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
- 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
- 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
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Deucravacitinib Pregnancy Exposure Study: A Prospective Observational Study of Deucravacitinib Safety in Pregnancy
- ClinicalTrials.gov ID
- NCT07017699
- Acronym / sponsor ID
- IM011-1111
- Conditions
- Psoriasis (PsO)
- Keywords
- Psoriasis (PsO)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 21 Mar 2025 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 12 Jun 2025 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Deucravacitinib Cohort | – | Drug: DeucravacitinibPregnant participants with psoriasis exposed to deucravacitinib treatment |
| Other Systemic Treatment Cohort | – | Drug: Other systemic treatments for PsOPregnant participants with psoriasis exposed to other systemic treatments for PsO |
| Unexposed Cohort | – | –Pregnant participants without psoriasis or any other autoimmune diseases |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- 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
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (21 listed)
- 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
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 |
|---|---|---|
| DeucravacitinibAccording to product label | Drug | Deucravacitinib Cohort |
| Other systemic treatments for PsOAccording to product label | Drug | Other Systemic Treatment Cohort |
Primary outcome
Number of major congenital malformations among infants
Time frame: 1-year post pregnancy outcome
1 secondary outcome
Number of other pregnancy and infant outcomes
Time frame: 1-year post pregnancy outcome
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 1 Oct 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
First line of the email MUST contain NCT # and Site #. contact
Bristol Myers Squibb study director
Bristol-Myers Squibb
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 Psoriasis (PsO), run by Bristol-Myers Squibb 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 13 inclusion and 21 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 1 Oct 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 BMS Study Connect Contact Center www.BMSStudyConnect.com (855-907-3286, Clinical.Trials@bms.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of major congenital malformations among infants (time frame: 1-year post pregnancy outcome). 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 1 Oct 2026.