Clinical Trials Register

Summary
EudraCT Number:	2018-002063-26
Sponsor's Protocol Code Number:	CAIN457M2301
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:	2020-10-07
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

2018-002063-26

A.3

Full title of the trial

A randomized, double-blind, multicenter study assessing short (16 weeks) and long-term efficacy (up to 1 year), safety, and tolerability of 2 subcutaneous secukinumab dose regimens in adult patients with moderate to severe hidradenitis suppurativa

Studio multicentrico, randomizzato, in doppio cieco, per
valutare l’efficacia a breve termine (16 settimane) e a lungo
termine (fino a 1 anno), la sicurezza e la tollerabilità di 2
schemi di dosaggio di secukinumab s.c. in pazienti adulti
con idrosadenite suppurativa di grado da moderato a
severo (SUNSHINE)

A.3.1

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

A clinical trial to evaluate treatment with a drug called secukinumab in
adult patients who are diagnosed with moderate to severe hidradenitis
suppurativa (long term skin disease characterized by the occurrence of
inflamed and swollen lumps)

Studio per valutare la terapia con secukinumab in pazienti adulti
con idrosadenite suppurativa di grado da moderato a severo

A.3.2

Name or abbreviated title of the trial where available

SUNSHINE

A.4.1

Sponsor's protocol code number

CAIN457M2301

A.5.1

ISRCTN (International Standard Randomised Controlled Trial) Number

ISRCTN12345678

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT12345678

A.5.3

WHO Universal Trial Reference Number (UTRN)

U1234-1234-1234

A.5.4

Other Identifiers

Name:

AIN457

Number:

AIN457

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	NOVARTIS PHARMA AG
B.1.3.4	Country	Switzerland
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	Novartis Pharma
B.4.2	Country	Switzerland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Novartis Farma
B.5.2	Functional name of contact point	Regulatory Affairs
B.5.3	Address:
B.5.3.1	Street Address	Lgo U. Boccioni 1
B.5.3.2	Town/ city	Origgio (VA)
B.5.3.3	Post code	21040
B.5.3.4	Country	Italy
B.5.4	Telephone number	0296542287
B.5.5	Fax number	029659066
B.5.6	E-mail	info.studiclinici@novartis.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.2.1.2	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	Secukinumab
D.3.2	Product code	[AIN457]
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.3.9.2	Current sponsor code	AIN457M
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	300
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	Yes
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	Subcutaneous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

hidradenitis suppurativa

E.1.1.1

Medical condition in easily understood language

a long term skin disease characterized by the occurrence of inflamed and swollen lumps

hidradenitis suppurativa

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	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10020041
E.1.2	Term	Hidradenitis suppurativa
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 demonstrate the efficacy of secukinumab compared to placebo with respect to HiSCR after 16 weeks of treatment.

L’obiettivo primario di questo studio è dimostrare l’efficacia di secukinumab rispetto al placebo basato sul raggiungimento di parametri di risposta clinica (Hidradenitis Suppurativa Clinical Response – HiSCR) dopo 16 settimane di trattamento.

E.2.2

Secondary objectives of the trial

To demonstrate the efficacy of secukinumab compared to placebo after 16 weeks of treatment with respect to:
¿ proportion of patients with HS flares
¿ proportion of patients with clinical response in HS related skin pain.

Dimostrare l’efficacia di secukinumab rispetto al placebo valutando:
• la percentuale di pazienti con flare di HS la percentuale di pazienti con miglioramento del dolore legato a HS dopo 16 settimane di trattamento

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: • Lo studio prevede un sotto-studio complementare basato su una biopsia cutanea facoltativa (il paziente dovrà firmare un consenso informato separato se acconsente a partecipare). La biopsia sarà proposta solo a pazienti afferenti a centri interessati a partecipare a questo sotto-studio. Saranno prelevati campioni di biopsia cutanea “punch” alla valutazione baseline e durante la terapia, ed inviate ad un laboratorio centralizzato, dove saranno effettuate analisi istologiche e di trascrittomica.
• Lo studio prevede un’analisi opzionale genetica del DNA (il paziente dovrà firmare un consenso informato separato se acconsente a partecipare). L’obiettivo dell’analisi genetica è l’individuazione di fattori genetici che possano predire la risposta al trattamento con secukinumab, la suscettibilità ad interazioni fra farmaci o la predisposizione ad eventi avversi, o fattori genetici associati a HS o malattie autoimmuni.

