PsoriasisNCT06710470
A Study on the Safety of Deucravacitinib Exposure in Pregnant Women and Their Offspring
An observational study of Psoriasis, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
This observational study aims to assess pregnancy and infant outcomes among pregnant women with psoriasis who have been exposed to deucravacitinib treatment in the USA. Read more about this study
- Who is it for?
- Ages 15 to 50 years, women only
- Conditions the study is for
- Psoriasis
- What is being tested?
- Deucravacitinib, Systemic psoriasis medications and No systemic medications
- How many people
- 833 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Aug 2024to 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 15 to 50 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: This study will include women aged 15 through 50 years with psoriasis who become pregnant (based on their estimated date of conception) from 09-Sep-2022 through 31-Oct-2026 that have been identified in the Optum Research Database (ORD).
Who may be able to join
- Maternal age 15 through 50 years at date of conception
- Start of pregnancy, defined as the estimated date of conception, during the accrual period (09-Sep-2022 through 31-Oct-2026)
- Continuous medical and pharmacy coverage for a minimum of 6 months prior to and including the estimated date of conception
- Presence of psoriasis from 12 months prior to the date of conception through the end of pregnancy
Who cannot join
- Exposure to any known teratogens from 5 half-lives prior to the estimated date of conception through the end of the relevant exposure window
Trial locations and contacts
1 site in 1 country.
United States1 site
Bristol-Meyers Squibb
Lawrenceville, New Jersey, 08648
About this study
Official title: Deucravacitinib Pregnancy Study: A Retrospective Observational Study on the Safety of Deucravacitinib Exposure in Pregnant Women and Their Offspring
This observational study aims to assess pregnancy and infant outcomes among pregnant women with psoriasis who have been exposed to deucravacitinib treatment in the USA.
- Conditions
- Psoriasis
- Being tested
- Deucravacitinib, Systemic psoriasis medications, No systemic medications
- Keywords
- Psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeucravacitinibDrug
As per product label
Systemic psoriasis medicationsDrug
As per product label
No systemic medicationsOther
Participants not exposed to any systemic medications
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Participants exposed to deucravacitinib for the full pregnancy duration Receives: Drug: Deucravacitinib | |
| Cohort 2 | Participants exposed to deucravacitinib for the first trimester Receives: Drug: Deucravacitinib | |
| Cohort 3 | Participants exposed to deucravacitinib for the first 20 weeks of gestation Receives: Drug: Deucravacitinib | |
| Cohort 4 | Participants exposed to other systemic psoriasis medications for the full pregnancy duration Receives: Drug: Systemic psoriasis medications | |
| Cohort 5 | Participants exposed to other systemic psoriasis medications for the first trimester Receives: Drug: Systemic psoriasis medications | |
| Cohort 6 | Participants exposed to other systemic psoriasis medications for the first 20 weeks of gestation Receives: Drug: Systemic psoriasis medications | |
| Cohort 7 | Participants not exposed to any systemic medications for the full pregnancy duration Receives: Other: No systemic medications | |
| Cohort 8 | Participants not exposed to any systemic medications during the first trimester Receives: Other: No systemic medications | |
| Cohort 9 | Participants not exposed to any systemic medications during the first 20 weeks of gestation Receives: Other: No systemic medications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of infants born with Major Congenital Malformations (MCMs)
MCMs defined as a structural abnormality with surgical, medical, or cosmetic importance (excluding chromosomal abnormalities or physiological features due to complications of prematurity, such as cryptorchidism, inguinal hernia, or isolated patent ductus arteriosus in infants born less than 37 weeks of gestation)
Measured: Up to 12 months after birth or date of health plan disenrollment
Secondary outcomes (2)
Pregnancy outcomes
Incidence of the following pregnancy outcomes: spontaneous abortion, induced abortion, ectopic pregnancy, stillbirth, pre-eclampsia, eclampsia and gestational diabetes
Measured: Up to 9 months or date of health plan disenrollment
Infant outcomes
Incidence of the following infant outcomes: small for gestational age, large for gestational age, low birthweight, preterm birth, serious or opportunistic infections, postnatal growth deficiency, infant developmental deficiency, neonatal hospitalization, and infant/neonatal/perinatal death
Measured: Up to 12 months after birth or date of health plan disenrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start2 Aug 2024
