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

Systemic Lupus Erythematosus Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01031836
• Other study ID #: D2800C00001
• Status: Completed
• Phase: Phase 2
• Start date: November 25, 2009
• Est. completion date: July 11, 2016

Study information

• Verified date: March 2018
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 11, 2016
• Est. primary completion date: November 7, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 130 Years

Eligibility

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

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Drug:
• MEDI-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.
• MEDI-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
• MEDI-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.
• MEDI-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.
• MEDI-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
• MEDI-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.

Locations

Country	Name	City	State
Japan	Research Site	Chiba-shi
Japan	Research Site	Fukuoka-shi
Japan	Research Site	Kanazawa-shi
Japan	Research Site	Kawagoe-shi
Japan	Research Site	Kitakyushu-shi
Japan	Research Site	Sapporo-shi
Japan	Research Site	Shinjuku-ku

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	MedImmune LLC

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Each Category of Adverse Events in Stage I		Stage I (up to 1 year)
Primary	Number of Participants in Each Category of Adverse Events (AE) in Stage II		Stage II (1 year to 3.5 years after first dose)
Secondary	Area Undre Curve (AUC) of MEDI-545 After First Dose in Stage I		After first dose in Stage I (0 upto 28 days)
Secondary	AUC0-14 of MEDI-545 After First Dose in Stage I	Summary of area under the concentration-time curve from zero to Day 14.	After first dose in Stage I
Secondary	Maximum Observed Concentration (Cmax) of MEDI-545 After First Dose in Stage I		After first dose in Stage I
Secondary	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.	Stage I
Secondary	Number of Participants With Positive Anti-drug Antibody (ADA) During Stage I		Stage I