Clinical Trials Register

Summary
EudraCT Number:	2017-002465-22
Sponsor's Protocol Code Number:	M16-011
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

2017-002465-22

A.3

Full title of the trial

A Phase 3, Randomized, Double-Blind, Study Comparing Risankizumab to Placebo in Subjects with Active Psoriatic Arthritis (PsA) Who Have a History of Inadequate Response to or intolerance to at Least One Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy (KEEPsAKE 1)

Studio Clinico di Fase 3, Randomizzato, e in Doppio Cieco per Confrontare Risankizumab Rispetto a Placebo in Soggetti Affetti da Artrite Psoriasica (PsA) in Fase Attiva con Storia di Risposta Inadeguata o Intolleranza ad Almeno un Farmaco Antireumatico Modificante la Malattia (DMARD) (KEEPsAKE 1)

A.3.1

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

A Study Comparing Risankizumab to Placebo in Subjects with Active Psoriatic Arthritis (PsA) Who Have a History of Inadequate Response to Intolerance to at Least One Disease Modifying Anti-Rheumatic Drug (DMARD)Therapy (KEEPsAKE 1)

Studio Clinico per Confrontare Risankizumab a Placebo in Soggetti con Artrite Psoriasica (PsA) in Fase Attiva, che hanno una Storia di Risposta Inadeguata oppure Intolleranza ad Almeno un Farmaco Antireumatico Modificante la Malattia (DMARD) (KEEPsAKE 1)

A.3.2

Name or abbreviated title of the trial where available

A.4.1

Sponsor's protocol code number

M16-011

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, Vanwell Business Park, Vanwall Road
B.5.3.2	Town/ city	Maidenhead
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	RISANKIZUMAB
D.3.2	Product code	[ABBV-066]
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	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	RISANKIZUMAB
D.3.9.1	CAS number	1612838-76-2
D.3.9.2	Current sponsor code	ABBV-066
D.3.9.4	EV Substance Code	SUB182635
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	Yes
D.3.11.13.1	Other medicinal product type	Humanized IgG monoclonal antibody

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	Subcutaneous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Psoriatic Arthritis

Artrite Psoriasica

E.1.1.1

Medical condition in easily understood language

Psoriatic Arthritis is an inflammatory disease where the immune system attacks healthy joints and skin causing pain, swelling, and stiffness in the joints, and red scaly patches on the skin.

L’artrite psoriasica è una patologia infiammatoria in cui il sistema immunitario attacca articolazioni e cute causando dolore,gonfiore,rigidità delle articolazioni e chiazze rosse squamose della pelle

E.1.1.2

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.0
E.1.2	Level	LLT
E.1.2	Classification code	10037160
E.1.2	Term	Psoriatic arthritis
E.1.2	System Organ Class	100000004859

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 compare the efficacy of Risankizumab 150 mg versus placebo for the treatment of signs and symptoms of PsA in patients with psoriatic arthritis.

Confrontare l’efficacia di Risankizumab 150 mg rispetto a placebo per il trattamento di segni e sintomi di PsA in pazienti affetti da artrite psoriasica.

E.2.2

Secondary objectives of the trial

Period 1 (Double Blind): 1.To compare the efficacy of Risankizumab 150 mg versus placebo for the inhibition of progression of structural damage as assessed by radiographs in the study population. 2.To compare the safety and tolerability of Risankizumab 150 mg versus placebo in patients with psoriatic arthritis.

Period 2: To evaluate the long-term, safety, tolerability and efficacy of Risankizumab 150 mg in subjects who have completed Period 1.

