Ulcerative ColitisNCT05953402
A Study of Ozanimod in Pregnant Women With Ulcerative Colitis and Their Offspring
An observational study of Ulcerative Colitis, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of this study is to evaluate association between ozanimod exposure during pregnancy and subsequent maternal, fetal, and infant outcomes. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Ulcerative Colitis
- How many people
- 1,182 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2026to 30 Jun 2034
- How long will I take part?
- 21 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: The study population will include women of any age who i) are currently or recently have been pregnant; ii) have a diagnosis of UC; iii) reside in a country where ozanimod is prescribed for the treatment of UC; iv) provide consent to participate as well as medical releases for their Healthcare Providers (HCPs) to provide data to the registry; and v) meet the criteria for inclusion.
Who may be able to join
- Currently or recently pregnant
- Diagnosis of UC
- Resident of country where ozanimod is prescribed for the treatment of UC
Who cannot join
- Exposure to other S1P therapies at any time during pregnancy
- Other protocol-defined eligibility criteria apply.
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 the NCT# and Site #. contact
United States1 site, 1 recruiting
- Recruiting
PPD Virtual - PPD - US
Wilmington, North Carolina, 28401-3331
Site 0001
About this study
Official title: ZEPOSIA® (Ozanimod) Ulcerative Colitis Pregnancy Registry: a Prospective, Observational Study on the Safety of Ozanimod Exposure in Pregnant Women With Ulcerative Colitis and Their Offspring
The purpose of this study is to evaluate association between ozanimod exposure during pregnancy and subsequent maternal, fetal, and infant outcomes.
- Conditions
- Ulcerative Colitis
- Keywords
- ZEPOSIA®, Ozanimod, Pregnancy, Sphingosine-1-phosphate (S1P) therapies, Inflammatory Bowel Disease, IBD, Ulcerative Colitis, UC
- Medical subject headings
- Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ozanimod-exposed participants with UC | Pregnant women with a diagnosis of UC who are exposed to ozanimod at any time during pregnancy | |
| Conventional therapy-exposed participants with UC | Pregnant women with a diagnosis of UC who are exposed to conventional therapies (aminosalicylates and/or thiopurines) but not exposed to ozanimod, other S1P therapies, or advanced therapies for UC (biologics and/or small molecules) at any time during pregnancy | |
| Advanced therapy-exposed participants with UC | Pregnant women with a diagnosis of UC who are exposed to advanced therapies for UC (biologics and/or small molecules) but not exposed to ozanimod or other S1P therapies at any time during pregnancy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event rate of Major Congenital Malformations (MCM)
Measured: Up to 12 months
Secondary outcomes (14)
Event rate of minor congenital malformations
Measured: Up to 12 months
Event rate of pre-eclampsia
Measured: Up to 9 months
Event rate of eclampsia
Measured: Up to 9 months
Event rate of Spontaneous Abortion (SAB)
Measured: Up to 9 months
Event rate of stillbirth
Measured: Up to 9 months
Event rate of elective termination
Measured: Up to 9 months
Event rate of preterm birth
Measured: Up to 9 months
Event rate of Small for Gestational Age (SGA)
Measured: Up to 12 months
Event rate of postnatal growth deficiency
Measured: Up to 12 months
Event rate of infant developmental deficiency
Measured: Up to 12 months
Event rate of perinatal death
Measured: Up to 10 months
Event rate of neonatal death
Measured: Up to 1 month
Event rate of infant death
Measured: Up to 12 months
Event rate of serious or opportunistic infant infections
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start21 Apr 2026
- Primary completion30 Jun 2034 (estimated)
- Study completion30 Jun 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies 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
- Prospective
- Enrolment
- 1,182 participants (estimated)
- Target duration
- 21 Months
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
- NCT05953402
- Sponsor's protocol ID
- IM047-026
- Status last verified
- Jun 2026
- First submitted
- 12 Jul 2023
- Last updated
- 15 Jun 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ZEPOSIA® (Ozanimod) Ulcerative Colitis Pregnancy Registry: a Prospective, Observational Study on the Safety of Ozanimod Exposure in Pregnant Women With Ulcerative Colitis and Their Offspring
- ClinicalTrials.gov ID
- NCT05953402
- Acronym / sponsor ID
- IM047-026
- Conditions
- Ulcerative Colitis
- Keywords
- ZEPOSIA®, Ozanimod, Pregnancy, Sphingosine-1-phosphate (S1P) therapies, Inflammatory Bowel Disease, IBD, Ulcerative Colitis, UC
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,182 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 21 Apr 2026 (actual)
- Primary completion
- 30 Jun 2034 (estimated)
- Study completion
- 30 Jun 2034 (estimated)
- First posted
- 20 Jul 2023 (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 evaluate association between ozanimod exposure during pregnancy and subsequent maternal, fetal, and infant outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 21 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ozanimod-exposed participants with UC | – | –Pregnant women with a diagnosis of UC who are exposed to ozanimod at any time during pregnancy |
| Conventional therapy-exposed participants with UC | – | –Pregnant women with a diagnosis of UC who are exposed to conventional therapies (aminosalicylates and/or thiopurines) but not exposed to ozanimod, other S1P therapies, or advanced therapies for UC (biologics and/or small molecules) at any time during pregnancy |
| Advanced therapy-exposed participants with UC | – | –Pregnant women with a diagnosis of UC who are exposed to advanced therapies for UC (biologics and/or small molecules) but not exposed to ozanimod or other S1P therapies at any time during pregnancy |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will include women of any age who i) are currently or recently have been pregnant; ii) have a diagnosis of UC; iii) reside in a country where ozanimod is prescribed for the treatment of UC; iv) provide consent to participate as well as medical releases for their Healthcare Providers (HCPs) to provide data to the registry; and v) meet the criteria for inclusion.
Key inclusion criteria (3 listed)
- Currently or recently pregnant
- Diagnosis of UC
- Resident of country where ozanimod is prescribed for the treatment of UC
Key exclusion criteria (2 listed)
- Exposure to other S1P therapies at any time during pregnancy
- Other protocol-defined eligibility criteria apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Event rate of Major Congenital Malformations (MCM)
Time frame: Up to 12 months
14 secondary outcomes
Event rate of minor congenital malformations
Time frame: Up to 12 months
Event rate of pre-eclampsia
Time frame: Up to 9 months
Event rate of eclampsia
Time frame: Up to 9 months
Event rate of Spontaneous Abortion (SAB)
Time frame: Up to 9 months
Event rate of stillbirth
Time frame: Up to 9 months
Event rate of elective termination
Time frame: Up to 9 months
Event rate of preterm birth
Time frame: Up to 9 months
Event rate of Small for Gestational Age (SGA)
Time frame: Up to 12 months
Event rate of postnatal growth deficiency
Time frame: Up to 12 months
Event rate of infant developmental deficiency
Time frame: Up to 12 months
Event rate of perinatal death
Time frame: Up to 10 months
Event rate of neonatal death
Time frame: Up to 1 month
Event rate of infant death
Time frame: Up to 12 months
Event rate of serious or opportunistic infant infections
Time frame: Up to 12 months
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 15 Jun 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- Investigator Inquiry FormLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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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 the 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 Ulcerative Colitis, 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 3 inclusion and 2 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 15 Jun 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?
Event rate of Major Congenital Malformations (MCM) (time frame: Up to 12 months). 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 15 Jun 2026.