A Phase 3 interventional study of Dapirolizumab pegol in Systemic Lupus Erythematosus, sponsored by UCB Biopharma SRL. Enrolling by invitation at 123 sites in 24 countries. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by UCB Biopharma SRL (part of UCB S.A.) · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate long-term safety and tolerability of dapirolizumab pegol treatment.
1,207 studies on the registry are indexed under Lupus Erythematosus, Systemic; 405 are open to participants now.
This study's planned enrollment of 760 is above the median of 52 across 876 interventional studies indexed under Lupus Erythematosus, Systemic.
Browse Lupus Erythematosus, Systemic studies →UCB Biopharma SRL is the lead sponsor of 129 studies on the registry; 17 are open to participants now.
Of its 71 completed or terminated interventional studies of FDA-regulated products, 50 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
- Study participant has any medical or psychiatric condition (including conditions due to neuropsychiatric systemic lupus erythematosus (SLE)) that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study. This includes study participants with a life-threatening condition or ongoing at the start of the study
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects will receive dapriolizumab pegol throughout the Treatment Period.
Drug: Dapirolizumab pegol
Subjects will receive dapirolizumab pegol at prespecified time-points.
Also known as: DZP, CDP7657
Incidence of treatment-emergent adverse events (TEAEs) during the study
Treatment-emergent adverse events (TEAEs) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment.
Time frame: From Baseline (Day 1) until Safety Follow-Up (up to Week 110)
Incidence of serious treatment-emergent adverse events during the study
A serious treatment-emergent adverse event (serious TEAE) is any untoward medical occurrence that at any dose: * Results in death * Is life-threatening * Requires in patient hospitalisation or prolongation of existing hospitalisation * Results in persistent disability/incapacity * Is a congenital anomaly or birth defect * Other important medical events which based on medical or scientific judgement may jeopardise the patients, or may require medical or surgical intervention to prevent any of the above
Time frame: From Baseline (Day 1) until Safety Follow-Up (up to Week 110)
Incidence of treatment-emergent adverse events (TEAEs) leading to permanent dapirolizumab pegol discontinuation
Treatment-emergent adverse events (TEAEs) are any untoward medical incidence in a subject during administered study treatment, and leading to permanent drug discontinuation whether or not these events are related to study treatment.
Time frame: From Baseline (Day 1) until Safety Follow-Up (up to Week 110)
Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 24
BILAG severe flare is defined as a new British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004) Grade A since previous visit in any system due to individual items that are new or worse qualifying for the Grade A (Isenberg et al, 2011). Determination of items that are new or worse qualifying for the Grade A will be according to the supplementary information for the numerical scoring of the BILAG-2004 index (Yee et al, 2010).
Time frame: Week 24
Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 52
BILAG severe flare is defined as a new British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004) Grade A since previous visit in any system due to individual items that are new or worse qualifying for the Grade A (Isenberg et al, 2011). Determination of items that are new or worse qualifying for the Grade A will be according to the supplementary information for the numerical scoring of the BILAG-2004 index (Yee et al, 2010).
Time frame: Week 52
Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 104
BILAG severe flare is defined as a new British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004) Grade A since previous visit in any system due to individual items that are new or worse qualifying for the Grade A (Isenberg et al, 2011). Determination of items that are new or worse qualifying for the Grade A will be according to the supplementary information for the numerical scoring of the BILAG-2004 index (Yee et al, 2010).
Time frame: Week 104
Achievement of LLDAS at ≥50% of all visits
Low lupus disease activity state (LLDAS) is defined as: * No significant disease activity as per SLEDAI-2K and BILAG 2004 (SLEDAI-2K score ≤4 with no activity in major organ systems (renal, central nervous system (CNS), cardiopulmonary, vasculitis, fever) * No new and/or worsening disease activity defined as no SLEDAI-2K component documented as present that was not documented present at previous visit * PGA ≤33 mm * Prednisone equivalent systemic dose for systemic lupus erythematosus (SLE) indication ≤7.5 mg per day * Stable standard maintenance doses of immunosuppressive drugs as allowed by protocol
Time frame: From Baseline (Day 1) until End of Treatment (Week 104)
Achievement of BICLA response at Week 24
A study participant is considered to be a BILAG 2004-based Composite Lupus Assessment (BICLA) responder if all of the following is fulfilled: 1. British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004) improvement without worsening (A scores at Baseline improved to B, C or D; B scores improved to C or D; no new A scores and ≤1 new B.); and 2. No worsening in the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score compared to Baseline Visit (defined as no increase in SLEDAI-2K total score); and 3. No worsening in the Physician's Global Assessment of Disease (PGA) compared to Baseline Visit defined as ≤10 mm increase on a 100 mm visual analog scale The parent studies Baseline will be used as reference point.
Time frame: Week 24
Achievement of BICLA response at Week 52
A study participant is considered to be a BICLA responder if all of the following is fulfilled: 1. BILAG 2004 improvement without worsening (A scores at Baseline improved to B, C or D; B scores improved to C or D; no new A scores and ≤1 new B.); and 2. No worsening in the SLEDAI-2K total score compared to Baseline Visit (defined as no increase in SLEDAI-2K total score); and 3. No worsening in the PGA compared to Baseline Visit defined as ≤10 mm increase on a 100 mm visual analog scale The parent studies Baseline will be used as reference point.
Time frame: Week 52
Achievement of BICLA response at Week 104
A study participant is considered to be a BICLA responder if all of the following is fulfilled: 1. BILAG 2004 improvement without worsening (A scores at Baseline improved to B, C or D; B scores improved to C or D; no new A scores and ≤1 new B.); and 2. No worsening in the SLEDAI-2K total score compared to Baseline Visit (defined as no increase in SLEDAI-2K total score); and 3. No worsening in the PGA compared to Baseline Visit defined as ≤10 mm increase on a 100 mm visual analog scale The parent studies Baseline will be used as reference point.
Time frame: Week 104
Showing the first 100 of 123 sites across 24 countries. Choose a country and city above to see the rest.
Plan to share: Yes — Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
Access criteria: Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed.All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
Data sharing details ↗ · www.vivli.org
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Dapirolizumab pegol
Lupus Erythematosus, Systemic →