A Study to Evaluate Biomarkers in Moderate to Severe Ulcerative Colitis (UC) Patients Treated With Different Targeted Therapies (ImmUniverse)

May 5, 2025 updated by: Dr Laurent PEYRIN-BIROULET, Central Hospital, Nancy, France

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
95

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
    • Lorraine
      • Nancy, Lorraine, France, 54500
        • Recruiting
        • Central Hospital
        • Contact:
          • Laurent MD PEYRIN-BIROULET, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with moderate to severe active UC with an indication to start a biologic treatment.

Description

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
UC patients
All patients with an established ulcerative colitis
Procedure: Blood sampling
Blood sampling
Procedure: Procedure: endoscopic biopsy
Per-endoscopic biopsies
Procedure: stool sampling
stool sampling

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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 clinical response at week 14
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 14
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 26.
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 deep clinical remission at week 52.
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 14.
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 mucosal healing at week 52.
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 14.
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 26.
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).
The percentage of subjects who achieve symptomatic remission at week 52.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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 14.
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 26.
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 without any disease progression (e.g. flares) at week 52.
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.
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).
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.
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).
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.
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).
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 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
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.
The percentage of subjects without long-term complications until week 104.
The percentage of subjects without long-term complications until week 104.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Central Hospital, Nancy, France

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Stefan MD SCHREIBER, PhD, Christian Albrechts Universität

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 28, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 9, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 9, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 30, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 13, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 6, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 021-A01092-39

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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