A Phase 3 interventional study of DZP and Placebo in Systemic Lupus Erythematosus, sponsored by UCB Biopharma SRL. Recruiting at 242 sites in 23 countries. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2026-10-02.
Sponsored by UCB Biopharma SRL · Phase 3, Interventional, and Treatment
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.
1,202 studies on the registry are indexed under Lupus Erythematosus, Systemic; 399 are open to participants now.
This study's planned enrollment of 450 is above the median of 50 across 867 interventional studies indexed under Lupus Erythematosus, Systemic.
Browse Lupus Erythematosus, Systemic studies →UCB Biopharma SRL is the lead sponsor of 128 studies on the registry; 19 are open to participants now.
Of its 69 completed or terminated interventional studies of FDA-regulated products, 48 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Study participants who have moderate to severe disease activity due to either persisting active systemic lupus erythematosus (SLE) or due to an acute worsening of SLE in the scope of frequent relapsing-remitting SLE despite stable standard of care(SOC) medication defined as:
a. Diagnosed with SLE at least 24 weeks before the Screening Visit by a qualified physician b. Classified by 2019 SLE European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria for SLE c. With serological evidence for SLE at Screening as demonstrated by at least 1 of the following: i) Evidence for anti-dsDNA (defined as evidence for anti-dsDNA antibodies in central laboratory) ii) Either complement C3 \<lower limit of normal (LLN) OR complement C4 \<LLN as measured by central laboratory iii) Antinuclear antibodies with a titer of at least 1:80 confirmed by central laboratory in combination with evidence of at least 1 of the following SLE typical autoantibodies:
Anti-ribonucleoprotein (RNP) autoantibodies (central laboratory) d. Moderately to severely active defined as:
Exclusion Criteria:
Study participants will receive dapriolizumab pegol throughout the Treatment Period.
Drug: DZP
Study participants will receive placebo throughout the Treatment Period.
Other: Placebo
Study participants will receive dapirolizumab pegol (DZP) at prespecified time-points.
Also known as: CDP7657
Study participants will receive placebo at prespecified time-points.
Also known as: PBO
Achievement of British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004)-based Composite Lupus Assessment (BICLA) response at Week 48
A study participant is a BICLA responder if all of the following is fulfilled: a. BILAG 2004 improvement without worsening, defined as BILAG 2004 Grade As at Baseline improved to B/C/D, BILAG 2004 Grade Bs at Baseline improved to C/D, and no BILAG 2004 worsening in other BILAG 2004 organ systems (that had BILAG 2004 Grade C/D/E at Baseline) such that there are no new BILAG 2004 Grades A nor greater than 1 new BILAG 2004 Grade(s) B; and b. No worsening in the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI- 2K) total score compared to Baseline (defined as no increase in SLEDAI-2K total score); and c. No worsening in the Physician's Global Assessment of Disease (PGA) compared to Baseline defined as ≤10 mm increase on a 100 mm visual analog scale Escape treatment intervention as indicated by investigator until the assessment time point will be defined as an intercurrent event for the primary endpoint leading to non-response from the day after the event onward.
Time frame: Week 48
Achievement of SRI 4 response at Week 48
The Systemic Lupus Erythematosus Responder Index-4 (SRI 4) define responders as (ie, all criteria must be met): * Reduction in SLEDAI-2K score of ≥4 * No shift from BILAG 2004 Grade B, C, D, or E to A post-Baseline * No more than 1 shift from BILAG 2004 Grade C, D, or E to B post-Baseline * No worsening in the PGA compared to Baseline score; "no worsening" is defined as either no worsening or worsening \<10% of the full 100 mm visual analog scale (VAS).
Time frame: Week 48
Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 48
Severe BILAG flare is defined as a BILAG 2004 Grade A in any system due to individual items that are new or worse qualifying for the Grade A. 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.
Time frame: Week 48
Achievement of LLDAS at Week 40 and maintaining LLDAS at Weeks 44 and 48
Low lupus disease activity state (LLDAS) is defined as: * No significant disease activity as per Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K); 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 * Physician's Global Assessment of Disease (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: Week 40 to Week 48
Change from Baseline to Week 48 in the FATIGUE-PRO Total score
The FATIGUE-PRO (Fatigue patient-reported outcome) is a PRO instrument measuring fatigue, a core symptom of SLE, developed using qualitative and quantitative research conducted in patients with SLE. It is composed of 31 items covering 3 domains: Physical Fatigue (items 1-9), Mental and Cognitive Fatigue (items 10-20), and Susceptibility to Fatigue (items 21-31). The study participant is asked to score each fatigue item based on how frequently they experienced the item during the past 7 days using the following response options: 1=none of the time; 2=a little of the time; 3=some of the time; 4=most of the time; 5=all of the time.
