Clinical Trials Register

Summary
EudraCT Number:	2020-003672-40
Sponsor's Protocol Code Number:	1368-0052
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:	2021-06-04
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

2020-003672-40

A.3

Full title of the trial

Randomized, double-blind, placebo-controlled, study of spesolimab in patients with moderate or severe hidradenitis suppurativa

Studio randomizzato, in doppio cieco, controllato verso placebo, su spesolimab in pazienti con idrosadenite suppurativa moderata o grave.

A.3.1

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

A study to test whether spesolimab helps people with a skin disease called hidradenitis suppurativa

Studio volto a verificare se spesolimab è in grado di aiutare le persone affette da una malattia della pelle denominata idrosadenite suppurativa.

A.3.2

Name or abbreviated title of the trial where available

A.4.1

Sponsor's protocol code number

1368-0052

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	BOEHRINGER-INGELHEIM ITALIA S.P.A.
B.1.3.4	Country	Italy
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	Boehringer Ingelheim Italia S.p.A.
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Boehringer Ingelheim Pharma GmbH&Co KG
B.5.2	Functional name of contact point	CT Disclosure & Data Transparency
B.5.3	Address:
B.5.3.1	Street Address	Binger Strasse 173
B.5.3.2	Town/ city	Ingelheim am Rhein
B.5.3.3	Post code	55216
B.5.3.4	Country	Germany
B.5.4	Telephone number	+498002430127
B.5.5	Fax number	+498008217119
B.5.6	E-mail	clintriage.rdg@boehringer-ingelheim.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	BI 655130
D.3.2	Product code	[BI 655130]
D.3.4	Pharmaceutical form	Solution for injection/infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	SPESOLIMAB
D.3.9.2	Current sponsor code	BI 655130
D.3.9.4	EV Substance Code	SUB194324
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	60
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.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	BI 655130
D.3.2	Product code	[BI 655130]
D.3.4	Pharmaceutical form	Solution for injection in pre-filled syringe
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	SPESOLIMAB
D.3.9.2	Current sponsor code	BI 655130
D.3.9.4	EV Substance Code	SUB194324
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	150
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/infusion
D.8.4	Route of administration of the placebo	Intravenous use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for injection in pre-filled syringe
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

idrosadenite suppurativa

E.1.1.1

Medical condition in easily understood language

a skin disease called hidradenitis suppurativa

malattia della pelle denominata idrosadenite 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

The primary objective is to estimate the effect of spesolimab compared to placebo for the mean percent change from baseline in total abscess and inflammatory nodule count at Week 12.

L’obiettivo primario è stimare l’effetto di spesolimab rispetto al placebo sulla variazione percentuale media dal basale del numero totale degli ascessi e dei noduli infiammatori alla Settimana 12

E.2.2

Secondary objectives of the trial

Not applicable

Non applicabile

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Male or female adult patients, 18 years of age or older.
- Signed and dated written informed consent in accordance with ICH
Good Clinical Practice (GCP) and local legislation prior to the start of any
screening procedures.
- Moderate to severe HS, based on IHS4 criteria, for at least 1 year prior
to the baseline visit, as determined by the investigator through
participant interview and/or review of the medical history.
- HS lesions in at least 2 distinct anatomic area (right/left axillary,
inguinal, inframammary, perineal)
- Biologic naive or TNFi-failure for HS.
- Inadequate response to an adequate course of appropriate oral
antibiotics for treatment of HS in the last 1 year, as per investigator
discretion. This is not applicable for TNFi-failure patients
- Total abscess and inflammatory nodule (AN) count of greater than or
equal to 5.
- Total draining fistula count of less than or equal to 20.
- Women of childbearing potential (WOCBP) must be ready and able to
use highly effective methods of birth control per ICH M3 (R2) that result
in a low failure rate of less than 1% per year when used consistently and
correctly, for the duration of the trial and 16 weeks after last
administration. A list of contraception methods meeting these criteria is provided in the patient information.

