Ulcerative ColitisImmUniverseNCT05456893
A Study to Evaluate Biomarkers in Moderate to Severe Ulcerative Colitis (UC) Patients Treated With Different Targeted Therapies
An observational study of Ulcerative Colitis and Inflammatory Bowel Diseases, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
UC is a chronic, idiopathic form of intestinal inflammatory disease (IBD) that affects the colon, most commonly afflicting adults aged 30-40 years and resulting in disability and lower quality of life (1). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis, Inflammatory Bowel Diseases
- What is being tested?
- Procedure: endoscopic biopsy, Blood sampling and stool sampling
- Type of treatment
- Surgery or procedure
- How many people
- 95 participants
- Where
- 1 siteFrance
- Study dates
- 28 Jul 2022to 9 Sep 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with moderate to severe active UC with an indication to start a biologic treatment.
Who may be able to join
- Male and female patients ≥ 18 years of age (at the time of signing the ICF)
- Established diagnosis of ulcerative colitis with a minimum disease duration of 3 months
- Moderate to severe active UC defined by Mayo Score ≥ 6
- Moderate to severe active UC defined by endoscopy score of ≥2
- Indication to start any biological or small molecule agent (anti-TNF, anti- IL12/23, anti-integrin and JAK-inhibitors)
- In case of treatment with corticosteroid: stable dose for at least 3 weeks prior to baseline, dosage ≤ 20 mg prednisone
Show all 10Show fewer
- Indication for an endoscopy for the assessment of disease activity as for standards of care and current guidelines
- Able to comply with the study procedures
- Person affiliated to or beneficiary of a social security plan
- Person informed about study organization and able to sign informed consent form
Who cannot join
- Diagnosis of indeterminate colitis, microscopic colitis, ischaemic colitis, infectious colitis, radiation colitis
- Absolute contraindications to endoscopy procedures or complication during previous endoscopy
- Bleeding disorders
- Indication for surgery for UC
- Rectal topical therapy (enemas or suppositories) ≤ 2 weeks prior to baseline
- Treatment with > 20 mg prednisone within 3 weeks prior to baseline
Show all 14Show fewer
- Anaemia (haemoglobin < 10 g/dl) at baseline
- Any circumstances which could contradict a study participation and lead the Investigator to assess the patient as unsuitable for study participation for any other reason
- Person referred in articles L.1121-5, L. 1121-7 and L.1121-8 of the Public Health Code:
- Pregnant, parturient or breastfeeding woman
- Minor person (non-emancipated)
- Adult person under legal protection (any form of public guardianship)
- Adult person incapable of giving consent and not under legal protection
- Person deprived of liberty for judicial or administrative decision, person under psychiatric care as referred in articles L. 3212-1 and L. 3213-1
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Central Hospital
Nancy, Lorraine, 54500
Laurent MD PEYRIN-BIROULET, PhD
About this study
Official title: A Multicentre Prospective Longitudinal Observational Study to Evaluate Biomarkers in Moderate to Severe Ulcerative Colitis (UC) Patients Treated With Different Targeted Therapies
UC is a chronic, idiopathic form of intestinal inflammatory disease (IBD) that affects the colon, most commonly afflicting adults aged 30-40 years and resulting in disability and lower quality of life (1). It is characterized by relapsing and remitting mucosal inflammation, starting in the rectum and extending to proximal segments of the colon. Although biologic therapies have provided clinical benefits to patients, these goals are still poorly met, due to the limited knowledge of the underlying mechanisms of immunopathology and the lack of predictive biomarkers that would allow proper patient stratification.
The hypothesis of this study is that by identifying new biomarkers in blood, stool and tissue that (i) predict response (or non-response) to therapy prior to the start of treatment and (ii) predict response to therapy in the early phase of treatment will allow to find the right treatment for the right patient (personalized medicine).
- Conditions
- Ulcerative Colitis, Inflammatory Bowel Diseases
- Being tested
- Procedure: endoscopic biopsy, Blood sampling, stool sampling
- Keywords
- Ulcerative Colitis, Immune-Mediated Inflammatory Diseases, Biomarkers
- 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.
Procedure: endoscopic biopsyProcedure or surgery
Per-endoscopic biopsies
Blood samplingProcedure or surgery
Blood sampling
stool samplingProcedure or surgery
stool sampling
| Study group | Role | What they receive |
|---|---|---|
| UC patients | All patients with an established ulcerative colitis Receives: Procedure: Procedure: endoscopic biopsy; Procedure: Blood sampling; Procedure: stool sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of subjects who achieve clinical response at week 14.
Clinical response will be defined as overall Mayo score of 2 or smaller with Mayo endoscopy score (Mayo ES) of 0 or 1 (without friability), and bleeding subscore of 0.
