Ulcerative ColitisNCT06126835
A Study to Evaluate the Safety of Ozanimod Exposure During Pregnancy in Women With Ulcerative Colitis and Their Infants
An observational study of Ulcerative Colitis, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of this retrospective observational cohort study is to assess pregnancy and infant outcomes in three groups: the first is women with ulcerative colitis (UC) who were exposed to ozanimod during pregnancy; the second is women with UC exposed to conventional therapy during pregnancy; the third is women with… Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Ozanimod, Conventional therapy and Advanced therapy
- How many people
- 2,828 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2024to 30 Jun 2032
- 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 18 to 49 years
- Women only
- No healthy volunteers
- Adult
Study population: Adult women with UC who became pregnant between June 1, 2021 and September 1, 2030
Who may be able to join
- Age 18 to 49 years on date of conception
- Date of conception between June 1, 2021 and September 1, 2030
- Continuous medical and pharmacy coverage for a minimum of 6 months prior to date of last menstrual period through the end of the pregnancy episode
- Diagnosis of UC during the 12 months prior to conception through the end of the first trimester
Who cannot join
- • Pregnancies exposed to any known teratogens and the exposure falls within the period of 5 half-lives prior to the estimated date of conception through the end of the first trimester (assessed via the presence of national drug codes or medical procedure codes)
Trial locations and contacts
1 site in 1 country.
United States1 site
OptumInsight Life Sciences Inc
Eden Prairie, Minnesota, 55344
About this study
Official title: Ozanimod Pregnancy Safety Study in Pregnant Women With Ulcerative Colitis and Their Offspring
The purpose of this retrospective observational cohort study is to assess pregnancy and infant outcomes in three groups: the first is women with ulcerative colitis (UC) who were exposed to ozanimod during pregnancy; the second is women with UC exposed to conventional therapy during pregnancy; the third is women with UC exposed to advanced therapy during pregnancy. This study will use data from a large US healthcare claims database.
- Conditions
- Ulcerative Colitis
- Being tested
- Ozanimod, Conventional therapy, Advanced therapy
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OzanimodDrug
Women with UC exposed to ozanimod during pregnancy
Women with UC exposed to conventional therapy (aminosalicylates, azathioprine, or mercaptopurine) during pregnancy
Advanced therapyDrug
Women with UC exposed to advanced therapy (infliximab, adalimumab, golimumab, vedolizumab, ustekinumab, tofacitinib, cyclosporine, or tacrolimus) during pregnancy
| Study group | Role | What they receive |
|---|---|---|
| Ozanimod exposed | Not described Receives: Drug: Ozanimod | |
| Conventional therapy exposed | Not described Receives: Drug: Conventional therapy | |
| Advanced therapy exposed | Not described Receives: Drug: Advanced therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of major congenital malformations among infants
To estimate and compare the prevalence of major congenital malformations among infants born to pregnant women with UC who were exposed to ozanimod during first trimester relative to the prevalence among (i) infants born to women with UC exposed to conventional UC treatments and (ii) infants born to women with UC exposed to advanced UC treatment during first trimester of pregnancy.
