Systemic Lupus ErythematosusPhase 2NCT01559090
Safety and Tolerability of Intravenous Dose of MEDI-546 in Japanese Subjects With Systemic Lupus Erythematosus.
A Phase 2 study testing MEDI-546 in people with Systemic Lupus Erythematosus, run by AstraZeneca at 6 sites in Japan.
Trial summary
The purpose of this study is to assess safety, tolerability, pharmacokinetics and pharmacodynamics of MEDI-546 in Japanese SLE patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- MEDI-546
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 6 sitesJapan
- Study dates
- 20 Apr 2012to 21 Feb 2017
- Phase
- Phase 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fulfils at least 4 of the 11 American College of Rheumatology (ACR) classification criteria for SLE.
- Weight greater than or equal to 40.0 kg.
- Diagnosis of pediatric or adult SLE with chronic disease activity requiring ongoing treatment or observation for ≥ 24 weeks prior to screening.
- Currently receiving stable dose of oral prednisone and/or antimalarials/immunosuppressives.
- Active moderate to severe SLE disease based on SLE disease activity score.
Who cannot join
- Active severe or unstable neuropsychiatric SLE.
- Active severe SLE-driven renal disease or unstable renal disease.
- Clinically significant active infection including ongoing and chronic infections.
- Known history of a primary immunodeficiency or an underlying condition such as human immunodeficiency virus infection or splenectomy that predisposes the subject to infection.
- Confirmed positive tests for hepatitis B or positive test for hepatitis C.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Japan6 sites
Research Site
Chiba, 260-8677
Research Site
Chūōku, 104-8560
Research Site
Ōta-ku, 143-8541
Research Site
Sendai, 980-8574
Research Site
Shimotsuke-shi, 329-0498
Research Site
Shinjuku-ku, 160-8582
About this study
Official title: A Phase 2, Multicenter, Open-label, Dose-escalation Study to Evaluate the Safety and Tolerability of Intravenous Dose of MEDI-546, a Human Monoclonal Antibody Directed Against Type I Interferon Receptor (IFNAR), in Japanese Subjects With Active Systemic Lupus Erythematosus (SLE).
The purpose of this study is to assess safety, tolerability, pharmacokinetics and pharmacodynamics of MEDI-546 in Japanese SLE patients.
Read the detailed description
A phase 2, multicenter, open-label, dose-escalation study to evaluate the safety and tolerability of intravenous dose of MEDI-546, a human monoclonal antibody directed against type I interferon receptor (IFNAR), in Japanese subjects with active systemic lupus erythematosus (SLE)
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- MEDI-546
- Keywords
- Japan, Phase2, Safety, Tolerability, Systemic Lupus Erythematosus, SLE, MEDI-546
- 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.
MEDI-546Drug
Stage I: 100 mg IV, single dose and multiple doses once every 4 wks for 48 wks Stage II: 300 mg IV, multiple doses once every 4 wks for 156 wks
MEDI-546Drug
Stage I: 300 mg IV, single dose and multiple doses once every 4 wks for 48 wks Stage II: 300 mg IV, multiple doses once every 4 wks for 156 wks
MEDI-546Drug
Stage I: 1000 mg IV, single dose and multiple doses once every 4 wks for 48 wks Stage II: 1000 mg IV, multiple doses once every 4 wks for 156 wks, the dose at Stage II was changed to 300 mg IV.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | MEDI-546 100 mg IV Receives: Drug: MEDI-546 |
| 2 | Experimental | MEDI-546 300 mg IV Receives: Drug: MEDI-546 |
| 3 | Experimental | MEDI-546 1000 mg IV Receives: Drug: MEDI-546 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Summary of Adverse Events
Measured: Stage I (up to 48 weeks)
Secondary outcomes (3)
Pharmacokinetic Parameters of MEDI-546 After Single Dose: Cmax
Measured: Pre-dose and within 30 minutes after end of infusion on Day 1, Days 2, 8, 15, and 22, and pre-dose on Day 29
Pharmacokinetic Parameters of MEDI-546 After Single Dose: AUClast
Measured: Pre-dose and within 30 minutes after end of infusion on Day 1, Days 2, 8, 15, and 22, and pre-dose on Day 29
Anti-drug Antibody (ADA)
MEDI-546 antibody detection measured by electrochemiluminescence (ECL).
