Clinical Trials Register

Summary
EudraCT Number:	2021-002012-31
Sponsor's Protocol Code Number:	CNTO1959PSA2003
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:	2021-08-05
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2021-002012-31

A.3

Full title of the trial

A Phase 2a, Multicenter, Randomized, Double-blind Study Evaluating the Efficacy and Safety of Subcutaneously Administered Guselkumab and Golimumab Combination Therapy in Participants with Active Psoriatic Arthritis

Estudio fase 2a, multicéntrico, aleatorizado, doble ciego para evaluar la eficacia y seguridad de Guselkumab y Golimumab administrados en terapia combinada subcutánea en pacientes con artritis psoriásica activa.

A.3.1

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

A Study of the Efficacy and Safety of Guselkumab and Golimumab in Participants with Active Psoriatic Arthritis

Estudio para evaluar la eficacia y la seguridad de Guselkumab y Golimumab en pacientes con artritis psoriásica activa

A.3.2

Name or abbreviated title of the trial where available

AFFINITY

A.4.1

Sponsor's protocol code number

CNTO1959PSA2003

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	Janssen-Cilag International NV
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	Janssen Research & Development
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	Janssen-Cilag, S.A
B.5.2	Functional name of contact point	Global Clinical Operations
B.5.3	Address:
B.5.3.1	Street Address	Paseo de las Doce Estrellas, 5-7
B.5.3.2	Town/ city	Madrid
B.5.3.3	Post code	28042
B.5.3.4	Country	Spain
B.5.4	Telephone number	+34917228687
B.5.6	E-mail	ccarrill@its.jnj.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	guselkumab
D.3.2	Product code	CNTO1959
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	GUSELKUMAB
D.3.9.2	Current sponsor code	CNTO 1959
D.3.9.3	Other descriptive name	GUSELKUMAB
D.3.9.4	EV Substance Code	SUB179789
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	100
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	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	Yes
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	Yes
D.3.11.13.1	Other medicinal product type	monoclonal antibody
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	golimumab
D.3.2	Product code	CNTO148
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	GOLIMUMAB
D.3.9.1	CAS number	476181-74-5
D.3.9.2	Current sponsor code	CNTO148
D.3.9.4	EV Substance Code	SUB25638
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	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	Yes
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	Yes
D.3.11.13.1	Other medicinal product type	monoclonal antibody

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 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

Active Psoriatic Arthritis

Artritis Psoriásica Activa

E.1.1.1

Medical condition in easily understood language

Psoriatic Arthritis

Artritis Psoriásica

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	21.0
E.1.2	Level	LLT
E.1.2	Classification code	10037160
E.1.2	Term	Psoriatic arthritis
E.1.2	System Organ Class	100000004859

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 guselkumab+golimumab combination treatment in participants with active PsA and IR to a prior anti-TNFα therapy by assessing clinical response compared with guselkumab monotherapy

Evaluar la eficacia de la politerapia con guselkumab+golimumab en pacientes con APs activa y respuesta inadecuada (RI) a un tratamiento anterior de inhibición del factor de necrosis tumoral alfa (TNFα) mediante la evaluación de la respuesta clínica en comparación con la monoterapia con guselkumab.

E.2.2

Secondary objectives of the trial

- Efficacy: To evaluate the efficacy of guselkumab+golimumab combination treatment in participants with active PsA and
IR to a prior anti-TNFα therapy by assessing the reduction in signs and symptoms of PsA compared with guselkumab monotherapy
- Safety: To evaluate the safety of guselkumab+golimumab combination treatment in participants with active PsA compared with guselkumab monotherapy
- PK and Immunogenicity: To evaluate the PK and immunogenicity of
guselkumab+golimumab combination treatment in participants with active PsA compared with guselkumab monotherapy

- Eficacia: Evaluar la eficacia de la politerapia con guselkumab+golimumab en pacientes con APs activa y RI a un tratamiento anterior de inhibición del TNFα mediante la evaluación de la reducción de los signos y los síntomas de la APs en comparación con la monoterapia con guselkumab.
- Seguridad: Evaluar la seguridad de la politerapia con guselkumab+golimumab en pacientes con APs activa en comparación con la monoterapia con guselkumab
- FC e inmunogenicidad: Evaluar la farmacocinética (FC) y la inmunogenicidad de la politerapia con guselkumab+golimumab en pacientes con APs activa en comparación con la monoterapia con guselkumab

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

Initial Clinical Protocol, 08 June 21, version 1.0. Biopsies from lesional and nonlesional skin may be collected from participants who consent to this optional substudy component of the study (with a separate ICF), as fixed blocks, slides, fresh or frozen samples, where local regulations permit.

