Clinical trial NCT06346288: A Study to Assess the Concentrations of Risankizumab in the Breast Milk of Adult Lactating Women With Inflammatory Bowel Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Inflammatory Bowel Disease
Keywords: IBD
Lactating
breastfeeding
risankizumab
Inflammatory Bowel Disease
Crohn's Disease
Ulcerative Colitis
SKYRIZI
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2024-04-04
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

Detailed description: The study will only include lactating women who are receiving treatment with risankizumab for IBD in accordance with their treating physician, although this study is non-interventional regarding treatment with risankizumab, it is considered interventional due to the collection of breast milk from the lactating mothers.

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.

Primary outcomes:
measure: 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)
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill /ID# 263316
state: North Carolina
city: Houston
country: United States
facility: UTHealth Women's Research Program - Memorial City /ID# 263939
state: Texas
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center /ID# 262738
state: Yerushalayim
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: