A Study to Assess the Concentrations of Risankizumab in the Breast Milk of Adult Lactating Women … (NCT06346288) | Clinical Trial Compass
CompletedPhase 4
A Study to Assess the Concentrations of Risankizumab in the Breast Milk of Adult Lactating Women With Inflammatory Bowel Disease
United States, Israel10 participantsStarted 2024-04-24
Plain-language summary
Inflammatory bowel disease (IBD) is a chronic inflammatory disease that requires lifelong treatment. This study will asses the concentrations of risankizumab in the breast milk of lactating women with IBD
Risankizumab is an approved drug for adults with plaque psoriasis, psoriatic arthritis, and Crohn's Disease. This is an open-label milk-only study lactation study to evaluate the presence of risankizumab in the milk of lactating women. Approximately 10 adult lactating women with IBD will be enrolled from approximately 3 sites in Israel and or the United States.
Participants will receive risakizumab maintenance therapy every 8 weeks postpartum prior to start of participation in this study. The study duration is approximately 7 months.
Participants will attend regular visits during the study at a hospital or clinic. The participants will also be completing questionnaires and will have medical assessments, checking for side effects.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participant must have received at least 2 doses of 360 mg risankizumab maintenance therapy every 8 weeks postpartum prior to start of participation in this study.
* Participant is at least 5 weeks postpartum by Day 1.
* Lactation is well established. The mother must be exclusively breastfeeding her infant (or not providing more than 1 supplemental bottle of formula/day) when enrolled in the study.
* Diagnosis of crohn's disease (or ulcerative colitis upon approval of ulcerative colitis in the participants location) as established by the principal investigator
Exclusion Criteria:
* Participants who have major surgery planned during the conduct of the study (e.g., hip replacement, aneurysm removal, stomach ligation)
* Participants with the following chronic or active infections:
\-- Active HBV or HCV infection, defined as:
* HBV: HBs Ag positive (+) test or detected sensitivity on the HBV DNA PCR qualitative test for participants who are HBc Ab positive (+) (and for HBs Ab positive \[+\] participants where mandated by local requirements).
* HCV: HCV RNA detectable in any subject with HCV Ab.
* Are infected with HIV, defined as confirmed positive anti-HIV Ab test. Note: In case a screened participant has a confirmed positive HIV Ab test,.
* Active tuberculosis
* Active systemic infection/clinically important infection during the last 2 weeks prior to the Baseline Visit as assessed by the investigator
* Participants who have any of the following me…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To determine the concentration of risankizumab in breastmilk
Timeframe: Pre-dose and 1 hour after dosing on Day 1, on Days 4 (± 1), 8 (± 2), 15 (± 3), 29 (± 3), and pre-dose on Day 57 (± 3)
2
Percentage of Infant Participants With Treatment-Emergent Adverse Event and Treatment-Emergent Serious Adverse Event (TEAEs/TESAEs)