Ulcerative ColitisNCT05896943
The Application of Transcriptomics in the Treatment of Ulcerative Colitis With Ustekinumab
An observational study of Ulcerative Colitis, run by Evangelismos Hospital at 1 site in Greece.
Trial summary
The investigators hope that the present study will highlight new transcriptomic prognostic markers of response to Ustekinumab with the ultimate goal of individualizing treatment and making a more targeted selection of UC patients who will benefit from this biological agent. 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?
- Ustekinumab
- How many people
- 38 participants
- Where
- 1 siteGreece
- Study dates
- 1 Apr 2022to 25 Sep 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
- Adult, Older adult
Study population: Patients with Ulcerative Colitis treated with Ustekinumab
Who may be able to join
- Active UC in accordance with applicable diagnostic criteria [25] •
- Aged 18 or above
Who cannot join
- Prior surgical history for UC
- Toxic megacolon
- Infectious complications (Cl. Difficile, CMV infection)
- Patients who received any approved biologic agent (e.g. Infliximab, adalimumab, vedolizumab, golimumab) within the previous 8 weeks or any investigational biologic or other agent in the last 35 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Application of Transcriptomics for Establishing Potential Prognostic Markers of Response to Treatment of Ulcerative Colitis With Ustekinumab
The investigators hope that the present study will highlight new transcriptomic prognostic markers of response to Ustekinumab with the ultimate goal of individualizing treatment and making a more targeted selection of UC patients who will benefit from this biological agent.
Read the detailed description
Introduction: Optimizing treatment with biological agents is an ideal goal for patients with ulcerative colitis (UC). At present, there are insufficient prognostic markers of response to each biological agent, which makes it difficult to individualize treatment. Recent data suggest that mucosal inflammation patterns and serum cytokine profiles differ between patients who respond and those who do not. These studies mainly focused on anti-TNFα agents and Vedolizumab, while there are no corresponding data for Ustekinumab, which is a monoclonal antibody to interleukins 12 and 23 and has recently been approved for the treatment of patients with UC.
Aim of the study: To highlight prognostic markers of response (clinical and endoscopic) to Ustekinumab, in patients with UC, utilizing information from their transcriptome before starting treatment.
Methods: This is a prospective, single-center cohort study that will evaluate transcriptomic markers of response to Ustekinumab in patients with active UC. The diagnosis of the disease will be based on the established clinical, endoscopic and histological criteria. The patients' recruitment will begin in April 2022, while their consent will be required. The duration of follow-up of patients will be at least 6 months from the start of biological treatment. Patients will undergo endoscopy (sigmoidoscopy or total colonoscopy) with a biopsy of the orthosigmoid before the start of biological treatment and a repeat endoscopy 6 months later. The RNA profile of the patients will be recorded after isolation of the total RNA from colon biopsies. Then, using biostatistics, the transcriptomic profiles of patients who responded to Ustekinumab and those who did not respond to 6 months of treatment, will be compared.
- Conditions
- Ulcerative Colitis
- Being tested
- Ustekinumab
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UstekinumabDrug
Patients with ulcerative colitis treated with ustekinumab
| Study group | Role | What they receive |
|---|---|---|
| Ulcerative colitis patients treated with ustekinumab | Patients with Ulcerative Colitis treated with ustekinumab Receives: Drug: Ustekinumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of clinical remission
Total Mayo score of 2 or lower and no subscore higher than 1
Measured: 6 months
Secondary outcomes (3)
Endoscopic response rate
Reduction of the endoscopic Mayo subscore ≥1
Measured: 6 months
Clinical response rate
Reduction in the Mayo score of at least 3 points and a decrease of at least 30% from the baseline score, with a decrease of at least 1 point on the rectal bleeding subscale or an Absolute rectal bleeding score of 0 or 1
Measured: 6 months
Endoscopic remission rate
Endoscopic Mayo subscore 0
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start1 Apr 2022
- Primary completion31 Oct 2023
- Study completion25 Sep 2024
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.
- 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
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evangelismos Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nikos Viazis, Evangelismos Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05896943
- Sponsor's protocol ID
- 479/15-12-2022
- Status last verified
- Mar 2025
- First submitted
- 8 May 2023
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of Transcriptomics for Establishing Potential Prognostic Markers of Response to Treatment of Ulcerative Colitis With Ustekinumab
- ClinicalTrials.gov ID
- NCT05896943
- Acronym / sponsor ID
- 479/15-12-2022
- Conditions
- Ulcerative Colitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Evangelismos HospitalUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 25 Sep 2024 (actual)
- First posted
- 9 Jun 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 investigators hope that the present study will highlight new transcriptomic prognostic markers of response to Ustekinumab with the ultimate goal of individualizing treatment and making a more targeted selection of UC patients who will benefit from this biological agent.
Detailed description
Introduction: Optimizing treatment with biological agents is an ideal goal for patients with ulcerative colitis (UC). At present, there are insufficient prognostic markers of response to each biological agent, which makes it difficult to individualize treatment. Recent data suggest that mucosal inflammation patterns and serum cytokine profiles differ between patients who respond and those who do not. These studies mainly focused on anti-TNFα agents and Vedolizumab, while there are no corresponding data for Ustekinumab, which is a monoclonal antibody to interleukins 12 and 23 and has recently been approved for the treatment of patients with UC.
Aim of the study: To highlight prognostic markers of response (clinical and endoscopic) to Ustekinumab, in patients with UC, utilizing information from their transcriptome before starting treatment.
Methods: This is a prospective, single-center cohort study that will evaluate transcriptomic markers of response to Ustekinumab in patients with active UC. The diagnosis of the disease will be based on the established clinical, endoscopic and histological criteria. The patients' recruitment will begin in April 2022, while their consent will be required. The duration of follow-up of patients will be at least 6 months from the start of biological treatment. Patients will undergo endoscopy (sigmoidoscopy or total colonoscopy) with a biopsy of the orthosigmoid before the start of biological treatment and a repeat endoscopy 6 months later. The RNA profile of the patients will be recorded after isolation of the total RNA from colon biopsies. Then, using biostatistics, the transcriptomic profiles of patients who responded to Ustekinumab and those who did not respond to 6 months of treatment, will be compared.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ulcerative colitis patients treated with ustekinumab | – | Drug: UstekinumabPatients with Ulcerative Colitis treated with ustekinumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with Ulcerative Colitis treated with Ustekinumab
Key inclusion criteria (2 listed)
- Active UC in accordance with applicable diagnostic criteria [25] •
- Aged 18 or above
Key exclusion criteria (4 listed)
- Prior surgical history for UC
- Toxic megacolon
- Infectious complications (Cl. Difficile, CMV infection)
- Patients who received any approved biologic agent (e.g. Infliximab, adalimumab, vedolizumab, golimumab) within the previous 8 weeks or any investigational biologic or other agent in the last 35 days
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 |
|---|---|---|
| UstekinumabPatients with ulcerative colitis treated with ustekinumab | Drug | Ulcerative colitis patients treated with ustekinumab |
Primary outcome
the rate of clinical remission
Time frame: 6 months
Total Mayo score of 2 or lower and no subscore higher than 1
3 secondary outcomes
Endoscopic response rate
Time frame: 6 months
Clinical response rate
Time frame: 6 months
Endoscopic remission rate
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Evangelismos Hospital at 1 site in Greece.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 12 Mar 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 Greece. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
the rate of clinical remission (time frame: 6 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 12 Mar 2025.