FindTrial
Sign In

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)

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)

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080220984
Enrollment
Unknown
Registered
2010-01-28
Start date
2010-01-28
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Lupus Erythematosus

Interventions

investigational material(s) Generic name etc : MEDI-545 INN of investigational material : Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investigat

Sponsors

AstraZeneca
Lead Sponsor
MedImmune LLC
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: -Patients must have previously met 4 or more of the 11 revised ACR criteria -Have positive antinuclear antibody test (ANA) at 1:80 serum dilute or more 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 or more

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

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026