Clinical Trials Register

Summary
EudraCT Number:	2014-001594-14
Sponsor's Protocol Code Number:	FITC-ADA-CU-01
National Competent Authority:	Germany - PEI
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2014-09-22
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Germany - PEI

A.2

EudraCT number

2014-001594-14

A.3

Full title of the trial

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

Prospektive, monozentrische, offene, einarmige klinische Prüfung der Phase I/IIa zum Nachweis der Sicherheit und Verträglichkeit und zur Untersuchung der prädiktiven Aussagekraft von FITC-Adalimumab bei zweimaliger topischer Applikation auf der intestinalen Schleimhaut als in vivo-Diagnostikum im Rahmen der konfokalen laserendomikroskopischen Untersuchung von Patienten mit Indikation zur Adalimumab-Therapie bei Colitis ulcerosa

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

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

Kann FITC-Adalimumab die Wirksamkeit von Adalimumab bei Colitis ulcerosa vorhersagen, wenn es im Rahmen einer endoskopischen Untersuchung auf die Darmschleimhaut aufgesprüht wird? Ist FITC-Adalimumab dabei sicher und verträglich? Offene, einarmige klinische Studie in einem Studienzentrum

A.3.2

Name or abbreviated title of the trial where available

MAgIC

A.4.1

Sponsor's protocol code number

FITC-ADA-CU-01

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Universitätsklinikum Erlangen
B.1.3.4	Country	Germany
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Medizinische Klinik I, Universitätsklinikum Erlangen
B.4.2	Country	Germany
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Universitätsklinikum Erlangen
B.5.2	Functional name of contact point	Direktion, Medizinische Klinik I
B.5.3	Address:
B.5.3.1	Street Address	Ulmenweg 18
B.5.3.2	Town/ city	Erlangen
B.5.3.3	Post code	91054
B.5.3.4	Country	Germany
B.5.4	Telephone number	+4991318535204
B.5.5	Fax number	+4991318535209
B.5.6	E-mail	markus.neurath@uk-erlangen.de

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	FITC-Adalimumab
D.3.2	Product code	FITC-Adalimumab
D.3.4	Pharmaceutical form	Gastroenteral solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Topical use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	FITC-Adalimumab
D.3.9.3	Other descriptive name	FITC-ADALIMUMAB
D.3.9.4	EV Substance Code	SUB191206
D.3.10	Strength
D.3.10.1	Concentration unit	µg/µl microgram(s)/microlitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2.5
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Ulcerative colitis

Colitis ulcerosa

E.1.1.1

Medical condition in easily understood language

Ulcerative colitis

Colitis ulcerosa

E.1.1.2

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.1
E.1.2	Level	LLT
E.1.2	Classification code	10066678
E.1.2	Term	Acute ulcerative colitis
E.1.2	System Organ Class	100000004856

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

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

Primäres Ziel der klinischen Prüfung ist der Nachweis der Sicherheit und Verträglichkeit geringer Dosen von FITC-Adalimumab bei zweizeitiger topischer Anwendung auf der Darmschleimhaut im Rahmen einer endomikroskopischen Untersuchung von Patienten mit klinisch und endoskopisch aktiver Colitis ulcerosa.

E.2.2

Secondary objectives of the trial

 Quantification of mTNF-expressing mucosal cells
 Predictive power for response to adalimumab treatment

 Die Überprüfung der Eignung von topisch auf die Darmschleimhaut appliziertem FITC-Adalimumab zur quantitativen Bestimmung von mTNF-exprimierenden intestinalen Zellen in vivo bei Patienten mit klinisch und endoskopisch aktiver Colitis ulcerosa.
 Die Überprüfung der Eignung von topisch auf die Darmschleimhaut appliziertem FITC-Adalimumab zur Prädiktion des Ansprechens auf eine Therapie mit Adalimumab.

E.2.3

Trial contains a sub-study

E.3

Principal 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 <20 mg/d prednisolon equivalent: stable for one week at least
• MMX budesonid (9mg/day) stable for eight weeks at least
• 5-aminosalicylate: stable dose for two weeks at least and initiated since eight weeks at least
• Immunsuppressive agents (except ciclosporine A and tacrolimus): treatment for three months at least and stable dose for eight weeks at least prior to enrolment
 For subjects with child-bearing potential: adequate contraception

uneingeschränkt aufklärungs- und einwilligungsfähig
Vorliegen der schriftlichen Einwilligung der Patientin/des Patienten nach erfolgter Aufklärung durch den Prüfer bzw. ein sonstiges ärztliches Mitglied der Prüfgruppe
Klinisch ungenügendes Ansprechen auf bzw. Kontraindikationen gegen eine systemische Therapie mit Glukokortikoiden oder Immunsuppressiva oder glukokortikoidabhängiger Verlauf
Falls Begleittherapie vorhanden, dann unter den folgenden Bedingungen
• Systemische Glukokortikoide ≥20 mg/d Prednisolon-Äquivalent: stabil seit mindestens einer Woche
• Systemische Glukokortikoide <20 mg/d Prednisolon-Äquivalent: stabil seit mindestens einer Woche
• MMX Budesonid (9 mg/Tag): stabil seit mindestens acht Wochen
• 5-Aminosalizylate: stabile Dosierung seit mindestens zwei Wochen und initiiert seit mindestens acht Wochen
• Immunsuppressiva (außer Ciclosporin A und Tacrolimus): Therapie seit mindestens drei Monaten und dabei stabile Dosierung über mindestens acht Wochen vor Studieneinschluss
Für Patientinnen im gebärfähigen Alter: adäquate Kontrazeption

E.4

Principal 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 <50% and/or PTT >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

Unklare Colitis mit in Frage kommenden Differentialdiagnosen wie M. Crohn, ischämische Colitis, infektiöse Colitis
Stenose im Rahmen der Colitis ulcerosa
Fulminante Verlaufsform
Toxisches Megakolon
Kolektomie (auch geplante Kolektomie), Anlage eines Ileo-analen Pouches, einer Ileorektostomie oder eines Ileostomas
Alleinige Proktitis
Vorbehandlung mit Adalimumab
Gabe von Vedolizumab, anti-TNF-Therapie innerhalb der letzten vier Wochen vor Studieneinschluss
Gabe von Methotrexat, Ciclosporin A oder Tacrolimus innerhalb der letzten acht Wochen vor Studieneinschluss
Eingeschränkte Blutgerinnung (Quick–Wert <50% und/oder PTT >55 sec und/oder Thrombozyten <50.000/μl)
Schwangerschaft und Stillzeit
Kontraindikationen für eine Therapie mit Adalimumab
Bekannte Überempfindlichkeit gegenüber einem der Inhaltsstoffe des Prüfpräparats oder gegenüber Arzneimittel mit ähnlicher chemischer Struktur

E.5 End points

E.5.1

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

 Auftreten von ARs Grad ≥2 an der mit FITC-Adalimumab markierten intestinalen Schleimhaut nach Applikation des Prüfpräparates
 Auftreten von AEs, ARs, SAEs und SARs im Beobachtungszeitraum

E.5.1.1

Timepoint(s) of evaluation of this end point

 Up to 24 hours after IMP administration
 Visit 2 (after IMP administration) to visit 7

 Bis max. 24 Stunden nach Applikation des Prüfpräparates
 Visite 2 nach Applikation des Prüfpräparates bis Visite 7

E.5.2

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.

 Anzahl m-TNF-exprimierender intestinaler Zellen nach Markierung mit FITC-Adalimumab in vivo ).
 Anzahl und Anteil der Patienten, die auf eine Therapie mit Adalimumab ansprechen/nicht ansprechen.
 Anzahl und Anteil der Patienten, die sich in Remission befinden/nicht in Remission befinden.
 Anzahl und Anteil der Patienten, bei denen endoskopisch ein mucosal healing nachweisbar/nicht nachweisbar ist.
 Riley Score, Nancy Index und Glukokortikoid-Dosis.
 Calprotektin-Wert.
 Adalimumab-Konzentration und –Antikörper im Serum.

E.5.2.1

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).

 Zu Visite 2 (Tag 1) und Visite 5 (Tag 64±4 Tage).
 Zu Visite 5 (Tag 64±4 Tage) und zu Visite 7 (Tag 372±14 Tage).
 Zu Visite 5 (Tag 64±4 Tage) und zu Visite 7 (Tag 372±14 Tage).
 Zu Visite 5 (Tag 64±4 Tage) und zu Visite 7 (Tag 372±14 Tage).
 Zu Visite 2 (Tag 1), Visite 5 (Tag 64±4 Tage) und Visite 7 (Tag 372±14 Tage).
 Zu Visite 1 (Tag -7±6 Tage), zu Visite 5 (Tag 64±4 Tage), zu Visite 6 (Tag 176±7 Tage) und zu Visite 7 (Tag 372±14 Tage).
 Zu Visite 4 (Tag 22±2), zu Visite 5 (Tag 64±4 Tage), zu Visite 6 (Tag 176±7 Tage) und zu Visite 7 (Tag 372±14 Tage).

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

Yes

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

Yes

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

Yes

E.7.1.3.1

Other trial type description

Assessment of safety and tolerability in patients affected by ulcerative colitis

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Standard treatment in accordance with the guideline of the Deutsche Gesellschaft für Verdauungs- und Stoffwechselkrankheiten.

Standardbehandlung entsprechend der Leitlinie der Deutschen Gesellschaft für Verdauungs- und Stoffwechselkrankheiten.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2017-11-29

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-12-19

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2023-02-14

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials