DZP for Lupus

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
LupusDZP - Drug
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test whether the drug DZP can help improve the symptoms of people with moderate to severe disease activity, when used alongside SOC medication.

Eligible Conditions
  • Lupus

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 16 Secondary · Reporting Duration: From Baseline (Day 1) until Safety Follow-Up (up to Week 54)

Week 48
Achievement of LLDAS in ≥50% of post-Baseline visits through Week 48
Achievement of prevention of moderate/severe BILAG flares (moderate/severe BILAG flare-free) through Week 48
Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 48
Time to moderate/severe BILAG flare through Week 48
Time to severe BILAG Flare through Week 48
Time to severe BILAG flare through Week 48
Week 48
Change from Baseline in PGA at Week 48
Change from Baseline in SLEDAI-2K at Week 48
Week 54
Percentage of participants with serious treatment-emergent adverse events during the study
Percentage of participants with treatment-emergent adverse events (TEAEs) during the study
Percentage of participants with treatment-emergent adverse events of special interest during the study
Percentage of participants with treatment-emergent adverse events of special monitoring during the study
Week 12
Achievement of BICLA response at Week 12
Week 24
Achievement of BICLA response at Week 24
Week 48
Achievement of BICLA response at Week 48
Achievement of BILAG improvement without worsening at Week 48
Achievement of SRI4 response at Week 48

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Dapirolizumab pegol
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

450 Total Participants · 2 Treatment Groups

Primary Treatment: DZP · Has Placebo Group · Phase 3

Dapirolizumab pegol
Drug
Experimental Group · 1 Intervention: DZP · Intervention Types: Drug
Placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from baseline (day 1) until safety follow-up (up to week 54)

Who is running the clinical trial?

UCB Biopharma SRLLead Sponsor
85 Previous Clinical Trials
20,324 Total Patients Enrolled
UCB CaresStudy Director001 844 599 2273 (UCB)
189 Previous Clinical Trials
43,210 Total Patients Enrolled

Eligibility Criteria

Age Any Age · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The study will be allowed to continue if the inclusion criteria are met at the first screening or if the study participant no longer meets an exclusion criterion or screening period exceeded the maximum duration due to delays in screening processes.
You have a British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004) Grade B in ≥2 organ systems and/or a BILAG 2004 Grade A in ≥1 organ systems at Screening and Baseline Visit.
You have a SLEDAI-2K score of ≥4 at baseline.
Treatment with corticosteroids and/or immunosuppressants is recommended if anti-malarial treatment is not possible.

Who else is applying?

What state do they live in?
New York100.0%
How old are they?
18 - 65100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%