- Primary completion31 Jan 2027 (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 PsoriasisStudies 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
- Retrospective
- Enrolment
- 833 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
- NCT06710470
- Sponsor's protocol ID
- IM011-201
- Status last verified
- Nov 2024
- First submitted
- 26 Nov 2024
- Last updated
- 29 Nov 2024
- 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 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deucravacitinib Pregnancy Study: A Retrospective Observational Study on the Safety of Deucravacitinib Exposure in Pregnant Women and Their Offspring
- ClinicalTrials.gov ID
- NCT06710470
- Acronym / sponsor ID
- IM011-201
- Conditions
- Psoriasis
- Keywords
- Psoriasis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 833 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 2 Aug 2024 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 29 Nov 2024 (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 observational study aims to assess pregnancy and infant outcomes among pregnant women with psoriasis who have been exposed to deucravacitinib treatment in the USA.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Drug: DeucravacitinibParticipants exposed to deucravacitinib for the full pregnancy duration |
| Cohort 2 | – | Drug: DeucravacitinibParticipants exposed to deucravacitinib for the first trimester |
| Cohort 3 | – | Drug: DeucravacitinibParticipants exposed to deucravacitinib for the first 20 weeks of gestation |
| Cohort 4 | – | Drug: Systemic psoriasis medicationsParticipants exposed to other systemic psoriasis medications for the full pregnancy duration |
| Cohort 5 | – | Drug: Systemic psoriasis medicationsParticipants exposed to other systemic psoriasis medications for the first trimester |
| Cohort 6 | – | Drug: Systemic psoriasis medicationsParticipants exposed to other systemic psoriasis medications for the first 20 weeks of gestation |
| Cohort 7 | – | Other: No systemic medicationsParticipants not exposed to any systemic medications for the full pregnancy duration |
| Cohort 8 | – | Other: No systemic medicationsParticipants not exposed to any systemic medications during the first trimester |
| Cohort 9 | – | Other: No systemic medicationsParticipants not exposed to any systemic medications during the first 20 weeks of gestation |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- This study will include women aged 15 through 50 years with psoriasis who become pregnant (based on their estimated date of conception) from 09-Sep-2022 through 31-Oct-2026 that have been identified in the Optum Research Database (ORD).
Key inclusion criteria (4 listed)
- Maternal age 15 through 50 years at date of conception
- Start of pregnancy, defined as the estimated date of conception, during the accrual period (09-Sep-2022 through 31-Oct-2026)
- Continuous medical and pharmacy coverage for a minimum of 6 months prior to and including the estimated date of conception
- Presence of psoriasis from 12 months prior to the date of conception through the end of pregnancy
Key exclusion criteria (1 listed)
- Exposure to any known teratogens from 5 half-lives prior to the estimated date of conception through the end of the relevant exposure window
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 |
|---|---|---|
| DeucravacitinibAs per product label | Drug | Cohort 1, Cohort 2, Cohort 3 |
| Systemic psoriasis medicationsAs per product label | Drug | Cohort 4, Cohort 5, Cohort 6 |
| No systemic medicationsParticipants not exposed to any systemic medications | Other | Cohort 7, Cohort 8, Cohort 9 |
Primary outcome
Number of infants born with Major Congenital Malformations (MCMs)
Time frame: Up to 12 months after birth or date of health plan disenrollment
MCMs defined as a structural abnormality with surgical, medical, or cosmetic importance (excluding chromosomal abnormalities or physiological features due to complications of prematurity, such as cryptorchidism, inguinal hernia, or isolated patent ductus arteriosus in infants born less than 37 weeks of gestation)
2 secondary outcomes
Pregnancy outcomes
Time frame: Up to 9 months or date of health plan disenrollment
Infant outcomes
Time frame: Up to 12 months after birth or date of health plan disenrollment
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 29 Nov 2024.
- 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. This study is not recruiting at the moment.
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, 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 4 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 29 Nov 2024. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of infants born with Major Congenital Malformations (MCMs) (time frame: Up to 12 months after birth or date of health plan disenrollment). 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 29 Nov 2024.