Pregnancy RelatedNCT03992729
Safety Study for Prospective Assessment of Pregnancy Outcomes in Patients Treated With Tildrakizumab
An observational study of Pregnancy Related, run by Sun Pharmaceutical Industries Limited at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- Pregnant women exposed to tildrakizumab and Pregnant women not exposed to tildrakizumab
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Aug 2019to 31 Jul 2028
- How long will I take part?
- 20 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Pregnant women diagnosed with tildrakizumab-approved indication with and without tildrakizumab
Who may be able to join
None listed.
Who cannot join
- Cohort 1: Tildrakizumab-Exposed Cohort:
- Women who have first contact with the project after prenatal diagnosis of any major structural defect
- Women who have enrolled in the tildrakizumab cohort study with a previous pregnancy (women may only enroll once in the Tildrakizumab Pregnancy Study)
- Women who have used tildrakizumab for an indication other than a currently approved indication
- Retrospective enrollment after the outcome of pregnancy is known
- Cohort 2: Disease-Matched Comparison Cohort
Show all 10Show fewer
- Women who have first contact with the project after prenatal diagnosis of any major structural defect
- Exposure to tildrakizumab anytime during the current pregnancy
- Women who have enrolled in the tildrakizumab cohort study with a previous pregnancy (women may only enroll once in the Tildrakizumab Pregnancy Study)
- Retrospective enrollment after the outcome of pregnancy is known
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Christina Chambers
San Diego, California, 92093
About this study
Official title: Post-authorization Safety Study for 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 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.
Read more
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
- Pregnancy Related
- Being tested
- Pregnant women exposed to tildrakizumab, Pregnant women not exposed to tildrakizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregnant women exposed to tildrakizumabDrug
Subjects exposure to tildrakizumab for the treatment of an approved indication, for any number of days, at any dose, and at any time from the first day of the last menstrual period (LMP) up to and including the end of pregnancy
Pregnant women not exposed to tildrakizumabDrug
Subjects diagnosed with a tildrakizumab-approved indication; frequency matched to the exposed group by disease indication, with the indication validated by medical records when possible, and Subjects with no exposure to tildrakizumab at any time in the current pregnancy; may or may not have taken another medication for their disease in the current pregnancy
| Study group | Role | What they receive |
|---|---|---|
| Tildrakizumab-Exposed Cohort | Exposure to tildrakizumab for the treatment of an approved indication Receives: Drug: Pregnant women exposed to tildrakizumab | |
| Disease-Matched Comparison Cohort | No exposure to tildrakizumab at any time in the current pregnancy Receives: Drug: Pregnant women not exposed to tildrakizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major structural defects in children
defined and classified using the US Centers for Disease Control and Prevention (CDC) coding manual that is used for the Metropolitan Atlanta Congenital Defects Program (MACDP) classification of major structural defects
Measured: Up to 1 year of age
Secondary outcomes (9)
Spontaneous abortion/miscarriage
defined as non-deliberate fetal death that occurs prior to 20.0 weeks post-last menstrual period
Measured: 20 weeks post-last menstrual period
Stillbirth
defined as non-deliberate fetal death anytime in gestation at or after 20.0 weeks post-last menstrual period
Measured: from 20 weeks post-last menstrual period to end of pregnancy
Elective termination/abortion
defined as deliberate discontinuation of pregnancy through medication or surgical procedures
Measured: At the end of pregnancy or through 9 month pregnancy period
neonatal/infant death
defined as any death in a live born infant during the first 6 months of age
Measured: 6 months of age
Small for gestational age
defined as birth size (weight, length, or head circumference) less than or equal to the 10th centile for sex and gestational age using standard pediatric CDC growth curves for full term or preterm infants
Measured: at birth
Postnatal growth deficiency
defined as postnatal size (weight, length or head circumference) less than or equal to the 10th centile for sex and age using standard pediatric growth curves and adjusted for postnatal age for premature infants if the postnatal measurement is obtained at less than 1 year of age
Measured: Up to 1 year of age
Malignancies in live born children
defined as any malignancy reported in an infant within the first year of life
Measured: Up to 1 year of age
