Clinical Trials Register

Summary
EudraCT Number:	2019-001227-12
Sponsor's Protocol Code Number:	M19-850
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:	2021-06-08
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

2019-001227-12

A.3

Full title of the trial

A Phase 3b, open label treatment extension study of upadacitinib for the treatment of adult subjects with moderate to severe atopic dermatitis who
successfully completed treatment in the M16-046 study

Studio clinico di estensione in aperto di upadacitinib per il trattamento di soggetti adulti affetti da dermatite atopica di grado da moderato a grave che hanno completato con successo il trattamento nell’ambito dello Studio M16-046

A.3.1

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

This is a study for adults (18-75 years) who have successfully completed treatment either with Dupilumab or with Upadacitinib in the M16-046 study. At the end of M16-046, they have the option to receive Upadacitinib with a duration of 52 weeks beyond the timeframe of Study M16-046. There will be a 30 day follow-up visit after the treatment period is completed

Si tratta di uno studio per soggetti adulti (età compresa fra 18 e 75 anni) che hanno completato con successo il trattamento con Dupilumab o con Upadacitinib nell’ambito dello studio M16-046. Alla fine dello studio M16-046, viene loro proposta la possibilità di ricevere Upadacitinib per un periodo di 52 settimane in aggiunta al periodo dello Studio M16-046. È prevista una visita di follow-up a 30 giorni una volta concluso il periodo di trattamento

A.3.2

Name or abbreviated title of the trial where available

Heads UP

A.4.1

Sponsor's protocol code number

M19-850

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	ABBVIE DEUTSCHLAND GMBH & CO. KG
B.1.3.4	Country	Germany
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	AbbVie Inc.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	AbbVie Ltd
B.5.2	Functional name of contact point	EU Clinical Trials Helpdesk
B.5.3	Address:
B.5.3.1	Street Address	AbbVie House, Vanwall Business Park, Vanwall Road
B.5.3.2	Town/ city	Maidenhead, Berkshire
B.5.3.3	Post code	SL6 4UB
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	00441628561090
B.5.5	Fax number	00441628461153
B.5.6	E-mail	eu-clinical-trials@abbvie.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	Upadacitinib
D.3.2	Product code	[ABT-494]
D.3.4	Pharmaceutical form	Film-coated 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	UPADACITINIB
D.3.9.1	CAS number	1310726-60-3
D.3.9.2	Current sponsor code	ABT-494
D.3.9.4	EV Substance Code	SUB187251
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	30
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	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	Yes
D.3.11.13.1	Other medicinal product type	Janus kinase (Jak) 1 inhibitor

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

Moderate to severe Atopic Dermatitis

Dermatite Atopica di grado da moderato a grave

E.1.1.1

Medical condition in easily understood language

Atopic Dermatitis, also known as Atopic Eczema

Dermatite Atopica, detta anche eczema atopico

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	21.1
E.1.2	Level	LLT
E.1.2	Classification code	10003639
E.1.2	Term	Atopic dermatitis
E.1.2	System Organ Class	100000004858

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 assess long-term safety, tolerability and efficacy of upadacitinib in adult subjects with moderate to severe atopic dermatitis who successfully completed treatment in the M16-046 study

Valutare la sicurezza, tollerabilità ed efficacia a lungo termine di upadacitinib in soggetti adulti affetti da dermatite atopica di grado da moderato a grave, che abbiano completato con successo il trattamento nell’ambito dello Studio M16-046

E.2.2

Secondary objectives of the trial

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Subjects should have successfully completed treatment in the M16-046 study, without developing any permanent discontinuation criteria.
• Subject is judged to be in general good health (other than AD) as determined by the Principal Investigator and remains eligible as per the criteria for the M16-046 study to continue treatment in the long term extension study.

• I soggetti devono aver completato con successo il trattamento nell’ambito dello Studio M16-046, senza aver mai presentato alcuno dei criteri relativi all’interruzione definitiva.
• Soggetti che secondo quanto determinato dal medico sperimentatore, presentano condizioni generali di salute soddisfacenti (oltre alla presenza di dermatite atopica) e continuano ad essere eleggibili in base ai criteri previsti dallo Studio M16-046 a proseguire il trattamento nell’ambito dello studio di estensione a lungo termine.

E.4

Principal exclusion criteria

• Requirement of prohibited medications during the study treatment or would interfere with appropriate assessment of atopic dermatitis lesions
• Female subject who is pregnant, breastfeeding, or considering pregnancy during the study

• Necessità di medicinali proibiti durante il trattamento sperimentale oppure di medicinali che interferirebbero con una appropriata valutazione delle lesioni da dermatite atopica
• Soggetto di sesso femminile che è in stato di gravidanza, sta allattando o sta pianificando una gravidanza nel corso dello studio

E.5 End points

E.5.1

Primary end point(s)

Treatment emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events (AEs) of special interest (AESI), AEs leading to discontinuation of study drug; vital signs, laboratory tests, and physical examination findings.

Eventi avversi emergenti dal trattamento (TEAE), eventi avversi seri (SAE), eventi avversi di interesse speciale (AESI), eventi avversi che richiedono l’interruzione del medicinale sperimentale; segni vitali, analisi di laboratorio e riscontri all’esame obiettivo.

E.5.1.1

Timepoint(s) of evaluation of this end point

At each visit

A ciascuna visita

E.5.2

Secondary end point(s)

• Variazione e variazione percentuale rispetto al Baseline del parametro EASI;
na

E.5.2.1

Timepoint(s) of evaluation of this end point

At each visit

A ciascuna visita

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)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

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

Yes

E.8.1.7.1

Other trial design description

Aperto

Open

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

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

Information not present in EudraCT

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

Australia

Canada

Israel

Malaysia

New Zealand

Singapore

Thailand

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

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:

570

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

325

F.4.2.2

In the whole clinical trial

600

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 subject's last study visit, the investigator will discuss the appropriate subsequent treatment with the subject. AbbVie will not provide drug or any other therapy once the subject's participation has concluded.

In occasione dell’ultima visita prevista per lo studio per il soggetto, il medico sperimentatore discuterà con il soggetto del trattamento successivo appropriato. Una volta conclusa la partecipazione del soggetto, AbbVie non fornirà alcun farmaco o altra terapia.

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

2019-10-31

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-01-14

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

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