Lupus Erythematosus, SystemicPhase 1NCT01127321
A Safety and Tolerability Study of MEDI-570 in Systemic Lupus Erythematosus
A Phase 1 study testing MEDI-570 0.03 MG, MEDI-570 0.1 MG and MEDI-570 0.3 MG in people with Lupus Erythematosus, Systemic, run by MedImmune LLC at 17 sites in 5 countries.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of MEDI-570 in adult subjects with moderately to severely active systemic lupus erythematosus (SLE). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lupus Erythematosus, Systemic
- What is being tested?
- MEDI-570 0.03 MG, MEDI-570 0.1 MG and MEDI-570 0.3 MG
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 17 sitesin 5 countries
- Study dates
- May 2010to Jul 2012
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet or have met at least 4 of the 11 revised American College of Rheumatology (ACR) classification criteria for systemic lupus erythematosus (SLE)
- Score greater than or equal to (>=) 6 points on the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) at Screening
- Ability to complete the study period, including follow-up period through Day 169
- Willingness to forego other forms of experimental treatment during the study.
Who cannot join
- History of cancer except basal cell carcinoma treated with apparent success with curative therapy >=1 year before randomization into the study
- Evidence of active or latent tuberculosis (TB)
- History of primary immunodeficiency
- Evidence of infection at any time with hepatitis B or C virus or human immunodeficiency virus (HIV)-1 or HIV-2, or active infection with hepatitis A, as determined by results of testing at Screening
- History of sepsis or serious, recurrent, chronic infection, current signs and symptoms of clinically significant chronic infection, or recent (within 6 months before Baseline visit) serious infection
- Any history or evidence of opportunistic infection within 6 months of Screening including severe cytomegalovirus (CMV) or herpetic infections (such as disseminated herpes, herpes encephalitis, ophthalmic herpes)
- Receipt of cyclophosphamide (intravenous or oral) within 6 months of Screening
- Have any absolute contraindications to skin punch biopsies, for example, a history of coagulation disorders.
Trial locations and contacts
17 sites in 5 countries.
17 sites in 5 countries
United States9 sites
Research Site
Atlanta, Georgia
Research Site
Columbus, Ohio
Research Site
Fort Lauderdale, Florida
Research Site
Lansing, Michigan
Research Site
Long Beach, California
Research Site
New York, New York
Research Site
Ocala, Florida
Research Site
San Leandro, California
Research Site
Winston-Salem, North Carolina
Mexico3 sites
Research Site
Chihuahua City
Research Site
Guadalajara
Research Site
México
About this study
Official title: A Phase 1, Double-blind, Randomized, Single Ascending Dose Study of the Safety and Tolerability of MEDI-570 in SLE
The purpose of this study is to evaluate the safety and tolerability of MEDI-570 in adult subjects with moderately to severely active systemic lupus erythematosus (SLE).
Read the detailed description
This is a Phase 1, double-blind, randomized, placebo-controlled study to evaluate the safety and tolerability of escalating single subcutaneous doses of MEDI-570 in adult subjects with moderately to severely active SLE.
- Conditions
- Lupus Erythematosus, Systemic
- Being tested
- Placebo, MEDI-570 0.03 MG, MEDI-570 0.1 MG, MEDI-570 0.3 MG, MEDI-570 1 MG
- Keywords
- Systemic lupus erythematosus, SLE, MEDI-570
- 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.
PlaceboOther
A single double-blind dose of placebo matched to MEDI-570 subcutaneous injection on Day 1.
MEDI-570 0.03 MGBiological
A single open-label dose of MEDI-570, 0.03 milligram (mg) subcutaneous injection on Day 1.
MEDI-570 0.1 MGBiological
A single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1.
MEDI-570 0.3 MGBiological
A single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1.
MEDI-570 1 MGBiological
A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | A single double-blind dose of placebo matched to MEDI-570 subcutaneous injection on Day 1. Receives: Other: Placebo |
| MEDI-570 0.03 MG | Experimental | A single open-label dose of MEDI-570, 0.03 milligram (mg) subcutaneous injection on Day 1. Receives: Biological: MEDI-570 0.03 MG |
| MEDI-570 0.1 MG | Experimental | A single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1. Receives: Biological: MEDI-570 0.1 MG |
| MEDI-570 0.3 MG | Experimental | A single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1. Receives: Biological: MEDI-570 0.3 MG |
| MEDI-570 1 MG | Experimental | A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1. Receives: Biological: MEDI-570 1 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between administration of study drug and Day 169 that were absent before treatment or that worsened relative to pretreatment state.
Measured: Day 1 to Day 169
Secondary outcomes (2)
Pharmacokinetic Parameters for MEDI-570
Following pharmacokinetic parameters were to be evaluated by using non-compartmental analysis: t1/2 = terminal phase elimination half-life which is the time measured for the serum concentration to decrease by one half; tmax = time to maximum observed serum concentration; Cmax = maximum observed serum concentration; AUC (0-t) = area under the serum concentration-time curve from time 0 to last measurable concentration; AUC (0-infinity) = area under the serum concentration-time curve from time 0 to extrapolated infinite time obtained from AUC (0-t) plus AUC (t-infinity); Vz/F = apparent volume of distribution, which is the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug; CL/F = apparent clearance which is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.
