Medi-546 for Lupus

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
LupusMedi-546 - Drug
Eligibility
18 - 70
All Sexes
What conditions do you have?
Select

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

2 of 3
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

3 of 3
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: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial 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?
California50.0%
Michigan50.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Research Site100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria50.0%
Met criteria50.0%