- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01838694
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Florida
-
Miami, Florida, United States, 33165
- Abel Buchheim Pharmaceutical Research
-
-
Illinois
-
Chicago, Illinois, United States
- Northwestern University School Of Medicine
-
-
Pennsylvania
-
Altoona, Pennsylvania, United States, 16635
- Altoona Arthritis and Osteoporosis Center
-
Hershey, Pennsylvania, United States
- Penn State Milton S. Hershey Medical Center
-
Philadelphia, Pennsylvania, United States
- Hospital of the University of Pennsylvania
-
-
Texas
-
Dallas, Texas, United States
- Metroplex Clinical Research Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo
Multiple doses of matched vehicle (no active ingredients) administered intravenously over 60 minutes.
|
|
EXPERIMENTAL: Ala-Cpn10
Recombinant minimally modified Chaperonin10 (Cpn10) Multiple doses in the range 10mg twice weekly to 100mg twice weekly administered intravenously by infusion over 60 minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change From Baseline Serum Interleukin 6 (IL-6) Levels at the End of Active Dosing, Comparing Treatment to Placebo Cohort.
Time Frame: 4 weeks
|
4 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IVXCpn001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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