1.Pazienti adulti di sesso maschile o femminile, di età pari o superiore a 18 anni.
2.Consenso informato scritto firmato e datato, conformemente alla buona pratica clinica (GCP) della ICH e alla legislazione locale, prima dell’inizio di qualsiasi procedura di screening.
3.Idrosadenite suppurativa da moderata a grave, sulla base dei criteri dell’IHS4, per almeno 1 anno prima della visita basale, secondo quanto determinato dallo sperimentatore durante il colloquio con i partecipanti e/o mediante l’analisi della storia clinica.
4.Lesioni causate dall’idrosadenite suppurativa in almeno 2 distinte aree anatomiche (regione ascellare destra/sinistra, inguinale, sottomammaria, perineale)
5.Pazienti naïve al trattamento con farmaci biologici o fallimento di terapia con TNFi per idrosadenite suppurativa.
6.Risposta insoddisfacente a un ciclo di antibiotici per via orale adeguato per il trattamento dell’idrosadenite suppurativa, nell’ultimo anno, a discrezione dello sperimentatore. Questo non è applicabile ai pazienti con fallimento di terapia con TNFi
7.Numero totale di ascessi e noduli infiammatori (AN) superiore o pari a 5.
8.Numero totale di fistole drenanti inferiore o pari a 20.
9.Per tutta la durata della sperimentazione e 16 settimane dopo l’ultima somministrazione, le donne in età fertile (women of childbearing potential, WOCBP ) dovranno essere disposte e in grado di utilizzare metodi contraccettivi altamente efficaci, ai sensi delle linee guida ICH M3 (R2), i quali, quando usati con costanza e correttamente, siano associati a un basso tasso di insuccesso (inferiore all’1% all’anno). Un elenco dei metodi contraccettivi che soddisfano tali criteri è fornito nel documento informativo per il paziente

E.4

Principal exclusion criteria

- Presence of active skin lesions other than HS that interferes with the
assessment of HS.
- Use of restricted medications as below.
-- Topical corticosteroids within 1 week of Visit 2
-- Systemic antibiotics within 4 weeks of visit 2.
-- Systemic non-biologic therapies for HS within 4 weeks of visit 2.
-- Biologic use within 12 weeks or 5 half-lives, whichever is longer, prior
to visit 2.
-- Opioid analgesics within 2 weeks of visit 2.
-- Live virus vaccine within 6 weeks of visit 2.
- Prior exposure to IL-36R inhibitors including spesolimab.
- Patients who must or choose to continue the intake of restricted
medications or any drug considered likely to interfere with the safe
conduct of the trial.
- Treatment with any investigational device or investigational drug of
chemical or biologic nature within a minimum of 30 days or 5 half-lives
of the drug, whichever is longer, prior to visit 2.
- Women who are pregnant, nursing, or who plan to become pregnant
while in the trial. Women who stop nursing before the study drug
administration do not need to be excluded from participating.
- History of allergy/hypersensitivity to the systemically administered
trial medication agent or its excipients.
- Patient with a transplanted organ (with exception of a corneal
transplant > 12 weeks prior to screening) or who have ever received
stem cell therapy (e.g., Remestemcel-L).
- Any documented active or suspected malignancy or history of
malignancy within 5 years prior to the screening visit, except
appropriately treated basal cell carcinoma of the skin, squamous cell
carcinoma of the skin or in situ carcinoma of uterine cervix.
Further criteria apply.

1.Presenza di lesioni cutanee attive diverse dall’idrosadenite suppurativa, che interferisca con la valutazione dell’idrosadenite suppurativa.
2.Uso di farmaci soggetti a restrizioni secondo quanto illustrato di seguito. Per ulteriori informazioni, si veda il paragrafo 4.2.2.
-Corticosteroidi topici entro 1 settimana dalla Visita 2
-Antibiotici sistemici entro 4 settimane dalla Visita 2.
-Terapie sistemiche non biologiche per l’idrosadenite suppurativa entro 4 settimane dalla Visita 2.
-Uso di farmaci biologici entro 12 settimane o 5 emivite, a seconda di quale abbia durata maggiore, prima della Visita 2.
-Analgesici oppioidi entro 2 settimane dalla Visita 2.
-Vaccinazioni con vaccini vivi entro 6 settimane dalla Visita 2.
3.Precedente esposizione a inibitori di IL-36R, incluso spesolimab.
4.Pazienti che devono o decidono di continuare l’assunzione di farmaci soggetti a restrizioni (si veda il paragrafo 4.2.2.1) o qualsiasi farmaco che si ritiene possa interferire con la conduzione sicura della sperimentazione.
5.Trattamento con qualsiasi dispositivo o farmaco sperimentale di natura chimica o biologica, entro un minimo di 30 giorni o 5 emivite del farmaco, a seconda di quale abbia durata maggiore, prima della Visita 2.
6.Donne in stato di gravidanza, in allattamento o che intendono iniziare una gravidanza nel corso della sperimentazione. Le donne che interrompono l’allattamento prima della somministrazione del farmaco in studio non devono essere escluse dalla partecipazione.
7.Anamnesi positiva per allergia/ipersensibilità al farmaco sperimentale somministrato per via sistemica o ai suoi eccipienti.
8.Pazienti sottoposti a trapianto d’organo (ad eccezione di trapianto di cornea >12 settimane prima dello screening) o che abbiano ricevuto in precedenza terapia con cellule staminali (ad es. remestemcel-L).
9.Qualsiasi neoplasia maligna attiva o sospetta documentata o anamnesi positiva per neoplasia maligna nei 5 anni precedenti la visita di screening, eccetto forme adeguatamente trattate di carcinoma cutaneo basocellulare o squamocellulare, o carcinoma in situ della cervice uterina.

