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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.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Invion, Inc.
ClinicalTrials.gov Identifier:
NCT01838694
First received: April 17, 2013
Last updated: December 5, 2016
Last verified: December 2016
  Purpose
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.

Condition Intervention Phase
Lupus Erythematosus, Systemic Biological: Ala-Cpn10 Drug: Placebo Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment

Further study details as provided by Invion, Inc.:

Primary Outcome Measures:
  • Change From Baseline Serum Interleukin 6 (IL-6) Levels at the End of Active Dosing, Comparing Treatment to Placebo Cohort. [ Time Frame: 4 weeks ]

Enrollment: 30
Study Start Date: July 2013
Study Completion Date: August 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Multiple doses of matched vehicle (no active ingredients) administered intravenously over 60 minutes.
Drug: Placebo
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.
Biological: Ala-Cpn10

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria (ALL must be met):

To be entered on study, subjects must meet the following criteria:

  1. Male or female
  2. Age 18 - 75 years
  3. Patients fulfilling at least 4 criteria for SLE as defined by the American College of Rheumatology (ACR)
  4. Laboratory values as follows:

    Documented ANA titer ≥ 1:160 or positive anti-dsDNA antibodies at, or any time prior to screening (verifiable laboratory result)

  5. Not pregnant or breast-feeding
  6. 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.
  7. Agreement to use an effective form of contraception for the duration of the study.
  8. Ability to understand and give consent.
  9. Willing to participate and able to comply with the study requirements, procedures and visits.

    Mild SLE only

  10. Present with mild active SLE disease

    Moderate SLE only

  11. Present with active SLE disease based on SLE disease activity score (SLEDAI) ≥4 and ≤10
  12. MCP-1 urinary level > 35 pg/ml
  13. IL-6 serum level > 10 pg/ml
  14. Meets the American College of Rheumatology (ACR) conditions for "renal disorder" as one of the diagnostic criteria for SLE i.e.

    1. Persistent proteinuria between 0.5 and 1.0 grams per day or > than 3+ by dipstick OR
    2. Cellular casts--may be red cell, hemoglobin, granular, tubular, or mixed

    OR

  15. Physician (Pathologist) diagnosis of lupus nephritis of no greater severity than:

    1. Class I - Minimal mesangial lupus nephritis, OR
    2. 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.

  16. 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):

  1. 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
  2. Pregnant or breast-feeding
  3. Lack of peripheral venous access.
  4. History of cardiovascular disease. An acute cardiovascular event within 12 months of study entry, including arterial or venous thrombosis (blood clots).
  5. Requirement for a stable dose of corticosteroid >0.3 mg/kg/day of prednisone or equivalent.
  6. Active therapy with human or murine monoclonal antibodies (i.e. belimumab), within 2 months of study entry.
  7. Any experimental therapy within 3 months of study entry.
  8. Therapy with cyclophosphamide p.o or parenteral; pulse methylprednisolone or IVIG within 4-6 weeks.
  9. Subjects being treated with sulfonylureas.
  10. 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.
  11. 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.
  12. Recent systemic bacterial, fungal, viral, or parasitic infections. Have required management/treatment or hospitalization for any infection within the last 4 weeks before screening.
  13. History of malignancy - except completely excised basal cell carcinoma.
  14. Impaired hepatic function
  15. Body weight of 260lbs/120kg or more (BMI > 35)
  16. History of tuberculosis (TB) or active, continuing treatment for TB
  17. History of or current alcohol or substance abuse

    Mild SLE only

  18. Active lupus nephritis and/or severe renal impairment (estimated or measured GFR < 50% predicted for age and gender)

    Moderate SLE only

  19. Subjects with recently diagnosed lupus nephritis (diagnosis made <6 months prior to commencement of study
  20. Subjects with active urinary sediment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01838694

Locations
United States, Florida
Abel Buchheim Pharmaceutical Research
Miami, Florida, United States, 33165
United States, Illinois
Northwestern University School of Medicine
Chicago, Illinois, United States
United States, Pennsylvania
Altoona Arthritis and Osteoporosis Center
Altoona, Pennsylvania, United States, 16635
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
United States, Texas
Metroplex Clinical Research Center
Dallas, Texas, United States
Sponsors and Collaborators
Invion, Inc.
  More Information

Responsible Party: Invion, Inc.
ClinicalTrials.gov Identifier: NCT01838694     History of Changes
Other Study ID Numbers: IVXCpn001
Study First Received: April 17, 2013
Results First Received: September 1, 2016
Last Updated: December 5, 2016

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Early pregnancy factor
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 19, 2017