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Clinical and Molecular Phenotyping in IBD

Systematic Profiling of Anti-inflammatory Drugs for the Detection of Drug- Specific Response Signatures in the Treatment of Chronic Inflammatory Disorders

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02694588
Acronym
Phen_IBD
Enrollment
90
Registered
2016-02-29
Start date
2014-06-30
Completion date
2021-12-31
Last updated
2022-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IBD

Keywords

Vedolizumab, Infliximab

Brief summary

Inflammatory bowel disease (IBD) and psoriasis (Ps) are common, chronic, immune- mediated barrier diseases with shared inflammatory pathways. Current therapeutic interventions with anti-cytokine antibodies (TNF-α, IL-23/IL-12) reflect the intent to disrupt specific pathways of inflammatory immunopathology. Individual responses to biological treatment can be thereby be exploited in a systems biology approach that employs a targeted mechanism of action (MOA) to decipher molecular signatures of therapeutic responses in the context of a distinct disease entity. Using a translational approach to investigate clinical and molecular phenotypes during therapeutic interference with cytokine signaling and leukocyte trafficking, the investigators aim to trace common and unique signatures of drug- and therapy-specific responses. Patients will undergo endoscopic evaluation of the mucosal surface and gastrointestinal wall by conventional HD-colonoscopy, endoscopic ultrasound and confocal laser endomicroscopy prior to and during specific therapies with biologicals. In parallel, mucosa samples will be obtained to define molecular phenotypes during the course of therapy.

Interventions

DRUGVedolizumab

HD-endoscopy, CLE, endoscopic ultrasound after application of Anti-Integrin antibody

DRUGInfliximab

HD-endoscopy, CLE, endoscopic ultrasound after application of TNF alpha antibody

Sponsors

University Hospital Schleswig-Holstein
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* inflammatory bowel disease * indication for biological therapy

Exclusion criteria

* pregnancy, breast feeding * no written informed consent to participate in the study

Design outcomes

Primary

MeasureTime frameDescription
Mucosal healing week 2week 2Scoring of mucosal healing according to endoscopic Mayo score at week 2 after initiation of therapy

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026