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Safety Study for Prospective Assessment of Pregnancy Outcomes in Patients Treated With Tildrakizumab
NCT03992729 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Pregnant women exposed to tildrakizumab
- DRUG Pregnant women not exposed to tildrakizumab
Study Locations (1)
California
- Christina Chambers — San Diego
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2019-08-29 |
| Est. Completion | 2028-07-31 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03992729
The ClinicalTrials.gov registry entry for NCT03992729 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sun Pharmaceutical Industries Limited, which has 13 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Pregnancy Related appearing as the primary indexed condition, and to 2 interventions — of which Pregnant women exposed to tildrakizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03992729 reports 1 study location spanning 1 distinct geographic area — top geographies include California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03992729 about?
NCT03992729 is a clinical study titled "Safety Study for Prospective Assessment of Pregnancy Outcomes in Patients Treated With Tildrakizumab". 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 ...
What is the current status of trial NCT03992729?
This trial is currently recruiting. The enrollment target is 200 participants. The study started on 2019-08-29. Estimated completion is 2028-07-31.
What conditions does trial NCT03992729 study?
This clinical trial studies the following conditions: Pregnancy Related. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03992729?
The interventions under investigation include: Pregnant women exposed to tildrakizumab (DRUG), Pregnant women not exposed to tildrakizumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03992729?
This trial is sponsored by Sun Pharmaceutical Industries Limited, which has 13 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03992729 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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