Clinical Trials Register

Summary
EudraCT Number:	2011-004763-72
Sponsor's Protocol Code Number:	IM133-005
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:	2012-09-03
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

2011-004763-72

A.3

Full title of the trial

A Phase IIb, Double-Blind, Randomized, Placebo-Controlled, Double-Dummy, Dose-Ranging Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-945429 in Subjects with Moderate to Severe Crohn's Disease Revised Protocol 01, incorporating Amendment 02 (dated 20-Mar-12)

Studio di fase 2b, in doppio cieco, randomizzato, controllato con placebo, in doppio falso, a diversi dosaggi, per valutare l'efficacia clinica e la sicurezza della terapia di induzione e di mantenimento con BMS-945429 in soggetti con Malattia di Crohn da moderata a grave.

A.3.1

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

Phase IIB Dose Ranging Study of BMS-945429 in subjects with moderate to severe Crohn’s Disease

Studio di fase 2b, a diversi dosaggi di BMS-945429 in soggetti con Malattia di Crohn da moderata a grave.

A.4.1

Sponsor's protocol code number

IM133-005

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	BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
B.1.3.4	Country	Belgium
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	Bristol Myers Squibb International Corporation
B.4.2	Country	Belgium
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	ol Myers Squibb International Corporation
B.5.2	Functional name of contact point	EU Start Up Department
B.5.3	Address:
B.5.3.1	Street Address	Parc de l'Alliance, Avenue de Finlande, 8
B.5.3.2	Town/ city	Braine l'Alleud
B.5.3.3	Post code	1420
B.5.3.4	Country	Belgium
B.5.4	Telephone number	ND
B.5.5	Fax number	ND
B.5.6	E-mail	clinical.trials@bms.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	Anti-Interleukin-6 Monoclonal Antibody
D.3.2	Product code	BMS-945429
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	1236278-28-6
D.3.9.2	Current sponsor code	BMS-945429
D.3.9.3	Other descriptive name	anti-IL-6 mAb
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
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	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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for injection
D.8.4	Route of administration of the placebo	Subcutaneous use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for infusion
D.8.4	Route of administration of the placebo	Intravenous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Crohn’s Disease

Malattia di Crohn da moderata a grave

E.1.1.1

Medical condition in easily understood language

Crohn’s Disease

Malattia di Crohn da moderata a grave

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	15.0
E.1.2	Level	SOC
E.1.2	Classification code	10017947
E.1.2	Term	Gastrointestinal disorders
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

The purpose of this study is to characterize the safety, efficacy and dose response of BMS-945429 in subjects with moderate to severe Crohn’s disease and who have had an insufficient response to conventional therapy or have failed anti-TNF therapy

Lo scopo di questo studio è quello di caratterizzare la sicurezza, l'efficacia e la risposta alle differenti dosi di BMS-945429 in soggetti con Malattia di Crohn da moderata a grave che hanno avuto una risposta insufficiente alla terapia convenzionale o hanno fallito la terapia con anti- TNF.

E.2.2

Secondary objectives of the trial

Proportion of subjects with clinical response during Induction Period 2. Change from baseline of IBDQ and SF-36 3. Safety and immunogenicity during the Induction Period 4. PK during Induction Period

1.Valutare la percentuale di soggetti con risposta clinica durante il periodo di induzione; 2. Valutare il cambiamento dal basale dell’ IBDQ e di SF-36; 3. Valutare la sicurezza e l’immunogenicità durante tutto il periodo di induzione; 4. Valutare la farmacocinetica durante tutto il periodo di induzione.

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

PHARMACOKINETIC/PHARMACODYNAMIC:
Vers:01
Date:2012/03/20
Title:Induction Period PK substudy,
Objectives:Maintenance Period PK Substudy & Open-Label Period PK Substudy: see section 5.5.1 of the protocol

FARMACOCINETICA/FARMACODINAMICA:
Vers:01
Data:2012/03/20
Titolo:sottostudio di farmacocinetica, il sottostudio è parte integrante dello studio principale
Obiettivi:analisi completa del profilo PK del farmaco BMS-945429.

