A Study to Evaluate the Placental Transfer of Dapirolizumab Pegol to the Infant(s) From Pregnant Study Participants With Active Systemic Lupus Erythematosus Who Are Administered Dapirolizumab Pegol
A Prospective, Open-Label, Single-Arm, Multicenter Pharmacokinetic Study Evaluating the Placental Transfer of Dapirolizumab Pegol to the Infant(s) From Pregnant Study Participants With Active Systemic Lupus Erythematosus Who Are Administered Dapirolizumab Pegol
The purpose of the study is to assess transfer of dapirolizumab pegol (DZP) across the placenta to infants from mothers who are administered DZP
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 1단계
연락처 및 위치
연구 연락처
연구 연락처
- 이름: UCB Cares
- 전화번호: 001 844 599 2273
연구 연락처 백업
- 이름: UCB Cares
- 전화번호: +18445992273
- 이메일: ucbcares@ucb.com
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Participant must be greater than or equal to (≥)18 to less than or equal to (≤) 45 years of age at the time of signing the informed consent form (ICF)
- Participant must be considered reliable and capable of adhering to the protocol and visit schedule according to the judgment of the investigator
- Participant is pregnant and at ≥14 gestational week (GW) and 0 days and <28 GW and 0 days at the time of the first dose of DZP in the study. An ultrasound examination and the last menstrual period (LMP) will be used to determine the estimated date of delivery, to document the gestational age for the study, and to document a viable intrauterine pregnancy
- Participant has not been previously exposed to DZP
- Participant has been diagnosed with SLE by a qualified physician (eg, rheumatologist, internal medicine expert, immunologist, nephrologist, or dermatologist) as confirmed by meeting the 2019 SLE EULAR/ACR classification criteria for SLE
- Participant has an unmet medical need for a treatment intervention for SLE during their pregnancy as determined by the investigator based on the following criteria:
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:
- Study participant has any evidence or medical history of a known non-autoimmune obstetrical condition with a high likelihood for pregnancy loss, or her fetus has any medical or surgical condition or history that, in the opinion of the investigator, could jeopardize or would compromise the study participant's ability to participate in this study or the outcome of the pregnancy
- Study participant has a history of chronic alcohol or drug abuse within the previous 24 weeks
- Study participant has a known hypersensitivity to any components of DZP including polyethylene glycol (PEG) or comparative drugs (and/or an investigational device) as stated in this protocol
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: Dapirolizumab pegol (DZP)
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). |
Study participants will receive DZP at pre-specified timepoints
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Plasma concentration of DZP in the infants at birth
기간: At Birth during this study
|
Plasma concentration of DZP will be reported in infants at birth. |
At Birth during this study
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Plasma concentration of DZP in mothers at delivery
기간: At Delivery during this study
|
Plasma concentration of DZP in mothers at delivery will be reported. |
At Delivery during this study
|
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Ratio between plasma concentration of DZP between the infants and mother at birth/delivery
기간: Infants: At Birth; Mothers: At Delivery during this study
|
Ratio of plasma concentration of DZP between the infants and mother at birth/delivery will be reported. |
Infants: At Birth; Mothers: At Delivery during this study
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Plasma concentration of DZP after birth in the infants from mothers continuing DZP treatment postpartum
기간: At 4 weeks, 8 weeks, and 12 weeks after birth
|
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. |
At 4 weeks, 8 weeks, and 12 weeks after birth
|
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Predose and postdose plasma concentrations of DZP in mothers during pregnancy
기간: Predose and postdose during second and third trimester
|
Predose and postdose plasma concentrations of DZP in mothers during pregnancy will be reported. |
Predose and postdose during second and third trimester
|
|
DZP plasma concentrations at 12 and 14 Weeks postpartum in mothers continuing DZP treatment postpartum
기간: Predose and postdose at Week 12 and Week 14 postpartum
|
DZP plasma concentrations at 12 weeks (predose and postdose) and 14 weeks postpartum in mothers continuing DZP treatment postpartum will be reported. |
Predose and postdose at Week 12 and Week 14 postpartum
|
|
DZP plasma concentrations at 12 weeks postpartum in mothers stopping DZP treatment postpartum
기간: At Week 12 postpartum
|
DZP plasma concentrations at 12 weeks postpartum in mothers stopping DZP treatment postpartum will be reported. |
At Week 12 postpartum
|
|
Treatment-emergent adverse events (TEAEs) of mothers
기간: From first intervention (Day1) to End of Safety Follow-Up (Up to 1 year and 9 months)
|
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. |
From first intervention (Day1) to End of Safety Follow-Up (Up to 1 year and 9 months)
|
|
Serious TEAEs of mothers
기간: From first intervention (Day1) to End of Safety Follow-Up (Up to 1 year and 9 months)
|
An SAE is any untoward medical occurrence that at any dose:
|
From first intervention (Day1) to End of Safety Follow-Up (Up to 1 year and 9 months)
|
|
TEAEs of special interest of mothers
기간: From first intervention (Day1) to End of Safety Follow-Up (Up to 1 year and 9 months)
|
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. |
From first intervention (Day1) to End of Safety Follow-Up (Up to 1 year and 9 months)
|
|
TEAEs of special monitoring of mothers
기간: From first intervention (Day1) to End of Safety Follow-Up (Up to 1 year and 9 months)
|
An AE of special monitoring is a product-specific AE, adverse reaction, or safety topic requiring special monitoring by UCB. |
From first intervention (Day1) to End of Safety Follow-Up (Up to 1 year and 9 months)
|
|
AEs of infants
기간: From birth to End of Safety Follow-Up (Up to 12 months)
|
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. |
From birth to End of Safety Follow-Up (Up to 12 months)
|
|
Serious AEs of infants
기간: From birth to End of Safety Follow-Up (Up to 12 months)
|
An SAE is any untoward medical occurrence that at any dose:
|
From birth to End of Safety Follow-Up (Up to 12 months)
|
|
AEs of special interest of infants
기간: From birth to End of Safety Follow-Up (Up to 12 months)
|
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. |
From birth to End of Safety Follow-Up (Up to 12 months)
|
|
AEs of special monitoring of infants
기간: From birth to End of Safety Follow-Up (Up to 12 months)
|
An AE of special monitoring is a product-specific AE, adverse reaction, or safety topic requiring special monitoring by UCB. |
From birth to End of Safety Follow-Up (Up to 12 months)
|
|
Pregnancy outcome
기간: At the end of pregnancy during the study
|
Pregnancy outcome at the end of pregnancy during the study will be reported |
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
기간: Second and Third Trimesters
|
Predicted AUC over the dosing interval at steady state across the second and third trimesters of pregnancy will be reported. |
Second and Third Trimesters
|
|
Predicted trough plasma concentration (Ctrough) over the dosing interval at steady state across the second and third trimesters of pregnancy
기간: Second and Third Trimesters
|
Predicted Ctrough over the dosing interval at steady state across the second and third trimesters of pregnancy will be reported. |
Second and Third Trimesters
|
|
Predicted maximum plasma concentration (Cmax) over the dosing interval at steady state across the second and third trimesters of pregnancy
기간: Second and Third Trimesters
|
Predicted Cmax over the dosing interval at steady state across the second and third trimesters of pregnancy will be reported. |
Second and Third Trimesters
|
|
Predicted AUC over the dosing interval at steady state across the postpartum
기간: Up to 14 weeks of postpartum
|
Predicted AUC over the dosing interval at steady state across the postpartum will be reported. |
Up to 14 weeks of postpartum
|
|
Predicted Ctrough over the dosing interval at steady state across the postpartum
기간: Up to 14 weeks of postpartum
|
Predicted Ctrough over the dosing interval at steady state across the postpartum will be reported. |
Up to 14 weeks of postpartum
|
|
Predicted Cmax over the dosing interval at steady state across the postpartum
기간: Up to 14 weeks of postpartum
|
Predicted Cmax over the dosing interval at steady state across the postpartum will be reported. |
Up to 14 weeks of postpartum
|
공동 작업자 및 조사자
수사관
수사관
- 연구 책임자: UCB Cares, 001 844 599 22733 (UCB)
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- UP0155
- 2025 (미국 NIH 보조금/계약)
- 2025-524595-37 (레지스트리 식별자: EU Clinical Trials)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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