Psoriasis Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Psoriasis

Estimated Enrollment:

818

Study ID:

NCT04846959

Recruitment Status:

Recruiting

Sponsor:

AbbVie

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There are 2 Locations for this study

See Locations Near You

Evidera, a PPD Business Unit /ID# 238688
Morrisville North Carolina, 27560, United States
PPD Development, LP /ID# 232134
Wilmington North Carolina, 28401, United States

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Estimated Enrollment:

818

Study ID:

NCT04846959

Recruitment Status:

Recruiting

Sponsor:


AbbVie

How clear is this clinincal trial information?

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