Clinical trial NCT01031836: A Study to Evaluate Safety and Tolerability of IV or SC Dose of MEDI-545 in Patients With Systemic Lupus Erythematosus.
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Systemic Lupus Erythematosus
Keywords: Systemic Lupus Erythematosus
Japanese
phase 2
safety
tolerability
MEDI-545
Autoimmune Disease
Immune System Diseases
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: MedImmune LLC
First posted: 2009-12-15
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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:

* 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

Primary outcomes:
measure: Number of Participants With Each Category of Adverse Events in Stage I
timeFrame: Stage I (up to 1 year)
measure: Number of Participants in Each Category of Adverse Events (AE) in Stage II
timeFrame: Stage II (1 year to 3.5 years after first dose)
Secondary outcomes:
measure: Area Undre Curve (AUC) of MEDI-545 After First Dose in Stage I
timeFrame: After first dose in Stage I (0 upto 28 days)
measure: AUC0-14 of MEDI-545 After First Dose in Stage I
timeFrame: After first dose in Stage I
measure: Maximum Observed Concentration (Cmax) of MEDI-545 After First Dose in Stage I
timeFrame: After first dose in Stage I
measure: Change From Baseline in 21-gene Signature Fold Change in Stage I
timeFrame: Stage I
measure: Number of Participants With Positive Anti-drug Antibody (ADA) During Stage I
timeFrame: Stage I
Other outcomes:
Locations:
city: Chiba-shi
country: Japan
facility: Research Site
city: Fukuoka-shi
country: Japan
facility: Research Site
city: Kanazawa-shi
country: Japan
facility: Research Site
city: Kawagoe-shi
country: Japan
facility: Research Site
city: Kitakyushu-shi
country: Japan
facility: Research Site
city: Sapporo-shi
country: Japan
facility: Research Site
city: Shinjuku-ku
country: Japan
facility: Research Site
Study officials:
affiliation: Department of Internal Medicine School of Medicine Keio University
name: Tsutomu Takeuchi
role: PRINCIPAL_INVESTIGATOR
affiliation: The University Hospital, University of Occupational and Environmental Health, Japan
name: Yoshiya Tanaka
role: PRINCIPAL_INVESTIGATOR
References: