Clinical Trials Register

Summary
EudraCT Number:	2012-004098-26
Sponsor's Protocol Code Number:	CD-IA-MEDI2070-1147/D5170C00001
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:	2013-01-11
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

2012-004098-26

A.3

Full title of the trial

A Phase 2a Study to Evaluate the Efficacy and Safety of MEDI2070 in
Subjects with Moderate to Severe Crohn's Disease Who Have Failed or Are
Intolerant to Anti-tumor Necrosis Factor-alpha Therapy

Studio di fase II per valutare lÃ¢Â€Â™efficacia e la sicurezza di MEDI2070 in soggetti con Morbo di Crohn di grado da moderato a severo dopo il fallimento o lÃ¢Â€Â™intolleranza ad una terapia con Anti-TNFÃŽÂ±

A.3.1

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

Evaluation of efficacy and safety of MEDI2070 in patients with active,
moderate-to-severe Crohn's disease.

Valutazione dell'efficacia e della sicurezza di MEDI2070 in pazienti con Morbo di Crohn di grado da moderato a severo

A.3.2

Name or abbreviated title of the trial where available

MEDI 2070

A.4.1

Sponsor's protocol code number

CD-IA-MEDI2070-1147/D5170C00001

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	ASTRAZENECA
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	MedImmune Ltd
B.4.2	Country	United Kingdom
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	AstraZeneca
B.5.2	Functional name of contact point	Clinical Study Information
B.5.3	Address:
B.5.3.1	Street Address	Clinical Study Information
B.5.3.2	Town/ city	Clinical Study Information
B.5.3.3	Post code	20080
B.5.3.4	Country	Italy
B.5.4	Telephone number	001 800 2369933
B.5.5	Fax number	001 800 2369933
B.5.6	E-mail	information.center@astrazeneca.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	MEDI2070
D.3.2	Product code	MEDI2070
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.3.9.2	Current sponsor code	MEDI2070
D.3.9.3	Other descriptive name	anticorpo monoclonale anti IL-23
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	70
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
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 infusion
D.8.4	Route of administration of the placebo	Intravenous 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 injection
D.8.4	Route of administration of the placebo	Subcutaneous 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

Morbo di Crohn

E.1.1.1

Medical condition in easily understood language

Inflammatory bowel disease

Malattia infiammatoria intestinale

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	PT
E.1.2	Classification code	10011401
E.1.2	Term	Crohn's disease
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 MEDI2070 versus placebo to induce a clinical effect (defined as at least a 100-point reduction in Crohn's Disease Activity Index [CDAI] from baseline) or remission at Week 8 in subjects with moderate to severe Crohn's disease.

Valutare l’efficacia di MEDI2070, rispetto al placebo nell’indurre un effetto clinico (definito come riduzione dell’indice CDAI -Crohn’s Disease Activity Index- di almeno 100 punti rispetto al baseline) o una remissione alla settimana 8, in soggetti con morbo di Crohn (CD) di grado da moderato a severo

E.2.2

Secondary objectives of the trial

To evaluate the efficacy of MEDI2070 versus placebo in achieving CDAI remission (defined as CDAI < 150) at Week 8 To evaluate the effect of MEDI2070 versus placebo in achieving at least a CDAI 100-point reduction from baseline at Week 8 To evaluate the effect of MEDI2070 versus placebo in achieving at least a CDAI 70-point reduction from baseline at Week 8 To evaluate the effect of MEDI2070 versus placebo in achieving CDAI remission or at least a CDAI 100-point reduction from baseline at Week 12 To evaluate the effect of MEDI2070 versus placebo on the change from baseline in CDAI at Week 8 To evaluate the safety and tolerability of MEDI2070 To evaluate the pharmacokinetics (PK) and immunogenicity (IM) of MEDI2070

Valutare l’efficacia di MEDI2070 rispetto al placebo nel raggiungimento della diminuzione del CDAI (definita come CDAI<150), alla Settimana 8
Valutare l’effetto di MEDI2070 rispetto al placebo nel raggiungimento della riduzione del CDAI di almeno 100 punti rispetto al basale alla Settimana 8
Valutare l’effetto di MEDI2070 rispetto al placebo nel raggiungimento della riduzione del CDAI di almeno 70 punti rispetto al basale, alla Settimana 8
Valutare l’effetto di MEDI2070 rispetto al placebo nel raggiungimento della remissione del CDAI o nel raggiungimento della riduzione del CDAI di almeno 100 punti rispetto al baseline , alla Settimana 12
Valutare l’effetto di MEDI2070 rispetto al placebo in termini di variazione del CDAI rispetto al basale, alla Settimana 8
Valutare la sicurezza e la tollerabilità di MEDI2070
Valutare la farmacocinetica (PK) e l’immunogenicità (IM) di MEDI2070

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Diagnosed ileal, ileo-colonic, or colonic CD at least 6 months prior to screening. Men or women age 18 - 65 years at the time of screening. Moderate-severe active CD, defined by a CDAI score of ≥ 220 and ≤ 450 at Day 1. No known history of active TB. Received at least one anti-TNFα agent for the treatment of CD and did not initially respond.

