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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.

Primary Purpose

Lupus Erythematosus, Systemic

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ala-Cpn10
Placebo
Sponsored by
Invion, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lupus Erythematosus, Systemic

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Abel Buchheim Pharmaceutical Research
  • Northwestern University School of Medicine
  • Altoona Arthritis and Osteoporosis Center
  • Penn State Milton S. Hershey Medical Center
  • Hospital of the University of Pennsylvania
  • Metroplex Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Ala-Cpn10

Arm Description

Multiple doses of matched vehicle (no active ingredients) administered intravenously over 60 minutes.

Recombinant minimally modified Chaperonin10 (Cpn10) Multiple doses in the range 10mg twice weekly to 100mg twice weekly administered intravenously by infusion over 60 minutes.

Outcomes

Primary Outcome Measures

Change From Baseline Serum Interleukin 6 (IL-6) Levels at the End of Active Dosing, Comparing Treatment to Placebo Cohort.

Secondary Outcome Measures

Full Information

First Posted
April 17, 2013
Last Updated
December 5, 2016
Sponsor
Invion, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01838694
Brief Title
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 Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Invion, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Erythematosus, Systemic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Multiple doses of matched vehicle (no active ingredients) administered intravenously over 60 minutes.
Arm Title
Ala-Cpn10
Arm Type
Experimental
Arm Description
Recombinant minimally modified Chaperonin10 (Cpn10) Multiple doses in the range 10mg twice weekly to 100mg twice weekly administered intravenously by infusion over 60 minutes.
Intervention Type
Biological
Intervention Name(s)
Ala-Cpn10
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change From Baseline Serum Interleukin 6 (IL-6) Levels at the End of Active Dosing, Comparing Treatment to Placebo Cohort.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Abel Buchheim Pharmaceutical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Facility Name
Northwestern University School of Medicine
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Altoona Arthritis and Osteoporosis Center
City
Altoona
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Metroplex Clinical Research Center
City
Dallas
State/Province
Texas
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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.

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