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A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus

Study acronym: PHOENYCS FLY
StatusRecruiting
PhasePhase 3
Started2024-11-21
View on ClinicalTrials.gov ↗

Amendment history

2026-09-03
Study Status, Contacts/Locations v47
Trial sites expanded: 238 → 242 locations
2026-08-20
Study Status, Contacts/Locations v46
Study sites236→238
2026-08-06
Study Status, Contacts/Locations v45
Trial sites expanded: 233 → 236 locations
2026-07-23
Study Status, Contacts/Locations v44
Study sites231→233
2026-07-09
Study Status, Contacts/Locations v43
Study sites230→231
Show 4 earlier versions
2026-06-25
Study Status, Contacts/Locations v42
Study sitesdetails revised at 3 of 230 sites
2026-06-11
Study Status, Contacts/Locations v41
Study sites229→230
2026-05-28
Study Status, Contacts/Locations v40
Study sites227→229
2026-05-14
Study Status, Contacts/Locations v39
Study sites225→227
2026-04-30
Study Status, Contacts/Locations v38
Trial sites expanded: 219 → 225 locations
2026-04-02
Study Status, Contacts/Locations v37
Trial sites expanded: 214 → 219 locations
2026-03-05
Study Status, Contacts/Locations v36
Study sites204→214
2026-02-19
Study Status, Contacts/Locations v35
Study sites202→204
2026-02-05
Study Status, Contacts/Locations v34
Study sites198→202
2026-02-02
Study Status, Outcome Measures v33
Secondary endpoints14 entries, revised
Change from Baseline in FACIT-Fatigue score at Week 48
2026-01-22
Study Status, Eligibility v32
Eligibility criteria+39 characters
[...] usion Study participant has used the prohibited medications definedwithin the time frame (Wash-Out Period) listed in the Protocol Study participant has previously been rando [...]
2026-01-15
Study Status, Outcome Measures, Eligibility v31
Eligibility criteria-213 characters
Inclusion Criteria: Study participant must be ≥16 years of age, (≥18 years of age for China), unless restricted by local regulation, at the time of sign [...] at stable dose: Antimalarial treatment in combination with corticosteroidsglucocorticoids and/or immunosuppressants or as stand-alone treatment if justified OR Treatment with corticosteroidsglucocorticoids and/or immunosuppressants if antimalarial treatment is not [...] l cell carcinoma, or dermatological squamous cell carcinoma Study participant has an increased risk for thromboembolic events due to an ongoing heart disease or due to a medical devi [...] [...]
Secondary endpoints15 to 14 entries
Achievement of British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004)-based Composite Lupus Assessment (BICLA) response at Week 24 Achievement of British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004)-based Composite Lupus Assessment (BICLA) response at [...] Achievement of LLDAS at Week 40 and maintaining LLDAS at Weeks 44 and 48 Change from Baseline to Week 48 in ≥50%the FATIGUE-PRO Total score Percentage of postparticipants having a reduction in glucocorticoid dose from >7.5mg/day prednisone-equivalent dose at Baseline visitsto ≤7.5mg/day at Week 36 a [...] [...]
2025-12-11
Study Status, Contacts/Locations v30
Study sites196→198
2025-11-27
Study Status, Contacts/Locations v29
Study sites185→196
2025-11-13
Study Status, Contacts/Locations v28
Study sites181→185
2025-10-30
Study Status, Contacts/Locations v27
Study sites177→181
2025-10-16
Study Status, Contacts/Locations v26
Study sites174→177
2025-10-01
Study Status, Contacts/Locations v25
Study sites167→174
2025-09-18
Study Status, Contacts/Locations v24
Study sites163→167
2025-09-04
Study Status, Contacts/Locations v23
Study sites164→163
2025-08-26
Study Status, Contacts/Locations v22
Primary completion date2027-09-15→2028-05-31
Completion date2027-09-15→2028-05-31
Study sites159→164
2025-08-07
Study Status, Contacts/Locations v21
Study sites155→159
2025-07-24
Study Status, Contacts/Locations v20
Study sites149→155
2025-07-10
Study Status, Contacts/Locations v19
Study sites142→149
2025-06-26
Study Status, Contacts/Locations v18
Study sites140→142
2025-06-12
Study Status, Contacts/Locations v17
Study sites133→140
2025-05-29
Study Status, Contacts/Locations v16
Study sites132→133
2025-05-15
Study Status, Contacts/Locations v15
Study sites129→132
2025-05-01
Study Status, Contacts/Locations v14
Study sites128→129
2025-04-17
Study Status, Contacts/Locations v13
Study sites122→128
2025-04-03
Study Status, Contacts/Locations v12
Study sites119→122
2025-03-20
Study Status, Contacts/Locations v11
Study sites114→119
2025-03-07
Study Status v10
Primary completion date2027-03-02→2027-09-15
Completion date2027-03-02→2027-09-15
2025-03-06
Study Status, Contacts/Locations v9
Study sites107→114
2025-02-20
Study Status, Contacts/Locations v8
Study sites100→107
2025-02-11
Study Identification, Study Status v7
Re-verified, no change to tracked fields
2025-02-06
Study Status, Contacts/Locations v6
Study sites95→100
2025-01-23
Study Status, Contacts/Locations v5
Study sites89→95
2025-01-09
Study Status, Contacts/Locations v4
Study sites78→89
2024-12-23
Study Status, Contacts/Locations v3
Study sites62→78
2024-12-12
Study Status, Contacts/Locations v2
Study sites1→62
2024-12-04
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-10-16→confirmed 2024-11-21
Study sites0→1
2024-09-24
Original filing
UCB Biopharma SRL
68 trials monitored
See 4 trials at risk
Lupus (SLE)
648 trials monitored
See 25 trials at risk
The purpose of this study is to evaluate the ability of dapirolizumab pegol (DZP) as an add-on treatment to standard of care (SOC) medication to achieve clinically relevant long term improvement of moderate to severe disease activity.
Trial Details
NCT Number NCT06617325
Lead Sponsor UCB Biopharma SRL
Conditions Systemic Lupus Erythematosus
Enrollment 450 participants
Start Date 2024-11-21
Primary Completion 2028-05-31 (estimated)
Study Completion 2028-05-31 (estimated)
Updated on ClinicalTrials.gov 2026-09-04