Can FITC-Adalimumab predict the efficacy of Adalimumab in patients with colitis ulcerosa, when it is applied to the intestinal mucosa during an endoscopic examination? Is FITC-Adalimumab safe and tolerable in this setting? Open-label, one-arm clinical trial in one study site

Prospective, single-centre, open-label, one-arm clinical trial, phase I/IIa, to assess the safety and tolerability and to investigate the predictive power of FITC-Adalimumab, when topically applied twice to the intestinal mucosa as an in-vitro diagnostic in the framework of a confocal laser-endomicroscopic examination of colitis ulcerosa patients with an indication for Adalimumab treatment - MAgIC

Status

Not yet recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-001594-14-DE

Enrollment

Registered

2014-09-22

Start date

2017-12-19

Completion date

Unknown

Last updated

2018-07-23

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

Conditions

Ulcerative colitis MedDRA version: 20.1 Level: LLT Classification code 10066678 Term: Acute ulcerative colitis System Organ Class: 100000004856

Interventions

Product Name: FITC-Adalimumab Product Code: FITC-Adalimumab Pharmaceutical Form: Gastroenteral solution INN or Proposed INN: FITC-Adalimumab Other descriptive name: FITC-ADALIMUMAB Concentration unit:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? Able to give informed consent ? Insufficient response or contra-indications to systemic treatment with glucocorticoids or immunosuppressive agents or glucocorticoid dependency ? If concomitant medication, • Systemic glucocorticoids =20 mg/d prednisolon equivalent: stable for one week at least • Systemic glucocorticoids =65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: Colitis of unclear origin Stenosis within the Framework of colitis ulcerosa Fulminant course of disease Toxic megacolon Colectomy (done or planned), ileo-anal pouch, ileorectostomy or ileostoma Proctitis only Pre-treatment with adalimumab Administration of vedolizumab, anti-TNF treatment within the last four weeks prior to enrolment Administration of methotrexate, ciclosporine A or tacrolimus within the last eight weeks prior to enrolment Compromised coagulation (Quick 55 sec and/or thrombocytes <50.000/µl) Pregnant or breast-feeding female Contraindications for adalimumab treatment Known hypersensitivity to an ingredient of the IMP or to a MP with similar chemical structure

Design outcomes

Primary

Measure	Time frame
Main Objective: Safety and tolerability of small doses of FITC-adalimumab after two-time topical application to the intestinal mucosa during an endomicroscopic investigation of patients affected by ulcerative colitis;Secondary Objective: ? Quantification of mTNF-expressing mucosal cells ? Predictive power for response to adalimumab treatment;Primary end point(s): ? ARs grade =2 at the site of FITC-adalimumab administration ? AEs, ARs, SAEs and SARs during the course of the study;Timepoint(s) of evaluation of this end point: ? Up to 24 hours after IMP administration ? Visit 2 (after IMP administration) to visit 7	—

Measure

Time frame

Main Objective: Safety and tolerability of small doses of FITC-adalimumab after two-time topical application to the intestinal mucosa during an endomicroscopic investigation of patients affected by ulcerative colitis;Secondary Objective: ? Quantification of mTNF-expressing mucosal cells ? Predictive power for response to adalimumab treatment;Primary end point(s): ? ARs grade =2 at the site of FITC-adalimumab administration ? AEs, ARs, SAEs and SARs during the course of the study;Timepoint(s) of evaluation of this end point: ? Up to 24 hours after IMP administration ? Visit 2 (after IMP administration) to visit 7

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Secondary

Measure	Time frame
Secondary end point(s): ? Number of m-TNF expressing intestinal cells after IMP administration. ? Number and percentage of patients responding to adalimumab treatment. ? Number and percentage of patients entering remission. ? Number and percentage of patients with endoscopic mucosal healing. ? Riley score, Nancy index and glucocorticoid dose. ? Calprotektin value. ? Adalimumab concentration and presence of antibody against adalimumab in serum. ;Timepoint(s) of evaluation of this end point: ? At visit 2 (Day 1) and visit 5 (Day 64±4 days). ? At visit 5 (Day 64±4 days) and at visit 7 (Day 372±14 days). ? At visit 5 (Day 64±4 days) and at visit 7 (Day 372±14 days). ? At visit 5 (Day 64±4 days) and at visit7 (Day 372±14 days). ? At visit 2 (Day 1), visit 5 (Day 64±4 days) and at visit 7 (Day 372±14 days). ? At visit 1 (Day -7±6 days), at visit 5 (Day 64±4 days), at visit 6 (Day 176±7 days) and at visit 7 (Day 372±14 days). ? At visit 4 (Day 22±2), at visit 5 (Day 64±4 days), at visit 6 (Day 176±7 days) and at visit 7 (Day 372±14 days).	—

Measure

Time frame

Secondary end point(s): ? Number of m-TNF expressing intestinal cells after IMP administration. ? Number and percentage of patients responding to adalimumab treatment. ? Number and percentage of patients entering remission. ? Number and percentage of patients with endoscopic mucosal healing. ? Riley score, Nancy index and glucocorticoid dose. ? Calprotektin value. ? Adalimumab concentration and presence of antibody against adalimumab in serum. ;Timepoint(s) of evaluation of this end point: ? At visit 2 (Day 1) and visit 5 (Day 64±4 days). ? At visit 5 (Day 64±4 days) and at visit 7 (Day 372±14 days). ? At visit 5 (Day 64±4 days) and at visit 7 (Day 372±14 days). ? At visit 5 (Day 64±4 days) and at visit7 (Day 372±14 days). ? At visit 2 (Day 1), visit 5 (Day 64±4 days) and at visit 7 (Day 372±14 days). ? At visit 1 (Day -7±6 days), at visit 5 (Day 64±4 days), at visit 6 (Day 176±7 days) and at visit 7 (Day 372±14 days). ? At visit 4 (Day 22±2), at visit 5 (Day 64±4 days), at visit 6 (Day 176±7 days) and at visit 7 (Day 372±14 days).

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Countries

Germany

Contacts

Public ContactDirektion, Medizinische Klinik I

Universitätsklinikum Erlangen

markus.neurath@uk-erlangen.de+4991318535204

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026