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

NCT04846959 | Recruiting FDA Drug

• 1 other identifier: P20-036
• Study Type: observational
• Target: 818
• Locations: 1 country
• Sites: 2

Brief Summary

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

Keywords

Pregnancy; Risankizumab; SKYRIZI™; risankizumab-rzaa

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Number of Participants with Minor Congenital Malformation

  Up to approximately 2 years (1 year post delivery)

• Number of Participants with Stillbirth

  Up to 9 months

• Number of Participants with Spontaneous Abortion (SAB)

  Up to 9 months

• Number of Participants with Elective Termination of Pregnancy

  Up to 9 months

• Number of Participants with Preterm Birth

  Up to 9 months

Study Arms (2)

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

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

Interventions

Risankizumab DRUG

Subcutaneous Injection

Also known as: Skyrizi

Pregnant Women Exposed to Risankizumab

Comparator DRUG

Subcutaneous or Intravenous Injection

Pregnant Women Not Exposed to Risankizumab

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• AbbVie: lead
• PPD Development, LP: collaborator

Study Sites (2)

Evidera, a PPD Business Unit /ID# 238688

Morrisville, North Carolina, 27560-7200, United States

RECRUITING

PPD Development, LP /ID# 232134

Wilmington, North Carolina, 28401-3331, United States

COMPLETED

Related Links

• Related Info

MeSH Terms

Conditions

Arthritis, Psoriatic; Crohn Disease

Interventions

risankizumab

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

PPD Inc

CONTACT

1-877-302-2161; glowpregnancyregistry@ppd.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2021
• First Posted: April 15, 2021
• Study Start: July 30, 2021
• Primary Completion (Estimated): June 1, 2032
• Study Completion (Estimated): June 1, 2032
• Last Updated: July 17, 2025

Record last verified: 2025-07

Locations

US (2)