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CompletedNCT01031836Updated Nov 19, 2018Results posted

A Study to Evaluate Safety and Tolerability of IV or SC Dose of MEDI-545 in Patients With Systemic Lupus Erythematosus.

A Phase 2 interventional study of MEDI-545 and MEDI-545 in Systemic Lupus Erythematosus, sponsored by AstraZeneca. Completed at 7 sites in Japan. Open to participants aged 20 Years to 130 Years. Per ClinicalTrials.gov, last updated 2018-11-19.

Sponsored by AstraZeneca · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
20 Years to 130 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Systemic Lupus Erythematosus

Keywords

  • Systemic Lupus Erythematosus
  • Japanese
  • phase 2
  • safety
  • tolerability
  • MEDI-545
  • Autoimmune Disease
  • Immune System Diseases
03

In context

Lupus Erythematosus, Systemic

1,202 studies on the registry are indexed under Lupus Erythematosus, Systemic; 399 are open to participants now.

This study's enrollment of 30 is below the median of 50 across 867 interventional studies indexed under Lupus Erythematosus, Systemic.

Browse Lupus Erythematosus, Systemic studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 130 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
    • 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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    MEDI-545 1.0 mg/kg

    Cohort 1

    Drug: MEDI-545

  • Experimental
    MEDI-545 3.0 mg/kg

    Cohort 2

    Drug: MEDI-545

  • Experimental
    MEDI-545 10.0 mg/kg

    Cohort 3

    Drug: MEDI-545

  • Experimental
    MEDI-545 100 mg

    Cohort 4

    Drug: MEDI-545

  • Experimental
    MEDI-545 600 mg

    Cohort 5

    Drug: MEDI-545 600

  • Experimental
    MEDI-545 1,200 mg

    Cohort 6

    Drug: MEDI-545

Interventions

  • DrugMEDI-545

    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.

  • DrugMEDI-545

    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

  • DrugMEDI-545

    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.

  • DrugMEDI-545

    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.

  • DrugMEDI-545

    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

  • DrugMEDI-545 600

    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.

06

What researchers measure

Primary outcomes

  1. Number of Participants With Each Category of Adverse Events in Stage I

    Time frame: Stage I (up to 1 year)

  2. 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)

Secondary outcomes

  1. 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)

  2. AUC0-14 of MEDI-545 After First Dose in Stage I

    Summary of area under the concentration-time curve from zero to Day 14.

    Time frame: After first dose in Stage I

  3. Maximum Observed Concentration (Cmax) of MEDI-545 After First Dose in Stage I

    Time frame: After first dose in Stage I

  4. 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.

    Time frame: Stage I

  5. Number of Participants With Positive Anti-drug Antibody (ADA) During Stage I

    Time frame: Stage I

07

Results

Posted Nov 19, 2018

Participant flow

This study was conducted at 7 centres in Japan. The first patient was enrolled on 25 November 2009 and the last enrolled patient had completed Stage II on 11 July 2016.

Stage I
Participant flow — Stage I
MilestoneMEDI-545 1.0 mg/kg IVMEDI-545 3.0 mg/kg IVMEDI-545 10.0 mg/kg IVMEDI-545 100 mg SCMEDI-545 600 mg IVMEDI-545 1200 mg IV
Started555555
Completed435554
Not completed120001
Withdrew: Adverse event110000
Withdrew: Other010001
Stage II
Participant flow — Stage II
MilestoneMEDI-545 1.0 mg/kg IVMEDI-545 3.0 mg/kg IVMEDI-545 10.0 mg/kg IVMEDI-545 100 mg SCMEDI-545 600 mg IVMEDI-545 1200 mg IV
Started314454
Completed112133
Not completed202321
Withdrew: Adverse event002211
Withdrew: Other200110

Outcome measures

SecondaryArea Undre Curve (AUC) of MEDI-545 After First Dose in Stage I
Time frame:
After first dose in Stage I (0 upto 28 days)
Reported as:
Median · day*ug/mL
Area Undre Curve (AUC) of MEDI-545 After First Dose in Stage I
day*ug/mLMEDI-545 1.0 mg/kg IVMEID-545 3.0 mg/kg IVMEDI-545 10.0 mg/kg IVMEDI-545 100mg SCMEDI-545 600mg IVMEDI-545 1200mg IV
Area Undre Curve (AUC) of MEDI-545 After First Dose in Stage I261.98 ± 16.8647.93 ± 7.43040.83 ± 24.2239.16 (239.16 to 239.16)2308.44 (2308.44 to 2308.44)5235.41 ± 11.6
SecondaryAUC0-14 of MEDI-545 After First Dose in Stage I

Summary of area under the concentration-time curve from zero to Day 14.