The Clinical Response will be categorized in four subcategories:
- Super responder: meets criteria of clinical response
- Responder: Mayo Score: reduction of 50%/ improvement of ≥ 3 from baseline, but does not meet criteria of remission; endoscopic Mayo: does not meet criteria of clinical response, but shows reduction of Mayo ES
- Partial responder: Mayo Score: reduction of up to 30%, endoscopic Mayo: no formal improvement by Mayo ES but in overall assessment by the physician slight improvement.
- Non-responder: reduction of less than 30% and in endoscopy no improvement in the overall assessment
Measured: The percentage of subjects who achieve clinical response at week 14
The percentage of subjects who achieve deep clinical remission at week 14.
Deep clinical remission will be defined as partial Mayo Score 0-1 with stool frequency (SF) ≤1 and rectal bleeding (RB) = 0.
Measured: The percentage of subjects who achieve deep clinical remission at week 14
The percentage of subjects who achieve deep clinical remission at week 26.
Deep clinical remission will be defined as partial Mayo Score 0-1 with stool frequency (SF) ≤1 and rectal bleeding (RB) = 0.
Measured: The percentage of subjects who achieve deep clinical remission at week 26.
The percentage of subjects who achieve deep clinical remission at week 52.
Deep clinical remission will be defined as partial Mayo Score 0-1 with stool frequency (SF) ≤1 and rectal bleeding (RB) = 0.
Measured: The percentage of subjects who achieve deep clinical remission at week 52.
The percentage of subjects who achieve mucosal healing at week 14.
Mucosal healing will be defined as Mayo endoscopic score = 0; Nancy histology index: ulceration: 0, neutrophils: 0, chronic infiltrate: 0 or 1.
Measured: The percentage of subjects who achieve mucosal healing at week 14.
The percentage of subjects who achieve mucosal healing at week 52.
Mucosal healing will be defined as Mayo endoscopic score = 0; Nancy histology index: ulceration: 0, neutrophils: 0, chronic infiltrate: 0 or 1.
Measured: The percentage of subjects who achieve mucosal healing at week 52.
The percentage of subjects who achieve symptomatic remission at week 14.
Symptomatic remission will be defined as reported by patient on PRO 2 (SF= 0-1 and RB= 0).
Measured: The percentage of subjects who achieve symptomatic remission at week 14.
The percentage of subjects who achieve symptomatic remission at week 26.
Symptomatic remission will be defined as reported by patient on PRO 2 (SF= 0-1 and RB= 0).
Measured: The percentage of subjects who achieve symptomatic remission at week 26.
The percentage of subjects who achieve symptomatic remission at week 52.
Symptomatic remission will be defined as reported by patient on PRO 2 (SF= 0-1 and RB= 0).
Measured: The percentage of subjects who achieve symptomatic remission at week 52.
Secondary outcomes (8)
The percentage of subjects without any disease progression (e.g. flares) at week 14.
The percentage of subjects without any disease progression (e.g. flares) at week 14.
Measured: The percentage of subjects without any disease progression (e.g. flares) at week 14.
The percentage of subjects without any disease progression (e.g. flares) at week 26.
The percentage of subjects without any disease progression (e.g. flares) at week 26.
Measured: The percentage of subjects without any disease progression (e.g. flares) at week 26.
The percentage of subjects without any disease progression (e.g. flares) at week 52.
The percentage of subjects without any disease progression (e.g. flares) at week 52.
Measured: The percentage of subjects without any disease progression (e.g. flares) at week 52.
The percentage of subjects who show an improvement on patient reported outcomes at week 14.
Patient reported outcomes include: PRO 2 (stool frequency (SF) and rectal bleeding (RB)), FACIT-F (level of fatigue), PROMIS Depression (level of depression), SF-36 (level of quality of life), Euro-QoL-5D (level of quality of life).
Measured: The percentage of subjects who show an improvement on patient reported outcomes at week 14.
The percentage of subjects who show an improvement on patient reported outcomes at week 26.
Patient reported outcomes include: PRO 2 (stool frequency (SF) and rectal bleeding (RB)), FACIT-F (level of fatigue), PROMIS Depression (level of depression), SF-36 (level of quality of life), Euro-QoL-5D (level of quality of life).
Measured: The percentage of subjects who show an improvement on patient reported outcomes at week 26.
The percentage of subjects who show an improvement on patient reported outcomes at week 52.
Patient reported outcomes include: PRO 2 (stool frequency (SF) and rectal bleeding (RB)), FACIT-F (level of fatigue), PROMIS Depression (level of depression), SF-36 (level of quality of life), Euro-QoL-5D (level of quality of life).
Measured: The percentage of subjects who show an improvement on patient reported outcomes at week 52.