Hospitalization in live born children
defined as any hospitalization of the infant within the first year of life after discharge following delivery
Measured: Up to 1 year of age
Postnatal serious or opportunistic infection in live born children
defined as any infection resulting in hospitalization, X-ray proven pneumonia, neonatal sepsis, meningitis, osteomyelitis, bacteremia, septic arthritis, abscess, mycobacteria infections, invasive fungal infection including histoplasmosis, coccidiomycosis, candidiasis, aspergillosis, and blastomycosis, pneumocystis jirovecii infection, systemic cytomegalovirus, herpes zoster and herpes simplex infection, listeria infections, and Legionella infection.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2019
- Study start29 Aug 2019
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by Sun Pharmaceutical Industries LimitedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 20 Months
Sponsor and investigators
- Lead sponsor
- Sun Pharmaceutical Industries Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03992729
- Sponsor's protocol ID
- TILD 3357-2
- Status last verified
- Jan 2026
- First submitted
- 17 Jun 2019
- Last updated
- 21 Jan 2026
- Results posted
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-authorization Safety Study for Assessment of Pregnancy Outcomes in Patients Treated With Tildrakizumab
- ClinicalTrials.gov ID
- NCT03992729
- Acronym / sponsor ID
- TILD 3357-2
- Conditions
- Pregnancy Related
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sun Pharmaceutical Industries LimitedIndustry (pharma, biotech, devices)
- Study start
- 29 Aug 2019 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 20 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 20 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tildrakizumab-Exposed Cohort | – | Drug: Pregnant women exposed to tildrakizumabExposure to tildrakizumab for the treatment of an approved indication |
| Disease-Matched Comparison Cohort | – | Drug: Pregnant women not exposed to tildrakizumabNo exposure to tildrakizumab at any time in the current pregnancy |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant women diagnosed with tildrakizumab-approved indication with and without tildrakizumab
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- Women who have first contact with the project after prenatal diagnosis of any major structural defect
- Women who have enrolled in the tildrakizumab cohort study with a previous pregnancy (women may only enroll once in the Tildrakizumab Pregnancy Study)
- Women who have used tildrakizumab for an indication other than a currently approved indication
- Retrospective enrollment after the outcome of pregnancy is known
- Cohort 2: Disease-Matched Comparison Cohort
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pregnant women exposed to tildrakizumabSubjects exposure to tildrakizumab for the treatment of an approved indication, for any number of days, at any dose, and at any time from the first day of the last menstrual period (LMP) up to and including the end of pregnancy | Drug | Tildrakizumab-Exposed Cohort |
| Pregnant women not exposed to tildrakizumabSubjects diagnosed with a tildrakizumab-approved indication; frequency matched to the exposed group by disease indication, with the indication validated by medical records when possible, and Subjects with no exposure to tildrakizumab at any time in the current pregnancy; may or may not have taken another medication for their disease in the current pregnancy | Drug | Disease-Matched Comparison Cohort |
Primary outcome
Major structural defects in children
Time frame: Up to 1 year of age
defined and classified using the US Centers for Disease Control and Prevention (CDC) coding manual that is used for the Metropolitan Atlanta Congenital Defects Program (MACDP) classification of major structural defects
9 secondary outcomes
Spontaneous abortion/miscarriage
Time frame: 20 weeks post-last menstrual period
Stillbirth
Time frame: from 20 weeks post-last menstrual period to end of pregnancy
Elective termination/abortion
Time frame: At the end of pregnancy or through 9 month pregnancy period
neonatal/infant death
Time frame: 6 months of age
Small for gestational age
Time frame: at birth
Postnatal growth deficiency
Time frame: Up to 1 year of age
Malignancies in live born children
Time frame: Up to 1 year of age
Hospitalization in live born children
Time frame: Up to 1 year of age
Postnatal serious or opportunistic infection in live born children
Time frame: Up to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Related, run by Sun Pharmaceutical Industries Limited at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Head, Clinical Development (91 2266455645 ext. 5689, Clinical.Trial@sunpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major structural defects in children (time frame: Up to 1 year of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.