Recruiting

Risankizumab

Sponsor:

AbbVie

Code:

NCT04846959

Conditions

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

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Risankizumab

Comparator

Study Details

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

Study ID

NCT04846959

Start date

Jul 30, 2021

Status verified date

Jul, 2025

Completion date

Jun, 2032

Anticipated

Primary completion date

Jun, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

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 Design

Enrollment

818 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Risankizumab

Subcutaneous Injection

Comparator

Subcutaneous or Intravenous Injection

Primary outcome measure

  • Number of Participants with Major Congenital Malformation (MCM) [ Time Frame: Up to 9 months ]

Central Contacts and Locations

Central contacts

PPD Inc

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

Locations

Evidera, a PPD Business Unit /ID# 238688

Recruiting

Morrisville, North Carolina, United States, 27560-7200

More Information

Sponsor

AbbVie

Last update posted

Jul 17, 2025

Last verified

Jul, 2025

Keywords

  • Pregnancy
  • Risankizumab
  • SKYRIZI™
  • risankizumab-rzaa

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-07. This information was provided to ClinicalTrials.gov by AbbVie on 2025-07-17.