Protocolo clínico inicial, 8 de junio de 2021, versión 1.0. Donde lo permita la regulación local, se obtendrán biopsias cutáneas de piel con lesión y sin lesión, de aquellos pacientes que consientan para este sub-estudio opcional del estudio (firmando un DCI separado) en bloque, laminillas, frescas o muestras congeladas.

E.3

Principal inclusion criteria

- Be ≥18 to ≤65 years of age, inclusive.
- Medically stable on the basis of physical examination, medical history, vital signs, and 12-lead ECG performed at screening. Any abnormalities must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and initialed by the investigator.
- Have a diagnosis of PsA for ≥6 months prior to the first administration of study intervention and meet ClASsification criteria for Psoriatic ARthritis criteria at screening.
- Have active PsA as defined by: At least 3 swollen joints and at least 3 tender joints at screening and at baseline and, hsCRP ≥0.3 mg/dL at screening from the central laboratory
- Have at least 1 of the following PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis.

For the complete overview of the inclusion criteria, please refer to section 5.1 of the protocol

- Tener ≥18 y ≤65 años, incluidos.
- Estar estable desde el punto de vista médico conforme a la exploración física, la historia clínica, las constantes vitales y el ECG de 12 derivaciones realizados en la selección. Cualquier anomalía debe ser coherente con la enfermedad subyacente en la población del estudio y esta determinación debe registrarse en los documentos originales del paciente con las iniciales del investigador.
- Contar con un diagnóstico de artritis psoriásica (AP) durante ≥6 meses antes de la primera administración del tratamiento del estudio y cumplir los criterios de clasificación para la artritis psoriásica en la fase de selección.
- Tener una AP activa, que se define del siguiente modo: al menos 3 articulaciones inflamadas y al menos 3 articulaciones dolorosas a la palpación en la fase de selección y en el momento de referencia y hsCRP ≥0,3 mg/dl en la selección según resultados del laboratorio central.
- Tener al menos 1 de los siguientes subconjuntos de AP: afectación de la articulación interfalángica distal, artritis poliarticular con ausencia de nódulos reumatoides, artritis periférica asimétrica o espondilitis con artritis periférica.

Por favor, refiérase a la sección 5.1 del protocolo para consultar todos los criterios de inclusión

E.4

Principal exclusion criteria

- Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal insufficiency, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, genitourinary, or metabolic disturbances.
- Has unstable cardiovascular disease, defined as a recent clinical deterioration in the last 3 months prior to screening or a cardiac hospitalization within the last 3 months prior to screening.
- Has a history of, or concurrent, congestive heart failure, including medically controlled, asymptomatic congestive heart failure.
- Has a history of a demyelinating disorder such as multiple sclerosis or optic neuritis.
- Has other inflammatory diseases that might confound the evaluations of benefit of guselkumab and/or golimumab therapy, including but not limited to RA, AS, nr-AxSpA, systemic lupus erythematosus, or lyme disease.

For the complete overview of the exclusion criteria, please refer to
section 5.2 of the protocol

- Tener antecedentes o signos o síntomas actuales de insuficiencia renal o alteraciones hepáticas, cardíacas, vasculares, pulmonares, gastrointestinales, endocrinas, neurológicas, hematológicas, reumatológicas (a excepción de la AP), psiquiátricas, genitourinarias o metabólicas, ya sean graves, progresivas o no controladas.
- Tener enfermedad cardiovascular inestable, definida como un deterioro clínico reciente en los últimos 3 meses antes de la selección o una hospitalización por motivos cardíacos en los últimos 3 meses antes de la selección.
- Tener antecedentes de insuficiencia cardíaca congestiva o concurrente, incluida la insuficiencia cardíaca congestiva asintomática y médicamente controlada.
- Tener antecedentes de un trastorno desmielinizante como esclerosis múltiple o neuritis óptica.
- Tener otras enfermedades inflamatorias que podrían confundir la evaluación de los beneficios del tratamiento con guselkumab o golimumab, lo que incluye, entre otras, artritis reumatoide (AR), espondilitis anquilosante (EA), espondiloartritis axial no radiográfica (nr-AxSpA), lupus eritematoso sistémico o enfermedad de Lyme.