The percentage of subjects without the following complications until week 52 :
The percentage of subjects without the following complications until week 52:
- hospitalizations due to UC
- treatment intensification including introduction of toxic long-term therapies (i.e. systemic glucocorticoids)
- new stenosis
- new fistula
- new development of primary sclerosing cholangitis (PSC)
- infections
- intestinal surgery
Measured: week 52
The percentage of subjects without long-term complications until week 104.
The percentage of subjects without long-term complications until week 104.
Measured: The percentage of subjects without long-term complications until week 104.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start28 Jul 2022
- Primary completion9 Sep 2027 (estimated)
- Study completion9 Sep 2027 (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 Central Hospital, Nancy, FranceThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 95 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Laurent PEYRIN-BIROULET, Central Hospital, Nancy, France
- Investigators
- Stefan MD SCHREIBER, PhD, Study director, Christian Albrechts Universität
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05456893
- Sponsor's protocol ID
- 021-A01092-39
- Acronym
- ImmUniverse
- Status last verified
- May 2025
- First submitted
- 30 Jun 2022
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Prospective Longitudinal Observational Study to Evaluate Biomarkers in Moderate to Severe Ulcerative Colitis (UC) Patients Treated With Different Targeted Therapies
- ClinicalTrials.gov ID
- NCT05456893
- Acronym / sponsor ID
- ImmUniverse / 021-A01092-39
- Conditions
- Ulcerative Colitis, Inflammatory Bowel Diseases
- Keywords
- Ulcerative Colitis, Immune-Mediated Inflammatory Diseases, Biomarkers
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 95 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 28 Jul 2022 (actual)
- Primary completion
- 9 Sep 2027 (estimated)
- Study completion
- 9 Sep 2027 (estimated)
- First posted
- 13 Jul 2022 (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.
UC is a chronic, idiopathic form of intestinal inflammatory disease (IBD) that affects the colon, most commonly afflicting adults aged 30-40 years and resulting in disability and lower quality of life (1). It is characterized by relapsing and remitting mucosal inflammation, starting in the rectum and extending to proximal segments of the colon. Although biologic therapies have provided clinical benefits to patients, these goals are still poorly met, due to the limited knowledge of the underlying mechanisms of immunopathology and the lack of predictive biomarkers that would allow proper patient stratification.
The hypothesis of this study is that by identifying new biomarkers in blood, stool and tissue that (i) predict response (or non-response) to therapy prior to the start of treatment and (ii) predict response to therapy in the early phase of treatment will allow to find the right treatment for the right patient (personalized medicine).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UC patients | – | Procedure: Procedure: endoscopic biopsy, Procedure: Blood sampling, Procedure: stool samplingAll patients with an established ulcerative colitis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with moderate to severe active UC with an indication to start a biologic treatment.
Key inclusion criteria (10 listed)
- Male and female patients ≥ 18 years of age (at the time of signing the ICF)
- Established diagnosis of ulcerative colitis with a minimum disease duration of 3 months
- Moderate to severe active UC defined by Mayo Score ≥ 6
- Moderate to severe active UC defined by endoscopy score of ≥2
- Indication to start any biological or small molecule agent (anti-TNF, anti- IL12/23, anti-integrin and JAK-inhibitors)
Key exclusion criteria (14 listed)
- Diagnosis of indeterminate colitis, microscopic colitis, ischaemic colitis, infectious colitis, radiation colitis
- Absolute contraindications to endoscopy procedures or complication during previous endoscopy
- Bleeding disorders
- Indication for surgery for UC
- Rectal topical therapy (enemas or suppositories) ≤ 2 weeks prior to baseline
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 |
|---|---|---|
| Procedure: endoscopic biopsyPer-endoscopic biopsies | Procedure or surgery | UC patients |
| Blood samplingBlood sampling | Procedure or surgery | UC patients |
| stool samplingstool sampling | Procedure or surgery | UC patients |
Primary outcome
The percentage of subjects who achieve clinical response at week 14.
Time frame: The percentage of subjects who achieve clinical response at week 14
Clinical response will be defined as overall Mayo score of 2 or smaller with Mayo endoscopy score (Mayo ES) of 0 or 1 (without friability), and bleeding subscore of 0. The Clinical Response will be categorized in four subcategories: * Super responder: meets criteria of clinical response * Responder: Mayo Score: reduction of 50%/ improvement of ≥ 3 from baseline, but does not meet criteria of remission; endoscopic Mayo: does not meet criteria of clinical response, but shows reduction of Mayo ES * Partial responder: Mayo Score: reduction of up to 30%, endoscopic Mayo: no formal improvement by Mayo ES but in overall assessment by the physician slight improvement. * Non-responder: reduction of less than 30% and in endoscopy no improvement in the overall assessment
The percentage of subjects who achieve deep clinical remission at week 14.
