Study Summary
This trial is testing a new drug for lupus patients who are not responding to current treatments.
Eligible Conditions
- Lupus
Treatment Effectiveness
Effectiveness Progress
This is further along than 85% of similar trials
Study Objectives
1 Primary · 10 Secondary · Reporting Duration: Baseline through Week 60
At week 12
≥ 50% reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score in the sub-group of patients with baseline CLASI activity score ≥ 10
At week 16
BICLA response
At week 52
BICLA response with maintained low (or reduced) use of oral corticosteroid (OCS)
British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response
Change in the number of swollen and tender joints compared to baseline among patients with ≥ 6 swollen and ≥ 6 tender joints at baseline.
Chronic Illness Therapy-FATIGUE (FACIT-F) score
Maintained oral corticosteroid (OCS) reduction among patients with baseline OCS ≥10 mg/day.
Systemic Lupus Erythematosus Responder Index of ≥ 4 (SRI[4]) response
Baseline through Week 60
Adverse Event Overview
Week 52
Annualized flare rate
Time to first BICLA response sustained through Week 52
Time to flare
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Trial Design
2 Treatment Groups
Anifrolumab
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group
360 Total Participants · 2 Treatment Groups
Primary Treatment: Medi-546 · Has Placebo Group · Phase 3
Anifrolumab
Drug
Experimental Group · 1 Intervention: Medi-546 · Intervention Types: DrugPlacebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: DrugTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline through week 60
Who is running the clinical trial?
AstraZenecaLead Sponsor
3,996 Previous Clinical Trials
247,423,265 Total Patients Enrolled
Iqvia Pty LtdIndustry Sponsor
93 Previous Clinical Trials
233,340 Total Patients Enrolled
Eligibility Criteria
Age 18 - 70 · All Participants · 8 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have a diagnosis of pediatric or adult SLE according to the ACR 1997 revised criteria for ≥ 24 weeks prior to signing the ICF.
You have BILAG2004 level B disease in ≥ 2 organ systems.
The patient has a PGA score of 1.0 or greater.
Who else is applying?
What state do they live in?
| California | 50.0% |
| Michigan | 50.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| Research Site | 100.0% |
What portion of applicants met pre-screening criteria?
| Did not meet criteria | 50.0% |
| Met criteria | 50.0% |
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Conditions
Cancer Related
Treatments