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MEDI-545

Phase 2

Lupus Erythematosus, Systemic | Small molecule | Immunology |AstraZeneca PLC|Last Updated: Nov 19, 2018

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment87

FDA Designations

No designations recorded

Clinical trial landscape

MEDI-545 · 3 trials · 4 indications

Phase 2 2Phase 1 1
NCT01031836A Study to Evaluate Safety and Tolerability of IV or SC Dose of MEDI-545 in Patients With Systemic Lupus Erythematosus.Systemic Lupus Erythematosus
COMPLETED30 Analytics
NCT00657189A Study to Evaluate Safety and Tolerability of Subcutaneous Doses of MEDI-545 in Subjects With LupusLupus Erythematosus, Systemic
COMPLETED87 Analytics
PHASE2COMPLETED
A Study to Evaluate Safety and Tolerability of IV or SC Dose of MEDI-545 in Patients With Systemic Lupus Erythematosus.
Systemic Lupus Erythematosus
NCT0103183630
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PHASE2COMPLETED
A Study to Evaluate Safety and Tolerability of Subcutaneous Doses of MEDI-545 in Subjects With Lupus
Lupus Erythematosus, Systemic
NCT0065718987
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Study Endpoints

Primary Endpoints

Number of Participants With Each Category of Adverse Events in Stage I
Stage I (up to 1 year)
Number of Participants in Each Category of Adverse Events (AE) in Stage II
Stage II (1 year to 3.5 years after first dose)
The safety and tolerability of MEDI-545 will be assessed primarily by summarizing treatment emergent AEs and SAEs and by assessing changes in viral cultures.
Immediately following the first administration of study drug through Study Day 168.
The primary endpoints of the study are safety and tolerability of multiple intravenous (IV) doses of MEDI-545 in adult patients with Dermatomyositis or Polymyositis, assessed primarily by summarizing AEs assessing changes in viral cultures and titers.
12 months

Secondary Endpoints

Area Undre Curve (AUC) of MEDI-545 After First Dose in Stage I
After first dose in Stage I (0 upto 28 days)
AUC0-14 of MEDI-545 After First Dose in Stage I
After first dose in Stage I
Maximum Observed Concentration (Cmax) of MEDI-545 After First Dose in Stage I
After first dose in Stage I
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MEDI-545 1.0 mg/kgEXPERIMENTALCohort 1
MEDI-545 3.0 mg/kgEXPERIMENTALCohort 2
MEDI-545 10.0 mg/kgEXPERIMENTALCohort 3
MEDI-545 100 mgEXPERIMENTALCohort 4
MEDI-545 600 mgEXPERIMENTALCohort 5
MEDI-545 1,200 mgEXPERIMENTALCohort 6
1EXPERIMENTALMEDI-545
2EXPERIMENTALMEDI-545
3EXPERIMENTALMEDI-545
4EXPERIMENTALMEDI-545
5PLACEBO_COMPARATORPlacebo

Interventions

NameTypeDescription
MEDI-545DRUGStage 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-545 600DRUGStage 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.
PlaceboDRUGSC Placebo every week × 13 doses
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Eligibility Criteria

Age Range20 Years to 130 Years
SexALL
Healthy VolunteersNo
Study Sites7

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 h...

Countries:JapanUnited States
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Frequently asked questions about MEDI-545

What is MEDI 545 used for?

MEDI 545 is an investigational monoclonal antibody being studied for chronic plaque psoriasis, lupus, systemic lupus erythematosus, and dermatomyositis or polymyositis. It is in Phase 1 clinical development for these conditions.

Who makes MEDI 545?

MEDI 545 is being developed by AstraZeneca PLC, which trades under the ticker AZN. The company is conducting clinical trials to evaluate the safety and tolerability of this investigational monoclonal antibody.

What phase is MEDI 545 in?

MEDI 545 is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities. Clinical trials are ongoing to assess its safety and tolerability in patients with conditions such as lupus and chronic plaque psoriasis.

What clinical trials is MEDI 545 in?

MEDI 545 has completed two Phase 1 trials: NCT00472758 in chronic plaque psoriasis and NCT00482989 in systemic lupus erythematosus. Both trials evaluated safety and tolerability of the drug.

Is MEDI 545 the same as MEDI-545?

Yes, MEDI 545 and MEDI-545 refer to the same investigational monoclonal antibody. The drug is also referred to as MEDI 545 in clinical trial records, with the hyphenated form used in some study titles.