Systemic Lupus ErythematosusPhase 2NCT01031836
A Study to Evaluate Safety and Tolerability of IV or SC Dose of MEDI-545 in Patients With Systemic Lupus Erythematosus.
A Phase 2 study testing MEDI-545 and MEDI-545 600 in people with Systemic Lupus Erythematosus, run by AstraZeneca at 7 sites in Japan.
Trial summary
The purpose of the study is to evaluate the safety and tolerability of MEDI-545 in Japanese adult SLE patients. This will be done by collecting the data from 3 cohorts of IV doses and 1 cohort of SC doses. Read more about this study
- Who is it for?
- Ages 20 to 130 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- MEDI-545 and MEDI-545 600
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 7 sitesJapan
- Study dates
- 25 Nov 2009to 11 Jul 2016
- 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 20 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have previously met ≥4 of the 11 revised ACR criteria
- Have positive antinuclear antibody test (ANA) at ≥1:80 serum dilute in the past or at screening
- Have at least 1 system with a score of A or 2 systems with a score of B on the BILAG index at screening, or have a SELENA-SLEDAI score ≥6
Who cannot join
- Have received prednisone >20 mg/day (or an equivalent dose of another oral corticosteroid) within 14 days before Visit 2 (Day 1)
- Have received the following medications within 28 days before Visit 2 (Day 1):
- Systemic cyclophosphamide at any dose
- Cyclosporine at any dose
- Tacrolimus at any dose
- Thalidomide at any dose
Show all 10Show fewer
- Mycophenolate mofetil >2 g/day
- Methotrexate >15 mg/week
- Azathioprine >2 mg/kg/day
- Women who have a positive pregnancy test (serum hCG) at Visit 1
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Japan7 sites
Research Site
Chiba, 260-8712
Research Site
Fukuoka, 810-8563
Research Site
Kanazawa, 920-8650
Research Site
Kawagoe-shi, 350-8550
Research Site
Kitakyushu-shi, 807-8555
Research Site
Sapporo, 060-8638
Research Site
Shinjuku-ku, 160-8582
About this study
Official title: A Phase II, Multicenter, Open-Label, Dose-Escalation Study to Evaluate Safety and Tolerability of IV or SC Dose of MEDI-545, a Fully Human Monoclonal Antibody Directed Against Interferon Alpha Subtypes, in Japanese Patients Who Have Systemic Lupus Erythematosus (SLE)
The purpose of the study is to evaluate the safety and tolerability of MEDI-545 in Japanese adult SLE patients. This will be done by collecting the data from 3 cohorts of IV doses and 1 cohort of SC doses.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- MEDI-545, MEDI-545 600
- Keywords
- Systemic Lupus Erythematosus, Japanese, phase 2, safety, tolerability, MEDI-545, Autoimmune Disease, Immune System Diseases
- Medical subject headings
- Lupus Erythematosus, Systemic, Autoimmune Diseases, Immune System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI-545Drug
Stage I: MEDI-545 1.0 mg/kg IV, on Day 1 and once every 2 weeks from Day 29, for a total of 14 doses.
Stage II: MEDI-545 1.0 mg/kg IV once every 2 weeks for a total of 79 doses.
MEDI-545Drug
Stage I: MEDI-545 3.0 mg/kg IV, on Day 1 and once every 2 weeks from Day 29, for a total of 14 doses.
Stage II: MEDI-545 3.0 mg/kg IV once every 2 weeks for a total of 79 doses
MEDI-545Drug
Stage I: MEDI-545 10.0 mg/kg IV, on Day 1 and once every 2 weeks from Day 29, for a total of 14 doses.
Stage II: MEDI-545 10.0 mg/kg IV once every 2 weeks for a total of 79 doses.
MEDI-545Drug
Stage I: MEDI-545 100 mg SC, on Day 1 and weekly or once every 2 weeks from Day 29, for a total of 14 doses.
Stage II: MEDI-545 100 mg SC once every 2 weeks for a total of 79 doses.
MEDI-545Drug
Stage I: MEDI-545 1,200 mg IV once every 4 weeks from Day 1 for a total of 8 doses.
Stage II: MEDI-545 1,200 mg IV once every 4 weeks for a total of 40 doses
MEDI-545 600Drug
Stage I: MEDI-545 600 mg IV once every 4 weeks from Day 1 for a total of 8 doses.
Stage II: MEDI-545 600 mg IV once every 4 weeks for a total of 40 doses.
| Study group | Role | What they receive |
|---|---|---|
| MEDI-545 1.0 mg/kg | Experimental | Cohort 1 Receives: Drug: MEDI-545 |
| MEDI-545 3.0 mg/kg | Experimental | Cohort 2 Receives: Drug: MEDI-545 |
| MEDI-545 10.0 mg/kg | Experimental | Cohort 3 Receives: Drug: MEDI-545 |
| MEDI-545 100 mg | Experimental | Cohort 4 Receives: Drug: MEDI-545 |
| MEDI-545 600 mg | Experimental | Cohort 5 Receives: Drug: MEDI-545 600 |
| MEDI-545 1,200 mg | Experimental | Cohort 6 Receives: Drug: MEDI-545 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Each Category of Adverse Events in Stage I
Measured: Stage I (up to 1 year)
Number of Participants in Each Category of Adverse Events (AE) in Stage II
Measured: Stage II (1 year to 3.5 years after first dose)
Secondary outcomes (5)
Area Undre Curve (AUC) of MEDI-545 After First Dose in Stage I
Measured: After first dose in Stage I (0 upto 28 days)
AUC0-14 of MEDI-545 After First Dose in Stage I
Summary of area under the concentration-time curve from zero to Day 14.
Measured: After first dose in Stage I
Maximum Observed Concentration (Cmax) of MEDI-545 After First Dose in Stage I
Measured: After first dose in Stage I
Change From Baseline in 21-gene Signature Fold Change in Stage I
21-gene signature fold change is pharmacodynamics (PD) parameter measuring expression of type I IFN-inducible gene.
Measured: Stage I
Number of Participants With Positive Anti-drug Antibody (ADA) During Stage I
Measured: Stage I
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2009 (estimated)
- Study start25 Nov 2009
- Primary completion7 Nov 2012
- Study completion11 Jul 2016
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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MedImmune LLC
- Responsible party
- Sponsor
- Investigators
- Tsutomu Takeuchi, Principal investigator, Department of Internal Medicine School of Medicine Keio UniversityYoshiya Tanaka, Principal investigator, The University Hospital, University of Occupational and Environmental Health, Japan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01031836
- Sponsor's protocol ID
- D2800C00001
- Status last verified
- Mar 2018
- First submitted
- 11 Dec 2009
- Last updated
- 19 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicenter, Open-Label, Dose-Escalation Study to Evaluate Safety and Tolerability of IV or SC Dose of MEDI-545, a Fully Human Monoclonal Antibody Directed Against Interferon Alpha Subtypes, in Japanese Patients Who Have Systemic Lupus Erythematosus (SLE)
- ClinicalTrials.gov ID
- NCT01031836
- Acronym / sponsor ID
- D2800C00001
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Systemic Lupus Erythematosus, Japanese, phase 2, safety, tolerability, MEDI-545, Autoimmune Disease, Immune System Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- MedImmune LLC
- Study start
- 25 Nov 2009 (actual)
- Primary completion
- 7 Nov 2012 (actual)
- Study completion
- 11 Jul 2016 (actual)
- First posted
- 15 Dec 2009 (estimated)
- Results
- Posted 19 Nov 2018
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 the study is to evaluate the safety and tolerability of MEDI-545 in Japanese adult SLE patients. This will be done by collecting the data from 3 cohorts of IV doses and 1 cohort of SC doses.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| MEDI-545 1.0 mg/kg | Experimental | Drug: MEDI-545Cohort 1 |
| MEDI-545 3.0 mg/kg | Experimental | Drug: MEDI-545Cohort 2 |
| MEDI-545 10.0 mg/kg | Experimental | Drug: MEDI-545Cohort 3 |
| MEDI-545 100 mg | Experimental | Drug: MEDI-545Cohort 4 |
| MEDI-545 600 mg | Experimental | Drug: MEDI-545 600Cohort 5 |
