ACTIVE_NOT_RECRUITING

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2024-04-24

Study Completion:2026-02-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06346288

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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: * 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.

Inclusion Criteria

Exclusion 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

* 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:
* 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.

Contacts and Locations

Principal Investigator

ABBVIE INC.

STUDY_DIRECTOR

AbbVie

Study Locations (Sites)

University of North Carolina at Chapel Hill /ID# 263316

Chapel Hill, North Carolina, 27514

United States

UTHealth Women's Research Program - Memorial City /ID# 263939

Houston, Texas, 77024

United States

Collaborators and Investigators

Sponsor: AbbVie

ABBVIE INC., STUDY_DIRECTOR, AbbVie

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-24

Study Completion Date2026-02-06

Study Record Updates

Study Start Date2024-04-24

Study Completion Date2026-02-06

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Inflammatory Bowel Disease