Clinical Trials Register

Summary
EudraCT Number:	2015-005161-23
Sponsor's Protocol Code Number:	M15-574
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:	2021-09-10
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

2015-005161-23

A.3

Full title of the trial

A Phase 4, Double-Blind, Randomized, Placebo-Controlled Multicenter Study to Assess the Safety and Efficacy of Adalimumab Used in Conjunction with Surgery in Subjects with Moderate to Severe Hidradenitis Suppurativa

Sperimentazione Multicentrica di Fase 4, Randomizzata, in Doppio Cieco, Controllata verso Placebo per Valutare la Sicurezza e l’Efficacia di Adalimumab Usato in Associazione al Trattamento Chirurgico in Soggetti con Idrosadenite Suppurativa di Grado da Moderato a Severo

A.3.1

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

Double-Blind, Randomized, Placebo Controlled Multicenter Study to Assess the Safety and Efficacy of Adalimumab Used in Conjunction with Surgery in Subjects with Moderate to Severe Hidradenitis Suppurativa

Sperimentazione Multicentrica, Randomizzata, in Doppio Cieco, Controllata verso Placebo per Valutare la Sicurezza e l’Efficacia di Adalimumab Usato in Associazione al Trattamento Chirurgico in Soggetti con Idrosadenite Suppurativa di Grado da Moderato a Severo

A.3.2

Name or abbreviated title of the trial where available

N.D.

A.4.1

Sponsor's protocol code number

M15-574

A.5.4

Other Identifiers

Name:

N.D.

Number:

M15-574

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
B.5.3.3	Post code	SL6 4UB
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	0044 1628561090
B.5.5	Fax number	0044 1628461153
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	Yes
D.2.1.1.1	Trade name	HUMIRA - 40 MG SOLUZIONE INIETTABILE USO SOTTOCUTANEO 2 SIRINGHE PRERIEMPITE 0.8 ML + 2 TAMPONI IMBEVUTI DI ALCOL IN 1 BLISTER
D.2.1.1.2	Name of the Marketing Authorisation holder	ABBVIE LIMITED
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	Adalimumab
D.3.2	Product code	N.A.
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	ADALIMUMAB
D.3.9.1	CAS number	331731-18-1
D.3.9.2	Current sponsor code	Humira
D.3.9.4	EV Substance Code	SUB20016
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
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)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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 (also known as Acne inversa)

Idrosadenite suppurativa (anche conosciuta come Acne Inversa)

E.1.1.1

Medical condition in easily understood language

A painful, chronic skin disease characterized by recurrent inflamed
nodules and abscesses, which may rupture to form fistulas and ooze
purulent drainage, and cause subsequent scarring.

Malattia della pelle cronica dolorosa caratterizzata da ricorrente infiammazione dei noduli e ascessi, che possono rompersi a formare fistole e secrezioni purulente, e causare la successiva cicatrizza

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

Assess the safety and efficacy of adalimumab prior to surgery in subjects
with moderate to severe Hidradenitis Suppurativa (HS) who are surgical
candidates.

Valutare la sicurezza e l’efficacia di adalimumab somministrato prima dell’intervento chirurgico a soggetti affetti da Idrosadenite Suppurativa (Hidradenitis Suppurativa, HS) di grado da moderato a severo che sono candidati al trattamento chirurgico.

E.2.2

Secondary objectives of the trial

- Assess the impact of adalimumab on the planned HS surgical site
before surgery
- Evaluate the safety and efficacy of adalimumab when used after
surgery, and
- Evaluate Patient Reported Outcomes (PRO) related to health status,
HS-related symptoms, physical functioning, treatment satisfaction, and
work/activity impairment.
- Evaluate the pharmacokinetics (PK) and immunogenicity of
adalimumab.

- Valutare l’impatto della somministrazione di adalimumab sulle lesioni da HS per cui è programmato l’intervento chirurgico prima dell’intervento;
- Valutare la sicurezza e l’efficacia di adalimumab quando usato dopo l’intervento chirurgico, e
- Valutare gli esiti segnalati dai pazienti (patient reported outcomes, PRO) in merito allo stato di salute, sintomi correlati all’HS, funzionalità fisica, soddisfazione per il trattamento, e difficoltà nello svolgimento del lavoro/attività.
- Valutare la farmacocinetica (PK) e immunogenicità di adalimumab

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Male and female subjects subjects between the ages of 18 and 65, inclusive.
- Subject must have skin lesions that are diagnostic of HS for at least 1 year (365 days) prior to the Baseline visit
- Subject must have at least 3 distinct anatomical regions involved with inflammatory ( also termed 'active') HS lesions; including
(a) either an axilla or unilateral inguinal region (limited to the inguinal- crural fold and adjacent areas) that requires excisional surgery (hereinafter designated the "HS surgical site"), and (b) with at least one of the other affected HS regions (e.g., contralateral inguinal region, buttocks, inframammary region; hereinafter designate the 'HS non-surgical sites) rated as Hurley Stage II or III
- Subject must have a total abscess and inflammatory nodule (AN) count of greater than or equal to 3 at the Baseline visit within the HS nonsurgical sites
- The HS surgical site must contain at least one active HS lesion
- The HS surgical site must require excisional surgery and is large enough to require healing by secondary intention as assessed by the
designated surgeon.

