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

NCT06346288 | Completed Phase 4 FDA Drug

• 1 other identifier: M24-144
• Study Type: interventional
• Target: 10
• Locations: 2 countries
• Sites: 3

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.

Conditions

Inflammatory Bowel Disease

Keywords

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

Outcome Measures

Primary Outcomes (2)

• To determine the concentration of risankizumab in breastmilk

  Breastmilk samples will be collected to evaluate the presence of risankizumab in the milk of lactating women

  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)

• Percentage of Infant Participants With Treatment-Emergent Adverse Event and Treatment-Emergent Serious Adverse Event (TEAEs/TESAEs)

  An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.

  6 months from Day 1 dose

Study Arms (1)

Pharmacokinetic samples

EXPERIMENTAL

Pharmacokinetic (PK) samples will be taken from breast milk of lactating mothers on an established dosing regimen of commercial risankizumab at 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). Participants will have already been taking commercial risankizumab and will continue on commercial risankizumab. Participants will not be provided risankizumab from the study. Participants must have received at least 2 doses of 360 mg of risankizumab SC every 8 weeks postpartum prior to start of participation in this study.

Procedure: Breast Milk Sampling; Drug: Risankizumab

Interventions

Breast Milk Sampling PROCEDURE

Pharmacokinetic (PK) samples will be taken from breast milk of lactating mothers on an established dosing regimen of commercial risankizumab at 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)

Pharmacokinetic samples

Risankizumab DRUG

Participants will have already been taking commercial risankizumab and will continue on commercial risankizumab. Participants will not be provided risankizumab from the study. Participants must have received at least 2 doses of 360 mg of risankizumab SC every 8 weeks postpartum prior to start of participation in this study.

Also known as: SKYRIZI

Pharmacokinetic samples

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (3)

University of North Carolina at Chapel Hill /ID# 263316

Chapel Hill, North Carolina, 27514, United States

Location

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

Houston, Texas, 77024, United States

Location

Shaare Zedek Medical Center /ID# 262738

Jerusalem, Jerusalem, 91031, Israel

Location

Related Links

• Related Info

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Breast Feeding; Crohn Disease; Colitis, Ulcerative

Interventions

risankizumab

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Feeding Behavior; Behavior; Colitis; Colonic Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2024
• First Posted: April 4, 2024
• Study Start: April 24, 2024
• Primary Completion: February 5, 2026
• Study Completion: February 5, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

IL (1); US (2)