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The purpose of the study is to assess the concentration of rozanolixizumab in mature breast milk of healthy study participants following administration of a single dose of rozanolixizumab
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rozanolixizumab arm | Experimental | Study participants enrolled in this arm will receive a single dose of subcutaneous rozanolixizumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rozanolixizumab | Drug | Dose formulation: Solution for injection Route of administration: Subcutaneous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of Rozanolixizumab in Breast Milk Over a 7-day Sampling Period | The concentration of Rozanolixizumab in breast milk was calculated over the 7-day sampling period. Here, '<=' denotes 'less than or equal to'; '>' denotes 'greater than'; 'min' indicates minutes; and 'hrs' indicates hours. | Predose (within 30 min) on Day 1 and at 0 to <=3, >3 to <=6, >6 to <=9, >9 to <=12, >12 to <=24, >24 to <=36, >36 to <=48, >48 to <=60, >60 to <=72, >72 to <=84, >84 to <=96, >96 to <=108, >108 to <=120, >120 to<=132, and >132 to<=144 hrs (Day 7) postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Estimated Daily Infant Dosage | The estimated daily infant dosage of Rozanolixizumab from breast milk was calculated based on the concentration of Rozanolixizumab in mature human breast milk. Estimated daily infant dosage (milligram per kilogram per day [mg/kg/day]) was equal to the milk-to-plasma ratio (M/P ratio) multiplied by the average maternal plasma concentration (Cav, plasma), and the standardized mean breastmilk intake by infant, which is 150 milliliters of breast milk per kilogram of infant body weight per day (150 mL/kg/day). |
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Inclusion criteria
A female participant is eligible to participate if she is not pregnant and at least 1 of the following conditions applies:
Exclusion criteria
The study will enroll adult (≥18 years of age) healthy lactating women.
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| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | 001 844 599 2273 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UP0141 2 | San Antonio | Texas | 78209 | United States | ||
| UP0141 1 |
Due to the small sample size in this trial, individual participant-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.
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The Participant Flow refers to the Safety Set (SS).
The study started to enroll participants in December 2024 and concluded in May 2025.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rozanolixizumab | Participants (healthy lactating women) received a single subcutaneous infusion dose of Rozanolixizumab (RLZ) on Day 1 of the study, following a body-weight-tiered dosing regimen in which those weighing less than (<) 50 kilograms (kg) received 420 milligrams (mg), those weighing greater than or equal to (>=) 50 kg to less than <100 kg received 560 mg, and those weighing >=100 kg received 840 mg. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The SS included all study participants who received a full or partial dose of the investigational medicinal product (IMP).
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| ID | Title | Description |
|---|---|---|
| BG000 | Rozanolixizumab | Participants (healthy lactating women) received a single subcutaneous infusion dose of Rozanolixizumab (RLZ) on Day 1 of the study, following a body-weight-tiered dosing regimen in which those weighing less than (<) 50 kilograms (kg) received 420 milligrams (mg), those weighing greater than or equal to (>=) 50 kg to less than <100 kg received 560 mg, and those weighing >=100 kg received 840 mg. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Concentration of Rozanolixizumab in Breast Milk Over a 7-day Sampling Period | The concentration of Rozanolixizumab in breast milk was calculated over the 7-day sampling period. Here, '<=' denotes 'less than or equal to'; '>' denotes 'greater than'; 'min' indicates minutes; and 'hrs' indicates hours. | The Pharmacokinetics-Set (PKS) included all study participants in the SS who had received a full dose of the IMP and provided at least 1 valid measurement of Rozanolixizumab concentration in plasma or breast milk. The 'overall number of participants analyzed' includes all participants evaluable for this outcome measure, while the 'number analyzed' refers to the participants evaluable for each specific category and time point. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms per milliter (ug/mL) | Predose (within 30 min) on Day 1 and at 0 to <=3, >3 to <=6, >6 to <=9, >9 to <=12, >12 to <=24, >24 to <=36, >36 to <=48, >48 to <=60, >60 to <=72, >72 to <=84, >84 to <=96, >96 to <=108, >108 to <=120, >120 to<=132, and >132 to<=144 hrs (Day 7) postdose |
|
From Day 1 Visit up to the Safety Follow-Up Visit (Day 57)
A Treatment-emergent adverse events (TEAEs) were defined as any adverse events with a start date/time on or after dosing of the study medication and up to 8 weeks inclusive after dosing of the study medication. Safety set included all study participants who received a full or partial dose of the IMP.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rozanolixizumab | Participants (healthy lactating women) received a single subcutaneous infusion dose of Rozanolixizumab (RLZ) on Day 1 of the study, following a body-weight-tiered dosing regimen in which those weighing less than (<) 50 kilograms (kg) received 420 milligrams (mg), those weighing greater than or equal to (>=) 50 kg to less than <100 kg received 560 mg, and those weighing >=100 kg received 840 mg. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB | Cares | 001 844 599 2273 | UCBCares@ucb.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 11, 2024 | May 8, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 28, 2025 | May 8, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000627812 | rozanolixizumab |
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| Predose (within 30 min) on Day 1 and at 0 to <=3, >3 to <=6, >6 to <=9, >9 to <=12, >12 to <=24, >24 to <=36, >36 to <=48, >48 to <=60, >60 to <=72, >72 to <=84, >84 to <=96, >96 to <=108, >108 to <=120, >120 to<=132, and >132 to<=144 hrs (Day 7) postdose |
| Relative Infant Dose of Rozanolixizumab From Breast Milk | The relative infant dose of Rozanolixizumab from breast milk was calculated by dividing the estimated daily infant dosage (mg/kg/day) by maternal dosage (mg/kg/day) and then multiplying the result by 100. | Predose (within 30 min) on Day 1 and at 0 to <=3, >3 to <=6, >6 to <=9, >9 to <=12, >12 to <=24, >24 to <=36, >36 to <=48, >48 to <=60, >60 to <=72, >72 to <=84, >84 to <=96, >96 to <=108, >108 to <=120, >120 to<=132, and >132 to<=144 hrs (Day 7) postdose |
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | An Adverse Event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. A Treatment-emergent adverse events (TEAEs) were defined as any adverse events with a start date/time on or after dosing of the study medication and up to 8 weeks inclusive after dosing of the study medication. The participant data was rounded to one decimal place. | From Day 1 Visit up to the Safety Follow-Up Visit (Day 57) |
| Salt Lake City |
| Utah |
| 84124 |
| United States |
| years |
|
| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG000 | Rozanolixizumab | Participants (healthy lactating women) received a single subcutaneous infusion dose of Rozanolixizumab (RLZ) on Day 1 of the study, following a body-weight-tiered dosing regimen in which those weighing less than (<) 50 kilograms (kg) received 420 milligrams (mg), those weighing greater than or equal to (>=) 50 kg to less than <100 kg received 560 mg, and those weighing >=100 kg received 840 mg. |
|
|
| Secondary | Estimated Daily Infant Dosage | The estimated daily infant dosage of Rozanolixizumab from breast milk was calculated based on the concentration of Rozanolixizumab in mature human breast milk. Estimated daily infant dosage (milligram per kilogram per day [mg/kg/day]) was equal to the milk-to-plasma ratio (M/P ratio) multiplied by the average maternal plasma concentration (Cav, plasma), and the standardized mean breastmilk intake by infant, which is 150 milliliters of breast milk per kilogram of infant body weight per day (150 mL/kg/day). | The PKS included all study participants in the SS who received a full dose of the IMP and provided at least 1 valid measurement of Rozanolixizumab concentration in plasma or breast milk. Here, the overall number of participants analyzed were those who had measurable Rozanolixizumab concentrations above the LLOQ (0.05 ug/mL) in primary outcome measure. | Posted | Predose (within 30 min) on Day 1 and at 0 to <=3, >3 to <=6, >6 to <=9, >9 to <=12, >12 to <=24, >24 to <=36, >36 to <=48, >48 to <=60, >60 to <=72, >72 to <=84, >84 to <=96, >96 to <=108, >108 to <=120, >120 to<=132, and >132 to<=144 hrs (Day 7) postdose |
|
|
| Secondary | Relative Infant Dose of Rozanolixizumab From Breast Milk | The relative infant dose of Rozanolixizumab from breast milk was calculated by dividing the estimated daily infant dosage (mg/kg/day) by maternal dosage (mg/kg/day) and then multiplying the result by 100. | The PKS included all study participants in the SS who received a full dose of the IMP and provided at least 1 valid measurement of Rozanolixizumab concentration in plasma or breast milk. Here, the overall number of participants analyzed were those who had measurable Rozanolixizumab concentrations above the LLOQ (0.05 ug/mL) in primary outcome measure. | Posted | Predose (within 30 min) on Day 1 and at 0 to <=3, >3 to <=6, >6 to <=9, >9 to <=12, >12 to <=24, >24 to <=36, >36 to <=48, >48 to <=60, >60 to <=72, >72 to <=84, >84 to <=96, >96 to <=108, >108 to <=120, >120 to<=132, and >132 to<=144 hrs (Day 7) postdose |
|
|
| Secondary | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | An Adverse Event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. A Treatment-emergent adverse events (TEAEs) were defined as any adverse events with a start date/time on or after dosing of the study medication and up to 8 weeks inclusive after dosing of the study medication. The participant data was rounded to one decimal place. | The SS included all study participants who received a full or partial dose of the IMP. | Posted | Number | percentage of participants | From Day 1 Visit up to the Safety Follow-Up Visit (Day 57) |
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| 0 |
| 15 |
| 0 |
| 15 |
| 11 |
| 15 |
| Vomiting | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Injection site haemorrhage | General disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Mastitis | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
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| Vulvovaginal candidiasis | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Breast milk discolouration | Reproductive system and breast disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
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