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

Korábbi kezelés

• Participants who have major surgery planned during the conduct of the study (e.g., hip replacement, aneurysm removal, stomach ligation)
• Active systemic infection/clinically important infection during the last 2 weeks prior to the Baseline Visit as assessed by the investigator

Más betegség

• 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
• 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.

• 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