Phase 2
N=30
A Study to Evaluate Safety and Tolerability of IV or SC Dose of MEDI-545 in Patients With Systemic Lupus Erythematosus.
Systemic Lupus Erythematosus
Bottom Line
View on ClinicalTrials.gov: NCT01031836 ↗Enrolled (actual)
30
Serious AEs
56.7%
Results posted
Nov 2018
Primary outcome: Primary: Number of Participants With Each Category of Adverse Events in Stage I — 5; 4; 5; 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- MEDI-545 (Drug); MEDI-545 600 (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Nov 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Each Category of Adverse Events in Stage I |
5; 4; 5; 5; 5; 5 | — |
| PRIMARY Number of Participants in Each Category of Adverse Events (AE) in Stage II |
3; 1; 4; 4; 5; 4 | — |
| SECONDARY Area Undre Curve (AUC) of MEDI-545 After First Dose in Stage I |
261.98; 647.93; 3040.83; 239.16; 2308.44; 5235.41 | — |
| SECONDARY AUC0-14 of MEDI-545 After First Dose in Stage I |
151.28; 432.26; 1728.01; 128.06; 1965.44; 4583.55 | — |
| SECONDARY Maximum Observed Concentration (Cmax) of MEDI-545 After First Dose in Stage I |
29.04; 71.72; 311.17; 11.70; 244.54; 607.64 | — |
| SECONDARY Change From Baseline in 21-gene Signature Fold Change in Stage I |
-3.70; -5.68; -2.30; -1.17; -4.91; -3.44 | — |
| SECONDARY Number of Participants With Positive Anti-drug Antibody (ADA) During Stage I |
0; 1; 0; 0; 0; 1 | — |
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
Data sourced from ClinicalTrials.gov (NCT01031836). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.