologist) diagnosis of lupus nephritis of no greater severity than:
- Class I - Minimal mesangial lupus nephritis, OR
- Class II - Mesangial proliferative lupus nephritis, in accordance with the International Society of Nephrology (ISN) and the Renal Pathology Society (RPS) 2003 histological classification.
- With diagnosis made ≥ 6 months prior to study commencement.
- If inclusion criteria #15 is met, subject must be receiving stable Standard of Care, including hydroxychloroquine, treatment appropriate for class I-II nephritis.
- Exclusion Criteria (NONE can apply):
- Active severe SLE flare with central nervous system (CNS) and/or renal manifestations, pericarditis, active pleuritis, active peritonitis or other SLE manifestations requiring treatment not allowed by the study protocol within 4 weeks of screening
- Pregnant or breast-feeding
- Lack of peripheral venous access.
- History of cardiovascular disease. An acute cardiovascular event within 12 months of study entry, including arterial or venous thrombosis (blood clots).
- Requirement for a stable dose of corticosteroid \>0.3 mg/kg/day of prednisone or equivalent.
- Active therapy with human or murine monoclonal antibodies (i.e. belimumab), within 2 months of study entry.
- Any experimental therapy within 3 months of study entry.
- Therapy with cyclophosphamide p.o or parenteral; pulse methylprednisolone or IVIG within 4-6 weeks.
- Subjects being treated with sulfonylureas.
- Subjects with any the following laboratory abnormalities: serum creatinine \>3.0 mg/dL, WBC \<3,500/μL, ANC \<3,000/μL, absolute lymphocyte count ≤500/μL, Hgb \<8.0 g/dL, platelets \<50,000/μL, ALT and/or AST \>1.5 x upper limit of normal (ULN), alkaline phosphatase \>1.5 ULN.
- Personal or psychiatric condition that precludes the subject being able to comply with the study requirements or understand and agree to the informed consent process.
- Recent systemic bacterial, fungal, viral, or parasitic infections. Have required management/treatment or hospitalization for any infection within the last 4 weeks before screening.
- History of malignancy - except completely excised basal cell carcinoma.
- Impaired hepatic function
- Body weight of 260lbs/120kg or more (BMI \> 35)
- History of tuberculosis (TB) or active, continuing treatment for TB
- History of or current alcohol or substance abuse
- Mild SLE only
- Active lupus nephritis and/or severe renal impairment (estimated or measured GFR \< 50% predicted for age and gender)
- Moderate SLE only
- Subjects with recently diagnosed lupus nephritis (diagnosis made \<6 months prior to commencement of study
- Subjects with active urinary sediment
Exclusion
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01838694
Start Date
July 1 2013
End Date
August 1 2015
Last Update
January 30 2017
Active Locations (6)
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1
Abel Buchheim Pharmaceutical Research
Miami, Florida, United States, 33165
2
Northwestern University School of Medicine
Chicago, Illinois, United States
3
Altoona Arthritis and Osteoporosis Center
Altoona, Pennsylvania, United States, 16635
4
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States