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

April 22, 2024 updated by: AbbVie

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pharmacokinetic samples

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
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)
Drug: Risankizumab
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.
Other Names:
  • SKYRIZI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine the concentration of risankizumab in breastmilk
Time Frame: 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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 Major Dates

Study Start (Estimated)

May 6, 2024

Primary Completion (Estimated)

January 20, 2025

Study Completion (Estimated)

May 27, 2025

Study Registration Dates

First Submitted

March 22, 2024

First Submitted That Met QC Criteria

April 2, 2024

First Posted (Actual)

April 4, 2024

Study Record Updates

Last Update Posted (Actual)

April 24, 2024

Last Update Submitted That Met QC Criteria

April 22, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M24-144

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

IPD Sharing Time Frame

For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

IPD Sharing Access Criteria

Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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