-Soggetti di ambo i sessi di età compresa fra 18 e 65 anni, inclusi,
-Soggetti con lesioni cutanee che pongono diagnosi di HS da almeno 1 anno (365 giorni) prima della visita di Baseline;
-Soggetti con almeno 3 distinte regioni anatomiche interessate da lesioni infiammatorie da HS (definite anche “in fase attiva”), che comprendono:
a.una ascella oppure una regione inguinale unilaterale (limitatamente alla piega inguino-crurale e aree adiacenti) per cui sia necessario un intervento chirurgico escissionale (di seguito “sito HS chirurgico”), e
b.con almeno una delle altre regioni interessate da HS (es., regione inguinale controlaterale, glutei, regione inframammaria, di seguito “siti HS non chirurgici”) classificata come Stadio Hurley II o III;
-Soggetti con conta totale AN (ascessi e noduli infiammatori) pari o superiore a 3 nei siti HS non chirurgici alla visita di Baseline;
-Il sito HS chirurgico deve contenere almeno una lesione da HS in fase attiva;
-Il sito HS chirurgico deve necessitare di chirurgia escissionale ed essere, a giudizio del chirurgo designato, di dimensioni tali da richiedere guarigione per seconda intenzione.

E.4

Principal exclusion criteria

- Subject has a draining fistula count of greater than 20 at the Baseline visit
- Subject requires surgery at any anatomical site other than an unilateral axilla or inguinal region site
- Subject requires surgical management prior to Week 13, based on the designated surgeon's assessment
- Subject requires, based on designated surgeon's assessment, excisional surgery with primary closure, partial surgical reduction of the excised area with surgical suture, or reconstruction techniques as the method of closure being most beneficial for the subject.

-Soggetti con conta di fistole drenanti > 20 alla visita di Baseline;
-Soggetti che necessitano di intervento chirurgico presso qualsiasi sito anatomico diverso da ascella unilaterale o regione inguinale unilaterale;
-Soggetti che secondo il giudizio del chirurgo designato necessitano di trattamento chirurgico prima della Settimana 13;
-Soggetti che secondo il giudizio del chirurgo designato necessitano di intervento chirurgico escissionale con chiusura primaria, parziale riduzione chirurgica dell’area sottoposta ed escissione mediante sutura chirurgica oppure tecniche di ricostruzione, come metodo di chiusura più vantaggioso per il soggetto.

E.5 End points

E.5.1

Primary end point(s)

- The primary efficacy variable is the proportion of subjects achieving HiSCR (Hidradenitis uppurativa Clinical Response). HiSCR is defined as at least a 50% reduction in the AN count with no increase in abscess count and no increase in draining fistula count relative to baseline.

La variabile primaria di efficacia è rappresentata dalla proporzione di soggetti che ottengono la risposta HiSCR (Hidradenitis Suppurativa Clinical Response). HiSCR è definita come una riduzione di almeno il 50% nella conta AN [ascessi più noduli infiammatori] senza alcun aumento rispetto al Baseline del numero di ascessi e del numero di fistole drenanti.

E.5.1.1

Timepoint(s) of evaluation of this end point

Week 12

12 settimane

E.5.2

Secondary end point(s)

- The proportion of subjects achieving HiSCR-es (defined as the HiSCR excluding the HS surgical site) at Weeks 12 and 24
- The percent change in surface area of the surgical site, and
- The proportion of subjects at Week 12 that require less extensive surgical than the surgical plan (determined at Baseline) or no surgery.

-Proporzione di soggetti che ottengono HiSCR-es (valutazione HiSCR escluso il sito HS chirurgico) alla Settimana 12 e 24;
-Variazione percentuale nell’area di superficie del sito chirurgico programmato; e
-Proporzione di soggetti alla settimana 12 che necessitano di un intervento chirurgico meno esteso rispetto al piano chirurgico (documentato al Baseline), o che non necessitano più di intervento chirurgico.

E.5.2.1

Timepoint(s) of evaluation of this end point

Weeks 12 and 24

12 e 24 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

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

Yes

E.6.11

Pharmacogenomic

Yes

E.6.12

Pharmacoeconomic

Yes

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)

E.7.4

Therapeutic use (Phase IV)

Yes

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

Brazil

Canada

Colombia

Israel

Mexico

Russian Federation

Saudi Arabia

Turkey

Norway

European Union

Argentina

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 or the last follow-up contact whichever is longer.

L'ultima visita dell'ultimo soggetto o l'ultimo follow-up in funzione di quale avvenga dopo

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:

197

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

156

F.4.2.2

In the whole clinical trial

200

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)

Upon completion of the study, the patients will be treated in accordance with the Investigator's best clinical judgement.

Al termine dello studio , i pazienti saranno trattati in secondo miglior giudizio clinico dello 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

2016-05-23

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2019-10-17

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