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.

NCT01838694 | Completed Phase 1 Results

• 1 other identifier: IVXCpn001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 6

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.

Conditions

Lupus Erythematosus, Systemic

Outcome Measures

Primary Outcomes (1)

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

  4 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Ala-Cpn10

EXPERIMENTAL

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

Interventions

Ala-Cpn10 BIOLOGICAL

Ala-Cpn10

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Invion, Inc.: lead

Study Sites (6)

Abel Buchheim Pharmaceutical Research

Miami, Florida, 33165, United States

Location

Northwestern University School of Medicine

Chicago, Illinois, United States

Location

Altoona Arthritis and Osteoporosis Center

Altoona, Pennsylvania, 16635, United States

Location

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Location

Metroplex Clinical Research Center

Dallas, Texas, United States

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Mitchell Glass, M.D., EVP of R&D
• Organization: Invion, Inc.

mitchell.glass@inviongroup.com

+61 7 3295 0500

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2013
• First Posted: April 24, 2013
• Study Start: July 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: January 30, 2017
• Results First Posted: January 30, 2017

Record last verified: 2016-12

Locations

US (6)