Periodo 1 (in Doppio Cieco): 1. Confrontare l’efficacia di Risankizumab 150 mg rispetto a placebo nell’inibire la progressione del danno strutturale determinata in base a valutazioni radiografiche nella popolazione in studio. 2. Confrontare la sicurezza e la tollerabilità di Risankizumab 150 mg rispetto a placebo in pazienti affetti da artrite psoriasica

Periodo 2: Valutare la sicurezza, tollerabilità ed efficacia a lungo termine di Risankizumab 150 mg nei soggetti che hanno completato il Periodo 1

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Clinical diagnosis of PsA with symptom onset at least 6 months prior to the Screening Visit and fulfillment of the Classification Criteria for PsA (CASPAR) at the Screening Visit.
• Subject has active disease at Baseline
• Diagnosis of active plaque psoriasis with at least one psoriatic plaque of = 2 centimeter (cm) diameter or nail changes consistent with
psoriasis at Screening Visit.
• Presence of either at Screening:
1. = 1 erosion on radiograph as determined by central imaging review or;
2. hs-CRP = 3.0 mg/L.
• Subject has demonstrated an inadequate response to previous or current treatment with at least 1 csDMARD OR subject must have an
intolerance to or contraindication for csDMARDs as determined by the investigator.

• Diagnosi clinica di PsA, con esordio dei sintomi almeno 6 mesi prima della visita di screening, e soddisfacimento dei criteri CASPAR (Classification Criteria for PsA) alla visita di Screening.
• Soggetto con malattia attiva al Baseline
• Diagnosi di psoriasi a placche in fase attiva, con almeno una placca psoriasica che misura = 2 centimetri (cm) di diametro oppure alterazioni ungueali caratteristiche della psoriasi alla Visita di Screening.
• Presenza allo Screening di uno fra i due parametri:
1. = 1 erosione confermata radiograficamente, secondo quanto determinato dalla valutazione del lettore centralizzato oppure;
2. valore di proteina C reattiva ad alta sensibilità (hsCRP) = 3,0 mg/L
• Il soggetto deve aver dimostrato una risposta inadeguata al trattamento pregresso oppure in atto con almeno 1 csDMARD OPPURE il soggetto deve essere intollerante oppure presentare controindicazione ai csDMARDs secondo quanto accertato dallo sperimentatore

E.4

Principal exclusion criteria

• Subject is considered by investigator, for any reason, to be an unsuitable candidate for the study.
• Subject has a known hypersensitivity to Risankizumab.
• Subject has previous treatment with biologic agent.

• Soggetto che il medico sperimentatore considera, per qualsiasi motivo, non idoneo a partecipare allo studio clinico.
• Soggetto con nota ipersensibilità a Risankizumab
• Soggetto che ha ricevuto trattamento pregresso con un agente biologico

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint is the proportion of subjects achieving American College of Rheumatology (ACR)20 Response (ACR20) at Week 24.

L’endpoint primario è rappresentato dalla percentuale di soggetti che ottengono la risposta ACR 20 (American College of Rheumatology, ACR) alla Settimana 24.

E.5.1.1

Timepoint(s) of evaluation of this end point

Week 24

Settimana 24

E.5.2

Secondary end point(s)

1. Change from Baseline in Health Assessment Questionnaire –
Disability Index (HAQ-DI) at Week 24;
2. Proportion of subjects achieving Psoriasis Area Severity Index (PASI)
90 response at Week 24 (in the subset of subjects with a BSA = 3% at
Baseline);
3. Change from Baseline in modified Total Sharp Score (PsA-mTSS) at
Week 24;
4. Proportion of subjects achieving Minimal Disease Activity (MDA) at
Week 24;
5. Change from Baseline in Fingernail-Physician Global Assessment (PGA-F, US)/ modified Nail Psoriasis Severity Index (mNAPSI, ex-US) at Week 24 (in the subset of subjects with nail psoriasis at Baseline); Note:
PGA-F and mNAPSI assessments will be obtained in all patients
6. Proportion of subjects with resolution of enthesitis (LEI = 0) at Week 24 in subjects with enthesitis at Baseline;
7. Proportion of subjects with resolution of dactylitis (LDI = 0) at Week 24 in subjects with dactylitis at Baseline;
8. Change from Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) at Week 24;
9. Change from Baseline in Functional Assessment of Chronic Illness
Therapy-Fatigue (FACIT Fatigue) Questionnaire at Week 24.

