Evaluating pregnancy outcomes in women exposed to risankizumab

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational registry aims to compare pregnancy outcomes between women exposed to risankizumab and those not exposed, focusing on conditions like plaque psoriasis, psoriatic arthritis, and Crohn's disease. Approximately 818 pregnant women will be enrolled, with half having been treated with risankizumab and the other half receiving different treatments. The study will track maternal, fetal, and infant outcomes during pregnancy and up to one year post-delivery. Participants will not receive risankizumab as part of this study.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Study coordinator: PPD Inc
• Email: glowpregnancyregistry@ppd.com
• Phone: 1-877-302-2161

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.