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NCT03992729 · ClinicalTrials.gov record · last posted 2026-01-21

Safety Study for Prospective Assessment of Pregnancy Outcomes in Patients Treated With Tildrakizumab

StatusRecruiting
PhaseNot specified
Started2019-08-29
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from the ClinicalTrials.gov record
This study will utilize a prospective, observational, exposure cohort design to examine pregnancy and infant outcomes in women and infants who are exposed to tildrakizumab during pregnancy to treat an approved indication. The pregnancy registry cohort study will be conducted by the Organization of Teratology Information Specialists (OTIS), which is a network of university and health department based information centers serving pregnant women and healthcare providers throughout North America. These services provide a basis for collaborative research such as this Registry. These Services located throughout the United States (US) and Canada will serve as a source of referrals not only for tildrakizumab-exposed pregnancies but also for similarly ascertained disease-matched comparison pregnant women who have not used tildrakizumab in pregnancy. The target follow-up period will be until end of pregnancy and 1 year of age for live born infants.

Amendment record 10 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 10 times since 2019-06-19; most recent amendment 2026-01-19. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2019-11-25
Status change Not Yet RecruitingRecruitingv1
Trial Details
NCT Number NCT03992729
Lead Sponsor Sun Pharmaceutical Industries Limited
Conditions Pregnancy Related
Enrollment 200 participants
Start Date 2019-08-29
Primary Completion 2028-07-31 (estimated)
Study Completion 2028-07-31 (estimated)
Updated on ClinicalTrials.gov 2026-01-21