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PHOENYCS FLY PHASE3 ACTIVE n=450
Drug: Dapirolizumab pegol · UCB
Study Design
DesignRandomized, double-blind, placebo-controlled, parallel-group
RandomizationTBD (likely 2:1 as in PHOENYCS GO)
BlindingDouble-blind
Enrollment450
Duration48 weeks
NCTNCT06617325
Treatment Arms
Dapirolizumab pegol + SOC 24 mg/kg IV every 4 weeks + standard of care n=300
Placebo + SOC Placebo IV every 4 weeks + standard of care n=150
Primary Endpoints
[{"id":"ep1","name":"BICLA response at Week 48","type":"PRIMARY","unit":"%","results":[],"timepoint":"Week 48","description":"Same primary as PHOENYCS GO. BICLA composite assessing lupus disease activity improvement across all organ systems at 48 weeks. This is the confirmatory study needed to support a regulatory filing."}]
Assessment
CONFIRMATORY STUDY - the key remaining catalyst for dapi in SLE. INVESTMENT IMPLICATIONS: - If positive: strong regulatory package for filing. Expected filing H1 2028, approval 2028-2029. - If negative: DZP program in serious trouble. PHOENYCS GO alone may not be enough. - Larger sample (450 vs 315) should provide more statistical power. TIMELINE: Initiated 2024, ~48 weeks treatment + follow-up. Topline expected H2 2027. Source: UCB/Biogen press release Nov 2024, Orphanet trial registry
Background & Context
Confirmatory Phase 3 required to support regulatory filing. PHOENYCS GO was positive on primary but the hierarchical testing chain broke at Wk24 BICLA. A second confirmatory trial strengthens the regulatory package.
Data from Supabase · Updated 2026-03-24