Clinical Trials Register

Summary
EudraCT Number:	2017-001225-41
Sponsor's Protocol Code Number:	M14-430
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:	2021-06-17
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

2017-001225-41

A.3

Full title of the trial

A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433

Sperimentazione Multicentrica, Randomizzata, In Doppio Cieco, Controllata Verso Placebo di Mantenimento ed Estensione a Lungo Termine per Valutare l’Efficacia e la Sicurezza di Upadacitinib (ABT-494) in Soggetti Affetti da Malattia di Crohn che Hanno Completato la Partecipazione alla Sperimentazione M14-431 o M14-433.

A.3.1

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

A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433

Sperimentazione di Mantenimento ed Estensione a Lungo Termine per Valutare l’Efficacia e la Sicurezza di Upadacitinib (ABT-494) in Soggetti Affetti da Malattia di Crohn che Hanno Completato la Partecipazione alla Sperimentazione M14-431 o M14-433.

A.3.2

Name or abbreviated title of the trial where available

A.4.1

Sponsor's protocol code number

M14-430

A.5.4

Other Identifiers

Name:

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	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	441628561090
B.5.5	Fax number	441628461153
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	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	Upadaticitib
D.3.9.1	CAS number	1310726-60-3
D.3.9.2	Current sponsor code	na
D.3.9.4	EV Substance Code	SUB125895
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.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	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	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	na
D.3.9.4	EV Substance Code	SUB125895
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	15
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Tablet
D.8.4	Route of administration of the placebo	Oral 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 (CD)

Malattia di Crohn

E.1.1.1

Medical condition in easily understood language

CD is an inflamatory bowel disease affects the lining of the digestive tract, often spreads into the layers of affected bowel tissue, can lead to abdominal pain, severe diarrhea, fatigue, weight loss.

Il Cd è una malattia infiammatoriaintestinale checolpisceil trattodigestivo,sidiffonde spesso neltessuto intestinaleinteressato,puòportare a doloreaddominale,grave diarrea,affaticamento,perdita dipeso

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	20.0
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

Substudy 1 (randomized, double-blind, placebo-controlled maintenance):
To evaluate the efficacy and safety of two doses of upadacitinib versus placebo as maintenance therapy in subjects with moderately to severely active Crohn's disease (CD) who responded to upadacitinib induction
treatment in Studies M14-431 or M14-433.
Substudy 2 (long-term extension [LTE]): To evaluate safety and efficacy of long-term administration of upadacitinib in subjects with moderately to severely active CD who participated in the Phase 3 upadacitinib
induction and maintenance studies.

Sottostudio 1 (di mantenimento randomizzato, in doppio cieco e controllato verso placebo): Valutare l’efficacia e la sicurezza di due dosi di upadacitinib rispetto a placebo come terapia di mantenimento in soggetti affetti da malattia di Crohn in fase attiva e di grado da moderato a grave, che hanno risposto al trattamento di induzione con upadacitinib nell’ambito delle Sperimentazioni M14-431 o M14-433.
Sottostudio 2 (estensione a lungo termine [long-term extension, LTE]): Valutare la sicurezza e l’efficacia della somministrazione a lungo termine di upadacitinib in soggetti con malattia di Crohn in fase attiva e di grado da moderato a grave che hanno partecipato alle sperimentazioni di Fase 3 di induzione e mantenimento con upadacitinib.

E.2.2

Secondary objectives of the trial

To evaluate improvements in several efficacy parameters, including steroid discontinuation, laboratory parameters and quality of life questionnaires.

Valutare i miglioramenti nei diversi parametri di efficacia, compresa la sospensione degli steroidi, i parametri di laboratorio e i questionari sulla qualità della vita.

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

Other types of substudies
Specify title, date and version of each substudy with relative objectives: Substudy 1 - 52-Week, Randomized, Double-Blind, Maintenance
Substudy 2 - 240-Week Long-Term-Extension

Altre tipologie di sottostudi
specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Substudy 1 - 52 settimane, randomizzato,
doppio cieco, di mantenimento
Substudy 2 - Estensione a lungo termine di 240 settimane

E.3

Principal inclusion criteria

For Substudy 1:
- Subject who receive double-blind treatment in Study M14- 431 or Study
M14-433 and achieve clinical response.
- Subject completes Week 12 or Week 24 study procedures in study M14-
431 or study M14-433. The final endoscopy for studies M14-431 or M14-
433 may be missing, if the endoscopy cannot be performed during the
coronavirus SARS-CoV-2 pandemic.
For Substudy 2:
- Subject completes Substudy 1 of Study M14-430. The week 52
endoscopy may be missing, if the endoscopy cannot be performed during
the coronavirus SARS-CoV-2 pandemic.
- Subject achieved clinical response at Week 24 and completed Week 24
visit and procedures in Part 3/Cohort 3 of Study M14-431.

