Clinical Trials Register

Summary
EudraCT Number:	2021-001984-25
Sponsor's Protocol Code Number:	-
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2022-01-27
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

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2021-001984-25

A.3

Full title of the trial

Mucosal healing after systemic steroid therapy by early treatment with ustekinumab in moderate-to-severe ulcerative colitis: an open-label prospective pilot study

Modulazione della guarigione endoscopica dopo terapia steroidea sistemica mediante trattamento precoce con ustekinumab nella colite ulcerosa moderata-severa: studio pilota prospettico in aperto

A.3.1

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

Early treatment with ustekinumab and mucosalhealing in ulcerative colitis after clinicalbut non endoscopicremission with steroids

Trattamento precoce con ustekinumab e guarigione endoscopica nella colite ulcerosa dopo remissione clinica ma non endoscopica con steroidi

A.3.2

Name or abbreviated title of the trial where available

MUcosal healing after Steroids 2020 (MuST 2020)

A.4.1

Sponsor's protocol code number

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	AZIENDA SOCIO SANITARIA TERRITORIALE DEI SETTE LAGHI
B.1.3.4	Country	Italy
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
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Asst Sette Laghi
B.5.2	Functional name of contact point	Segreteria Amministrativa del Comit
B.5.3	Address:
B.5.3.1	Street Address	V.le Borri 57
B.5.3.2	Town/ city	VARESE
B.5.3.3	Post code	21100
B.5.3.4	Country	Italy
B.5.4	Telephone number	0332278844
B.5.5	Fax number	0332393631
B.5.6	E-mail	comitato.etico@asst-settelaghi.it

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	Yes
D.2.1.1.1	Trade name	STELARA - 90 MG - SOLUZIONE INIETTABILE IN SIRINGHE PRERIEMPITE - USO SOTTOCUTANEO - SIRINGA PRERIEMPITA(VETRO) 1 ML(90MG/ML) 1 SIRINGA PRERIEMPITA DA 1 ML
D.2.1.1.2	Name of the Marketing Authorisation holder	JANSSEN-CILAG INTERNATIONAL N.V.
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	USTEKINUMAB
D.3.2	Product code	[STELARA]
D.3.4	Pharmaceutical form	Solution for injection in pre-filled syringe
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	USTEKINUMAB
D.3.9.1	CAS number	815610-63-0
D.3.9.2	Current sponsor code	STELARA
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	90
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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.IMP: 2
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	Yes
D.2.1.1.1	Trade name	Stelara
D.2.1.1.2	Name of the Marketing Authorisation holder	Janssen-Cilag International NV Turnhoutseweg 30 B-2340 Beerse Belgio
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	ustekinumab
D.3.2	Product code	[Stelara]
D.3.4	Pharmaceutical form	Concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	USTEKINUMAB
D.3.9.1	CAS number	815610-63-0
D.3.9.2	Current sponsor code	Stelara
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	130
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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

Ulcerative colitis

Colite ulcerosa

E.1.1.1

Medical condition in easily understood language

Ulcerative colitis

Colite ulcerosa

E.1.1.2

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

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	10045365
E.1.2	Term	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

Valutazione di efficacia e tossicità (vedi sezioni 6 e 8) del trattamento precoce con ustekinumab nell’induzione della risposta endoscopica della colite ulcerosa a 8 e 54 settimane.