Diagnosi di Morbo di Cronh a livello ileale, ileo-colonico o colonico per un minimo di 6 mesi prima dello screening come stabilito dallo sperimentatore;
maschi e femmine di età compresa tra 18 e 65 anni al momento dello screening
Morbo di Cronh attivo con grado da moderato a severo , definito da un risultato dell’indice CDAI compreso tra 220 e 450 al giorno 1;
Soggetti che non hanno una storia conosciuta di TB attiva
Soggetti che abbiano ricevuto almeno un farmaco anti-TNFα alla dose approvata per il trattamento del Morbo di Cronh e che non hanno risposto inizialmente

E.4

Principal exclusion criteria

Pregnant or breastfeeding women. Presence of ileostomy and/or colostomy. Short bowel syndrome. Bowel performation or obstruction. History of cancer.

Donne in gravidanza o allattamento
Soggetti con ileostomia o colostomia
Soggetti con sindrome dell’intestino corto
Perforazione intestinale o evidenza di ostruzione non infiammatoria

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint of the study is CDAI response at Week 8, defined by either a CDAI score of < 150 or a CDAI reduction from baseline of at least 100 points

L'endpoint primario dello studio è la risposta CDAI alla settimana 8, definita o come punteggio CDAI <150 o come una riduzione del CDAI rispetto al basale pari almeno a 100 punti.

E.5.1.1

Timepoint(s) of evaluation of this end point

Week 8

settimana 8

E.5.2

Secondary end point(s)

1- CDAI remission at Week 8, as defined by a CDAI score of < 150 2- A reduction of at least 100 points from baseline in CDAI at Week 8 3- A reduction of at least 70 points from baseline in CDAI at Week 8 4- CDAI response (either remission defined by CDAI < 150 or a CDAI reduction from baseline of at least 100 points from baseline) at Week 12 5- Change from baseline CDAI at Week 8 6- Pharmacokinetic (PK) evaluation of Multiple Doses of MEDI2070 7- Immunogenicity (IM) evaluation of Multiple Doses of MEDI2070

1 - remissione del CDAI alla settimana 8, definito come punteggio CDAI <150
2 - Una riduzione CDAI
di almeno 100 punti rispetto al basale alla settimana 8
3 - Una riduzione CDAI di almeno 70 punti rispetto al basale alla settimana 8
4 - risposta CDAI (o remissione definita da CDAI <150 o CDAI
riduzione rispetto al basale di almeno 100 punti rispetto ai valori basali) alla settimana 12)
5 - Variazione CDAI
dal basale alla settimana 8
6 - farmacocinetica (PK) valutazione di dosi multiple di MEDI2070
7 - Immunogenicità (IM) la valutazione di dosi multiple di MEDI2070

E.5.2.1

Timepoint(s) of evaluation of this end point

secondary endpoint 1, 2, 3 and 5 - Week 8 secondary endpoint 4 - week 12 secondary endpoint 6 - Week 0(Visit 3), Week 4 (Visit 5), Week 8 (Visit 6) predose; Week 0(Visit 3), Week 4 (Visit 5) postdose secondary endpoint 7 - Week 0(Visit 3), Week 8 (Visit 6) postdose

- SE n° 1, 2, 3 aned 5 - settimana 8
- SE n°4 - settimana 12
- SE n° 6 - settimana 0(Visit 3), settimana 4 (Visit 5), settimana 8 (Visit6) predose; settimana 0(Visit 3), settimana 4 (Visit 5) postdose
- SE n° 7 - settimana 0(Visit 3), settimana 8 (Visit 6) postdose

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

Yes

E.6.13.1

Other scope of the trial description

Immunogenicity

immunogenicità

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

Yes

E.8.1.7.1

Other trial design description

In aperto dalla settimana 12 alla 112

Open label from week 12 to week 112

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

Canada

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

LSLV (compreso il contatto telefonico)

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:

120

F.1.3

Elderly (>=65 years)

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

F.4.2.2

In the whole clinical trial

120

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)

None

Nessuno

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

2013-01-26

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-02-25

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

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