A Phase 1 interventional study of Dapirolizumab pegol (DZP) in Systemic Lupus Erythematosus, sponsored by UCB Biopharma SRL. Not yet recruiting. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-11-13.
Sponsored by UCB Biopharma SRL (part of UCB S.A.) · Phase 1, Interventional, and Treatment
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Among 21 studies in Lupus Erythematosus, Systemic by UCB S.A. — 4 open to participants now, 4 under way, 2 of them phase 3. Lupus Erythematosus, Systemic · UCB S.A..
Among the 21 studies in Lupus Erythematosus, Systemic by UCB S.A., this one is the 16th largest by planned enrollment, is the only one that started in 2026, is one of 5 in phase 1, and was the 21st registered.
1,210 studies on the registry are indexed under Lupus Erythematosus, Systemic; 406 are open to participants now.
Browse Lupus Erythematosus, Systemic studies →4 of the 21 studies in Lupus Erythematosus, Systemic by UCB S.A. are open now, in 12 countries. Recruiting first, the newest first:
Candid Therapeutics · Sites in China
Ages 18–75
UCB Biopharma SRL · Sites in United States, Argentina, Belgium and 20 more countries
Ages 16+
UCB Biopharma SRL · Sites in United States, Argentina, Belgium and 21 more countries
Ages 16+
By country, each count listing its studies:
Of the 284 Lupus Erythematosus, Systemic studies recruiting now, 93 (33%) set no upper age limit and 161 (57%) stop at 75 or younger; 54 take children under 18; 33 take healthy volunteers.
This study: 18 Years to 45 Years · female · no healthy volunteers.
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21 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 6 · Phase 2 7 · Phase 3 9
First in 2005; this study’s year is marked. 1 started in 2026.
This study's planned enrollment of 25 is below the median of 52 across 878 interventional studies indexed under Lupus Erythematosus, Systemic.
Median enrollment 54 across the 21 interventional studies. Of the 16 that completed or were terminated, 5 (31%) have results posted.
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This study is registered under UCB Biopharma SRL, one of the names counted as UCB S.A.. Under that name alone:
UCB Biopharma SRL is the lead sponsor of 130 studies on the registry; 18 are open to participants now.
Of its 71 completed or terminated interventional studies of FDA-regulated products, 50 (70%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 21 studies in Lupus Erythematosus, Systemic by UCB S.A., from their registry updates:
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The purpose of the study is to assess transfer of dapirolizumab pegol (DZP) across the placenta to infants from mothers who are administered DZP
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.
Maternal disease activity score as measured by a SLEPDAI score without serology ≥1 AND at least one of the risk factors specified in the protocol for SLE-associated maternal and/or fetal complications during pregnancy
- Body weight ≥40 kilograms (kg) and ≤150kg
Exclusion Criteria:
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Pregnant women will receive DZP by intravenous (iv) administration during 2nd and 3rd trimester and after delivery they may continue for up to 1 year (if not breastfeeding).
Drug: Dapirolizumab pegol (DZP)
Study participants will receive DZP at pre-specified timepoints
Also known as: DZP, CDP7657
Plasma concentration of DZP in the infants at birth
Plasma concentration of DZP will be reported in infants at birth.
Time frame: At Birth during this study
Plasma concentration of DZP in mothers at delivery
Plasma concentration of DZP in mothers at delivery will be reported.
Time frame: At Delivery during this study
Ratio between plasma concentration of DZP between the infants and mother at birth/delivery
Ratio of plasma concentration of DZP between the infants and mother at birth/delivery will be reported.
Time frame: Infants: At Birth; Mothers: At Delivery during this study
Plasma concentration of DZP after birth in the infants from mothers continuing DZP treatment postpartum
Plasma concentration of DZP at 4 weeks or 8 weeks, and at 12 weeks after birth in the infants from mothers continuing DZP treatment postpartum will be reported.
Time frame: At 4 weeks, 8 weeks, and 12 weeks after birth
Predose and postdose plasma concentrations of DZP in mothers during pregnancy
Predose and postdose plasma concentrations of DZP in mothers during pregnancy will be reported.
Time frame: Predose and postdose during second and third trimester
DZP plasma concentrations at 12 and 14 Weeks postpartum in mothers continuing DZP treatment postpartum
DZP plasma concentrations at 12 weeks (predose and postdose) and 14 weeks postpartum in mothers continuing DZP treatment postpartum will be reported.
Time frame: Predose and postdose at Week 12 and Week 14 postpartum
DZP plasma concentrations at 12 weeks postpartum in mothers stopping DZP treatment postpartum
DZP plasma concentrations at 12 weeks postpartum in mothers stopping DZP treatment postpartum will be reported.
Time frame: At Week 12 postpartum
Treatment-emergent adverse events (TEAEs) of mothers
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs for the mothers will be considered TEAEs if they occur after the start of DZP treatment in this study.
Time frame: From first intervention (Day1) to End of Safety Follow-Up (Up to 1 year and 9 months)
Serious TEAEs of mothers
An SAE is any untoward medical occurrence that at any dose: * Results in death * Is life-threatening * Requires inpatient hospitalization or prolongation of existing hospitalization * Results in persistent or significant disability/incapacity * Is a congenital anomaly/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 first intervention (Day1) to End of Safety Follow-Up (Up to 1 year and 9 months)
TEAEs of special interest of mothers
An AE of special interest is any AE that a regulatory authority has mandated to 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 first intervention (Day1) to End of Safety Follow-Up (Up to 1 year and 9 months)
TEAEs of special monitoring of mothers
An AE of special monitoring is a product-specific AE, adverse reaction, or safety topic requiring special monitoring by UCB.
Time frame: From first intervention (Day1) to End of Safety Follow-Up (Up to 1 year and 9 months)
AEs of infants
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Time frame: From birth to End of Safety Follow-Up (Up to 12 months)
Serious AEs of infants
An SAE is any untoward medical occurrence that at any dose: * Results in death * Is life-threatening * Requires inpatient hospitalization or prolongation of existing hospitalization * Results in persistent or significant disability/incapacity * Is a congenital anomaly/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 birth to End of Safety Follow-Up (Up to 12 months)
AEs of special interest of infants
An AE of special interest is any AE that a regulatory authority has mandated to 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 birth to End of Safety Follow-Up (Up to 12 months)
AEs of special monitoring of infants
An AE of special monitoring is a product-specific AE, adverse reaction, or safety topic requiring special monitoring by UCB.
Time frame: From birth to End of Safety Follow-Up (Up to 12 months)
Pregnancy outcome
Pregnancy outcome at the end of pregnancy during the study will be reported
Time frame: At the end of pregnancy during the study
Predicted area under the curve (AUC) over the dosing interval at steady state across the second and third trimesters of pregnancy
Predicted AUC over the dosing interval at steady state across the second and third trimesters of pregnancy will be reported.
Time frame: Second and Third Trimesters
Predicted trough plasma concentration (Ctrough) over the dosing interval at steady state across the second and third trimesters of pregnancy
Predicted Ctrough over the dosing interval at steady state across the second and third trimesters of pregnancy will be reported.
Time frame: Second and Third Trimesters
Predicted maximum plasma concentration (Cmax) over the dosing interval at steady state across the second and third trimesters of pregnancy
Predicted Cmax over the dosing interval at steady state across the second and third trimesters of pregnancy will be reported.
Time frame: Second and Third Trimesters
Predicted AUC over the dosing interval at steady state across the postpartum
Predicted AUC over the dosing interval at steady state across the postpartum will be reported.
Time frame: Up to 14 weeks of postpartum
Predicted Ctrough over the dosing interval at steady state across the postpartum
Predicted Ctrough over the dosing interval at steady state across the postpartum will be reported.
Time frame: Up to 14 weeks of postpartum
Predicted Cmax over the dosing interval at steady state across the postpartum
Predicted Cmax over the dosing interval at steady state across the postpartum will be reported.
Time frame: Up to 14 weeks of postpartum
No study locations are listed for this record.
Plan to share: No — Due to the small sample size in this trial, individual patient-level data cannot be adequately anonymized as there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Dec 2028, 25 months later.
Of 108 industry-sponsored phase 1 interventional studies under Lupus Erythematosus, Systemic, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 35. This study's planned 25 months is below that.
Counting every sponsor, half of 147 studies reached it within 28 months; a quarter within 16 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
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 ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dapirolizumab pegol
Lupus Erythematosus, Systemic →