Trial Outcomes & Findings for A Study to Assess the Concentration of Rozanolixizumab in the Breast Milk of Healthy Lactating Women (NCT NCT06720714)

NCT ID: NCT06720714

Last Updated: 2026-06-04

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

15 participants

Primary outcome timeframe

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

Results posted on

2026-06-04

Participant Flow

The study started to enroll participants in December 2024 and concluded in May 2025.

The Participant Flow refers to the Safety Set (SS).

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Assess the Concentration of Rozanolixizumab in the Breast Milk of Healthy Lactating Women

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rozanolixizumab n=15 Participants 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.
Age, Continuous	30.5 years STANDARD_DEVIATION 4.6 • n=9 Participants
Age, Customized 18 - <65 years	15 Participants n=9 Participants
Age, Customized 65 - <85 years	0 Participants n=9 Participants
Age, Customized >= 85 years	0 Participants n=9 Participants
Sex: Female, Male Female	15 Participants n=9 Participants
Sex: Female, Male Male	0 Participants n=9 Participants
Race/Ethnicity, Customized Race · Black	1 Participants n=9 Participants
Race/Ethnicity, Customized Race · White	14 Participants n=9 Participants
Race/Ethnicity, Customized Ethnicity · Hispanic or Latino	3 Participants n=9 Participants
Race/Ethnicity, Customized Ethnicity · Not Hispanic or Latino	12 Participants n=9 Participants

PRIMARY outcome

Timeframe: 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

Population: 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.

Outcome measures

Outcome measures
Measure	Rozanolixizumab n=15 Participants 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.
Concentration of Rozanolixizumab in Breast Milk Over a 7-day Sampling Period Predose (Day 1)	NA micrograms per milliter (ug/mL) Geometric Coefficient of Variation NA Geometric means, and Geometric coefficient of variation were only calculated if at least 2/3 of the concentrations were above lower limit of quantification \[LLOQ: 0.05ug/mL\]. Here, all participants were below the LLOQ.
Concentration of Rozanolixizumab in Breast Milk Over a 7-day Sampling Period 0 to <=3 hours postdose (Day 1)	NA micrograms per milliter (ug/mL) Geometric Coefficient of Variation NA Geometric means, and Geometric coefficient of variation were only calculated if at least 2/3 of the concentrations were above LLOQ (0.05ug/mL). Here, all participants were below the LLOQ.
Concentration of Rozanolixizumab in Breast Milk Over a 7-day Sampling Period >3 to <=6 hours postdose (Day 1)	NA micrograms per milliter (ug/mL) Geometric Coefficient of Variation NA Geometric means, and Geometric coefficient of variation were only calculated if at least 2/3 of the concentrations were above LLOQ (0.05ug/mL). Here, all participants were below the LLOQ.
Concentration of Rozanolixizumab in Breast Milk Over a 7-day Sampling Period >6 to <=9 hours postdose (Day 1)	NA micrograms per milliter (ug/mL) Geometric Coefficient of Variation NA Geometric means, and Geometric coefficient of variation were only calculated if at least 2/3 of the concentrations were above LLOQ (0.05ug/mL). Here, all participants were below the LLOQ.
Concentration of Rozanolixizumab in Breast Milk Over a 7-day Sampling Period >9 to <=12 hours postdose (Day 1)	NA micrograms per milliter (ug/mL) Geometric Coefficient of Variation NA Geometric means, and Geometric coefficient of variation were only calculated if at least 2/3 of the concentrations were above LLOQ (0.05ug/mL). Here, all participants were below the LLOQ.
Concentration of Rozanolixizumab in Breast Milk Over a 7-day Sampling Period >12 to <=24 hours postdose (Day 1)	NA micrograms per milliter (ug/mL) Geometric Coefficient of Variation NA Geometric means, and Geometric coefficient of variation were only calculated if at least 2/3 of the concentrations were above LLOQ (0.05ug/mL). Here, all participants were below the LLOQ.
Concentration of Rozanolixizumab in Breast Milk Over a 7-day Sampling Period >24 to <=36 hours postdose (Day 2)	NA micrograms per milliter (ug/mL) Geometric Coefficient of Variation NA Geometric means, and Geometric coefficient of variation were only calculated if at least 2/3 of the concentrations were above LLOQ (0.05ug/mL). Here, all participants were below the LLOQ.
Concentration of Rozanolixizumab in Breast Milk Over a 7-day Sampling Period >36 to <=48 hours postdose (Day 2)	NA micrograms per milliter (ug/mL) Geometric Coefficient of Variation NA Geometric means, and Geometric coefficient of variation were only calculated if at least 2/3 of the concentrations were above LLOQ (0.05ug/mL). Here, all participants were below the LLOQ.
Concentration of Rozanolixizumab in Breast Milk Over a 7-day Sampling Period >48 to <=60 hours postdose (Day 3)	NA micrograms per milliter (ug/mL) Geometric Coefficient of Variation NA Geometric means, and Geometric coefficient of variation were only calculated if at least 2/3 of the concentrations were above LLOQ (0.05ug/mL). Here, all participants were below the LLOQ.
Concentration of Rozanolixizumab in Breast Milk Over a 7-day Sampling Period >60 to <=72 hours postdose (Day 3)	NA micrograms per milliter (ug/mL) Geometric Coefficient of Variation NA Geometric means, and Geometric coefficient of variation were only calculated if at least 2/3 of the concentrations were above LLOQ (0.05ug/mL). Here, all participants were below the LLOQ.
Concentration of Rozanolixizumab in Breast Milk Over a 7-day Sampling Period >72 to <=84 hours postdose (Day 4)	NA micrograms per milliter (ug/mL) Geometric Coefficient of Variation NA Geometric means, and Geometric coefficient of variation were only calculated if at least 2/3 of the concentrations were above LLOQ (0.05ug/mL). Here, all participants were below the LLOQ.
Concentration of Rozanolixizumab in Breast Milk Over a 7-day Sampling Period >84 to <=96 hours postdose (Day 4)	NA micrograms per milliter (ug/mL) Geometric Coefficient of Variation NA Geometric means, and Geometric coefficient of variation were only calculated if at least 2/3 of the concentrations were above LLOQ (0.05ug/mL). Here, all participants were below the LLOQ.
Concentration of Rozanolixizumab in Breast Milk Over a 7-day Sampling Period >96 to <=108 hours postdose (Day 5)	NA micrograms per milliter (ug/mL) Geometric Coefficient of Variation NA Geometric means, and Geometric coefficient of variation were only calculated if at least 2/3 of the concentrations were above LLOQ (0.05ug/mL). Here, all participants were below the LLOQ.
Concentration of Rozanolixizumab in Breast Milk Over a 7-day Sampling Period >108 to <=120 hours postdose (Day 5)	NA micrograms per milliter (ug/mL) Geometric Coefficient of Variation NA Geometric means, and Geometric coefficient of variation were only calculated if at least 2/3 of the concentrations were above LLOQ (0.05ug/mL). Here, all participants were below the LLOQ.
Concentration of Rozanolixizumab in Breast Milk Over a 7-day Sampling Period >120 to <=132 hours postdose (Day 6)	NA micrograms per milliter (ug/mL) Geometric Coefficient of Variation NA Geometric means, and Geometric coefficient of variation were only calculated if at least 2/3 of the concentrations were above LLOQ (0.05ug/mL). Here, all participants were below the LLOQ.
Concentration of Rozanolixizumab in Breast Milk Over a 7-day Sampling Period >132 to <=144 hours postdose (Day 7)	NA micrograms per milliter (ug/mL) Geometric Coefficient of Variation NA Geometric means, and Geometric coefficient of variation were only calculated if at least 2/3 of the concentrations were above LLOQ (0.05ug/mL). Here, all participants were below the LLOQ.

SECONDARY outcome

Population: 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.

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).

Outcome measures

Outcome data not reported

SECONDARY outcome

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Day 1 Visit up to the Safety Follow-Up Visit (Day 57)

Population: The SS included all study participants who received a full or partial dose of the IMP.

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.

Outcome measures

Outcome measures
Measure	Rozanolixizumab n=15 Participants 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.
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)	73.3 percentage of participants

Adverse Events

Rozanolixizumab

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Rozanolixizumab n=15 participants at risk 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.
Gastrointestinal disorders Nausea	6.7% 1/15 • Number of events 1 • 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.
Gastrointestinal disorders Vomiting	6.7% 1/15 • Number of events 1 • 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.
General disorders Injection site haemorrhage	6.7% 1/15 • Number of events 1 • 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.
Infections and infestations Mastitis	13.3% 2/15 • Number of events 2 • 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.
Infections and infestations Vulvovaginal candidiasis	6.7% 1/15 • Number of events 1 • 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.
Infections and infestations Upper respiratory tract infection	20.0% 3/15 • Number of events 3 • 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.
Nervous system disorders Headache	60.0% 9/15 • Number of events 9 • 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.
Reproductive system and breast disorders Breast milk discolouration	6.7% 1/15 • Number of events 1 • 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.
Skin and subcutaneous tissue disorders Urticaria	6.7% 1/15 • Number of events 1 • 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.

Additional Information

UCB

Cares

Phone: 001 844 599 2273

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60