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Dapirolizumab Pegol for Lupus (PHOENYCS FLY Trial)

Phase 3

Recruiting

Research Sponsored by UCB Biopharma SRL

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

1. Anti-Smith (anti-Sm) antibodies (central laboratory or source verifiable history)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline (day 1) until safety follow-up (up to week 54)

Awards & highlights

Pivotal Trial

Summary

"This trial aims to see if adding dapirolizumab pegol (DZP) to standard treatment can help improve symptoms in patients with moderate to severe disease over a long period of time

Who is the study for?

This trial is for individuals over the age of 16 with moderately to severely active systemic lupus erythematosus. Participants must have certain autoantibodies (anti-Sm, Anti-SSA/Ro, anti-SSB/La or anti-dsDNA) and meet specific disease activity criteria. They should be on standard treatments like antimalarials, corticosteroids, or immunosuppressants.

What is being tested?

The study tests if adding dapirolizumab pegol (DZP) to standard care helps people with severe lupus symptoms improve long-term. Some participants will receive DZP while others get a placebo; both groups continue their usual medications.

What are the potential side effects?

Potential side effects of DZP are not detailed here but may include reactions similar to other immune-modulating drugs such as infusion-related reactions, increased risk of infections, and possible impacts on blood cell counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have anti-Smith antibodies.

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I have tested positive for Anti-SSA or Anti-SSB antibodies.

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My lupus affects at least two organs moderately or one organ severely.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline (day 1) until safety follow-up (up to week 54)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline (day 1) until safety follow-up (up to week 54)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (day 1) until safety follow-up (up to week 54) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Achievement of British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004)-based Composite Lupus Assessment (BICLA) response at Week 48

Secondary study objectives

Achievement of BILAG 2004 improvement without worsening at Week 48

Achievement of British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004)-based Composite Lupus Assessment (BICLA) response at Week 12

Achievement of British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004)-based Composite Lupus Assessment (BICLA) response at Week 24

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