Clinical Trials Register

Summary
EudraCT Number:	2018-004763-31
Sponsor's Protocol Code Number:	CRO.CO.DEX
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:	2019-09-18
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

2018-004763-31

A.3

Full title of the trial

Therapy with dexamethasone intra-erythrocytes in patients with Crohn
disease and ulcerative colitis

Terapia con desametasone intra-eritrocitario in pazienti con morbo di
Crohn e Colite Ulcerosa

A.3.1

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

Therapy with dexamethasone intra-erythrocytes in patients with Crohn
disease and ulcerative colitis

Terapia con desametasone intra-eritrocitario in pazienti con morbo di
Crohn e Colite Ulcerosa

A.3.2

Name or abbreviated title of the trial where available

CRO.CO.DEX

A.4.1

Sponsor's protocol code number

CRO.CO.DEX

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	EryDel S.p.A.
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	EryDel 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	EryDel S.p.A.
B.5.2	Functional name of contact point	EryDel S.p.A.
B.5.3	Address:
B.5.3.1	Street Address	Via Meucci 3
B.5.3.2	Town/ city	Bresso
B.5.3.3	Post code	20091
B.5.3.4	Country	Italy
B.5.4	Telephone number	00390236504470
B.5.6	E-mail	info@erydel.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	dexametasone sodium phosphate
D.3.2	Product code	dexametasone sodium phosphate
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	Other use (Noncurrent)
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	Yes
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	Other use (Noncurrent)

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

patients with Crohn’s Disease and Ulcerative Colitis

E.1.1.1

Medical condition in easily understood language

patients with Crohn’s Disease and Ulcerative Colitis

E.1.1.2

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

evaluate the patients response rate in IBD patients receiving Dex 21-P encapsulated autologous erythrocytes. The evaluation of efficacy (primary endpoint) was conducted comparing the percentages of responder patients in Dex 21-P and placebo treatment group. response rate in patients treated with Dex-21P encapsulated in erythrocytes against the response rate reported by patients treated with Placebo

E.2.2

Secondary objectives of the trial

The secondary objectives of the present study were to evaluate:
• the endogenous cortisol production after the study treatment
• the inflammatory indexes (ESR and CPR) after the study treatment
• the safety of dexamethasone intra-erytrocyte therapy with particular attention to steroid-related adverse events
• the endoscopic remission in patients suffering from mesalazine refractory UC.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

− More than 18 years of age
− Patient suffering from one of the following chronic inflammatory intestinal diseases: Steroid-dependent Crohn’s Disease or Ulcerative Colitis following ECCO definition or Mild-moderate active UC (Powell-Tuck between 3 and 14 –an index of 14 is allowed; endoscopic Baron score >1) refractory to mesalazine
− Disease extension over the rectum (at least 15 cm) in patient suffering from ulcerative colitis
− Patient willing and able to give written informed consent.

E.4

Principal exclusion criteria

− Intestinal sub-occlusion or a suspected abdomen abscess or a severe degree of the disease (CDAI > 450) in patient suffering from Crohn’s Disease
− Patient affected by a severe Ulcerative Colitis (more than 6 evacuation of liquid, mucous-blooding stools combined to at least one systemic sign as body temperature > 37.8 °C, heart rate > 90 bpm, ESR > 30 mm/h or haemoglobin < 10.5 g/dL)
- Severe concurrent disease:
Medullar deficit: white blood cells < 3000/mm3; platelets < 75000/mm3; haemoglobin <10 g/dL;
Hepatic diseases presenting total bilirubin ³ 3 mg/dL; AST (GOT) ³ 5 UNL; alkaline phosphatase ³ 5 UNL;
Renal failure with serum creatinine ³ 3 mg/dL
Heart failure
Respiratory failure
Disabling neurological diseases
Neoplasia
Patient deemed candidate to surgery due to Crohn’s Disease or Ulcerative Colitis
Chronic alcohol or drug abuse
Patient for whom the use of steroids is contraindicated (e.g. systemic infections)
− Treatment with Infliximab in the previous 4 months
− Pregnant woman or female for whom the possibility of a pregnancy during the study could not be excluded.
− Non collaborating patient or subject unable to regularly undergo the scheduled study procedures.

E.5 End points

E.5.1

Primary end point(s)

E.5.1.1

Timepoint(s) of evaluation of this end point

6 months (for steroid dependent Crohn disease patients) or 45 days (for Ulcerative colitis patients)

E.5.2

Secondary end point(s)

E.5.2.1

Timepoint(s) of evaluation of this end point

6 months (for steroid dependent Crohn disease patients) or 45 days (for Ulcerative colitis patients)

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

Yes

E.8.1.1

Randomised

Yes

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

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

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

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

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)

None

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

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

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

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IMP with orphan designation in the indication
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