Assessing Risankizumab Levels in Breast Milk of Lactating Women with Inflammatory Bowel Disease

A Phase 4, Open-Label, Milk-Only Lactation Study to Assess Concentration of Risankizumab in Breast Milk of Lactating Women With Inflammatory Bowel Disease Who Are Receiving Risankizumab Therapeutically

This study is testing how much of the medication risankizumab is found in the breast milk of breastfeeding women with inflammatory bowel disease.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: AbbVie (Industry-sponsored)
• Drugs / interventions: risankizumab, risakizumab
• Locations: 3 sites (Chapel Hill, North Carolina and 2 other locations)
• Trial ID: NCT06346288 on ClinicalTrials.gov

What this trial studies

This study evaluates the concentrations of risankizumab, a medication used for inflammatory bowel disease (IBD), in the breast milk of lactating women. It involves approximately 10 adult women who are at least 5 weeks postpartum and exclusively breastfeeding. Participants will have received at least two doses of risankizumab maintenance therapy prior to enrollment. The study will collect breast milk samples and conduct regular medical assessments over a duration of about 7 months.

Who should consider this trial

Good fit: Ideal candidates are lactating women with a diagnosis of Crohn's disease or ulcerative colitis who are receiving risankizumab treatment.

Not a fit: Patients who are not lactating or those with planned major surgeries during the study may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable information on the safety and transfer of risankizumab through breast milk, aiding treatment decisions for lactating women with IBD.

How similar studies have performed: While studies on drug concentrations in breast milk are common, this specific assessment of risankizumab in lactating women with IBD is novel.

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.

Where this trial is running

Chapel Hill, North Carolina and 2 other locations

• University of North Carolina at Chapel Hill /ID# 263316 — Chapel Hill, North Carolina, United States (Recruiting)
• UTHealth Women's Research Program - Memorial City /ID# 263939 — Houston, Texas, United States (Recruiting)
• Shaare Zedek Medical Center /ID# 262738 — Jerusalem, Yerushalayim, Israel (Recruiting)

Study contacts

• Study coordinator: Abbvie Call Center

Conditions Inflammatory Bowel Disease; IBD; Lactating; breastfeeding; risankizumab; Crohn's Disease; Ulcerative Colitis; SKYRIZI