Psoriasis (PsO)NCT07017699
A Study to Assess Deucravacitinib Safety in Pregnancy
An observational study of Psoriasis (PsO), run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of this study is to assess pregnancy and infant outcomes among pregnant participants enrolled in an established North American pregnancy registry (Organization of Teratology Information Specialists [OTIS]) who were exposed to deucravacitinib. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Psoriasis (PsO)
- What is being tested?
- Deucravacitinib and Other systemic treatments for PsO
- How many people
- 900 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2025to 28 Feb 2029
- Phase
- Observational
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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study population will include pregnant women participating in the The Organization of Teratology Information Specialists (OTIS) pregnancy registry in the US or Canada
Who may be able to join
- Cohort 1: Deucravacitinib-exposed cohort
- Currently pregnant during the enrollment period
- Diagnosed with psoriasis (PsO) validated by medical records when possible
- Exposure to deucravacitinib for any number of days, at any dose, and at any time from 2 days prior to date of conception (DOC) to the end of pregnancy
- Agree to the conditions and requirements of the study including the interview schedule, release of medical records, and the dysmorphology examination of live born infants
- Cohort 2: PsO Disease-matched unexposed comparator cohort
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- Currently pregnant during the enrollment period
- Diagnosed with PsO validated by medical records when possible
- May be exposed to systemic treatments for PsO
- Agree to the conditions and requirements of the study including the interview schedule, release of medical records, and the dysmorphology examination of live born infants
- Cohort 3: Non-disease unexposed comparator cohort
- Currently pregnant during the enrollment period
- Agree to the conditions and requirements of the study including the interview schedule, release of medical records, and the dysmorphology examination of live born infants
Who cannot join
- Cohort 1: Deucravacitinib-exposed cohort
- Pregnant women who have enrolled in this cohort study with a previous pregnancy
- Pregnant women who have used deucravacitinib for an indication other than PsO
- Women who do not have exposure to deucravacitinib anytime from 2 days prior to DOC to the end of pregnancy
- Women who have exposure to another oral tyrosine kinase 2 (TYK2) inhibitor or any oral Janus kinase (JAK) inhibitor from within 5 half-lives of DOC to the end of pregnancy
- Women who have exposure to methotrexate or an oral retinoid
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- Retrospective enrollment after the outcome of pregnancy is known (ie, the pregnancy has ended prior to enrollment)
- Results of a diagnostic test are positive for an major congenital malformation(s) (MCM) prior to enrollment. However, women who have had any normal or abnormal prenatal screening or diagnostic test prior to enrollment are eligible as long as the test result does not indicate an MCM
- Cohort 2: Disease-matched unexposed comparator cohort
- Pregnant women who have enrolled in this cohort study with a previous pregnancy
- Women who have exposure to deucravacitinib or any other oral TYK2 inhibitor except deucravacitinib, or any oral JAK inhibitor from within 5 half-lives of DOC to the end of pregnancy
- Women who have exposure to methotrexate or an oral retinoid
- Retrospective enrollment after the outcome of pregnancy is known (ie, the pregnancy has ended prior to enrollment)
- Results of a diagnostic test are positive for an MCM prior to enrollment. However, women who have had any normal or abnormal prenatal screening or diagnostic test prior to enrollment are eligible as long as the test result does not indicate an MCM
- Cohort 3: Non-disease unexposed comparator cohort
- Pregnant women who have enrolled in this cohort study with a previous pregnancy
- Women who have had exposure to deucravacitinib or any other oral TYK2 inhibitor, or any oral JAK inhibitor from within 5 half-lives of DOC to the end of pregnancy
- Retrospective enrollment after the outcome of pregnancy is known (ie, the pregnancy has ended prior to enrollment)
- Results of a diagnostic test are positive for an MCM prior to enrollment. However, women who have had any normal or abnormal prenatal screening or diagnostic test prior to enrollment are eligible as long as the test result does not indicate an MCM
- Women exposed to a known, possible, or suspected human teratogen during pregnancy as confirmed by the OTIS Research Center (see Appendix 3 for list of known, possible, and suspected human teratogens)
- Women who are diagnosed with PsO, or any other autoimmune disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
First line of the email MUST contain NCT # and Site #. contact
United States1 site, 1 recruiting
- Recruiting
University of California San Diego
La Jolla, California, 92037
www.mothertobaby.org/ongoing-study/sotyktu-deucravacitinib/ The Organization of Teratology Information Specialists (OTIS), 877-311-8972, mothertobaby@health.ucsd.edu
858-246-1741, d4johnson@health.ucsd.edu
About this study
Official title: The Deucravacitinib Pregnancy Exposure Study: A Prospective Observational Study of Deucravacitinib Safety in Pregnancy
The purpose of this study is to assess pregnancy and infant outcomes among pregnant participants enrolled in an established North American pregnancy registry (Organization of Teratology Information Specialists [OTIS]) who were exposed to deucravacitinib.
- Conditions
- Psoriasis (PsO)
- Being tested
- Deucravacitinib, Other systemic treatments for PsO
- Keywords
- Psoriasis (PsO)
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeucravacitinibDrug
According to product label
Other systemic treatments for PsODrug
According to product label
| Study group | Role | What they receive |
|---|---|---|
| Deucravacitinib Cohort | Pregnant participants with psoriasis exposed to deucravacitinib treatment Receives: Drug: Deucravacitinib | |
| Other Systemic Treatment Cohort | Pregnant participants with psoriasis exposed to other systemic treatments for PsO Receives: Drug: Other systemic treatments for PsO | |
| Unexposed Cohort | Pregnant participants without psoriasis or any other autoimmune diseases |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of major congenital malformations among infants
Measured: 1-year post pregnancy outcome
Secondary outcomes (1)
Number of other pregnancy and infant outcomes
Other pregnancy and infant outcomes include:
- Minor congenital malformations,
- Small for gestational age
- Small for age postnatal growth at 1 year of age
- Serious or opportunistic infections
- Neonatal hospitalization
- Infant deaths
- Neonatal deaths
- Perinatal deaths
- Spontaneous abortions
- Stillbirths
- Elective terminations/abortions
- Preterm deliveries
- Preeclampsia/eclampsia
- Gestational hypertension
Measured: 1-year post pregnancy outcome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start21 Mar 2025
- Primary completion1 Apr 2028 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis (PsO)Studies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe 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
- Other
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07017699
- Sponsor's protocol ID
- IM011-1111
- Status last verified
- Sep 2026
- First submitted
- 4 Jun 2025
- Last updated
- 1 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No