Study to Evaluate Pregnancy Outcomes in Risankizumab Exposed Pregnancies Relative to Those Non-risankizumab Exposed Pregnancies in Women With Moderate to Severe Plaque Psoriasis

Risankizumab Pregnancy Exposure Registry: a Prospective Observational Study on the Safety of Risankizumab Exposure in Pregnant Women and Their Offspring

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.

Clinical Trial: Study to Evaluate Pregnancy Outcomes in Risankizumab Exposed Pregnancies Relative to Those Non-risankizumab Exposed Pregnancies in Women With Moderate to Severe Plaque Psoriasis

Study to Evaluate Pregnancy Outcomes in Risankizumab Exposed Pregnancies Relative to Those Non-risankizumab Exposed Pregnancies in Women With Moderate to Severe Plaque Psoriasis

Recruitment

Summary

Participation Requirements

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