Lupus Erythematosus, SystemicPhase 1/2NCT01838694

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.

A Phase 1/2 study testing Ala-Cpn10 in people with Lupus Erythematosus, Systemic, run by Invion, Inc. at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Lupus Erythematosus, Systemic
What is being tested?: Ala-Cpn10
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 30 participants
Where: 6 sitesUnited States
Study dates: Jul 2013to Aug 2015
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

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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.

Who cannot join

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.

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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

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

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

Other trials in United States

About this study

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
Being tested: Ala-Cpn10, Placebo
Medical subject headings: Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ala-Cpn10Biological
PlaceboDrug

Study groups in NCT01838694
Study group	Role	What they receive
Placebo	Placebo comparator	Multiple doses of matched vehicle (no active ingredients) administered intravenously over 60 minutes. Receives: 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. Receives: Biological: Ala-Cpn10

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline Serum Interleukin 6 (IL-6) Levels at the End of Active Dosing, Comparing Treatment to Placebo Cohort.
Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2013Aug 2015

First posted24 Apr 2013 (estimated)
Study startJul 2013
Primary completionAug 2015
Study completionAug 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Lupus Erythematosus, SystemicStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01838694
Sponsor's protocol ID: IVXCpn001
Status last verified: Dec 2016
First submitted: 17 Apr 2013
Last updated: 30 Jan 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Lupus Erythematosus, Systemic trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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.
ClinicalTrials.gov ID: NCT01838694
Acronym / sponsor ID: IVXCpn001
Conditions: Lupus Erythematosus, Systemic
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Invion, Inc.Industry (pharma, biotech, devices)
Study start: Jul 2013
Primary completion: Aug 2015 (actual)
Study completion: Aug 2015 (actual)
First posted: 24 Apr 2013 (estimated)
Results: Posted 30 Jan 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboMultiple doses of matched vehicle (no active ingredients) administered intravenously over 60 minutes.
Ala-Cpn10	Experimental	Biological: Ala-Cpn10Recombinant minimally modified Chaperonin10 (Cpn10) Multiple doses in the range 10mg twice weekly to 100mg twice weekly administered intravenously by infusion over 60 minutes.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (26 listed)

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)

Key exclusion criteria (22 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ala-Cpn10	Biological	Ala-Cpn10
Placebo	Drug	Placebo

Primary outcome

Change From Baseline Serum Interleukin 6 (IL-6) Levels at the End of Active Dosing, Comparing Treatment to Placebo Cohort.
Time frame: 4 weeks

Results and safety

Results posted to the registry on 30 Jan 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	8	8
Ala-Cpn10	22	21

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

Time frame: 4 weeks. Mean (Standard Deviation). Unit: percentage change from baseline

Measure	Placebo n = 5	Ala-Cpn10 - 10mgs in Mild SLE n = 5	Ala-Cpn10 - 30mgs in Mild SLE n = 4	Ala-Cpn10 - 100mgs in Mild SLE n = 3	Ala-Cpn10 - 30mgs in Moderate SLE n = 1
Value	1.6 (24.7)	987.7 (2202.1)	-82.5 (20.4)	-29.7 (59.1)	5000 (0)

Population analysed: Analysis Population reflects participants for whom adequate analyzable samples were collected

Adverse events

Time frame: Up to 30 days following each patient's discontinuation of the study, for up to 9 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 8 (0%)	4 of 8 (50%)	Not reported
Ala-Cpn10	1 of 22 (4.5%)	6 of 22 (27.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Ala-Cpn10 in people with Lupus Erythematosus, Systemic, run by Invion, Inc. at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 26 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline Serum Interleukin 6 (IL-6) Levels at the End of Active Dosing, Comparing Treatment to Placebo Cohort. (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01838694.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2017.