E.2.2

Secondary objectives of the trial

Valutazione di efficacia e tossicità del trattamento precoce con ustekinumab nel mantenere la risposta clinica della colite ulcerosa a 54 settimane. Valutazione dell’impatto della risposta endoscopica ottenuta con ustekinumab sul decorso clinico della colite ulcerosa, in termini di tasso di recidiva, ospedalizzazione, chirurgia a 54 settimane.Valutazione della risposta istologica ad ustekinumab

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Age >18 and >= 70 years; Diagnosis of ulcerative colitis according to International guidelines;Clinical but not endoscopic remission to a recent treatment with steroids for moderate-severe active disease

1. Età >18 e < =70 anni
2. Diagnosi di colite ulcerosa da almeno 3 mesi
3. Risposta clinica ma non endoscopica ad un recente ciclo steroideo sistemico per malattia attiva moderata-severa

E.4

Principal exclusion criteria

Active systemic or severe local bacteric or fungal infections;
Active tubercular disease of latent tubercular infection without prophylactic treatment;
Toxic megacolon;
Intestinalperforation;
Malignancy or a history of malignancies within 5 years before the inclusion;
Abnormal bone marrow function, as defined by neutrophils <1,5 x 103/¿l, CD4+-lymphocytes < 200 x 103/¿l, platelets < 50 x 103/¿l;
Pregnant or lactating women;

Storia di infezioni opportunistiche negli ultimi 6 mesi
Infezioni batteriche o fungine, in atto al momento del reclutamento;
Infezioni virali note come CMV, HIV, HBV, HCV
Malattia tubercolare attiva o infezione tubercolare latente non in profilassi;
Megacolon tossico;
Lesioni displasiche del colon-retto non rimosse;
Perforazione intestinale;
Malattie neoplastiche negli ultimi 5 anni compresi disordini linfoproliferativi;
Insufficienza midollare, definita come neutropenia (neutrofili <1,5 x 103/¿l), linfocitopenia (CD4+ < 200 x 103/¿l), trombocitopenia (PLT < 50 x 103/¿l), in assenza di cause documentabili e non reversibili;
Severa anemia (emoglobina < 8 g/dL);
Gravidanza o allattamento

E.5 End points

E.5.1

Primary end point(s)

Proportion of patients in endoscopic remission at 54 weeks

percentuale di pazienti trattati con ustekinumab che hanno raggiunto la remissione endoscopica a 54 settimane

E.5.1.1

Timepoint(s) of evaluation of this end point

54 weeks

54 settimane

E.5.2

Secondary end point(s)

1. proportion of patients in endoscopic remission at 8 weeks, without intercurrent clinical relapse
2. proportion of patients in clinical remission at 8 weeks
3. proportion of patients with histologicalremissionat 8 or 54 weeks
4. proportion of patients with clinical relapse within 54 weeks
5. proportion of patientsdevelopingsteroid dependance within 54 weeks
6. proportion of patientstreated with colectomywithin 54 weeks
7. proportion of patientsrequiringhospitalization for active UC within 54 weeks

1. percentuale di pazienti trattati con ustekinumab che hanno ottenuto la remissione endoscopica a 8 settimane, senza recidive cliniche intercorrenti;
2. percentuale di pazienti trattati con ustekinumab che hanno mantenuto la remissione clinica a 54 settimane, senza recidive cliniche intercorrenti;
3. percentuale di pazienti trattati con ustekinumab che hanno mantenuto la remissione clinica a 8 settimane, senza recidive cliniche intercorrenti;
4. percentuale di pazienti trattati con ustekinumab che hanno raggiunto la remissione istologica a 8 e/o 54 settimane;
5. percentuale di pazienti trattati con ustekinumabche hanno sviluppato recidiva clinica entro 54 settimane;
6. percentuale di pazienti trattati con ustekinumab che hanno sviluppato corticodipendenza entro 54 settimane;
7. percentuale di pazienti trattati con ustekinumabsottoposti a chirurgia per colite entro 54 settimane;
8. percentuale di pazienti trattati con ustekinumab sottoposti ad ospedalizzazione per colite entro 54 settimane.

E.5.2.1

Timepoint(s) of evaluation of this end point

8 or 54 weeks

8 o 54 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

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)

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

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.8.4.1

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

Information not present in EudraCT

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

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.1.1.1

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.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

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)

follow standard care

proseguimento assistenza convenzionale

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

2022-06-14

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-08-09

P. End of Trial
P.	End of Trial Status	Ongoing

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