Clinical Trials Register

Summary
EudraCT Number:	2016-000101-37
Sponsor's Protocol Code Number:	IM128-035
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2018-02-27
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

2016-000101-37

A.3

Full title of the trial

A Phase II, Randomized, Multi-Center, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of BMS-931699 (lulizumab) or BMS-986142 in Subjects with Moderate to Severe Primary Sjögren's Syndrome

Studio di fase II randomizzato, multicentrico, in doppio cieco, controllato con placebo, per valutare l’efficacia e la sicurezza di BMS-931699 (lulizumab) o di BMS-986142 in soggetti affetti da sindrome di Sjögren primaria da moderata a grave

A.3.1

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

Proof of Concept Study to Evaluate the Efficacy and Safety of BMS-931699 (lulizumab) or BMS-986142 in Primary Sjögren's Syndrome

Studio per valutare l'efficacia e la sicurezza di BMS-931699 (Lulizumab) o BMS-986142 nella sindrome di Sjögren primaria

A.3.2

Name or abbreviated title of the trial where available

POC H2H study

A.4.1

Sponsor's protocol code number

IM128-035

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT02843659

A.5.3

WHO Universal Trial Reference Number (UTRN)

U1111-1171-5832

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	BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
B.1.3.4	Country	Belgium
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	Bristol-Myers Squibb International Corporation
B.4.2	Country	Belgium
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Bristol-Myers Squibb International Corporation
B.5.2	Functional name of contact point	GCT-SU
B.5.3	Address:
B.5.3.1	Street Address	Parc de l'Alliance - Avenue de Finlande, 4
B.5.3.2	Town/ city	Braine-l'Alleud
B.5.3.3	Post code	1420
B.5.3.4	Country	Belgium
B.5.4	Telephone number	0032
B.5.5	Fax number	0032
B.5.6	E-mail	clinical.trials@bms.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	BTK Inhibitor
D.3.2	Product code	BMS-986142
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	BTK Inhibitor
D.3.9.1	CAS number	1643368-58-4
D.3.9.2	Current sponsor code	BMS986142
D.3.9.3	Other descriptive name	BMS986142
D.3.9.4	EV Substance Code	SUB179398
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	50
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	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	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	BTK Inhibitor
D.3.2	Product code	1643368-58-4
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	BTK Inhibitor
D.3.9.1	CAS number	1643368-58-4
D.3.9.2	Current sponsor code	BMS986142
D.3.9.3	Other descriptive name	BMS986142
D.3.9.4	EV Substance Code	SUB179398
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	150
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	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	No
D.IMP: 3
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	Anti-CD28dab
D.3.2	Product code	BMS-931699
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
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Anti-CD28dAb
D.3.9.1	CAS number	1421830-13-8
D.3.9.2	Current sponsor code	BMS-931699
D.3.9.3	Other descriptive name	Anti-CD28dAb
D.3.9.4	EV Substance Code	SUB168198
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	12.5
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 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Film-coated tablet
D.8 Placebo: 3
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for injection

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

subjects with moderate to severe Sjögren's syndrome

Soggetti affetti da sindrome di Sjögren da moderata a grave

E.1.1.1

Medical condition in easily understood language

subjects with moderate to severe Sjögren's syndrome

Soggetti affetti da sindrome di Sjögren da moderata a grave

E.1.1.2

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

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	10040766
E.1.2	Term	Sjogren's disease
E.1.2	System Organ Class	10028395 - Musculoskeletal and connective tissue disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.1
E.1.2	Level	PT
E.1.2	Classification code	10048676
E.1.2	Term	Sjogren-Larsson syndrome
E.1.2	System Organ Class	10010331 - Congenital, familial and genetic disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10040767
E.1.2	Term	Sjogren's syndrome
E.1.2	System Organ Class	10028395 - Musculoskeletal and connective tissue disorders

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	10042846
E.1.2	Term	Syndrome Sjogren's
E.1.2	System Organ Class	10028395 - Musculoskeletal and connective tissue disorders

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	10040765
E.1.2	Term	Sjogren's
E.1.2	System Organ Class	10028395 - Musculoskeletal and connective tissue disorders

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 evaluate the efficacy of treatment with either lulizumab or BMS-986142 versus placebo in subjects with moderate to severe primary Sjögren’s syndrome as measured by the change from baseline in ESSDAI at Week 12 between active treatment arms (lulizumab or BMS-986142, respectively) and the placebo arm

Valutare l’efficacia del trattamento con lulizumab o con BMS-986142 rispetto al placebo in soggetti affetti da sindrome di Sjögren primaria da moderata a grave, in base alla variazione del punteggio ESSDAI dal basale alla Settimana 12 tra i bracci in trattamento attivo (lulizumab o BMS-986142, rispettivamente) e il braccio placebo.

E.2.2

Secondary objectives of the trial

To assess the:-Change from baseline in ESSPRI score at Wk 12 -Proportion of subject from baseline at wk12 with:>3 pt improvement in ESSDAI/>1 pt improvement in ESSPRI/both >3 pt improvement in ESSDAI and >1 pt improvement in ESSPRI -Change from baseline at Wk 4 and Wk 8: in ESSDAI and ESSPRI scores -Change from baseline in ESSPRI components at Wk 4, 8 and 12-Change from baseline in unstimulated and stimulated salivary flow at Wks 4, 8, and 12-Change from baseline in ocular surface staining, Schirmer’s test, and tear-break up time test at Wks 4, 8,and 12-Safety and tolerability of lulizumab or BMS-986142 in subjects with moderate to severe pSS, as measured by adverse events, laboratory parameters, vital signs, physical exams, and ECGs-Change from baseline in patient and physician assessments of disease activity:NRS scores for mouth, eye and vaginal dryness/patGDA and phyGDA/PROMIS Fatigue SF/SF-36 acute/FSFI/WPAI-Trough plasma concentrations of lulizumab and BMS-986142 in pSS subjects

Valutare i seguenti parametri:
• Variazione dal basale del punteggio dell’indice riferito dal paziente con sindrome Sjögren della Lega europea contro le malattie reumatiche (EULAR’s Sjögren’s Syndrome Patient-Reported Index, ESSPRI) alla Settimana 12
• Proporzione di soggetti con un miglioramento di  3 punti rispetto al basale del punteggio ESSDAI alla Settimana 12
• Proporzione di soggetti con un miglioramento di  1 punto dal basale del punteggio ESSPRI alla Settimana 12
• Proporzione di soggetti con un miglioramento sia di  3 punti del punteggio ESSDAI sia di ≥ 1 punto del punteggio ESSPRI dal basale alla Settimana 12
• Variazione rispetto al basale dei punteggi ESSDAI alla Settimana 4 e alla Settimana 8
• Variazione rispetto al basale dei punteggi ESSPRI alla Settimana 4 e alla Settimana 8
• Variazione rispetto al basale delle componenti dell’indice ESSPRI (secchezza, affaticamento e dolore) alle Settimane 4, 8 e 12
ecc
PER LA LISTA COMPLETA, FAR RIF. AL PROTOCOLLO DI STUDIO

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Age 18-70 years old
- Subjects diagnosed or classified as having moderate to severe primary Sjögren’s syndrome based on the 2015 ACR-EULAR Classification Criteria
- ESSDAI ≥ 5 including disease activity (any score > 0) in at least one of the following domains: Glandular, Articular, Hematological, Biological, Lymphadenopathy
- Positive anti-SS-A/Ro or anti-SS-B/La autoantibody
- Unstimulated whole saliva secretion > 0.01 ml/min
- Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug and must not be pregnant or breastfeeding. Male and female subjects must be willing to adhere to protocol-mandated highly effective contraception for the duration of the study and for the protocol-specified follow up period. Hormone-based contraceptive methods are not permitted.

• Età compresa tra 18-70 anni;
• Soggetti che hanno ricevuto una diagnosi di, o sono stati classificati come affetti da, sindrome di Sjögren da moderata a grave in base ai criteri di classificazione per la sindrome di Sjögren ACR-EULAR del 2015, con una durata della malattia dalla diagnosi che deve essere, alla visita di screening, di almeno 16 settimane, ma non superiore a 7 anni
• Punteggio ESSDAI  5; inclusa attività della malattia (qualsiasi punteggio > 0) in almeno uno dei seguenti domini: ghiandolare, articolare, ematologico, biologico, linfoadenopatia
• Positività agli autoanticorpi anti-SS-A/Ro o anti-SS-B/La
• Secrezione salivare non stimolata > 0,01 ml/min
• Donne in età fertile (donne potenzialmente fertili) devono avere una negatività del siero o
del test di gravidanza (sensibilità minima di 25 IU/L o unità
equivalenti di HCG) nelle 24 ore prima dell'inizio del farmaco in studio e non devono essere
gravide o in l'allattamento. Soggetti maschi e femmine devono essere disposti ad adottare metodi contraccettivi altamente efficaci come descritti nel protocollo di studio per tutta la
durata dello studio e per il periodo di follow-up specificato nel protocollo.
Non sono consentiti metodi contraccettivi a base di ormoni.

E.4

Principal exclusion criteria

-Secondary Sjögren's syndrome or the presence of any other systemic autoimmune disease (eg, RA, SLE, multiple sclerosis)
-Very severe primary Sjögren's syndrome or severe complications of primary Sjögren's syndrome at the time of the screening visit
-Active systemic bacterial (including tuberculosis), viral or fungal infection, or evidence of prior or current Hepatitis B or C, HIV infection, latent bacterial, viral or fungal infections
-Any significant concurrent medical condition at the time of screening or baseline visit
-Use of methotrexate, cyclophosphamide, cyclosporine, tacrolimus, azathioprine, mycophenolate mofetil (MMF) or leflunomide within 12 weeks of screening visit
-Previous treatment with other biologics either marketed or in development within 6 months prior to screening visit
-Treatment started or an unstable dose of hydroxychloroquine within
8 weeks of screening visit.
-Oral corticosteroids > 10 mg/day within 14 days of dosing (Day 1), corticosteroid therapy ≥ 1 mg/kg during the 4 weeks preceding enrollment, or intravenous, intramuscular or intra-articular corticosteroids within 4 weeks of screening visit.

- Sindrome di Sjögren secondaria o presenza di qualsiasi altra malattia sistemica
autoimmune (es, RA, LES, sclerosi multipla)
- Sindrome di Sjogren primaria molto grave o con gravi complicazioni, al momento della visita di screening.
- Infezione sistemica batterica (compresa la tubercolosi) virale o fungina attiva o evidenza di una precedente epatite B o C, infezione da HIV, infezioni latenti batteriche, virali o fungine;
- qualsiasi condizione medica concomitante significativa al momento dello screening o della
visita basale;
- Uso di metotrexato, ciclofosfamide, ciclosporina, tacrolimus, azatioprina, micofenolato mofetile (MMF) o leflunomide entro 12 settimane dalla visita di screening;
- Precedente trattamento con altri farmaci biologici sia in commercio o in sviluppo nei 6 mesi precedenti la visita di screening;
-Iniziare un trattamento o avere una dose instabile di idrossiclorochina entro le 8 settimane dalla visita di screening.
- Corticosteroidi orali > 10 mg /die entro 14 giorni dal giorno 1 di somministrazione dei farmaci in studio, terapia con corticosteroidi ≥ 1 mg / kg durante le 4 settimane precedenti l’arruolamento, corticosteroidi per via endovenosa, intramuscolare o intra-articolare entro 4 settimane dalla visita di screening.

E.5 End points

E.5.1

Primary end point(s)

To compare the change from baseline in ESSDAI score at Week 12
between active treatment arms (lulizumab or BMS-986142) and the
placebo arm

L’endpoint primario consiste nel confrontare la variazione del punteggio ESSDAI dal basale alla Settimana 12 tra i bracci in trattamento attivo (lulizumab o BMS-986142) e il braccio placebo

E.5.1.1

Timepoint(s) of evaluation of this end point

Week 12

settimana 12

E.5.2

Secondary end point(s)

(1)Change from baseline in ESSPRI score
(1)Proportions of subjects with >3 points of improvement from baseline in ESSDAI
(1)Proportions of subjects with >1 point of improvement from baseline in ESSPRI
(1)Proportion of subjects with both >3 points improvement in ESSDAI and >1 point improvement in ESSPRI from baseline
(2)Change from baseline in ESSDAI score
(2)Change from baseline in ESSPRI score
(3)Change from baseline in ESSPRI individual component (Dryness, Fatigue, and Pain) scores
(3)Change from baseline in unstimulated and stimulated salivary flow
(3)Change from baseline in ocular surface staining, Schrimer's test, and the tear break-up time test
(4)Safety and tolerability of lulizumab or BMS-986142 in subjects with moderate to severe pSS
(4)Numeric rating scale (NRS) for mouth, eye and vaginal dryness
(4)Patient and physician Global Assessment of Disease activity
(4)Short Form-36 acute (SF-36 acute)
(4)Female Sexual Function Index (FSFI)
(4)Work Participation and Activity Impairment Questionnaire (WPAI)
(4)PROMIS Fatigue Short Form
(4)Trough plasma concentrations of lulizumab and BMS-986142 in pSS subjects

(1) Variazione dal basale del punteggio ESSPRI alla Settimana 12
(1) Proporzione di soggetti con un miglioramento di ≥ 3 punti del punteggio ESSDAI dal basale alla Settimana 12
(1) Proporzione di soggetti con un miglioramento di ≥ 1 punti del punteggio ESSPRI dal basale alla Settimana 12
(1) Proporzione di soggetti con un miglioramento sia di ≥ 3 punti nel punteggio ESSDAI sia di ≥ 1 punto nel punteggio ESSPRI dal basale alla Settimana 12
• Variazione rispetto al basale dei seguenti parametri:
o (2) Punteggi ESSDAI alla Settimana 4 e alla Settimana 8
o (2) Punteggi ESSPRI alla Settimana 4 e alla Settimana 8
o (3)Punteggi delle singole componenti dell’indice ESSPRI (secchezza, affaticamento e dolore) alle Settimane 4, 8 e 12
o (3) Tasso di flusso salivare non stimolato e stimolato alle Settimane 4, 8 e 12
o (3)Colorazione della superficie oculare, test di Schirmer e tempo di rottura del film lacrimale alle Settimane 4, 8 e 12
(4) Sicurezza e tollerabilità di lulizumab o BMS-986142 misurate in base ad eventi avversi, parametri di laboratorio, parametri vitali, esami obiettivi ed ECG
(4) Variazione rispetto al basale delle valutazioni di paziente e medico dell’attività della malattia:
o Scala numerica (NRS) relativa alla secchezza orale, oculare e vaginale
o Valutazione globale del soggetto dell’attività della malattia (SubGDA) e valutazione globale del medico dell’attività della malattia (phyGDA)
o Questionario Short Form-36 (SF-36)
o Indice di funzionalità sessuale femminile (FSFI)
o Questionario sull’attività lavorativa e la compromissione dell’attività (WPAI)
o Modulo breve PROMIS
(4) Concentrazioni minime di BMS-931699 e BMS-986142 nei punti di rilevazione specificati dal protocollo

E.5.2.1

Timepoint(s) of evaluation of this end point

(1)Week 12
(2)Up to Week 8
(3)Up to Week 12
(4)Up to Week 18

(1) Settimana 12
(2) Fino alla settimana 8
(3 Fino alla settimana 12
(4) Fino alla settimana 18

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

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

Belgium

Chile

Colombia

Denmark

France

Greece

Italy

Mexico

Netherlands

Norway

Peru

Poland

Romania

Russian Federation

South Africa

United Kingdom

United States

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

Number of subjects for this age range:

F.1.1.1

In Utero

Information not present in EudraCT

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

Information not present in EudraCT

F.1.1.3

Newborns (0-27 days)

Information not present in EudraCT

F.1.1.4

Infants and toddlers (28 days-23 months)

Information not present in EudraCT

F.1.1.5

Children (2-11years)

Information not present in EudraCT

F.1.1.6

Adolescents (12-17 years)

Information not present in EudraCT

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

144

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

Yes

F.3.3.2

Women of child-bearing potential using contraception

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

120

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)

At the end of the study, BMS will not continue to provide BMS supplied study drug to subjects/investigators unless BMS chooses to extend the study. Please refer to section 3.2 of the protocol

Al termine dello studio, BMS non continuerà a fornire i farmaci in studio a meno che non decida, a sua discrezione, di estendere lo studio . Si prega di fare riferimento alla sezione 3.2 del protocollo.

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

2017-03-29

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-01-19

P. End of Trial
P.	End of Trial Status	Prematurely Ended

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IMP with orphan designation in the indication
Orphan Designation Number:
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