Measured: Stage I (up to Week 48)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2012 (estimated)
- Study start20 Apr 2012
- Primary completion19 Aug 2014
- Study completion21 Feb 2017
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 Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MedImmune LLC
- Responsible party
- Sponsor
- Investigators
- Roberta Weiss, MD, Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01559090
- Sponsor's protocol ID
- D3461C00002
- Status last verified
- Mar 2019
- First submitted
- 19 Mar 2012
- Last updated
- 13 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Open-label, Dose-escalation Study to Evaluate the Safety and Tolerability of Intravenous Dose of MEDI-546, a Human Monoclonal Antibody Directed Against Type I Interferon Receptor (IFNAR), in Japanese Subjects With Active Systemic Lupus Erythematosus (SLE).
- ClinicalTrials.gov ID
- NCT01559090
- Acronym / sponsor ID
- D3461C00002
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Japan, Phase2, Safety, Tolerability, Systemic Lupus Erythematosus, SLE, MEDI-546
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- MedImmune LLC
- Study start
- 20 Apr 2012 (actual)
- Primary completion
- 19 Aug 2014 (actual)
- Study completion
- 21 Feb 2017 (actual)
- First posted
- 21 Mar 2012 (estimated)
- Results
- Posted 13 Mar 2019
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 assess safety, tolerability, pharmacokinetics and pharmacodynamics of MEDI-546 in Japanese SLE patients.
Detailed description
A phase 2, multicenter, open-label, dose-escalation study to evaluate the safety and tolerability of intravenous dose of MEDI-546, a human monoclonal antibody directed against type I interferon receptor (IFNAR), in Japanese subjects with active systemic lupus erythematosus (SLE)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: MEDI-546MEDI-546 100 mg IV |
| 2 | Experimental | Drug: MEDI-546MEDI-546 300 mg IV |
| 3 | Experimental | Drug: MEDI-546MEDI-546 1000 mg IV |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Fulfils at least 4 of the 11 American College of Rheumatology (ACR) classification criteria for SLE.
- Weight greater than or equal to 40.0 kg.
- Diagnosis of pediatric or adult SLE with chronic disease activity requiring ongoing treatment or observation for ≥ 24 weeks prior to screening.
- Currently receiving stable dose of oral prednisone and/or antimalarials/immunosuppressives.
- Active moderate to severe SLE disease based on SLE disease activity score.
Key exclusion criteria (5 listed)
- Active severe or unstable neuropsychiatric SLE.
- Active severe SLE-driven renal disease or unstable renal disease.
- Clinically significant active infection including ongoing and chronic infections.
- Known history of a primary immunodeficiency or an underlying condition such as human immunodeficiency virus infection or splenectomy that predisposes the subject to infection.
- Confirmed positive tests for hepatitis B or positive test for hepatitis C.
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 |
|---|---|---|
| MEDI-546Stage I: 100 mg IV, single dose and multiple doses once every 4 wks for 48 wks Stage II: 300 mg IV, multiple doses once every 4 wks for 156 wks | Drug | 1 |
| MEDI-546Stage I: 300 mg IV, single dose and multiple doses once every 4 wks for 48 wks Stage II: 300 mg IV, multiple doses once every 4 wks for 156 wks | Drug | 2 |
| MEDI-546Stage I: 1000 mg IV, single dose and multiple doses once every 4 wks for 48 wks Stage II: 1000 mg IV, multiple doses once every 4 wks for 156 wks, the dose at Stage II was changed to 300 mg IV. | Drug | 3 |
Primary outcome
Overall Summary of Adverse Events
Time frame: Stage I (up to 48 weeks)
3 secondary outcomes
Pharmacokinetic Parameters of MEDI-546 After Single Dose: Cmax
Time frame: Pre-dose and within 30 minutes after end of infusion on Day 1, Days 2, 8, 15, and 22, and pre-dose on Day 29
Pharmacokinetic Parameters of MEDI-546 After Single Dose: AUClast
Time frame: Pre-dose and within 30 minutes after end of infusion on Day 1, Days 2, 8, 15, and 22, and pre-dose on Day 29
Anti-drug Antibody (ADA)
Time frame: Stage I (up to Week 48)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
- 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.
Roberta Weiss, MD study director
MedImmune LLC
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MEDI-546 in people with Systemic Lupus Erythematosus, run by AstraZeneca at 6 sites in Japan.
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 5 inclusion and 5 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 13 Mar 2019. 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 Japan. 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. 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 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 13 Mar 2019). 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?
Overall Summary of Adverse Events (time frame: Stage I (up to 48 weeks)). 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 13 Mar 2019.