E.3

Principal inclusion criteria

Confirmed CD diagnosis via radiology, endoscopy or histology within prior 12 months. Diagnosed for at least 3 months. • Active Disease with CDAI ≥ 220 and ≤ 450 • Failed conventional therapy or steroid dependent

Diagnosi confermata di Malattia di Crohn attraverso esami radiologici, endoscopici o istologici nei 12 mesi precedenti. Malattia di Crohn diagnosticata da almeno 3 mesi; • Malattia attiva con CDAI ≥ 220 e ≤ 450; • Fallimento della terapia convenzionale o steroide-dipendente.

E.4

Principal exclusion criteria

Diagnosed/clinical findings of UC, indeterminate colitis, non colonic/ileal disease • Stricture/stenosis, Stoma, proctocolectomy, subtotal colectomy, ileorectal anastomosis • History of diverticulitis, or evidence of GI perforations

•Diagnosi di colite ulcerosa (UC) o colite indeterminata. Sindrome dell’intestino corto; •Stenosi nota o stenosi infiammatoria responsabili di sintomi di ostruzione. Presenza di stoma o necessità di eseguire una colostomia o ileostomia; • Storia di diverticolite o evidenza di perforazioni nel tratto gastrointestinale.

E.5 End points

E.5.1

Primary end point(s)

Proportion of subjects with clinical remission as measured by the Crohn’s Disease Activity Index

Valutare la proporzione di soggetti in remissione clinica come definita dall’indice CDAI - Crohn’s Disease Activity Index

E.5.1.1

Timepoint(s) of evaluation of this end point

At 8 weeks during the Induction Period

a 8 settimane del periodo di induzione

E.5.2

Secondary end point(s)

1. Proportion of subjects with clinical response during Induction Period 2. Change from baseline of IBDQ and SF-36 3. Safety and immunogenicity during the Induction Period 4. PK during Induction Period

1.Valutazione della percentuale di soggetti con risposta clinica durante il periodo di induzione; 2. Valutazione del cambiamento dal basale dell’ IBDQ e SF-36; 3. Valutazione della sicurezza e dell’ immunogenicità durante tutto il periodo di induzione; 4. Valutazione della farmacocinetica durante tutto il periodo di induzione;

E.5.2.1

Timepoint(s) of evaluation of this end point

1. After 8 weeks in the Induction Period 2. After 8 weeks in the Induction Period and after 24 & 48 weeks in the Maintenance Period 3. From Week 0 to Week 12 during the Induction Period; 4. From Week 0 to Week 8 during the Induction Period

1. Dopo 8 settimane nel periodo di induzione 2. Dopo 8 settimane nel periodo di induzione e dopo 24 e 48 settimane nel periodo di mantenimento; 3. Dalla settimana 0 alla settimana 12 durante il periodo di induzione; 4. Dalla settimana 0 alla settimana 8 durante il periodo di induzione.

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

Yes

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

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

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

Yes

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

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

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

European Union

Australia

Brazil

Canada

Hong Kong

India

Israel

Korea, Democratic People's Republic of

Korea, Republic of

Mexico

Russian Federation

Singapore

Switzerland

Taiwan

United States

E.8.7

Trial has a data monitoring committee

Yes

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

LPLV: last patient last visit

Ultima visita dell'ultimo paziente

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

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial 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:

280

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.4.2

For a multinational trial

F.4.2.1

In the EEA

127

F.4.2.2

In the whole clinical trial

350

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)

At the conclusion of the study, subjects who continue to demonstrate clinical benefit will be eligible to receive study drug up to 12 months after the approval of study drug by the responsible health authority or until the study drug becomes commercially available within the country, whichever occurs sooner. For additional details, see protocol section 3.2

Al termine dello studio, i soggetti che continueranno a dimostrare un certo beneficio clinico saranno idonei a ricevere il farmaco in studio fino a 12 mesi dopo l'approvazione del farmaco in studio da parte del Ministero della Salute o fino a quando il farmaco in studio sarà disponibile in commercio in Italia. Per ulteriori dettagli, fare riferimento alla sezione 3.2 del protocollo.

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

2012-07-16

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-06-25

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2013-12-30

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