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
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ 1
連絡先と場所
研究連絡先
- 名前：UCB Cares
- 電話番号：001 844 599 2273
研究連絡先のバックアップ
- 名前：UCB Cares
- 電話番号：+18445992273
- メール：ucbcares@ucb.com
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Plasma concentration of DZP in the infants at birth
時間枠：At Birth during this study
|
Plasma concentration of DZP will be reported in infants at birth. |
At Birth during this study
|
|
Plasma concentration of DZP in mothers at delivery
時間枠：At Delivery during this study
|
Plasma concentration of DZP in mothers at delivery will be reported. |
At Delivery during this study
|
|
Ratio between plasma concentration of DZP between the infants and mother at birth/delivery
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Plasma concentration of DZP after birth in the infants from mothers continuing DZP treatment postpartum
時間枠：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
|
|
Predose and postdose plasma concentrations of DZP in mothers during pregnancy
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター：UCB Cares、001 844 599 22733 (UCB)
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- UP0155
- 2025 (米国 NIH グラント/契約)
- 2025-524595-37 (レジストリ識別子：EU Clinical Trials)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。