Other secondary endpoints without multiplicity adjustment are:
1. Proportion of subjects achieving ACR50 response at Week 24;
2. Proportion of subjects achieving ACR70 response at Week 24.

1. Variazione rispetto al Baseline nel punteggio HAQ-DI (Health Assessment Questionnaire – Disability Index) rilevato alla Settimana 24;
2. Percentuale di soggetti che ottengono la risposta PASI 90 (Psoriasis Area Severity Index) alla Settimana 24 (nel sottogruppo di soggetti con BSA = 3% al Baseline);
3. Variazione rispetto al Baseline del punteggio PsA-mTSS (modified Total Sharp Score) alla Settimana 24;
4. Percentuale di soggetti che ottengono la risposta MDA (Minimal Disease Activity) alla Settimana 24;
5. Variazione rispetto al Baseline della valutazione PGA-F (FIngernail-Physician Global Assessment, USA) / mNAPSI (Nail Psoriasis Severity6 Index (tutti gli altri paesi) alla Settimana 24 (nel sottogruppo di soggetti con psoriasi ungueale al Baseline); NB: Le valutazioni PGA-F e mNAPSI saranno realizzate in tutti i pazienti, negli Stati Uniti ed in tutti gli altri paesi.
6. Percentuale di soggetti con risoluzione dell'entesite (LEI = 0) alla 24a settimana nei soggetti con entesite al Baseline;
7. Percentuale di soggetti con risoluzione della dattilite (LDI = 0) alla Settimana 24 in soggetti con dattilite al Baseline;
8. Variazione rispetto al Baseline del punteggio del dominio relativo alla componente fisica (PCS, Physical Component Summary) del questionario SF-36 (36-Item Short Form Health Survey) alla Settimana 24
9. Variazione rispetto al Baseline del punteggio FACIT Fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue) alla Settimana 24

Altri endpoint secondari senza regolazione della molteplicità sono:
1. 2. Percentuale di soggetti che ottengono una risposta ACR50 alla 24a settimana;
2. 2. Percentuale di soggetti che hanno raggiunto la risposta ACR70 alla 24a settimana.

E.5.2.1

Timepoint(s) of evaluation of this end point

Week 24

Settimana 24

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

Yes

E.6.11

Pharmacogenomic

Yes

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

Yes

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

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

144

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

Bosnia and Herzegovina

Brazil

Canada

Chile

China

Israel

Korea, Republic of

Malaysia

Mexico

New Zealand

Puerto Rico

Russian Federation

Serbia

Singapore

South Africa

Taiwan

Ukraine

United States

Belgium

Bulgaria

Croatia

Denmark

Estonia

Finland

Germany

Italy

Latvia

Lithuania

Netherlands

Poland

Portugal

Romania

Slovakia

Spain

Sweden

United Kingdom

Czechia

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

Last protocol contact or last protocol follow-up of the last subject, whichever is longer.

Ultimo contatto previsto dal protocollo oppure ultimo follow-up previsto dal protocollo dell’ultimo soggetto, quale dei due si verifichi per ultimo

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:

712

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

168

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

490

F.4.2.2

In the whole clinical trial

880

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)

Active subjects randomized to Risankizumab: subjects will continue on study treatment throughout the study for a period of up to 1456
days/208 weeks/4 years or until premature discontinuation of study drug. At the subject's last study visit, the investigator will discuss the
appropriate subsequent treatment with the subject. Risankizumab may not be commercially available. AbbVie will not provide Risankizumab or any other therapy once the subject's participation is concluded.

Soggetti attivi randomizzati a Risankizumab:i soggetti continueranno a ricevere il trattamento durante lo studio clinico per un massimo di 1456giorni/208settimane/4anni,oppure fino all’interruzione anticipata del trattamento con il medicinale sperimentale.All’ultima visita,lo sperimentatore discuterà del successivo trattamento appropriato con il soggetto.Risankizumab potrebbe non essere in commercio.AbbVie non fornirà Risankizumab o altra terapia una volta conclusa la partecipazione del soggetto

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

2019-01-04

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-03-28

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

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