Time frame:
After first dose in Stage I
Reported as:
Geometric mean · day*ug/mL
AUC0-14 of MEDI-545 After First Dose in Stage I
day*ug/mLMEDI-545 1.0 mg/kg IVMEID-545 3.0 mg/kg IVMEDI-545 10.0 mg/kg IVMEDI-545 100mg SCMEDI-545 600mg IVMEDI-545 1200mg IV
AUC0-14 of MEDI-545 After First Dose in Stage I151.28 ± 19.3432.26 ± 11.01728.01 ± 16.8128.06 ± 56.11965.44 ± 41.44583.55 ± 15.2
PrimaryNumber of Participants With Each Category of Adverse Events in Stage I
Time frame:
Stage I (up to 1 year)
Reported as:
Count of participants · Participants
Number of Participants With Each Category of Adverse Events in Stage I
ParticipantsMEDI-545 1.0 mg/kg IVMEID-545 3.0 mg/kg IVMEDI-545 10.0 mg/kg IVMEDI-545 100mg SCMEDI-545 600mg IVMEDI-545 1200mg IV
Any AE545555
Any AE of CTC grade at least 3032001
Any AE with outcome=death000000
Any serious adverse events (SAE)033003
Any AE leading to discontinuation of IP111000
Any causally related AE535345
SecondaryMaximum Observed Concentration (Cmax) of MEDI-545 After First Dose in Stage I
Time frame:
After first dose in Stage I
Reported as:
Geometric mean · ug/mL
Maximum Observed Concentration (Cmax) of MEDI-545 After First Dose in Stage I
ug/mLMEDI-545 1.0 mg/kg IVMEID-545 3.0 mg/kg IVMEDI-545 10.0 mg/kg IVMEDI-545 100mg SCMEDI-545 600mg IVMEDI-545 1200mg IV
Maximum Observed Concentration (Cmax) of MEDI-545 After First Dose in Stage I29.04 ± 31.371.72 ± 19.6311.17 ± 19.011.70 ± 61.1244.54 ± 47.4607.64 ± 16.1
SecondaryChange 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.

Time frame:
Stage I
Reported as:
Mean · fold change
Change From Baseline in 21-gene Signature Fold Change in Stage I
fold changeMEDI-545 1.0 mg/kg IVMEID-545 3.0 mg/kg IVMEDI-545 10.0 mg/kg IVMEDI-545 100mg SCMEDI-545 600mg IVMEDI-545 1200mg IV
Day 1 8 hours post-dose-3.70 ± 2.07-5.68 ± 5.92-2.30 ± 0.93-1.17 ± 0.80-4.91 ± 2.26-3.44 ± 1.77
Day 3-2.57 ± 2.61-4.53 ± 7.02-2.49 ± 1.06-1.80 ± 0.97-4.81 ± 2.63-3.37 ± 1.69
Day 15-1.40 ± 2.56-1.11 ± 5.99-0.41 ± 1.60-0.59 ± 1.69-1.61 ± 1.23-1.84 ± 1.72
Day 290.03 ± 2.54-0.16 ± 8.44-0.34 ± 1.38-0.85 ± 0.81-1.13 ± 1.40-1.27 ± 2.46
SecondaryNumber of Participants With Positive Anti-drug Antibody (ADA) During Stage I
Time frame:
Stage I
Reported as:
Count of participants · Participants
Number of Participants With Positive Anti-drug Antibody (ADA) During Stage I
ParticipantsMEDI-545 1.0 mg/kg IVMEID-545 3.0 mg/kg IVMEDI-545 10.0 mg/kg IVMEDI-545 100mg SCMEDI-545 600mg IVMEDI-545 1200mg IV
Number of Participants With Positive Anti-drug Antibody (ADA) During Stage I010001
PrimaryNumber 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)
Reported as:
Count of participants · Participants
Number of Participants in Each Category of Adverse Events (AE) in Stage II
ParticipantsMEDI-545 1.0 mg/kg IVMEID-545 3.0 mg/kg IVMEDI-545 10.0 mg/kg IVMEDI-545 100mg SCMEDI-545 600mg IVMEDI-545 1200mg IV
Any AE314454
Any AE of CTC grade at least 3001232
Any AE with outcome=death000000
Any serious adverse events (SAE)002424
Any AE leading to discontinuation of IP001311
Any causally related AE213454