Altre tipologie di sottostudi
specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: • Lo studio prevede un sotto-studio complementare basato su una biopsia cutanea facoltativa (il paziente dovrà firmare un consenso informato separato se acconsente a partecipare). La biopsia sarà proposta solo a pazienti afferenti a centri interessati a partecipare a questo sotto-studio. Saranno prelevati campioni di biopsia cutanea “punch” alla valutazione baseline e durante la terapia, ed inviate ad un laboratorio centralizzato, dove saranno effettuate analisi istologiche e di trascrittomica.
• Lo studio prevede un’analisi opzionale genetica del DNA (il paziente dovrà firmare un consenso informato separato se acconsente a partecipare). L’obiettivo dell’analisi genetica è l’individuazione di fattori genetici che possano predire la risposta al trattamento con secukinumab, la suscettibilità ad interazioni fra farmaci o la predisposizione ad eventi avversi, o fattori genetici associati a HS o malattie autoimmuni.

E.3

Principal inclusion criteria

Patients eligible for inclusion in this study must meet all of the following criteria:
1. Written informed consent must be obtained before any assessment is performed.
2. Male and female patients >= 18 years of age.
3. Diagnosis of HS >= 1 year prior to baseline.
4. Patients with moderate to severe HS defined as:
- A total of at least 5 inflammatory lesions, i.e. abscesses and/or inflammatory nodules
AND
- Inflammatory lesions should affect at least 2 distinct anatomic areas
5. Patients agree to daily use of topical over-the-counter antiseptics on the areas affected by HS lesions while on study treatment

1. Il consenso informato scritto deve essere ottenuto prima di procedere con qualsiasi valutazione.
2. Pazienti maschi o femmine di >= 18 anni di età
3. Diagnosi di HS >= 1 anno prima della visita Baseline
4. Pazienti con HS di grado da moderato a severo, definita come (entrambe le condizioni devono essere presenti):
• Presenza di un totale di 5 o più lesioni infiammatorie (es: ascessi e/o noduli infiammatori)
• Lesioni infiammatorie che coinvolgono 2 o più regioni anatomiche distinte
5. I pazienti acconsentono all’uso quotidiano di antisettici topici nelle aree affette da lesioni tipiche di HS durante il trattamento in studio

E.4

Principal exclusion criteria

Patients meeting any of the following criteria are not eligible for inclusion in this study.
1. Total fistulae count >= 20 at baseline.
2. Any other active skin disease or condition that may interfere with assessment of HS.
3. Active ongoing inflammatory diseases other than HS that require treatment with prohibited medications.
4. Underlying conditions (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal) which in the opinion of the investigator significantly immunocompromises the patient and/or places the patient at unacceptable risk for receiving an immunomodulatory therapy.
5. Current severe progressive or uncontrolled diseases which renders the patient unsuitable for the trial or puts the patient at increased risk, including any medical or psychiatric condition which, in the Investigator’s opinion, would preclude the participant from adhering to the protocol or completing the study per protocol.
6. Use or planned use of prohibited treatment. Washout periods detailed in the protocol have to be adhered to.
7. For patients enrolling in the non-antibiotic strata: use of systemic antibiotics for the treatment of HS within 28 days before baseline.
For patients enrolling in the antibiotic strata: patients enter the study under concomitant treatment with systemic antibiotics (as per protocol) on a stable dose (defined as a dose or dose regimen that has not changed in the previous 28 days before baseline and is considered unlikely to change at least for the first 16 weeks during the study).
8. History of hypersensitivity to any of the study drug constituents.
9. Previous exposure to secukinumab (AIN457) or any other biologic drug directly targeting IL-17 A/F or the IL-17 receptor.
10. History of chronic or recurrent systemic infections or active systemic infections during the last two weeks (exception: common cold) prior to randomization.
11. Evidence of tuberculosis infection as defined by a positive QuantiFERON® TB-Gold test (QFT) at screening. Patients with a positive or indeterminate QFT test may participate in the study if a full tuberculosis work-up (according to local practice/guidelines) completed within 12 weeks prior to randomization, establishes conclusively that the patient has no evidence of active or latent tuberculosis.
12. Medical history record of infection with human immunodeficiency virus (HIV), hepatitis B or C prior to randomization, except for hepatitis C successfully treated and cured.
13. History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system treated or untreated within the past 5 years, regardless of whether there is evidence of local recurrence or metastases (except for skin Bowen’s disease, or basal cell carcinoma or actinic keratoses that have been treated with no evidence of recurrence in the past 12 weeks; carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed).
14. History or evidence of ongoing alcohol or drug abuse, which in the opinion of the investigator will prevent the patient from adhering to the protocol and completing the study.
15. Pregnant or lactating women.
16. Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using methods of contraception during the entire study or longer if required by locally approved prescribing information (e.g. in European Union (EU) 20 weeks).

