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A Study to Evaluate the Safety and Tolerability of Dapirolizumab Pegol in Study Participants With Systemic Lupus Erythematosus

StatusEnrolling by Invitation
PhasePhase 3
Started2021-07-27
View on ClinicalTrials.gov ↗

Amendment history

The 50 most recent of 103 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

2026-09-03
minor
Study Status, Contacts/Locations v102
Study sites119→120
2026-08-20
minor
Study Status, Contacts/Locations v101
Study sites121→119
2026-08-06
minor
Study Status, Contacts/Locations v100
Trial sites expanded: 118 → 121 locations
2026-07-23
minor
Study Status, Contacts/Locations v99
Trial sites expanded: 113 → 118 locations
2026-07-09
minor
Study Status, Contacts/Locations v98
Study sites115→113
2026-06-25
minor
Study Status, Contacts/Locations v97
Study sitesdetails revised at 1 of 115 sites
2026-06-11
minor
Study Status, Contacts/Locations v96
Trial sites expanded: 109 → 115 locations
2026-05-28
minor
Study Status, Contacts/Locations v95
Trial sites expanded: 106 → 109 locations
2026-05-14
minor
Study Status, Contacts/Locations v94
Study sites106 entries, revised
Sl0046 2003150671
2026-04-30
minor
Study Status, Contacts/Locations v93
Study sites104→106
2026-04-16
minor
Study Status, Contacts/Locations v92
Study sites102→104
2026-04-02
minor
Study Status, Contacts/Locations v91
Trial sites reduced: 105 → 102 locations
2026-03-19
minor
Study Status, Contacts/Locations v90
Study sites102→105
2026-03-05
minor
Study Status, Contacts/Locations v89
Study sites98→102
2026-02-05
minor
5 amendments v84-v88
5 re-verifications since 2025-12-11, no change to tracked fields
2025-11-27
minor
Study Status, Contacts/Locations v83
Study sitesdetails revised at 1 of 98 sites
2025-10-30
minor
Study Status, Contacts/Locations v82
Study sites97→98
2025-10-01
minor
2 amendments v80-v81
2 re-verifications since 2025-09-04, no change to tracked fields
2025-08-26
minor
Study Status v79
Primary completion date2029-04-10→2030-08-07
Completion date2029-04-10→2030-08-07
2025-08-07
minor
Study Status, Contacts/Locations v78
Study sitesdetails revised at 1 of 97 sites
2025-07-24
minor
6 amendments v72-v77
6 re-verifications since 2025-05-01, no change to tracked fields
2025-04-17
minor
Study Status, Contacts/Locations v71
Study sitesdetails revised at 1 of 97 sites
2025-02-11
minor
3 amendments v68-v70
3 re-verifications since 2025-01-09, no change to tracked fields
2024-12-03
minor
Study Identification, Study Status, Outcome Measures, Eligibility v67
Eligibility criteria-36 characters
[...] b pegol (DZP) treatment The participant completed one of the placebo controlled (PBO-controlled) parent studies within 4 weeks prior to entry to this study [...]
2024-11-14
minor
Study Status, Contacts/Locations v66
Study sitesdetails revised at 1 of 97 sites
2024-10-29
minor
Study Status v65
Re-verified, no change to tracked fields
2024-10-17
minor
Study Status, Contacts/Locations v64
Study sitesdetails revised at 1 of 97 sites
2024-09-19
minor
4 amendments v60-v63
4 re-verifications since 2024-07-11, no change to tracked fields
2024-05-30
minor
Study Status, Contacts/Locations v59
Study sites95→97
2024-05-16
minor
Study Status, Contacts/Locations v58
Study sites94→95
2024-05-02
minor
Study Status, Contacts/Locations v57
Study sites88→94
2024-02-22
minor
3 amendments v54-v56
3 re-verifications since 2024-01-26, no change to tracked fields
2024-01-25
minor
Study Status, Contacts/Locations v53
Study sites86→88
648 trials monitored
See 25 trials at risk
The purpose of this study is to evaluate long-term safety and tolerability of dapirolizumab pegol treatment.
Trial Details
NCT Number NCT04976322
Lead Sponsor UCB Biopharma SRL
Conditions Systemic Lupus Erythematosus
Enrollment 760 participants
Start Date 2021-07-27
Primary Completion 2030-08-07 (estimated)
Study Completion 2030-08-07 (estimated)
Updated on ClinicalTrials.gov 2026-09-18