Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04846959

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Plaque Psoriasis, Psoriatic Arthritis, Crohn's Disease, or Other Conditions for Which Risankizumab is an FDA-approved Treatment Arthritis Arthritis, Psoriatic Bone Diseases Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Joint Diseases Musculoskeletal Diseases Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Sex eligibility

Female

Study type

Observational

Primary location

Evidera, a PPD Business Unit /ID# 238688, Morrisville, North Carolina, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

  • 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 criteria

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

Treatment and study plan

Risankizumab

Drug

Subcutaneous Injection

Other names: Skyrizi

Comparator

Drug

Subcutaneous or Intravenous Injection

Primary outcomes

  1. Number of Participants with Major Congenital Malformation (MCM)

    Time frame: 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.

Secondary outcomes

  1. Number of Participants with Minor Congenital Malformation

    Time frame: Up to approximately 2 years (1 year post delivery)

    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.

  2. Number of Participants with Stillbirth

    Time frame: Up to 9 months

    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).

  3. Number of Participants with Spontaneous Abortion (SAB)

    Time frame: Up to 9 months

    Spontaneous abortion is defined as an involuntary fetal loss or expulsion of products of conception occurring at less than 20 gestational weeks.

  4. Number of Participants with Elective Termination of Pregnancy

    Time frame: Up to 9 months

    Elective termination of pregnancy is defined as an voluntary fetal loss or interruption of pregnancy, including pregnancy termination that occurs electively.

  5. Number of Participants with Preterm Birth

    Time frame: Up to 9 months

    Preterm birth is defined as live birth occurring at less than 37 gestational weeks.

  6. Number of Participants who are Small for Gestational Age (SGA)

    Time frame: Up to 9 months

    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.

  7. Number of Participants with Neonatal Death

    Time frame: Up to approximately 10 months (one month post delivery)

    Neonatal death is defined as death of a live-born infant within 28 days of life.

  8. Number of Participants with Serious Infection in the First 6 Months of Life

    Time frame: Up to approximately 2 years (1 year post delivery)

    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.

  9. Number of Participants with Postnatal Growth Deficiency

    Time frame: Up to approximately 2 years (1 year post-delivery)

    Postnatal growth deficiency is defined as postnatal infant weight less than the 10th percentile for sex and chronological age using standard growth charts.

  10. Number of Participants with Infant Developmental Delay

    Time frame: Up to approximately 2 years (1 year post delivery)

    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) .

Study contacts

Contact information is provided by the study sponsor or research team.

PPD Inc

CONTACT

[email protected]

1-877-302-2161

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Collaborators

  • PPD Development, LP

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2032
Study completion
2032
First posted
Apr 15, 2021
Registry last updated
Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.