Adverse events

Collected over Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
MEDI-545 1.0 mg/kg IV0/5 (0%)0/5 (0%)5/5 (100%)
MEDI-545 3.0 mg/kg IV0/5 (0%)3/5 (60%)4/5 (80%)
MEDI-545 10.0 mg/kg IV0/5 (0%)3/5 (60%)5/5 (100%)
MEDI-545 100 mg SC0/5 (0%)4/5 (80%)5/5 (100%)
MEDI-545 600 mg IV0/5 (0%)2/5 (40%)5/5 (100%)
MEDI-545 1200 mg IV0/5 (0%)5/5 (100%)5/5 (100%)
Most frequent serious events
Showing 10 of 26
Most frequent serious events
EventMEDI-545 1.0 mg/kg IVMEDI-545 3.0 mg/kg IVMEDI-545 10.0 mg/kg IVMEDI-545 100 mg SCMEDI-545 600 mg IVMEDI-545 1200 mg IV
Systemic lupus erythematosusMusculoskeletal and connective tissue disorders0/30/10/42/41/51/4
Systemic lupus erythematosusMusculoskeletal and connective tissue disorders0/52/51/50/50/50/5
OsteoarthritisMusculoskeletal and connective tissue disorders0/30/10/40/40/51/4
Intervertebral disc protrusionMusculoskeletal and connective tissue disorders0/30/10/40/40/51/4
BronchitisInfections and infestations0/30/10/40/40/51/4
PyelonephritisInfections and infestations0/30/10/40/40/51/4
SepsisInfections and infestations0/30/10/40/40/51/4
Prinzmetal anginaCardiac disorders0/30/10/40/40/51/4
CataractEye disorders0/30/11/40/40/51/4
Splenic infarctionBlood and lymphatic system disorders0/30/10/41/40/50/4
Most frequent other events
Showing 10 of 25
Most frequent other events
EventMEDI-545 1.0 mg/kg IVMEDI-545 3.0 mg/kg IVMEDI-545 10.0 mg/kg IVMEDI-545 100 mg SCMEDI-545 600 mg IVMEDI-545 1200 mg IV
NasopharyngitisInfections and infestations3/31/12/43/44/53/4
InfluenzaInfections and infestations0/31/10/42/41/50/4
Musculoskeletal chest painMusculoskeletal and connective tissue disorders0/31/10/41/41/50/4
Iron deficiency anaemiaBlood and lymphatic system disorders1/31/10/41/42/50/4
NasopharyngitisInfections and infestations2/54/53/53/54/52/5
DiarrhoeaGastrointestinal disorders3/52/51/51/50/50/5
HeadacheNervous system disorders0/51/53/50/51/50/5
Upper respiratory tract infectionInfections and infestations1/30/11/41/40/52/4
DizzinessNervous system disorders1/30/10/42/40/50/4
Haemorrhage subcutaneousSkin and subcutaneous tissue disorders0/30/10/41/40/52/4

Baseline characteristics

Age, Continuous
Age, Continuous(years)MEDI-545 1.0 mg/kg IVMEDI-545 3.0 mg/kg IVMEDI-545 10.0 mg/kg IVMEDI-545 100 mg SCMEDI-545 600 mg IVMEDI-545 1200 mg IVTotal
Mean30 ± 343 ± 1334 ± 937 ± 946 ± 1048 ± 1340 ± 11
Sex: Female, Male
Sex: Female, Male(Participants)MEDI-545 1.0 mg/kg IVMEDI-545 3.0 mg/kg IVMEDI-545 10.0 mg/kg IVMEDI-545 100 mg SCMEDI-545 600 mg IVMEDI-545 1200 mg IVTotal
Female55455428
Male0010012
08

Study locations

7 sites
  • Research Site
    Chiba-shi, 260-8712, Japan
  • Research Site
    Fukuoka-shi, 810-8563, Japan
  • Research Site
    Kanazawa-shi, 920-8650, Japan
  • Research Site
    Kawagoe-shi, 350-8550, Japan
  • Research Site
    Kitakyushu-shi, 807-8555, Japan
  • Research Site
    Sapporo-shi, 060-8638, Japan
  • Research Site
    Shinjuku-ku, 160-8582, Japan
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01031836
Lead sponsor
AstraZeneca
Collaborators
MedImmune LLC
Responsible party
Sponsor
First posted
Dec 15, 2009
Start date
Nov 25, 2009
Primary completion
Nov 7, 2012
Completion
Jul 11, 2016
Results posted
Nov 19, 2018
Last update
Nov 19, 2018

Study contacts

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

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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