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

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ClinicalTrials.gov Identifier: NCT05456893
Recruitment Status : Recruiting
First Posted : July 13, 2022
Last Update Posted : July 13, 2022
Sponsor:
Information provided by (Responsible Party):
Laurent Peyrin-Biroulet, Central Hospital, Nancy, France

Study Description
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Brief 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). 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).


Condition or disease Intervention/treatment
Ulcerative Colitis Inflammatory Bowel Diseases Procedure: Procedure: endoscopic biopsy Procedure: Blood sampling Procedure: stool sampling

Study Design
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Study Type : Observational
Estimated Enrollment : 95 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Multicentre Prospective Longitudinal Observational Study to Evaluate Biomarkers in Moderate to Severe Ulcerative Colitis (UC) Patients Treated With Different Targeted Therapies
Estimated Study Start Date : July 28, 2022
Estimated Primary Completion Date : December 9, 2024
Estimated Study Completion Date : September 9, 2027

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
UC patients
All patients with an established ulcerative colitis
 Procedure: Procedure: endoscopic biopsy
Per-endoscopic biopsies

Procedure: Blood sampling
Blood sampling

Procedure: stool sampling
stool sampling


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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).

  8. 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).

  9. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. 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).

  6. 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).

  7. 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

  8. 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.


Biospecimen Retention:   Samples With DNA
Blood sampling (RNA and DNA profiling, PBMC isolation, Immunophenotyping, serum and plasma markers) Endoscopic biopsy sampling : Healthy and lesion area (DMSO) Stool sampling (RNA later)

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05456893


Contacts
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Contact: Laurent MD Peyrin-Biroulet, PhD 0383153661 peyrinbiroulet@gmail.com

Locations
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France
Central Hospital Recruiting
Nancy, Lorraine, France, 54500
Contact: Laurent MD PEYRIN-BIROULET, PhD         
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
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Study Director: Stefan MD SCHREIBER, PhD Christian Albrechts Universität
More Information
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Responsible Party: Laurent Peyrin-Biroulet, Principal Investigator (France), Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT05456893    
Other Study ID Numbers: 021-A01092-39
First Posted: July 13, 2022    Key Record Dates
Last Update Posted: July 13, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Laurent Peyrin-Biroulet, Central Hospital, Nancy, France:
Ulcerative Colitis
Immune-Mediated Inflammatory Diseases
Biomarkers
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Inflammatory Bowel Diseases
Ulcer
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes