Plaque Psoriasis, Psoriatic Arthritis, Crohn's Disease, or Other Conditions for Which Risankizumab is an FDA-approved TreatmentNCT04846959

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

An observational study of Plaque Psoriasis, Psoriatic Arthritis, Crohn's Disease, or Other Conditions for Which Risankizumab is an FDA-approved Treatment, run by AbbVie at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Any age, women only
Conditions the study is for: Plaque Psoriasis, Psoriatic Arthritis, Crohn's Disease, or Other Conditions for Which Risankizumab is an FDA-approved Treatment
What is being tested?: Risankizumab and Comparator
Type of treatment: Injection or infusion
How many people: 818 participants
Where: 2 sitesUnited States
Study dates: 30 Jul 2021to Jun 2032
Phase: Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
Women only
No healthy volunteers
Child, Adult, Older adult

Study population: The study population will comprise 2 cohorts of pregnant women. * One cohort will include pregnant women of any age in the US who are diagnosed with plaque psoriasis, psoriatic arthritis, Crohn's disease, or other conditions for which risankizumab is an FDA-approved treatment and exposed to risankizumab at any time during pregnancy . * The second cohort will include pregnant women of any age in the US who are diagnosed with plaque psoriasis, psoriatic arthritis, Crohn's disease, or other conditions for which risankizumab is an FDA-approved treatment and not exposed to risankizumab but who are exposed to other medications in the same class or line of therapy as risankizumab at any time during pregnancy.

Who may be able to join

Risankizumab-Exposed Cohort
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).
Diseased Comparison Cohort

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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).

Who cannot join

Risankizumab-Exposed Cohort
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
Diseased Comparison Cohort
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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

PPD Inc contact

1-877-302-2161

glowpregnancyregistry@ppd.com

United States2 sites, 1 recruiting

Evidera, a PPD Business Unit /ID# 238688
Morrisville, North Carolina, 27560-7200
Recruiting
PPD Development, LP /ID# 232134
Wilmington, North Carolina, 28401-3331
Completed

Other trials in United States

About this study

Official title: Risankizumab Pregnancy Exposure Registry: a Prospective Observational Study on the Safety of Risankizumab Exposure in Pregnant Women and Their Offspring

The objective of this registry is to compare outcomes of risankizumab-exposed pregnancies with those of pregnancies that were not exposed to risankizumab among women with plaque psoriasis, psoriatic arthritis (PsA), Crohn's disease (CD), or other conditions for which risankizumab is an FDA-approved treatment. The registry is designed to estimate the association between risankizumab and maternal, fetal, and infant outcomes by comparing the prevalence rates of these outcomes in the exposed and unexposed populations.

Approximately 818 female participants with pregnancy will be enrolled (409 participants exposed to risankizumab and 409 without exposure) at multiple sites across the United States.

Participants will not receive risankizumab as part of this study. Maternal and fetal outcomes during pregnancy for female participants who received risankizumab or other treatment will be followed for and up to 1 year after delivery

There may be a higher burden for participants in this study compared to standard of care. Participants will attend visits determined by HCPs during the study at a hospital or clinic. The pregnancy outcomes including side effects will be collected during routine clinical care.

Conditions: Plaque Psoriasis, Psoriatic Arthritis, Crohn's Disease, or Other Conditions for Which Risankizumab is an FDA-approved Treatment
Being tested: Risankizumab, Comparator
Keywords: Pregnancy, Risankizumab, SKYRIZI™, risankizumab-rzaa
Medical subject headings: Arthritis, Psoriatic, Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RisankizumabDrug
Also called Skyrizi
Subcutaneous Injection
ComparatorDrug
Subcutaneous or Intravenous Injection

Study groups in NCT04846959
Study group	Role	What they receive
Pregnant Women Exposed to Risankizumab		Pregnant women of any age in the United States (US) who are diagnosed with plaque psoriasis, psoriatic arthritis, Crohn's disease, or other conditions for which risankizumab is an FDA-approved treatment and exposed to risankizumab at any time during pregnancy. Receives: Drug: Risankizumab
Pregnant Women Not Exposed to Risankizumab		Pregnant women of any age in the US who are diagnosed with plaque psoriasis, psoriatic arthritis, Crohn's disease, or other conditions for which risankizumab is an FDA-approved treatment and not exposed to risankizumab, but who are exposed to other medications in the same class or line of therapy as risankizumab at any time during pregnancy. Receives: Drug: Comparator

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants with Major Congenital Malformation (MCM)
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.
Measured: Up to 9 months

Secondary outcomes (10)

Number of Participants with Minor Congenital Malformation
Minor Congenital Malformation is an anomaly or abnormality of body structure that is present at birth, is of prenatal origin (i.e., birth defect), poses no significant health problem in the neonatal period, and tends to have limited social or cosmetic consequences for the affected individual.
Measured: Up to approximately 2 years (1 year post delivery)
Number of Participants with Stillbirth
Stillbirth is defined by the American College of Obstetricians and Gynecologists (ACOG), an involuntary fetal loss occurring at 20 gestational weeks or greater (>=20 gestational weeks), or, if gestational age is unknown, a fetus weighing 350 g or more (>=350 g).
Measured: Up to 9 months
Number of Participants with Spontaneous Abortion (SAB)
Spontaneous abortion is defined as an involuntary fetal loss or expulsion of products of conception occurring at less than 20 gestational weeks.
Measured: Up to 9 months
Number of Participants with Elective Termination of Pregnancy
Elective termination of pregnancy is defined as an voluntary fetal loss or interruption of pregnancy, including pregnancy termination that occurs electively.
Measured: Up to 9 months
Number of Participants with Preterm Birth
Preterm birth is defined as live birth occurring at less than 37 gestational weeks.
Measured: Up to 9 months
Number of Participants who are Small for Gestational Age (SGA)
SGA is defined as Birth weight less than the 10th percentile for sex and gestational age using standard growth charts for full and preterm live-born infants.
Measured: Up to 9 months
Number of Participants with Neonatal Death
Neonatal death is defined as death of a live-born infant within 28 days of life.
Measured: Up to approximately 10 months (one month post delivery)
Number of Participants with Serious Infection in the First 6 Months of Life
Serious infection is defined as an infection that occurs within an infant's first 6 months of life and results in significant disability, incapacity, or death, is life-threatening, requires inpatient or prolonged hospitalization, or is considered medically important.
Measured: Up to approximately 2 years (1 year post delivery)
Number of Participants with Postnatal Growth Deficiency
Postnatal growth deficiency is defined as postnatal infant weight less than the 10th percentile for sex and chronological age using standard growth charts.
Measured: Up to approximately 2 years (1 year post-delivery)
Number of Participants with Infant Developmental Delay
Infant developmental delay is defined as failure to achieve the developmental milestones for chronological age, as defined by the Center for Disease Control and Prevention (CDC) .
Measured: Up to approximately 2 years (1 year post delivery)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jul 2021Jun 2032

First posted15 Apr 2021
Study start30 Jul 2021
Primary completionJun 2032 (estimated)
Study completionJun 2032 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Plaque Psoriasis, Psoriatic Arthritis, Crohn's Disease, or Other Conditions for Which Risankizumab is an FDA-approved TreatmentStudies of the same condition, open and under way.
More trials run by AbbVieThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Prospective
Enrolment: 818 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04846959
Sponsor's protocol ID: P20-036
Status last verified: Jul 2025
First submitted: 14 Apr 2021
Last updated: 17 Jul 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided