Clinical Trials Register

Summary
EudraCT Number:	2011-003283-78
Sponsor's Protocol Code Number:	GED-0507-01-11
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2012-03-01
Trial results	View 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

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2011-003283-78

A.3

Full title of the trial

A PROOF-OF-CONCEPT CLINICAL STUDY, TO ASSESS THE EFFECT OF GED-0507-34-Levo 80 mg Tablets IN INDUCTION OF REMISSION OF ACTIVE ULCERATIVE COLITIS

STUDIO CLINICO PER LA VERIFICA DELL`™EFFETTO DI GED-0507-34-Levo COMPRESSE 80 MG NELL`™INDUZIONE ALLA REMISSIONE DI COLITE ULCEROSA IN FASE ATTIVA

A.3.1

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

A PROOF-OF-CONCEPT CLINICAL STUDY, TO ASSESS THE EFFECT OF GED-0507-34-Levo 80 mg Tablets IN INDUCTION OF REMISSION OF ACTIVE ULCERATIVE COLITIS

STUDIO CLINICO PER LA VERIFICA DELL’EFFETTO DI GED-0507-34-Levo COMPRESSE 80 MG NELL’INDUZIONE ALLA REMISSIONE DI COLITE ULCEROSA IN FASE ATTIVA

A.4.1

Sponsor's protocol code number

GED-0507-01-11

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	GIULIANI
B.1.3.4	Country	Italy
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	GIULIANI S.P.A.
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	GIULIANI S.P.A.
B.5.2	Functional name of contact point	DIREZIONE ETICA
B.5.3	Address:
B.5.3.1	Street Address	VIA P. PALAGI 2
B.5.3.2	Town/ city	MILANO
B.5.3.3	Post code	20129
B.5.3.4	Country	Italy
B.5.4	Telephone number	+39 02 2054208
B.5.5	Fax number	+39 02 2054285
B.5.6	E-mail	sbellinvia@giulianipharma.com

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	NA
D.3.2	Product code	GED-0507-34-Levo
D.3.4	Pharmaceutical form	Prolonged-release tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	(-)-3-(4-Aminophenyl)-2-methoxypropionic acid
D.3.9.1	CAS number	NA
D.3.9.2	Current sponsor code	GED-0507-34-Levo
D.3.9.3	Other descriptive name	NA
D.3.9.4	EV Substance Code	NA
D.3.10	Strength
D.3.10.1	Concentration unit	mg/g milligram(s)/gram
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	160
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	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	No
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

Active Ulcerative Colitis Patients

Pazienti affetti da Colite Ulcerosa in Fase Attiva

E.1.1.1

Medical condition in easily understood language

Active Ulcerative Colitis Patients

Pazienti affetti da Colite Ulcerosa in Fase Attiva

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	14.1
E.1.2	Level	LLT
E.1.2	Classification code	10021184
E.1.2	Term	IBD
E.1.2	System Organ Class	10017947 - Gastrointestinal disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To evaluate the efficacy of GED-0507-34-Levo in patients with active ulcerative colitis defined as the percentage of patients in remission at Week 8 (after 8 weeks of treatment). The Remission is defined as Ulcerative Colitis Disease Activity Index (UC-DAI)≤ 1 with a score of 0 for rectal bleeding and stool frequency and at least a 1 point reduction from Baseline in the sigmoidoscopy score.
To assess the safety and tolerability of GED-0507-34-Levo 160 mg/day.

Valutare l’efficacia di GED-0507-34-Levo, in pazienti affetti da colite ulcerosa in fase attiva, definita come la percentuale di pazienti in remissione alla settimana 8 (dopo 8 settimane di trattamento). La Remissione è definita come Indice di Attività della Colite Ulcerosa (UC-DAI) ≤ 1 con un punteggio di 0 per il sanguinamento rettale e frequenza di scariche, e almeno la riduzione di 1 punto dal basale nel punteggio della sigmoidoscopia
Valutare la sicurezza e la tollerabilità di GED-0507-34-Levo 160 mg/die.

E.2.2

Secondary objectives of the trial

To evaluate the percentage of patients that show clinical improvement (drop in UC DAI ≥ 3 points from baseline to 8 weeks of treatment). To evaluate the change in UC-DAI score from baseline to 8 weeks of treatment. To evaluate the change in symptoms (rectal bleeding and stool frequency) from Baseline to 2, 4 and 8 Weeks. To evaluate the change in sigmoidoscopic (mucosal) appearance from baseline to 8 weeks of treatment

Valutare la percentuale di pazienti che mostrano miglioramento clinico (riduzione UC DAI ≥ 3 punti dal basale a 8 settimane di trattamento). Valutare la variazione nel punteggio UC-DAI dal basale a 8 settimane di trattamento. Valutare la variazione nei sintomi (sanguinamento rettale e frequenza di scariche) dal basale a 2, 4 e 8 settimane.
Valutare la variazione dell’aspetto sigmoidoscopico (delle mucose) rispetto al basale, dopo 8 settimane di trattamento

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Written informed consent, personally signed and dated by the patient prior any study-related procedures is carried out, ie before inclusion.
• Patients must have a relapsing ulcerative colitis for < 6 weeks (score of 4 – 10 inclusive on the UC-DAI, with a sigmoidoscopy score of 2).
• Patients who have relapsed on maintenance therapy with 5-ASA doses of ≥2.4 gr/day for at least 3 months
• Out-patients of both sexes aging 18 and over years old.
• CMV Negative Test (at screening)
• Female patients not of childbearing potential (post menopausal – defined as one year post menopause – surgically or biologically sterile); female patients of childbearing potential upon negative urine pregnancy test at screening and using effective method of birth control during the studyand at least for 30 days after the administration of the study drug.
• Male patients who agree to use a condom throughout the duration of the study and for 30 days after the administration of the study drug.
• Ability, willingness and likeliness to understand and comply with study procedures and restrictions.

• Consenso informato scritto, firmato e datato personalmente dal paziente deve essere raccolto prima dell’esecuzione di qualsiasi procedura dello studio, es. prima dell’inclusione.
• I pazienti devono avere una colite ulcerosa recidivante da meno di 6 settimane (punteggio di 4–10 inclusi al UC-DAI, con un punteggio alla sigmoidoscopia 2)
• I pazienti recidivanti in terapia di mantenimento con 5-ASA a dosi ≥ 2.4 gr/giorno da almeno tre mesi
• Pazienti ambulatoriali di entrambi i sessi con età uguale o maggiore a 18 anni
• Test negativo al Citomegalovirus (CMV) alla visita di screening
• Pazienti di sesso femminile non potenzialmente fertili (post menopausa – definite come un anno dopo la menopausa – chirurgicamente o biologicamente sterili); pazienti donne potenzialmente fertili con test di gravidanza negativo allo screening e che stiano usando un metodo di contraccezione efficace e che lo utilizzino per almeno 30 giorni dopo l’assunzione del farmaco in studio.
•Pazienti di sesso maschile che accettino di utilizzare il profilattico durante lo studio e per i 30 giorni successivi alla fine dello studio.
•Pazienti abili, disponibili, e capaci di comprendere e aderire alle procedure e alle restrizione previste nello studio.

E.4

Principal exclusion criteria

• Pregnant or breast-feeding women.
• Patients with relapsing ulcerative colitis who have been in relapse for > 6 weeks.
• Patients who have relapsed on maintenance therapy with doses of 5-ASA < 2.4 g/day.
• Patients with proctitis (extent of inflammation ≤ 15 cm), previous colonic surgery, Crohn’s disease, immediate risk of toxic megacolon or a stool culture positive for enteric pathogen.
• The use of systemic or rectal steroids or rectal 5-ASA within the last 4 weeks
• The use of immunosuppressants within the last 6 weeks
• Antibiotic use within 7 days prior to the Baseline Visit will exclude patients.
• Use prescription or non-prescription drugs, vitamins, or dietary supplements and herbal OTC products within 7 days prior to the administration of study drug
• CMV Positive Test at screening
• Patients having a disease or condition or any finding in his medical history, physical examination or clinical laboratory tests giving reasonable suspicion of a disease, which in the opinion of the investigator, may put the patients at risk because of participation in the study or may influence either the results of the study or the patient’s ability to participate in the study,
• Patients with a history of drug or alcohol abuse.
• Patients with a history of hypersensitivity to at least one ingredient of the test product.
• Patients not able to understand information and give informed consent, or potentially presenting poor reliability (e.g. bad mental conditions).
• Patients who used another investigational agent or who took part in a clinical trial within the last 6 months prior first dose.

• Donne in gravidanza o in corso di allattamento.
• Pazienti con colite ulcerosa recidivante che sono in ricaduta da più di 6 settimane.
• Pazienti che hanno recidivato in terapia di mantenimento con dosi di 5-ASA minori di 2,4 g / giorno.
• Pazienti con proctite (estensione dell'infiammazione ≤ 15 cm), precedente chirurgia del colon, malattia di Crohn, rischio immediato di megacolon tossico o una cultura delle feci positiva per patogeni enterici.
• Uso di steroidi per via sistemica o rettale o 5-ASA per via rettale nelle ultime 4 settimane
• Uso di immunosoppressori nelle ultime 6 settimane
• Uso di antibiotici nei 7 giorni precedenti la visita basale
• Uso di farmaci, vitamine, o supplementi dietetici e prodotti OTC a base di erbe su prescrizione e non, nei 7 giorni precedenti la visita basale
• Test positivo al Citomegalovirus (CMV) alla visita di screening
• Pazienti che hanno una malattia o condizione clinica, che porti a ragionevole sospetto, a giudizio dello sperimentatore, di mettere i pazienti a rischio a causa della partecipazione alla studio o possa influenzare sia i risultati dello studio o la capacità del paziente a partecipare allo studio.
• Pazienti con storia di abuso di droga o alcool.
• Pazienti con storia di ipersensibilità ad almeno uno degli ingredienti del prodotto in studio.
• Paziente non in grado di comprendere le informazioni e dare il consenso informato, o che possono presentare scarsa affidabilità (ad esempio non buone condizioni mentali).
• Pazienti che hanno utilizzato un altro farmaco sperimentale o che hanno preso parte ad una sperimentazione clinica negli ultimi 6 mesi prima della prima dose.

E.5 End points

E.5.1

Primary end point(s)

Percentage of patients in remission (defined as patients with UC-DAI score ≤1 with a score of 0 for rectal bleeding and stool frequency and at least a 1 point reduction from baseline in the sigmoidoscopy score) at Week 8 (after 8 weeks of study drug treatment).

% pazienti in remissione (definita come score UCDAI≤1, con punteggio 0 per il sanguinamento rettale e frequenza delle scariche, ed una riduzione di almeno 1 del punteggio della sigmoidoscopia, rispetto al valore basale) alla settimana 8 (dopo 8 settimane di terapia sperimentale)

E.5.1.1

Timepoint(s) of evaluation of this end point

At 8 weeks, end of tretament period

Alla settimana 8, fine del periodo di trattamento

E.5.2

Secondary end point(s)

percentage of patients who show a clinical improvement (drop in UC DAI ≥ 3 points from baseline).
•change in UC-DAI score from baseline to 8 weeks of treatment.
•change in symptoms (rectal bleeding and stool frequency) from baseline to 2, 4 and 8 weeks.
•change in sigmoidoscopic (mucosal) appearance from baseline to 8 weeks of treatment.
•safety and tolerability

percentuale di pazienti che mostrano miglioramento clinico (riduzione UC DAI ≥ 3 punti dal basale a 8 settimane di trattamento). variazione nel punteggio UC-DAI dal basale a 8 settimane di trattamento. variazione nei sintomi (sanguinamento rettale e frequenza di scariche) dal basale a 2, 4 e 8 settimane. variazione dell’aspetto sigmoidoscopico (delle mucose) rispetto al basale, dopo 8 settimane di trattamento

E.5.2.1

Timepoint(s) of evaluation of this end point

at 2, 4 and 8 weeks

a 2, 4 e 8 settimane

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

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)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

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

Yes

E.8.1.7.1

Other trial design description

Disegno di Fleming, a singolo stadio

Fleming's Design, single Stage

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Information not present in EudraCT

E.8.2.2

Placebo

Information not present in EudraCT

E.8.2.3

Other

Information not present in EudraCT

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in 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

Number of subjects for this age range:

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)

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

2012-01-09

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-07-20

P. End of Trial
P.	End of Trial Status	Completed

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