Study to Evaluate Pregnancy Outcomes in Risankizumab Exposed Pregnancies Relative to Those Non-risankizumab Exposed Pregnancies in Women With Moderate to Severe Plaque Psoriasis

Study Overview
=================
Brief Summary
-----------------
Psoriasis is a skin disorder wherein skin cells multiply faster than normal, making the skin itchy and look patchy and red. It is caused by an overactive immune system where the body attacks healthy tissue by mistake. The main objective of this study is to assess maternal, fetal, and infant outcomes of women who are exposed to risankizumab during pregnancy with those in an unexposed comparator population. Risankizumab is an approved drug for the treatment of Plaque Psoriasis. 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.

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

Conditions
-----------------
Psoriasis

Intervention / Treatment
-----------------
* Drug: Risankizumab
* Drug: Comparator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Risankizumab-Exposed Cohort US resident. Current pregnancy. Diagnosis of plaque psoriasis. 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. 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). Exposure to known teratogens and/or investigational medications during pregnancy (at least 1 dose during pregnancy or prior to pregnancy within a specified time period based on the product's half-life). Diagnostic prenatal test results known prior to first contact with the registry coordination center (RCC). Inclusion in the analysis population for a prior pregnancy. Diseased Comparison Cohort Exposure to risankizumab at any time during pregnancy (at least 1 dose during pregnancy or within 20 weeks prior to conception). Exposure to known teratogens and/or investigational medications during pregnancy (at least 1 dose during pregnancy or prior to pregnancy within a specified time period based on the product's half-life). Diagnostic prenatal test results known prior to first contact with the RCC. Inclusion in the analysis population for a prior pregnancy.
Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant Women Exposed to Risankizumab<br>Pregnant women of any age in the United States (US) who are diagnosed with plaque psoriasis and exposed to risankizumab at any time during pregnancy. | Drug: Risankizumab<br>* Subcutaneous Injection<br>* Other names: Skyrizi;|
| Pregnant Women Not Exposed to Risankizumab<br>Pregnant women of any age in the US who are diagnosed with plaque psoriasis 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. | Drug: Comparator<br>* Subcutaneous or Intravenous Injection<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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). | 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. | 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. | Up to 9 months | 
| Number of Participants with Preterm Birth | Preterm birth is defined as live birth occurring at less than 37 gestational weeks. | 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. | 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. | 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. | 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. | 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) . | Up to approximately 2 years (1 year post delivery) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pregnancy, Risankizumab, SKYRIZI™, risankizumab-rzaa