Clinical Trials Register

Summary
EudraCT Number:	2019-000612-29
Sponsor's Protocol Code Number:	IM011075
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2020-02-28
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

Spain - AEMPS

A.2

EudraCT number

2019-000612-29

A.3

Full title of the trial

An Open-Label, Multi-Center Extension Study to Characterize the Long-Term Safety and Efficacy of BMS-986165 in Subjects with Moderate-to-Severe Plaque Psoriasis

Estudio de extensión abierto y multicéntrico para caracterizar la seguridad y la eficacia a largo plazo de BMS-986165 en pacientes con psoriasis en placas de moderada a grave

A.3.1

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

Long-Term Safety and Efficacy of BMS-986165 in Subjects with Psoriasis

Seguridad y eficacia a largo plazo de BMS-986165 en pacientes con psoriasis

A.4.1

Sponsor's protocol code number

IM011075

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 Research and Development
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.5.6	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	BMS-986165
D.3.2	Product code	BMS-986165
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	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	BMS-986165
D.3.9.1	CAS number	1609392-28-0
D.3.9.2	Current sponsor code	BMS986165
D.3.9.3	Other descriptive name	BMS986165
D.3.9.4	EV Substance Code	SUB180283
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	6
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
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	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.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Moderate-to-Severe Plaque Psoriasis

Psoriasis en placas de moderada a grave

E.1.1.1

Medical condition in easily understood language

Psoriasis

E.1.1.2

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

MedDRA Classification

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 characterize the safety and tolerability of long-term
use of BMS-986165 in subjects with moderate-to-severe
plaque psoriasis

Caracterizar la seguridad y tolerabilidad del uso a largo plazo de BMS-986165 en pacientes con psoriasis en placas de moderada a grave

E.2.2

Secondary objectives of the trial

To characterize the maintenance of response to
BMS-986165 in the treatment of subjects with moderateto-
severe plaque psoriasis

Caracterizar el mantenimiento de la respuesta a BMS-986165 en el tratamiento de pacientes con psoriasis en placas de moderada a grave

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1) Completion of the protocol-required treatment period in an applicable study of BMS-986165 in moderate-to-severe psoriasis
2) Subjects must be willing to participate in IM011075 and must have the ability to sign the informed consent form (ICF).
3) Women must not be pregnant, lactating, breastfeeding, or planning pregnancy during the study period (must have a negative urine pregnancy test 24 hours prior to the start of study drug.

1)Finalización del período de tratamiento requerido por el protocolo en un estudio aplicable de BMS-986165 en psoriasis moderada a severa
2)Los sujetos deben estar dispuestos a participar en IM011075 y deben poder firmar el formulario de consentimiento informado (FCI).
3)Las mujeres no deben estar embarazadas, lactando, amamantando o planeando un embarazo durante el período de estudio (deben tener una prueba de embarazo en orina negativa hecha 24 horas antes de empezar con la medicación del estudio)

E.4

Principal exclusion criteria

1) Any disease or medical condition that, in the opinion of the investigator, would make the subject unsuitable for this study, would interfere with the interpretation of subject safety or study results, or is considered unsuitable by the investigator for any other reason
2) Prior permanent discontinuation of study treatment in the parent study
3) Findings Related to Possible TB Infection
4) Evidence of active TB

1)Cualquier enfermedad o afección médica que, en opinión del investigador, haría al sujeto inadecuado para este estudio, interferiría con la interpretación de la seguridad del sujeto o los resultados del estudio, o el investigador lo considera inadecuado por cualquier otro motivo.
2)Interrupción permanente previa del tratamiento en el estudio parental.
3)Hallazgos relacionados con posible infección de TB
4)Evidencia de TB activa

E.5 End points

E.5.1

Primary end point(s)

Adverse events and serious adverse events

Acontecimientos adversos y Acontecimientos adversos severos

E.5.1.1

Timepoint(s) of evaluation of this end point

Each visit (10)

Cada visita (10)

E.5.2

Secondary end point(s)

sPGA 0/1 response; PASI 75 response; sPGA 0 response; PASI 90 response; PASI 100 response; Change from baseline and percent change from baseline in BSA; Change from baseline in PSSD total score; Change from baseline in PSSD symptom score; Change from baseline in PSSD sign score; PSSD total score of 0; PSSD symptom score of 0; PSSD sign score of 0; Change from baseline in DLQI score; DLQI 0/1; EQ-5D-3L; Change from baseline in WLQ score; ss-PGA 0/1 response; PGA-F 0/1 response

Respuesta sPGA 0/1; Respuesta PASI 75; Respuesta sPGA 0; Respuesta PASI 90; Respuesta PASI 100; Cambio desde el inicio y cambio porcentual desde el inicio en BSA; Cambio desde el inicio en la puntuación total PSSD;
Cambio desde el inicio en la puntuación de síntomas de PSSD; Cambio desde el inicio de la valoración de signos PSSD; Puntuación total de PSSD de 0; Puntuación de síntomas de PSSD de 0; Puntuación de la valoración de signos de PSSD de 0; Cambio desde el inicio en la puntuación DLQI; DLQI 0/1; EQ-5D-3L; Cambio desde el inicio en la puntuación WLQ; Respuesta ss-PGA 0/1; Respuesta PGA-F 0/1

E.5.2.1

Timepoint(s) of evaluation of this end point

sPGA 0 response (each visit: wk 4, 8, 16, 24, 36, 48, 60, 72, 84, 96); PASI 90 response (each visit: see sPGA);
PASI 100 response (each visit: see sPGA); Change from baseline and percent change from baseline in BSA (each visit: see sPGA); Change from baseline in PSSD total score (wk 16, 24, 48, 72, 96); Change from baseline in PSSD symptom score (see above); Change from baseline in PSSD sign score (see above); PSSD total score of 0 (see above); PSSD symptom score of 0 (see above); PSSD sign score of 0 (see above); Change from baseline in DLQI score (wk 16, 24, 48, 72, 96); DLQI 0/1 (week 16, 24, 48, 72, 96); EQ-5D-3L (week 4, 24, 48, 60, 72, 84 96);
Change from baseline in WLQ score (week 16, 24, 48, 72, 96); ss-PGA 0/1 response (week 16, 24, 48, 72, 96);
PGA-F 0/1 response (see above)

Resp. sPGA 0 (s 4, 8, 16, 24, 36, 48, 60, 72, 84, 96); Resp. PASI 90 (ver sPGA); Resp. PASI 100 (ver sPGA); Cambio desde el inicio y cambio porcentual desde el inicio en BSA (ver sPGA);Cambio desde el inicio en puntuación total PSSD (s 16, 24, 48, 72, 96); Cambio desde el inicio en puntuación síntomas de PSSD (ver arriba); Cambio desde el inicio de valoración de signos PSSD (ver arriba); Punt. total de PSSD de 0 (ver arriba); Punt. de síntomas de PSSD de 0 (ver arriba); Punt. valoración de signos de PSSD de 0 (ver arriba); Cambio desde el inicio en la punt. DLQI (s 16, 24, 48, 72, 96); DLQI 0/1 (s 16, 24, 48, 72, 96); EQ-5D-3L (s 4, 24, 48, 60, 72, 84 96); Cambio desde el inicio en la punt; WLQ (s 16, 24, 48, 72, 96); Resp.ss-PGA 0/1 (s 16, 24, 48, 72, 96); Resp. PGA-F 0/1 (ver arriba)

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

E.6.8

Bioequivalence

E.6.9

Dose response

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

E.8.1.1

Randomised

E.8.1.2

Open

Yes

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

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

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

130

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

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

China

Czech Republic

Denmark

Finland

France

Germany

Hungary

Israel

Italy

Japan

Korea, Republic of

New Zealand

Poland

Russian Federation

Spain

Sweden

Taiwan

United Kingdom

United States

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

LPLV

Última visita del último paciente

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:

1800

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

200

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

398

F.4.2.2

In the whole clinical trial

1950

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, the investigator should ensure that subjects continue to receive appropriate
standard of care to treat the condition under study. In addition, for subjects who continue to
demonstrate clinical benefit, BMS may continue to provide study treatment through another
mechanism at the discretion of BMS.

Al final del estudio, el investigador debe asegurarse de que los sujetos continúen recibiendo
atención adecuada estándar para tratar la afección en estudio. Además, para sujetos que continúan
demostrando beneficio clínico, BMS puede continuar brindando tratamiento de estudio a través de otro
mecanismo a discreción de BMS.

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

2020-04-03

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-04-01

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

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