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

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.

Study Overview

• Status: Recruiting
• Conditions: Plaque Psoriasis; Crohn Disease; Psoriatic Arthritis; Other Conditions for Which Risankizumab is an FDA-approved Treatment
• Intervention / Treatment: Drug: Risankizumab; Drug: Comparator

• Study Type: Observational
• Enrollment (Estimated): 818

Contacts and Locations

• Study Contact: Name: PPD Inc; Phone Number: 1-877-302-2161; Email: glowpregnancyregistry@ppd.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: Risankizumab; Subcutaneous Injection; Other Names: Skyrizi
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.	Drug: Comparator; Subcutaneous or Intravenous Injection

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 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)
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

Collaborators and Investigators

• Sponsor: AbbVie
• Collaborators: PPD
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2021
• Primary Completion (Estimated): January 1, 2033
• Study Completion (Estimated): January 1, 2033

Study Registration Dates

• First Submitted: April 14, 2021
• First Submitted That Met QC Criteria: April 14, 2021
• First Posted (Actual): April 15, 2021

Study Record Updates

• Last Update Posted (Actual): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Pregnancy; Risankizumab; SKYRIZI™; risankizumab-rzaa
• Additional Relevant MeSH Terms: Digestive System Diseases; Skin Diseases; Gastrointestinal Diseases; Joint Diseases; Musculoskeletal Diseases; Gastroenteritis; Arthritis; Intestinal Diseases; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Inflammatory Bowel Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Psoriasis; Crohn Disease; Arthritis, Psoriatic
• Other Study ID Numbers: P20-036

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes