Clinical Trials Register

Summary
EudraCT Number:	2020-005587-55
Sponsor's Protocol Code Number:	1368-0067
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:	2021-06-08
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

2020-005587-55

A.3

Full title of the trial

An open-label, long-term extension trial of spesolimab treatment in adult patients with Hidradenitis Suppurativa (HS)

Studio di estensione a lungo termine in aperto sul trattamento con spesolimab in pazienti adulti affetti da idrosadenite suppurativa (HS).

A.3.1

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

A study investigating long-term treatment with spesolimab in people with a skin disease called hidradenitis suppurativa who completed a previous clinical trial.

studio a lungo termine con spesolimab in pazienti con una malattia della pelle chiamata idrosadenite suppurativa che abbiano completato una precedente sperimentazione clinica.

A.3.2

Name or abbreviated title of the trial where available

A.4.1

Sponsor's protocol code number

1368-0067

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	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 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.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/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.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	Subcutaneous 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/infusion
D.8.4	Route of administration of the placebo	Intravenous 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 (HS).

E.1.1.1

Medical condition in easily understood language

Hidradenitis Suppurativa

idrosadenite suppurativa (HS).

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 of this trial is to assess the long-term safety of spesolimab in patients with HS who have completed the 1368-0052 PoCC trial and are qualified for entry into this trial.

L’obiettivo primario di questo studio è valutare la sicurezza a lungo termine di spesolimab nei pazienti affetti da HS, che abbiano completato lo studio 1368-0052 PoCC e siano qualificati per partecipare al presente studio di estensione.

E.2.2

Secondary objectives of the trial

The secondary objectives are to evaluate efficacy at a lower dose than tested in PoCC trial.

Gli obiettivi secondari consistono nel valutare l’efficacia a una dose inferiore a quella testata nello studio PoCC.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Patients who have completed treatment in the parent HS spesolimab trial (1368-0052) without premature discontinuation.
- Signed and dated written informed consent in accordance with ICH Harmonized Guideline for Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
- WOCBP1 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. A list of contraception methods meeting these criteria is provided in the patient information and consent form

1. Pazienti che abbiano completato il trattamento dello studio originario su spesolimab per l’HS (1368-0052) senza interruzione anticipata.
2. Pazienti che, prima di essere arruolati nello studio, abbiano firmato e datato il consenso informato scritto, in conformità con le linee guida armonizzate dell’ICH di buona pratica clinica (ICH-GCP) e con la legislazione locale.
3. Le donne in età fertile (WOCBP) dovranno essere disposte e in grado di utilizzare, ai sensi delle linee guida ICH M3 (R2) metodi contraccettivi altamente efficaci che, quando usati con costanza e correttamente, siano associati a un basso tasso di insuccesso (inferiore all’1% all’anno). Nel paragrafo 4.2.2.7 del foglio informativo e modulo per il consenso del paziente è riportato un elenco di metodi anticoncezionali che soddisfano questi criteri.

N.B.: Le donne sono considerate in età fertile (WOCBP) dopo il menarca e fino alla postmenopausa, eccetto laddove si trovino in una condizione di sterilità permanente. I metodi di sterilizzazione permanente includono isterectomia, salpingectomia bilaterale e ooforectomia bilaterale. La legatura delle tube NON è un metodo di sterilizzazione permanente. Lo stato postmenopausale è definito come l’assenza di mestruazioni per 12 mesi senza causa medica alternativa.

E.4

Principal exclusion criteria

- Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
- Patients who experienced study treatment-limiting adverse events during the 1368-0052 parent trial.
- Severe, progressive, or uncontrolled condition such as renal, hepatic, haematological, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease, or signs and symptoms thereof.
- Any new documented active or suspected malignancy except appropriately treated basal cell carcinoma, squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix.
- Use of any restricted medication or any drug considered by the investigator likely to interfere with the safe conduct of the study since the last visit of the 1368-0052 parent trial.
- History of allergy/hypersensitivity to the systemically administered trial medication agent or its excipients.
- Major surgery (major according to the investigator’s assessment) planned during this extension trial (e.g. hip replacement, aneurysm removal, stomach ligation), as assessed by the investigator.
- Any condition which in the opinion of the investigator affects the safety of the patient, the patient’s ability to participate in this trial or could compromise the quality of data.
- Any suicidal behaviour in the past 2 years (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behaviour).
- Any suicidal ideation of type 4 or 5 on the C-SSRS in the past 3 months (i.e. active suicidal thoughts with method and intent but without specific plan, or active suicidal thoughts with method, intent and plan).
- Currently enrolled in another investigational device or drug trial, except for 1368-0052.
- Previous participation in this trial.

1. Donne in stato di gravidanza, in allattamento o che intendono iniziare una gravidanza nel corso della sperimentazione.
2. Pazienti che, durante lo studio originario 1368-0052, abbiano avuto eventi avversi in grado di determinare limitazioni al trattamento dello studio.
3. Patologie gravi, progressive o non controllate, quali malattie renali, epatiche, ematologiche, endocrine, polmonari, cardiache, neurologiche, cerebrali o psichiatriche, o segni e sintomi di tali malattie.
4. Qualsiasi nuova neoplasia maligna, attiva o sospetta, documentata, a eccezione del carcinoma cutaneo basocellulare o squamocellulare o del carcinoma in situ della cervice uterina opportunamente trattati.
5. L’uso di qualsiasi medicinale soggetto a restrizioni o di qualsiasi farmaco considerato dallo sperimentatore in grado di interferire con la conduzione sicura dello studio dopo l’ultima visita dello studio originario 1368-0052.
6. Anamnesi positiva per allergia/ipersensibilità al farmaco sperimentale somministrato per via sistemica o ai suoi eccipienti.
7. Intervento di chirurgia maggiore (ritenuta tale secondo la valutazione dello sperimentatore) pianificato nel corso di questo studio di estensione (ad es. sostituzione protesica dell’anca, resezione di aneurisma, bendaggio gastrico), come valutato dallo sperimentatore.
8. Qualsiasi patologia che, secondo l’opinione dello sperimentatore, influisca sulla sicurezza del paziente e sulla sua capacità di partecipare a questo studio o che potrebbe compromettere la qualità dei dati.
9. Comportamenti suicidari negli ultimi 2 anni (ovvero, tentativo concreto, tentativo interrotto, tentativo fallito, oppure comportamenti o atti preparatori).
10. Ideazioni suicidarie di tipo 4 o 5 secondo la C-SSRS negli ultimi 3 mesi (ovvero, ideazioni suicidarie attive con un metodo e intenzione di agire, ma senza un piano specifico; oppure ideazioni suicidarie attive con un metodo, un piano e con intenzione).
11. Pazienti attualmente arruolati in un altro studio relativo a un dispositivo o un farmaco sperimentale, ad eccezione del 1368-0052.
12. Precedente partecipazione a questo studio

E.5 End points

E.5.1

Primary end point(s)

1) Occurrence of treatment emergent adverse events (TEAE) up to the end of maintenance treatment period including REP (i.e., 16 weeks after the last study treatment).

1) L’endpoint primario è la comparsa di eventi avversi emersi durante il trattamento (TEAE) fino alla fine del periodo di trattamento di mantenimento, incluso il periodo di effetto residuo (cioè 16 settimane dopo l’ultimo trattamento di studio).

E.5.1.1

Timepoint(s) of evaluation of this end point

1) 120 weeks

1) 120 settimane

E.5.2

Secondary end point(s)

1) Percentage change in total abscess and inflammatory nodule (AN) count from baseline up to Week 12.
2) Percentage change in total draining fistula (DF) count from baseline up to Week 12.
3) Hidradenitis Suppurativa Clinical Response (HiSCR) up to Week 12.
4) Change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) value up to Week 12.
5) Hidradenitis Suppurativa Physician Global Assessment (HS-PGA) score of 0 or 1 up to Week 12.
6) Absolute change from baseline in Hidradenitis Suppurativa Area and Severity Index (HASI) score up to Week 12.
7) Occurence of 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.
8) Achievement of at least 30% reduction from baseline in Numerical Rating Scale (NRS30) in Patient’s Global Assessment of HS Pain up to Week 12.

1) Variazione percentuale del numero totale di ascessi e noduli infiammatori (AN) dal basale fino alla Settimana 12.
2) Variazione percentuale del numero totale di fistole drenanti dal basale fino alla Settimana 12.
3) Risposta clinica dell’idrosadenite suppurativa (HiSCR) fino alla Settimana 12.
4) Variazione rispetto al basale nel valore dell’International Hidradenitis Suppurativa Severity Score System (IHS4) fino alla Settimana 12
5) Hidradenitis Suppurativa Physician Global Assessment (HS-PGA) con un punteggio di 0 o 1 fino alla Settimana 12.
6) Variazione assoluta rispetto al basale nel punteggio dell’Hidradenitis Suppurativa Area and Severity Index (HASI) fino alla Settimana 12.
7) Numero 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.
8) Numero di pazienti che abbiano ottenuto una riduzione almeno del 30% rispetto al basale nella scala di valutazione numerica (NRS30) nella valutazione globale del dolore del paziente causato da idrosadenite suppurativa fino 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

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

E.8.1.1

Randomised

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

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

Only Visit 1 is BLINDED. Remainder of trial is OPEN LABEL.

Solo la prima visita è in cieco. Il resto è "OPEN LABEL"

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)

None

nessuno

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

2021-06-17

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-05-13

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

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