Por favor, refiérase a la sección 5.2 del protocolo para consultar todos los criterios de exclusión

E.5 End points

E.5.1

Primary end point(s)

Proportion of participants who achieve MDA at Week 24

Proporción de pacientes que consiguen una actividad mínima de la enfermedad (AME) en la semana 24

E.5.1.1

Timepoint(s) of evaluation of this end point

Week 24

Semana 24

E.5.2

Secondary end point(s)

- Proportion of participants who achieve ACR 50 at Week 24
- Proportion of participants who achieve MDA at Week 16
- Proportion of participants who achieve Psoriasis Area and Severity Index 90/100 at Week 24 among the participants with ≥3% BSA psoriatic involvement and an IGA score of ≥2 at baseline
- Proportion of participants with an Investigator Global Assessment-psoriasis response at Week 24 among participants with ≥3% BSA psoriatic involvement and an IGA score of ≥2 at baseline
- Change from baseline in Health Assessment Questionnaire Disability Index at Week 24
- Resolution of enthesitis at Week 24 among the participants with enthesitis at baseline
- Resolution of dactylitis at Week 24 among the participants with dactylitis at baseline
- Change from baseline in Short Form Health Survey Physical Component Score (PCS) at Week 24

- Proporción de pacientes que consiguen una puntuación de 50 según los criterios del American College of Rheumatology (ACR) en la semana 24.
- Proporción de pacientes que consiguen una AME en la semana 16.
- Proporción de pacientes que consiguen una puntuación de 90/100 en el Índice de extensión y gravedad de la psoriasis (PASI) en la semana 24 entre los pacientes con una superficie corporal (SC) afectada por la psoriasis ≥3 % y una puntuación de ≥2 (leve) según la evaluación global del investigador (IGA) en la visita basal.
- Proporción de pacientes con una respuesta a la psoriasis en la IGA (es decir, una puntuación de 0 [desaparecida] o 1 [mínima] Y una reducción de grado ≥2 con respecto a la visita basal) en la semana 24 entre los pacientes con una SC afectada por la psoriasis ≥3 % y una puntuación IGA de ≥2
(leve) en la visita basal.
- Cambio respecto al momento de referencia en el Índice de discapacidad del cuestionario de evaluación de la salud (HaQ-DI) en la semana 24.
- Resolución de la entesitis en la semana 24 entre los pacientes con entesitis en la visita basal.
- Resolución de la dactilitis en la semana 24 entre los pacientes con dactilitis en la visita basal.
- Cambio respecto a la visita basal en la puntuación de componentes físicos (PCS) del Cuestionario de salud breve (SF-36) en la semana 24

E.5.2.1

Timepoint(s) of evaluation of this end point

Week 16 and 24

Semana 16 y 24

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

E.6.11

Pharmacogenomic

Yes

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

MRI, Biomarker and Immunogenicity assessments

Evaluaciones de RM, biomarcadores e inmunogenicidad

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

Yes

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

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

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

Russian Federation

Ukraine

United States

Poland

Spain

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

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

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)

Participants will be instructed that study intervention will not be made available to them after they have completed/discontinued study intervention and that they should return to their primary physician to determine standard of care. Local regulations on continued access will always take precedence. Plans for continued access stated in this protocol may change if new information on the benefit-risk profile of guselkumab becomes available during the study or program.

Se informará a los pacientes de que el tratamiento del estudio no se pondrá a su disposición una vez que hayan completado/discontinuado el estudio y de que deben volver a su médico de cabecera para determinar el estándar de atención. La normativa local sobre el acceso continuado tendrá siempre prioridad. Los planes de acceso continuado indicados en este protocolo pueden cambiar si se dispone de nueva información sobre el perfil beneficio-riesgo de guselkumab durante el estudio o el programa.

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

2021-10-08

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-08-23

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

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials