InflammationPhase 1NCT00960362
An Investigation of AGS-009 in Patients With Systemic Lupus Erythematosus (SLE)
A Phase 1 study testing AGS-009 in people with Inflammation and Systemic Lupus Erythematosus (SLE), run by Argos Therapeutics at 6 sites in United States.
Trial summary
This trial is conducted in North America. The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetic and signs of bioactivity of increasing single doses of AGS-009 in patients with systemic lupus erythematosus (SLE). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Inflammation, Systemic Lupus Erythematosus (SLE)
- What is being tested?
- AGS-009
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 6 sitesUnited States
- Study dates
- Jul 2009to Dec 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of SLE
- Disease duration longer or equal to 6 months
- Stable, mild to moderate active SLE
- Receiving stable maintenance therapy
Who cannot join
- Significant lupus nephritis
- Active central nervous system (CNS) disease
- Significant arterial or venous thrombosis (blood clots) within 12 months prior to dosing
- Active vasculitis requiring treatment
- Body weight over 120 kg
- History of cancer
Show all 11Show fewer
- Infections
- viral: HIV, hepatitis B or C, Epstein-Barr virus (EBV), cytomegalovirus (CMV), varicella zoster virus (VZV), or herpes simplex virus (HSV-1 or HSV-2)
- tuberculosis (TB)
- Severe systemic microbial infections within the past 12 months prior to dosing
- Immunosuppressive and immune modulating therapy
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Study site
Birmingham, Alabama, 35294
Study site
Dallas, Texas, 75390
Study site
Duncansville, Pennsylvania, 16635
Study site
Durham, North Carolina, 27710
Study site
Kansas City, Kansas, 66160
Study site
Lake Success, New York, 11042
About this study
Official title: A Randomised, Double-blind, Placebo-controlled, and Single Dose-escalation Trial of AGS-009 Administered in Subjects With Systemic Lupus Erythematosus
This trial is conducted in North America. The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetic and signs of bioactivity of increasing single doses of AGS-009 in patients with systemic lupus erythematosus (SLE).
- Conditions
- Inflammation, Systemic Lupus Erythematosus (SLE)
- Being tested
- AGS-009, placebo
- Medical subject headings
- Inflammation, Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AGS-009Drug
Single dose in the range of 0.01 to 30 mg/kg administered intravenously (in the vein)
placeboDrug
Single dose of 0 mg/kg administered intravenously (in the vein) cohort 1-6.
| Study group | Role | What they receive |
|---|---|---|
| A | Placebo comparator | Not described Receives: Drug: placebo |
| B | Experimental | Intravenous cohort 1; 0.01 mg/kg Receives: Drug: AGS-009 |
| C | Experimental | Intravenous cohort 2; 0.1 mg/kg Receives: Drug: AGS-009 |
| D | Experimental | Intravenous cohort 3; 0.6 mg/kg Receives: Drug: AGS-009 |
| E | Experimental | Intravenous cohort 4; 3.0 mg/kg Receives: Drug: AGS-009 |
| F | Experimental | Intravenous cohort 5; 10 mg/kg Receives: Drug: AGS-009 |
| G | Experimental | Intravenous cohort 6; 30 mg/kg Receives: Drug: AGS-009 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of adverse events
Measured: From dosing at visit 2 until end of safety visits at visit 8.
Secondary outcomes (1)
Pharmacokinetic - AUC (area under the curve)
Measured: From dosing at visit 2 until end of safety visits at visit 8.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2009 (estimated)
- Study startJul 2009
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Argos Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fred Miesowicz, Ph.D., Study director, Argos Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00960362
- Sponsor's protocol ID
- AGS-009-001
- Status last verified
- Jan 2012
- First submitted
- 14 Aug 2009
- Last updated
- 30 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled, and Single Dose-escalation Trial of AGS-009 Administered in Subjects With Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT00960362
- Acronym / sponsor ID
- AGS-009-001
- Conditions
- Inflammation, Systemic Lupus Erythematosus (SLE)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Argos TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 17 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is conducted in North America. The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetic and signs of bioactivity of increasing single doses of AGS-009 in patients with systemic lupus erythematosus (SLE).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| A | Placebo comparator | Drug: placebo |
| B | Experimental | Drug: AGS-009Intravenous cohort 1; 0.01 mg/kg |
| C | Experimental | Drug: AGS-009Intravenous cohort 2; 0.1 mg/kg |
| D | Experimental | Drug: AGS-009Intravenous cohort 3; 0.6 mg/kg |
| E | Experimental | Drug: AGS-009Intravenous cohort 4; 3.0 mg/kg |
| F | Experimental | Drug: AGS-009Intravenous cohort 5; 10 mg/kg |
| G | Experimental | Drug: AGS-009Intravenous cohort 6; 30 mg/kg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of SLE
- Disease duration longer or equal to 6 months
- Stable, mild to moderate active SLE
- Receiving stable maintenance therapy
Key exclusion criteria (11 listed)
- Significant lupus nephritis
- Active central nervous system (CNS) disease
- Significant arterial or venous thrombosis (blood clots) within 12 months prior to dosing
- Active vasculitis requiring treatment
- Body weight over 120 kg
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 |
|---|---|---|
| AGS-009Single dose in the range of 0.01 to 30 mg/kg administered intravenously (in the vein) | Drug | B, C, D, E, F, G |
| placeboSingle dose of 0 mg/kg administered intravenously (in the vein) cohort 1-6. | Drug | A |
Primary outcome
Frequency of adverse events
Time frame: From dosing at visit 2 until end of safety visits at visit 8.
1 secondary outcome
Pharmacokinetic - AUC (area under the curve)
Time frame: From dosing at visit 2 until end of safety visits at visit 8.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2012.
- Argos TherapeuticsLink provided by the sponsor.
Related trials for Inflammation
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
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.
Fred Miesowicz, Ph.D. study director
Argos Therapeutics
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AGS-009 in people with Inflammation and Systemic Lupus Erythematosus (SLE), run by Argos Therapeutics 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 4 inclusion and 11 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 2012. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Frequency of adverse events (time frame: From dosing at visit 2 until end of safety visits at visit 8.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2012.