| MEDI-545 1,200 mg | Experimental | Drug: MEDI-545Cohort 6 |
Who may qualify
- Ages
- 20 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients must have previously met ≥4 of the 11 revised ACR criteria
- Have positive antinuclear antibody test (ANA) at ≥1:80 serum dilute in the past or at screening
- Have at least 1 system with a score of A or 2 systems with a score of B on the BILAG index at screening, or have a SELENA-SLEDAI score ≥6
Key exclusion criteria (10 listed)
- Have received prednisone >20 mg/day (or an equivalent dose of another oral corticosteroid) within 14 days before Visit 2 (Day 1)
- Have received the following medications within 28 days before Visit 2 (Day 1):
- Women who have a positive pregnancy test (serum hCG) at Visit 1
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-545Stage I: MEDI-545 1.0 mg/kg IV, on Day 1 and once every 2 weeks from Day 29, for a total of 14 doses. Stage II: MEDI-545 1.0 mg/kg IV once every 2 weeks for a total of 79 doses. | Drug | MEDI-545 1.0 mg/kg |
| MEDI-545Stage I: MEDI-545 3.0 mg/kg IV, on Day 1 and once every 2 weeks from Day 29, for a total of 14 doses. Stage II: MEDI-545 3.0 mg/kg IV once every 2 weeks for a total of 79 doses | Drug | MEDI-545 3.0 mg/kg |
| MEDI-545Stage I: MEDI-545 10.0 mg/kg IV, on Day 1 and once every 2 weeks from Day 29, for a total of 14 doses. Stage II: MEDI-545 10.0 mg/kg IV once every 2 weeks for a total of 79 doses. | Drug | MEDI-545 10.0 mg/kg |
| MEDI-545Stage I: MEDI-545 100 mg SC, on Day 1 and weekly or once every 2 weeks from Day 29, for a total of 14 doses. Stage II: MEDI-545 100 mg SC once every 2 weeks for a total of 79 doses. | Drug | MEDI-545 100 mg |
| MEDI-545Stage I: MEDI-545 1,200 mg IV once every 4 weeks from Day 1 for a total of 8 doses. Stage II: MEDI-545 1,200 mg IV once every 4 weeks for a total of 40 doses | Drug | MEDI-545 1,200 mg |
| MEDI-545 600Stage I: MEDI-545 600 mg IV once every 4 weeks from Day 1 for a total of 8 doses. Stage II: MEDI-545 600 mg IV once every 4 weeks for a total of 40 doses. | Drug | MEDI-545 600 mg |
Primary outcome
Number of Participants With Each Category of Adverse Events in Stage I
Time frame: Stage I (up to 1 year)
Number of Participants in Each Category of Adverse Events (AE) in Stage II
Time frame: Stage II (1 year to 3.5 years after first dose)
5 secondary outcomes
Area Undre Curve (AUC) of MEDI-545 After First Dose in Stage I
Time frame: After first dose in Stage I (0 upto 28 days)
AUC0-14 of MEDI-545 After First Dose in Stage I
Time frame: After first dose in Stage I
Maximum Observed Concentration (Cmax) of MEDI-545 After First Dose in Stage I
Time frame: After first dose in Stage I
Change From Baseline in 21-gene Signature Fold Change in Stage I
Time frame: Stage I
Number of Participants With Positive Anti-drug Antibody (ADA) During Stage I
Time frame: Stage I
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2018.
- 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.
Tsutomu Takeuchi principal investigator
Department of Internal Medicine School of Medicine Keio University
Yoshiya Tanaka principal investigator
The University Hospital, University of Occupational and Environmental Health, Japan
7 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-545 and MEDI-545 600 in people with Systemic Lupus Erythematosus, run by AstraZeneca at 7 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 3 inclusion and 10 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 19 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 19 Nov 2018). 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 Each Category of Adverse Events in Stage I (time frame: Stage I (up to 1 year)). The study lists 2 primary outcomes in all. 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 19 Nov 2018; AzTrials last refreshed its copy on 6 Nov 2026.