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Monoclonal Antibodies

Risankizumab for Inflammatory Bowel Disease

Phase 4

Recruiting

Research Sponsored by AbbVie

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Be older than 18 years old

Must not have

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.

Are infected with HIV, defined as confirmed positive anti-HIV Ab test.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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)

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Drug Has Already Been Approved

Summary

"This trial is studying the levels of risankizumab in the breast milk of lactating women with Inflammatory Bowel Disease (IBD). Risankizumab is a drug used to

Who is the study for?

This trial is for lactating women at least 5 weeks postpartum with Inflammatory Bowel Disease who have been treated with risankizumab. They must be exclusively breastfeeding or giving no more than one bottle of formula per day.

What is being tested?

The study assesses the levels of risankizumab, a drug used for psoriasis and Crohn's Disease, in breast milk. About 10 women from Israel or the US will participate over approximately 7 months, providing milk samples and undergoing medical assessments.

What are the potential side effects?

While specific side effects are not listed, participants will be monitored for any adverse reactions during their regular visits to the hospital or clinic as part of the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have received at least 2 doses of risankizumab 360 mg every 8 weeks after giving birth.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am HIV positive.

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I do not have any major surgeries planned during the study.

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I do not have active hepatitis B or C infections.

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I do not have active tuberculosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To determine the concentration of risankizumab in breastmilk

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Pharmacokinetic samplesExperimental Treatment2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Risankizumab

2021

Completed Phase 4

~3340

0 / 6Eligibility criteria met