Sottostudio 1
- Soggetto che abbia ricevuto trattamento in doppio cieco nell'ambito Sperimentazione M14-431 o M14-433 e ottenuto la risposta clinica.
- Soggetto che ha completato la visita della Settimana 12 oppure della Settimana 24 ed è stato sottoposto alle procedure previste.È possibile che manchi l’endoscopia della Settimana 52 nel caso in cui non sia possibile eseguire l’endoscopia durante la pandemia coronavirus SARS-CoV-2 .
Sottostudio 2:
- Il soggetto che ha completato il Sottostudio 1 dello Studio M14-430. È possibile che manchi l’endoscopia della Settimana 52 nel caso in cui non sia possibile eseguire l’endoscopia durante la pandemia coronavirus SARS-CoV-2 .
- Il soggetto che ha ottenuto la risposta clinica alla Settimana 24 e ha completato la Settimana 24 visita e procedure nella Parte 3/Coorte 3 dello Studio M14-431.

E.4

Principal exclusion criteria

For Sub-studies 1 and 2:
- Participant is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
- Participant who has a known hypersensitivity to upadacitinib or its excipients, or had an adverse event during Study M14-431 or Substudy 1 of Study M14-430 that in the investigator's judgment makes the subject unsuitable for this study.
- Participant with any active or chronic recurring infections based on the investigator's assessment that makes the subject an unsuitable candidate for the study. Subjects with ongoing infections undergoing treatment may be enrolled BUT NOT dosed until the infection treatment has been completed and the infection is cured, based on the investigator's assessment.
- Participants with high grade colonic dysplasia or malignancy diagnosed at the endoscopy performed at the final visit of Study M14-431 (Week 24) or Substudy 1 of Study M14-430 (Week 52).

Sottostudi 1 e 2
- Soggetto che per qualsiasi motivo non è considerato essere idoneo alla sperimentazione dallo sperimentatore.
- Soggetto con nota ipersensibilità a upadacitinib oppure ai suoi eccipienti, oppure che ha presentato un evento avverso insorto durante la Sperimentazione M14-431, M14-433 o durante il Sottostudio 1 della Sperimentazione M14-430, che a giudizio dello sperimentatore rende il soggetto non idoneo a partecipare alla presente sperimentazione.
- Soggetto con qualsiasi infezione in fase attiva o cronica ricorrente che a giudizio dello sperimentatore rende il soggetto non idoneo a partecipare alla sperimentazione. I soggetti con
infezioni attive e che ricevono il trattamento potranno essere arruolati SENZA TUTTAVIA ricevere il trattamento fino alla conclusione del trattamento anti-infettivo e alla risoluzione dell’infezione, secondo il giudizio dello sperimentatore.
4. Soggetti con displasia ad alto grado o neoplasia del colon diagnosticati in occasione della procedura endoscopica eseguita alla vista finale della Sperimentazione M14-431, M14-433, o del Sottostudio 1 della Sperimentazione M14-430 (Settimana 52).

E.5 End points

E.5.1

Primary end point(s)

Substudy 1, Cohort 1 (Upadacitinib vs Placebo)
Co-Primary Endpoints:
- Proportion of subjects with clinical remission per PRO at Week 52, AND
- Proportion of subjects with endoscopic response at Week 52
Substudy 2
Primary Endpoint: Incidence of AEs over time

Sottostudio 1, Coorte 1 (Upadacitinib vs Placebo)
Endpoint Co-Primari:
- Percentuale di soggetti con remissione per PRO clinica alla Settimana 52, IN AGGIUNTA A
- Percentuale di soggetti con risposta endoscopica alla Settimana 52
Sottostudio 2
- Incidenza di eventi avversi nel tempo

E.5.1.1

Timepoint(s) of evaluation of this end point

Week 52

Settimana 52

E.5.2

Secondary end point(s)

Substudy 1
1. Proportion of subjects with clinical remission per CDAI (CDAI < 150)
at Week 52
2. Proportion of subjects with clinical remission at Week 0 and Week 52
3. Proportion of subjects with endoscopic remission at Week 52
4. Change in Baseline in Inflammatory Bowel Disease Questionnaire
(IBDQ) at Week 52
5. Proportion of subjects achieving CR-100 at Week 52
6. Change from Baseline in Functional Assessment of Chronic Illness
Therapy-Fatigue (FACIT-F) at Week 52
7. Proportion of subjects with clinical remission and endoscopic
remission at Week 52
8. Proportion of subjects who discontinue corticosteroid use for CD at 90
days and achieve clinical remission per PROs at Week 52 in subjects
taking corticosteroids for CD at Baseline of induction
9. Proportion of subjects with CD-related hospitalizations during the 52-
Week double-blind maintenance period.
10. Proportion of subjects with resolution of extra-intestinal
manifestation (EIM) at Week 52, in subjects with EIMs at Baseline.
Substudy 2
Proportion of subjects
¿ with clinical remission over time
¿ with enhanced clinical response over time
¿ with endoscopic remission at Week 0, and every 48 weeks thereafter
¿ with endoscopic response at Week 0, and every 48 weeks thereafter
¿ who discontinue corticosteroid use and achieve clinical remission over
time among subjects taking steroids at Baseline (of induction)
¿ with clinical remission over time who were in clinical remission at
Week 0
¿ achieving Inflammatory Bowel Disease Questionnaire (IBDQ)
response (increase of IBDQ = 16 over time)
Time loss of
¿ enhanced clinical response
¿ clinical remission