Measured: Predose and postdose on Day 1; Day 3, 5, 8, 15, 29, 57, 85, 113, 141, and 169
Number of Participants With Anti-Drug Antibodies to MEDI-570 at Any Visit
Measured: Predose on Day 1; Day 85, 113, and 169
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2010 (estimated)
- Study startMay 2010
- Primary completionJul 2012
- Study completionJul 2012
Why it stopped: Business reasons
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- David Close, PhD, Study director, MedImmune Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01127321
- Sponsor's protocol ID
- MI-CP209
- Status last verified
- Aug 2014
- First submitted
- 14 Apr 2010
- Last updated
- 26 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double-blind, Randomized, Single Ascending Dose Study of the Safety and Tolerability of MEDI-570 in SLE
- ClinicalTrials.gov ID
- NCT01127321
- Acronym / sponsor ID
- MI-CP209
- Conditions
- Lupus Erythematosus, Systemic
- Keywords
- Systemic lupus erythematosus, SLE, MEDI-570
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business reasons
- Enrolment
- 44 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Collaborators
- AstraZeneca
- Study start
- May 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 20 May 2010 (estimated)
- Results
- Posted 26 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and tolerability of MEDI-570 in adult subjects with moderately to severely active systemic lupus erythematosus (SLE).
Detailed description
This is a Phase 1, double-blind, randomized, placebo-controlled study to evaluate the safety and tolerability of escalating single subcutaneous doses of MEDI-570 in adult subjects with moderately to severely active SLE.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboA single double-blind dose of placebo matched to MEDI-570 subcutaneous injection on Day 1. |
| MEDI-570 0.03 MG | Experimental | Biological: MEDI-570 0.03 MGA single open-label dose of MEDI-570, 0.03 milligram (mg) subcutaneous injection on Day 1. |
| MEDI-570 0.1 MG | Experimental | Biological: MEDI-570 0.1 MGA single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1. |
| MEDI-570 0.3 MG | Experimental | Biological: MEDI-570 0.3 MGA single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1. |
| MEDI-570 1 MG | Experimental | Biological: MEDI-570 1 MGA single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Meet or have met at least 4 of the 11 revised American College of Rheumatology (ACR) classification criteria for systemic lupus erythematosus (SLE)
- Score greater than or equal to (>=) 6 points on the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) at Screening
- Ability to complete the study period, including follow-up period through Day 169
- Willingness to forego other forms of experimental treatment during the study.
Key exclusion criteria (8 listed)
- History of cancer except basal cell carcinoma treated with apparent success with curative therapy >=1 year before randomization into the study
- Evidence of active or latent tuberculosis (TB)
- History of primary immunodeficiency
- Evidence of infection at any time with hepatitis B or C virus or human immunodeficiency virus (HIV)-1 or HIV-2, or active infection with hepatitis A, as determined by results of testing at Screening
- History of sepsis or serious, recurrent, chronic infection, current signs and symptoms of clinically significant chronic infection, or recent (within 6 months before Baseline visit) serious infection
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 |
|---|---|---|
| PlaceboA single double-blind dose of placebo matched to MEDI-570 subcutaneous injection on Day 1. | Other | Placebo |
| MEDI-570 0.03 MGA single open-label dose of MEDI-570, 0.03 milligram (mg) subcutaneous injection on Day 1. | Biological | MEDI-570 0.03 MG |
| MEDI-570 0.1 MGA single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1. | Biological | MEDI-570 0.1 MG |
| MEDI-570 0.3 MGA single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1. | Biological | MEDI-570 0.3 MG |
| MEDI-570 1 MGA single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1. | Biological | MEDI-570 1 MG |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Time frame: Day 1 to Day 169
An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between administration of study drug and Day 169 that were absent before treatment or that worsened relative to pretreatment state.
2 secondary outcomes
Pharmacokinetic Parameters for MEDI-570
Time frame: Predose and postdose on Day 1; Day 3, 5, 8, 15, 29, 57, 85, 113, 141, and 169
Number of Participants With Anti-Drug Antibodies to MEDI-570 at Any Visit
Time frame: Predose on Day 1; Day 85, 113, and 169
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2014.
- 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.
David Close, PhD study director
MedImmune Ltd
17 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MEDI-570 0.03 MG, MEDI-570 0.1 MG and MEDI-570 0.3 MG in people with Lupus Erythematosus, Systemic, run by MedImmune LLC at 17 sites in 5 countries.
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 8 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: stopped early, as of the sponsor's last update on 26 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, Mexico, Peru, South Africa, Canada. 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?
Yes. Results are posted in the registry (first posted 26 Aug 2014). 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?
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) (time frame: Day 1 to Day 169). 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 26 Aug 2014.