• Un numero di fistole >= 20 alla visita Baseline.
• Altre patologie o condizioni cutanee attive che possano interferire con la valutazione della HS.
• Altre malattie infiammatorie attive oltre all’idrosadenite suppurativa, che richiedano la terapia con farmaci non consentiti durante la partecipazione allo studio (vedi Tabella 6-2 del protocollo).
• Uso (in corso o previsto) di farmaci non consentiti da protocollo. Per alcune terapie sono richiesti dettagliati periodi di wash out (vedi Tabella 6-2 del protocollo).
• Storia di ipersensibilità nei confronti dei costituenti del farmaco.
• Storia di malattia linfoproliferativa o altra nota neoplasia trattata o non trattata nei 5 anni precedenti, indipendentemente dalla presenza/assenza di recidive locali o metastasi (fanno eccezione: carcinoma a cellule squamose in situ (malattia cutanea di Bowen), carcinoma a cellule basali o cheratosi attinica trattati senza evidenza di recidiva nelle 12 settimane precedenti; carcinoma in situ della cervice o poliposi del colon maligna non invasiva dopo rimozione).
• Donne in gravidanza o allattamento

E.5 End points

E.5.1

Primary end point(s)

Achievement of HiSCR at Week 16. HiSCR is defined as at least a 50% decrease in Abscess and Inflammatory Nodule (AN) count with no increase in the number of abscesses or in the number of draining fistulae.

E.5.1.1

Timepoint(s) of evaluation of this end point

Week 16

Settimana 16

E.5.2

Secondary end point(s)

Flaring up to Week 16. Flare is defined as at least a 25%
increase in AN counts with a minimum increase of 2 AN
relative to baseline.
¿ Achievement of NRS30 at Week 16, among subjects with
baseline NRS = 3. NRS30 is defined as at least a 30%
reduction from baseline in Patient's Global Assessment of
Skin Pain - at worst

Flaring fino alla settimana 16. Flare è definito come almeno il 25%
di aumento in AN con un aumento minimo di 2 AN
relativo al basale.
Ottenimento NRS30 alla Settimana 16, tra i soggetti con
NRS = 3 basale. NRS30 è definito come almeno il 30% di
reduzione rispetto al basale nella Patient's Global Assessment of Skin Pain-at worst

E.5.2.1

Timepoint(s) of evaluation of this end point

at/ up to Week 16

a / fino alla settimana 16

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

Yes

E.6.10

Pharmacogenetic

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

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

Argentina

Australia

Austria

Belgium

Brazil

Bulgaria

Canada

Czech Republic

France

Germany

Greece

Hungary

India

Israel

Italy

Japan

Korea, Republic of

Mexico

Philippines

Poland

Portugal

Russian Federation

Slovakia

Spain

Sweden

Switzerland

Taiwan

Turkey

United Kingdom

United States

Jordan

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:

447

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

259

F.4.2.2

In the whole clinical trial

471

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)

Patients completing the core study may be eligible to continue into a planned extension study to collect further safety and efficacy data on secukinumab and provide continuous access to treatment. Investigators must provide follow-up medical care for all subjects who are prematurely withdrawn from the core study or do not continue in
the extension, or must refer them for appropriate ongoing care. This care may include use of long term antibiotics, surgical intervention and/or use of biologics.

I pazienti che completano lo studio principale, se idonei, possono entrare nello studio di estensione. Gli investigators devono fornire assistenza medica di follow-up per tutti i soggetti che si ritirano prematuramente dallo studio principale o che non proseguono nello studio di estensione, o deve riferirli per un'assistenza continua appropriata. Questo trattamento può includere l'uso di antibiotici a lungo termine, l'intervento chirurgico e/o l'uso di prodotti biologici.

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

2019-02-27

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-02-05

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

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