Study to Evaluate Pregnancy Outcomes in Risankizumab Exposed Pregnancies Relative to Those Non-risankizumab Exposed Pregnancies in Women With FDA Approved Indications
Recruiting · NCT04846959
Conditions: Plaque Psoriasis, Psoriatic Arthritis, Crohn's Disease, or Other Conditions for Which Risankizumab is an FDA-approved Treatment
At a glance
- Research payments reported, 2025
- $950
- U.S. investigators named
- 9
- Sites paid
- 9
- Planned or actual enrollment
- 818
About the trial
- Sponsor
- AbbVie (with PPD Development, LP)
- Tested
- Risankizumab (drug), Comparator (drug)
- Dates
- Started 2021-07-30; completion 2032-06
- Results posted
- Not yet
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 Sta…
From ClinicalTrials.gov, last updated 2025-07-17. Full record, eligibility and contacts (opens in a new tab)
Industry funding
AbbVie Inc. reported $950 in research payments for this study in 2025 (9 payments).
Products named: Skyrizi
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Abha S. Gupta, M.D. Specialist · Santa Ana, CA
- Melissa A. Kushlak, D.O. OB-GYN (Obstetrics & Gynecology) · Boulder, CO
- Adine F. Regan, MD Urology · Farmington, CT
- Catherine B. Bowman, MD Pediatrics · Alpharetta, GA
- Christine D. Albrecht, M.D. OB-GYN (Obstetrics & Gynecology) · Houma, LA
- Katelyn Hartung, D.O. OB-GYN (Obstetrics & Gynecology) · Grand Blanc, MI
- Elizabeth C. Abraham, M.D. Pediatrics · Saint Louis, MO
- Joshua M. Nathan, MD OB-GYN (Obstetrics & Gynecology) · Manchester, NH
- Christina Fisher, PMHNP-BC Psychiatric Nurse Practitioners · Irving, TX
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Physicians for Womens Health LLC $150
- Advanced Obgyn for Women By Women $150
- Henry Ford Health Hospital, MI $150
- Advocare Lansdale Pediatrics $100
- St Gianna Pediatrics LLC $100
- Manchester Obstetrical Associates PA $100
- Boulder Womens Care $100
- Roswell Pediatric Center PC $50
- Abha S Gupta $50
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.