Time frame: From Baseline to Week 48
Percentage of participants having a reduction in glucocorticoid dose from >7.5mg/day prednisone-equivalent dose at Baseline to ≤7.5mg/day at Week 36 and maintained through Week 48
The achievement of a reduction in glucocorticoid dose from \>7.5mg/day prednisone equivalent dose at Baseline to ≤7.5mg/day prednisone equivalent at Week 36 and maintained through Week 48 will be assessed.
Time frame: From Baseline to Week 48
Achievement of BILAG 2004 improvement without worsening at Week 48
BILAG 2004 improvement without worsening can be defined as 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.
Time frame: Week 48
Change from Baseline in PGA at Week 48
Physician's Global Assessment of Disease (PGA), the investigator will rate the overall status of the study participant. The PGA of disease activity used will be a 100 mm linear scale without anchors. The very far left end is 'very good, asymptomatic and no limitation of normal activities'; the very far right end indicates 'severe disease'.
Time frame: From Baseline to Week 48
Achievement of prevention of moderate/severe BILAG flares (moderate/severe BILAG flare-free) through Week 48
A BILAG severe flare is defined as a BILAG 2004 Grade A in any system due to individual items that are new or worse qualifying for the Grade A. 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. A BILAG moderate flare is defined as 2 or more BILAG 2004 Grade Bs due to individual items that are new or worse since previous visit and are qualifying for the Grade B in any system. Determination of items that are new or worse qualifying for the Grade B will be according to the supplementary information for the numerical scoring of the BILAG-2004 index.
Time frame: During Treatment Period up to Week 48
Change from Baseline in SLEDAI-2K at Week 48
SLEDAI-2K measures disease activity. Disease activity in the 30 days prior to and at the time point of the assessment shall be considered. It is a global index and includes 24 clinical symptoms and laboratory variables that are weighted by the type of manifestation, but not by severity or dynamic of the individual item. The total score falls between 0 and 105, with higher scores representing increased disease activity.
Time frame: From Baseline to Week 48
Change from Baseline in FACIT-Fatigue score at Week 48
The FACIT (Functional Assessment of Chronic Illness Therapy)-Fatigue scale is a patient-reported outcome (PRO) measure assessing symptoms and impacts of fatigue originally developed in patients with cancer (Cella et al, 2002). It is composed of 13 items, all scored from 0 (Not at all) to 4 (Very much), and uses a recall period of the past 7 days. The FACIT-Fatigue score ranges from 0 to 52 with 0 being the worst possible score and 52 being the best possible score (lowest level of fatigue). To obtain a score from 0 to 52, all negatively worded questions have to be recoded, so that responses range from worst (0) to the best (4) outcome.
Time frame: From Baseline to Week 48
Percentage of participants with treatment-emergent adverse events (TEAEs) during the study
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication.
Time frame: From Baseline until Safety Follow-Up (up to Week 54)
Percentage of participants with serious treatment-emergent adverse events during the study
A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: 1. Results in death 2. Is life-threatening 3. Requires inpatient hospitalization or prolongation of existing hospitalization 4. Results in persistent disability/incapacity 5. Is a congenital anomaly/birth defect 6. Is an Important medical event
Time frame: From Baseline until Safety Follow-Up (up to Week 54)
Percentage of participants with treatment-emergent adverse events of special interest during the study
An adverse event of special interest is any adverse event (AE) that a regulatory authority has mandated be reported on an expedited basis, regardless of the seriousness, expectedness, or relatedness of the AE to the administration of a UCB product/compound.
Time frame: From Baseline until Safety Follow-Up (up to Week 54)
Percentage of participants with treatment-emergent adverse events of special monitoring during the study
An adverse event of special monitoring is a product-specific adverse event (AE), adverse reaction, or safety topic considered as requiring special monitoring by UCB.
Time frame: From Baseline until Safety Follow-Up (up to Week 54)
Showing the first 100 of 242 sites across 23 countries.
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, Sap, Csr
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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