1. Percentuale di soggetti con remissione clinica sulla base degli esiti segnalati dai pazienti alla Settimana 52
2. Percentuale di soggetti che ottengono CR-100 alla Settimana 52
3. Percentuale di soggetti che hanno interrotto l’uso di corticosteroidi almeno 90 giorni prima della Settimana 52 e ottengono la remissione clinica sulla base del punteggio CDAI alla Settimana 52, in trattamento con corticosteroidi al Baseline di induzione
4. Percentuale di soggetti con remissione clinica sulla base del punteggio CDAI e remissione endoscopica alla Settimana 52
5. Percentuale di soggetti con remissione clinica sulla base del punteggio CDAI alla Settimana 0 e alla Settimana 52
6. Percentuale di soggetti con remissione endoscopica alla Settimana 52
7. Variazione rispetto al Baseline del punteggio del questionario IBDQ sulle malattie infiammatorie intestinali alla Settimana 52
8. Cambiamento rispetto al basale nel punteggio FACIT-F alla Settimana 52
9. Percentuale di soggetti con ricoveri ospedalieri dovuti alla malattia di Crohn nel corso del periodo di mantenimento in doppio cieco della durata di 52 settimane
10. Percentuale di soggetti con risoluzione delle manifestazioni extra-intestinali (EIM) alla Settimana 52, in soggetti che presentavano EIM al Baseline.

Sottostudio 2
Endpoint Secondari:
Percentuale di soggetti
- con remissione clinica nel tempo
- con risposta clinica incrementata nel tempo
- con remissione endoscopica alla Settimana 0, ed in seguito ogni 48 settimane
- con risposta endoscopica alla Settimana 0, ed in seguito ogni 48 settimane
- che interrompono l’uso di corticosteroidi e ottengono la remissione clinica nel tempo nei soggetti che erano in trattamento con steroidi al Baseline (dell’induzione)
- con remissione clinica nel tempoe che erano in remissione clinica alla settimana 0
- raggiungimento della risposta al questionario sulla malattia infiammatoria dell'intestino (IBDQ) (aumento di IBDQ = 16 nel tempo)
Tempo necessario per:
- risposta clinica incrementata
- remissione clinica
Ulteriori endpoint prestabiliti sono descritti nel protocollo.

E.5.2.1

Timepoint(s) of evaluation of this end point

Substudy 1
1. week 52
2. week 52
3. week 52
4. week 52
5. week 52
6. week 52
7. week 52
8. week 52
9. week 52
10. week 52

Substudy 2
Over study duration

Substudy 1
1.Settimana 52
2.Settimana 52
3.Settimana 52
4.Settimana 52
5.Settimana 52
6.Settimana 52
7.Settimana 52
8.Settimana 52
9.Settimana 52
10.Settimana 52

Sottostudio 2
Oltre durata dello studio

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

Yes

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

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

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

Sottostudio 1 Randomizzato, Doppio Cieco.
Sottostudio 2 sia in Aperto che in Doppio Cieco

Substudy 1 Randomized, double-blind. Substudy 2 Both open-label and double-blind

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

146

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

Brazil

Canada

Chile

China

Colombia

Egypt

Hong Kong

Israel

Japan

Malaysia

Mexico

Puerto Rico

Russian Federation

Serbia

Singapore

South Africa

Taiwan

Turkey

Ukraine

United States

Switzerland

Argentina

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:

710

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

457

F.4.2.2

In the whole clinical trial

738

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)

This study will be active until upadacitinib is approved. Subject may continue to receive upadacitinib once available in the approved country, or have the treatment change to standard of care, per the investigatory decision.

Questo studio sarà attivo fino all'approvazione di upadacitinib. Il soggetto può continuare a ricevere upadacitinib una volta disponibile nel Paese in cui verrà Approvato o il trattamento cambia in base agli standard di cura, a seguito di decisione del medico sperimentatore.

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

2018-04-05

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-03-21

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

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IMP with orphan designation in the indication
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