Measured: Up to 10 years
Secondary outcomes (13)
Number of spontaneous abortions
Measured: Up to 10 years
Number of stillbirths
Measured: Up to 10 years
Number of participants with pre-eclampsia
Measured: Up to 10 years
Number of participants with eclampsia
Measured: Up to 10 years
Number of preterm births
Measured: Up to 10 years
Number of infants small for gestational age
Measured: Up to 10 years
Number of serious or opportunistic infections in liveborn infants up to 1 year of age
Measured: Up to 10 years
Number of infant postnatal growth deficiencies
Measured: Up to 10 years
Number of infant developmental deficiencies
Measured: Up to 10 years
Number of neonatal hospitalizations
Measured: Up to 10 years
Number of infant deaths
Measured: Up to 10 years
Number of neonatal deaths
Measured: Up to 10 years
Number of perinatal deaths
Measured: Up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start26 Aug 2024
- Primary completion31 May 2031 (estimated)
- Study completion30 Jun 2032 (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
- Retrospective
- Enrolment
- 2,828 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
- NCT06126835
- Sponsor's protocol ID
- IM047-025
- Status last verified
- Sep 2024
- First submitted
- 6 Oct 2023
- Last updated
- 1 Oct 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 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ozanimod Pregnancy Safety Study in Pregnant Women With Ulcerative Colitis and Their Offspring
- ClinicalTrials.gov ID
- NCT06126835
- Acronym / sponsor ID
- IM047-025
- Conditions
- Ulcerative Colitis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,828 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 26 Aug 2024 (actual)
- Primary completion
- 31 May 2031 (estimated)
- Study completion
- 30 Jun 2032 (estimated)
- First posted
- 13 Nov 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 retrospective observational cohort study is to assess pregnancy and infant outcomes in three groups: the first is women with ulcerative colitis (UC) who were exposed to ozanimod during pregnancy; the second is women with UC exposed to conventional therapy during pregnancy; the third is women with UC exposed to advanced therapy during pregnancy. This study will use data from a large US healthcare claims database.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ozanimod exposed | – | Drug: Ozanimod |
| Conventional therapy exposed | – | Drug: Conventional therapy |
| Advanced therapy exposed | – | Drug: Advanced therapy |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Adult women with UC who became pregnant between June 1, 2021 and September 1, 2030
Key inclusion criteria (4 listed)
- Age 18 to 49 years on date of conception
- Date of conception between June 1, 2021 and September 1, 2030
- Continuous medical and pharmacy coverage for a minimum of 6 months prior to date of last menstrual period through the end of the pregnancy episode
- Diagnosis of UC during the 12 months prior to conception through the end of the first trimester
Key exclusion criteria (1 listed)
- • Pregnancies exposed to any known teratogens and the exposure falls within the period of 5 half-lives prior to the estimated date of conception through the end of the first trimester (assessed via the presence of national drug codes or medical procedure codes)
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 |
|---|---|---|
| OzanimodWomen with UC exposed to ozanimod during pregnancy | Drug | Ozanimod exposed |
| Conventional therapyWomen with UC exposed to conventional therapy (aminosalicylates, azathioprine, or mercaptopurine) during pregnancy | Drug | Conventional therapy exposed |
| Advanced therapyWomen with UC exposed to advanced therapy (infliximab, adalimumab, golimumab, vedolizumab, ustekinumab, tofacitinib, cyclosporine, or tacrolimus) during pregnancy | Drug | Advanced therapy exposed |
Primary outcome
Prevalence of major congenital malformations among infants
Time frame: Up to 10 years
To estimate and compare the prevalence of major congenital malformations among infants born to pregnant women with UC who were exposed to ozanimod during first trimester relative to the prevalence among (i) infants born to women with UC exposed to conventional UC treatments and (ii) infants born to women with UC exposed to advanced UC treatment during first trimester of pregnancy.
13 secondary outcomes
Number of spontaneous abortions
Time frame: Up to 10 years
Number of stillbirths
Time frame: Up to 10 years
Number of participants with pre-eclampsia
Time frame: Up to 10 years
Number of participants with eclampsia
Time frame: Up to 10 years
Number of preterm births
Time frame: Up to 10 years
Number of infants small for gestational age
Time frame: Up to 10 years
Number of serious or opportunistic infections in liveborn infants up to 1 year of age
Time frame: Up to 10 years
Number of infant postnatal growth deficiencies
Time frame: Up to 10 years
Number of infant developmental deficiencies
Time frame: Up to 10 years
Number of neonatal hospitalizations
Time frame: Up to 10 years
Number of infant deaths
Time frame: Up to 10 years
Number of neonatal deaths
Time frame: Up to 10 years
Number of perinatal deaths
Time frame: Up to 10 years
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 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 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 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 1 Oct 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?
Prevalence of major congenital malformations among infants (time frame: Up to 10 years). 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 2024; AzTrials last refreshed its copy on 7 Nov 2026.