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Observational Study of Risankizumab in Pregnancy

This study is looking at pregnancy outcomes in women who have been exposed to risankizumab (a medication for conditions like plaque psoriasis, psoriatic arthritis, and Crohn's disease) compared to those who haven't. The goal is to understand if risankizumab is linked to any differences in the health of mothers, babies, and infants. You could join if you are a pregnant US resident with one of these conditions and have been exposed to risankizumab during or shortly before your pregnancy. The study will compare about 409 women who used risankizumab with 409 who did not. The main thing they're looking for is the number of babies born with major birth defects up to 9 months after birth. The current recruitment status is unclear.

Study design
This is an observational study, meaning participants will not receive risankizumab as part of the study. It aims to enroll approximately 818 female participants, split between those exposed to risankizumab and those not exposed.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed to measure major congenital malformations (birth defects) up to 9 months after birth.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04846959

Study to Evaluate Pregnancy Outcomes in Risankizumab Exposed Pregnancies Relative to Those Non-risankizumab Exposed Pregnancies in Women With FDA Approved Indications

Recruiting
Not specifiedAll AgesObservational
AbbVie
~818 participants
Updated 2025-07-17 on ClinicalTrials.gov
What's tested:RisankizumabComparator

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with Major Congenital Malformation (MCM)
Measured over Up to 9 months

Conditions

Plaque Psoriasis, Psoriatic Arthritis, Crohn's Disease, or Other Conditions for Which Risankizumab is an FDA-approved Treatment

Explore related trials

Chronic small plaque psoriasisCrohn DiseasePsoriatic Arthritis

Where it's being run

2 sites across 1 states
North Carolina2

Study leadership

  • ABBVIE INC. · STUDY_DIRECTOR · AbbVie

Who to contact

PPD Inc
[email protected]
1-877-302-2161
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

US resident.
Current pregnancy.
Diagnosis of plaque psoriasis, PsA, CD, or other condition(s) for which Risankizumab is an FDA-approved treatment while the study is recruiting.
Exposure to risankizumab at any time during pregnancy (at least 1 dose during pregnancy or within 20 weeks prior to conception).
US resident.
Current pregnancy.
Diagnosis of plaque psoriasis, PsA, CD, or other condition(s) for which Risankizumab is an FDA-approved treatment while the study is recruiting.
Exposure to other medications in the same class or line of therapy as risankizumab (TNF inhibitors, IL-17 inhibitors, IL-12/23 inhibitor, and other IL-23 inhibitors) at any time during pregnancy (at least 1 dose during pregnancy or prior to pregnancy within a specified time period based on the product's half-life).

Exclusion

Exposure to other medications in the same class or line of therapy as risankizumab (TNF inhibitors, IL-17 inhibitors, IL-12/23 inhibitor, and other IL-23 inhibitors) at any time during pregnancy (at least 1 dose during pregnancy or prior to pregnancy within a specified time period based on the product's half-life).
Occurrence of pregnancy outcome prior to enrollment in the registry
Exposure to risankizumab at any time during pregnancy (at least 1 dose during pregnancy or within 20 weeks prior to conception).
Occurrence of pregnancy outcome prior to enrollment in the registry

What this trial measures

  • Number of Participants with Major Congenital Malformation (MCM)Up to 9 months

    MCM is an abnormality of body structure or function that is present at birth, is of prenatal origin (i.e., birth defect), has significant medical, social, or cosmetic consequences for the affected individual, and typically requires medical intervention.