A Study to Assess the Concentrations of Risankizumab in the Breast Milk of Adult Lactating Women With Inflammatory Bowel Disease

Launched by ABBVIE · Apr 2, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the levels of a medication called risankizumab in the breast milk of women who have inflammatory bowel disease (IBD) and are breastfeeding. Risankizumab is already used to treat conditions like Crohn's disease, and the researchers want to understand how much of this drug can be found in the milk of lactating mothers. The study will include about 10 women from Israel and the United States who are at least 5 weeks postpartum (after giving birth) and are exclusively breastfeeding.

To participate, women must have already received at least two doses of risankizumab after giving birth. They will attend regular visits at a hospital or clinic for about 7 months, during which they will fill out questionnaires and undergo medical check-ups to monitor for any side effects. This study is important because it can help determine how safe it is for mothers with IBD to continue using this medication while breastfeeding, ensuring the health of both the mother and baby.

Gender

FEMALE

Eligibility criteria

• 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 medical diseases or conditions:
• • Recent (within past 6 months) cerebrovascular accident or myocardial infarction;
• • History of an organ transplant which requires continued immunosuppression;
• • Active or suspected malignancy or history of any malignancy within the last 5 years except for successfully treated non-melanoma skin cancer or localized carcinoma in situ of the cervix.