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.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01838694
Recruitment Status : Completed
First Posted : April 24, 2013
Results First Posted : January 30, 2017
Last Update Posted : January 30, 2017
Information provided by (Responsible Party):
Invion, Inc.

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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : July 2013
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Arm Intervention/treatment
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

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

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

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


  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

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 identifier (NCT number): NCT01838694

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.

Responsible Party: Invion, Inc. Identifier: NCT01838694     History of Changes
Other Study ID Numbers: IVXCpn001
First Posted: April 24, 2013    Key Record Dates
Results First Posted: January 30, 2017
Last Update Posted: January 30, 2017
Last Verified: December 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