Time frame: The percentage of subjects who achieve deep clinical remission at week 14
Deep clinical remission will be defined as partial Mayo Score 0-1 with stool frequency (SF) ≤1 and rectal bleeding (RB) = 0.
The percentage of subjects who achieve deep clinical remission at week 26.
Time frame: The percentage of subjects who achieve deep clinical remission at week 26.
Deep clinical remission will be defined as partial Mayo Score 0-1 with stool frequency (SF) ≤1 and rectal bleeding (RB) = 0.
The percentage of subjects who achieve deep clinical remission at week 52.
Time frame: The percentage of subjects who achieve deep clinical remission at week 52.
Deep clinical remission will be defined as partial Mayo Score 0-1 with stool frequency (SF) ≤1 and rectal bleeding (RB) = 0.
The percentage of subjects who achieve mucosal healing at week 14.
Time frame: The percentage of subjects who achieve mucosal healing at week 14.
Mucosal healing will be defined as Mayo endoscopic score = 0; Nancy histology index: ulceration: 0, neutrophils: 0, chronic infiltrate: 0 or 1.
The percentage of subjects who achieve mucosal healing at week 52.
Time frame: The percentage of subjects who achieve mucosal healing at week 52.
Mucosal healing will be defined as Mayo endoscopic score = 0; Nancy histology index: ulceration: 0, neutrophils: 0, chronic infiltrate: 0 or 1.
The percentage of subjects who achieve symptomatic remission at week 14.
Time frame: The percentage of subjects who achieve symptomatic remission at week 14.
Symptomatic remission will be defined as reported by patient on PRO 2 (SF= 0-1 and RB= 0).
The percentage of subjects who achieve symptomatic remission at week 26.
Time frame: The percentage of subjects who achieve symptomatic remission at week 26.
Symptomatic remission will be defined as reported by patient on PRO 2 (SF= 0-1 and RB= 0).
The percentage of subjects who achieve symptomatic remission at week 52.
Time frame: The percentage of subjects who achieve symptomatic remission at week 52.
Symptomatic remission will be defined as reported by patient on PRO 2 (SF= 0-1 and RB= 0).
8 secondary outcomes
The percentage of subjects without any disease progression (e.g. flares) at week 14.
Time frame: The percentage of subjects without any disease progression (e.g. flares) at week 14.
The percentage of subjects without any disease progression (e.g. flares) at week 26.
Time frame: The percentage of subjects without any disease progression (e.g. flares) at week 26.
The percentage of subjects without any disease progression (e.g. flares) at week 52.
Time frame: The percentage of subjects without any disease progression (e.g. flares) at week 52.
The percentage of subjects who show an improvement on patient reported outcomes at week 14.
Time frame: The percentage of subjects who show an improvement on patient reported outcomes at week 14.
The percentage of subjects who show an improvement on patient reported outcomes at week 26.
Time frame: The percentage of subjects who show an improvement on patient reported outcomes at week 26.
The percentage of subjects who show an improvement on patient reported outcomes at week 52.
Time frame: The percentage of subjects who show an improvement on patient reported outcomes at week 52.
The percentage of subjects without the following complications until week 52 :
Time frame: week 52
The percentage of subjects without long-term complications until week 104.
Time frame: The percentage of subjects without long-term complications until week 104.
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 6 May 2025.
- Individual participant dataSharing planned: No
Related trials for Ulcerative Colitis
RecruitingPhase 2
Aquamin® for Prevention of Ulcerative Colitis J-Pouch-associate Intestinal Inflammation
Ulcerative Colitis, Ileal Pouch
RecruitingPhase 1/2
An Open-Label, Proof of Consent Study of Vorinostat for the Treatment of Mdoerate-to-Severe Crohn s Disease and Maintenance Therapy With Ustekinumab
Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
Active, not recruitingPhase 2
A Study to Investigate the Efficacy and Safety of Brivekimig in Adult Participants With Ulcerative Colitis
Ulcerative Colitis
RecruitingPhase 3
Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011)
Crohn Disease, Colitis, Ulcerative
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.
Stefan MD SCHREIBER, PhD study director
Christian Albrechts Universität
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 and Inflammatory Bowel Diseases, run by Central Hospital, Nancy, France at 1 site in France.
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 10 inclusion and 14 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 6 May 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 France. 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 Laurent MD Peyrin-Biroulet, PhD (0383153661, peyrinbiroulet@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of subjects who achieve clinical response at week 14. (time frame: The percentage of subjects who achieve clinical response at week 14). The study lists 9 primary outcomes in all. 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 6 May 2025.