Ulcerative ColitisNCT05809583
Define Predictors of Response to Ozanimod in UC Discovering Biomarkers in the Management of Ulcerative Colitis
An observational study of Ulcerative Colitis, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
A diagnostic tool that identifies biomarkers that predict response prior to and during induction of ozanimod will have a major impact on improving outcomes in UC patients. Using SOMAscan from SomaLogic (Boulder, CO), our study aims to discover serum protein biomarkers in UC patients that predict response to ozanimod… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Ozanimod
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Apr 2023to 1 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients ≥18 years of age with established diagnosis of UC starting ozanimod therapy as part of their clinical care
Who may be able to join
- Patients ≥18 years of age with established diagnosis of UC starting ozanimod therapy as part of their clinical care
- Patients with moderate to severe UC, determined by a 3-component Mayo score of 5-9 with an endoscopic subscore ≥ 2.Endoscopy must be performed within 90 days of ozanimod initiation
- Elevated CRP (greater than upper limit of normal on assay) and/or fecal calprotectin (>250 mcg/g) within 90 days of drug initiation
Who cannot join
- Diagnosis of Crohn's disease or indeterminate colitis
- Total (procto)colectomy
- Ileoanal pouch anastomosis
- Current ileostomy or colostomy
- Untreated Clostridium difficile infection
- Known pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: Applying Precision Medicine to Define Predictors of Response to Ozanimod and Discovering Biomarkers in the Management of Ulcerative Colitis Using 7,000 Protein SOMAscan
A diagnostic tool that identifies biomarkers that predict response prior to and during induction of ozanimod will have a major impact on improving outcomes in UC patients. Using SOMAscan from SomaLogic (Boulder, CO), our study aims to discover serum protein biomarkers in UC patients that predict response to ozanimod and to gain insight into the pathophysiological mechanisms underlying ozanimod response.
- Conditions
- Ulcerative Colitis
- Being tested
- Ozanimod
- Keywords
- biomarkers, ozanimod, somascan
- 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
Patients with established diagnosis of UC starting ozanimod therapy as part of their clinical care
| Study group | Role | What they receive |
|---|---|---|
| ozanimod | Patients with UC starting ozanimod therapy as part of their clinical care Receives: Drug: Ozanimod |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response
The primary endpoint measure is clinical response defined as a decrease of at least 50% in PRO2 at week 10 (end of induction)
Measured: 10 weeks
Secondary outcomes (5)
Clinical response
Clinical response defined as a decrease of at least 50% in PRO2 at week 22
Measured: 22 weeks
Clinical remission
Symptomatic/PRO2 remission defined as stool frequency subscore of 0 or 1 and rectal bleeding subscore of 0 at weeks 10 and 22.
Measured: 10 weeks
Fecal calprotectin
Change from baseline in level of fecal calprotectin at weeks 2, 10, and 22
Measured: 2, 10, 22 weeks
CRP
Change from baseline in level of CRP at weeks 2, 10, 22
Measured: 2, 10, 22 weeks
Corticosteroid free remission
Corticosteroid free remission at week 22
Measured: 22 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start12 Apr 2023
- Primary completion1 Dec 2024
- Study completion1 Dec 2024
Why it stopped: Funding withdrawn
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 Beth Israel Deaconess Medical CenterThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laurie Grossberg, Beth Israel Deaconess Medical Center
- Investigators
- Laurie Grossberg, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05809583
- Sponsor's protocol ID
- 2022P000954
- Status last verified
- May 2025
- First submitted
- 30 Mar 2023
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- 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 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applying Precision Medicine to Define Predictors of Response to Ozanimod and Discovering Biomarkers in the Management of Ulcerative Colitis Using 7,000 Protein SOMAscan
- ClinicalTrials.gov ID
- NCT05809583
- Acronym / sponsor ID
- 2022P000954
- Conditions
- Ulcerative Colitis
- Keywords
- biomarkers, ozanimod, somascan
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Funding withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- 12 Apr 2023 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 12 Apr 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.
A diagnostic tool that identifies biomarkers that predict response prior to and during induction of ozanimod will have a major impact on improving outcomes in UC patients. Using SOMAscan from SomaLogic (Boulder, CO), our study aims to discover serum protein biomarkers in UC patients that predict response to ozanimod and to gain insight into the pathophysiological mechanisms underlying ozanimod response.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ozanimod | – | Drug: OzanimodPatients with UC starting ozanimod therapy as part of their clinical care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients ≥18 years of age with established diagnosis of UC starting ozanimod therapy as part of their clinical care
Key inclusion criteria (3 listed)
- Patients ≥18 years of age with established diagnosis of UC starting ozanimod therapy as part of their clinical care
- Patients with moderate to severe UC, determined by a 3-component Mayo score of 5-9 with an endoscopic subscore ≥ 2.Endoscopy must be performed within 90 days of ozanimod initiation
- Elevated CRP (greater than upper limit of normal on assay) and/or fecal calprotectin (>250 mcg/g) within 90 days of drug initiation
Key exclusion criteria (6 listed)
- Diagnosis of Crohn's disease or indeterminate colitis
- Total (procto)colectomy
- Ileoanal pouch anastomosis
- Current ileostomy or colostomy
- Untreated Clostridium difficile infection
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 |
|---|---|---|
| OzanimodPatients with established diagnosis of UC starting ozanimod therapy as part of their clinical care | Drug | ozanimod |
Primary outcome
Clinical response
Time frame: 10 weeks
The primary endpoint measure is clinical response defined as a decrease of at least 50% in PRO2 at week 10 (end of induction)
5 secondary outcomes
Clinical response
Time frame: 22 weeks
Clinical remission
Time frame: 10 weeks
Fecal calprotectin
Time frame: 2, 10, 22 weeks
CRP
Time frame: 2, 10, 22 weeks
Corticosteroid free remission
Time frame: 22 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- 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.
Laurie Grossberg, MD principal investigator
Beth Israel Deaconess Medical Center
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 Beth Israel Deaconess Medical Center 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 6 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: withdrawn, as of the sponsor's last update on 4 Jun 2025. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Clinical response (time frame: 10 weeks). 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 4 Jun 2025.