Per altri criteri vedere la sinossi in italiano

E.5 End points

E.5.1

Primary end point(s)

1) percent change from baseline in total abscess and inflammatory nodule count at Week 12

1) L’endpoint primario è la variazione percentuale rispetto al basale del numero totale di ascessi e noduli infiammatori alla Settimana 12.

E.5.1.1

Timepoint(s) of evaluation of this end point

1) week 12

1) settimana 12

E.5.2

Secondary end point(s)

1) Percent change from baseline in draining fistula count at Week 12
2) Percentage of patients achieving Hidradenitis Suppurativa Clinical
Response (HiSCR) at Week 12. HiSCR is defined as at least a 50%
reduction in the total AN count with no increase in abscess count and no
increase in draining fistula count relative to baseline.
3) Absolute change from baseline in International Hidradenitis
Suppurativa Severity Score System (IHS4) value at Week 12
4) Absolute change from baseline in HASI score at Week 12
5) Percentage of patients achieving PGA score of 0 or 1 at Week 12
6) Percentage of patients with at least 30% reduction from baseline in
Numerical rating scale (NRS30) in Patient's Global Assessment of HS
Pain at Week 12
7) Complete elimination of draining fistulas at Week 12
8) At least one flare (defined as at least 25 % increase in AN count with a minimum increase of 2 relative to baseline) up to Week 12.
9) Absolute change from baseline in DLQI Score at Week 12.
10) Absolute change from baseline in HiS-QoL Total Score at Week 12.

1)Variazione percentuale rispetto al basale del numero di fistole drenanti alla Settimana 12
2)Percentuale di pazienti che abbiano ottenuto una risposta clinica per l’idrosadenite suppurativa (HiSCR) alla Settimana 12.
3)Variazione assoluta rispetto al basale nel valore dell’International Hidradenitis Suppurativa Severity Score System (IHS4) alla Settimana 12
4)Variazione assoluta rispetto al basale nel punteggio HASI alla Settimana 12
5)Percentuale di pazienti che abbiano raggiunto il punteggio PGA di 0 o 1 alla Settimana 12
6Numero di pazienti che abbiano ottenuto una riduzione almeno del 30% rispetto al basale nella scala di valutazione numerica (NRS30) nella valutazione globale del dolore causato da idrosadenite suppurativa alla Settimana 12
7)Completa eliminazione delle fistole drenanti alla Settimana 12
8)Percentuale di pazienti che hanno avuto almeno una riacutizzazione (definita come un aumento di almeno il 25% nel numero di AN, con aumento minimo di 2 rispetto al basale) fino alla Settimana 12.
9)Variazione assoluta dal basale nel punteggio DLQI alla Settimana 12.
10Variazione assoluta dal basale nel punteggio HiS-QoL totale alla Settimana 12.

E.5.2.1

Timepoint(s) of evaluation of this end point

1) week 12
2) week 12
3) week 12
4) week 12
5) week 12
6) week 12
7) week 12
8) week 12
9) week 12
10) week 12

1) settimana 12
2) settimana 12
3) settimana 12
4) settimana 12
5) settimana 12
6) settimana 12
7) settimana 12
8) settimana 12
9) settimana 12
10) settimana 12

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)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

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

Australia

Canada

United States

Belgium

Denmark

France

Germany

Greece

Hungary

Italy

Netherlands

Norway

Poland

Spain

United Kingdom

Czechia

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:

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

F.4.2.2

In the whole clinical trial

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)

SoC according to investigator

Terapia standard

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

2021-03-04

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-04-15

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

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Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
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