Clinical Trials Register

Summary
EudraCT Number:	2021-000482-32
Sponsor's Protocol Code Number:	CNTO1959PSA3005
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:	2022-08-05
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

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A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2021-000482-32

A.3

Full title of the trial

A Phase 3B, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants with Active Psoriatic Arthritis who had an Inadequate Response and/or Intolerance to One Prior Anti-Tumor Necrosis Factor α Agent

Estudio de fase 3B, multicéntrico, aleatorizado, doble ciego y controlado con placebo que evalúa la eficacia y seguridad de Guselkumab administrado por vía subcutánea en participantes con artritis psoriásica activa que tuvieron una respuesta inadecuada y/o intolerancia a un tratamiento anterior de inhibición del factor de necrosis tumoral α

A.3.1

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

A Phase 3B, study of Guselkumab in Participants with Active Psoriatic Arthritis who had an Inadequate Response and/or Intolerance to One Prior Anti-Tumor Necrosis Factor α Agent

Estudio de fase 3B de Guselkumab en participantes con artritis psoriásica activa con respuesta inadecuada y/o intolerancia a un tratamiento anterior de inhibición del factor de necrosis tumoral α

A.3.2

Name or abbreviated title of the trial where available

SOLSTICE

A.4.1

Sponsor's protocol code number

CNTO1959PSA3005

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 Pharmaceutica N.V.
B.4.2	Country	Netherlands
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	+34647305705
B.5.6	E-mail	achamarr@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	Yes
D.2.1.1.1	Trade name	TREMFYA™
D.2.1.1.2	Name of the Marketing Authorisation holder	Janssen Cilag International NV
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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 milligram(s)
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.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

Psoriatic Arthritis

Artritis psoriásica

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 treatment in participants with active PsA and IR and/or intolerance to a prior anti-TNF by assessing the reduction in signs and symptoms of PsA.

Evaluar la eficacia del tratamiento con guselkumab en participantes con APS activa y respuesta inadecuada y/o intolerancia a un anti-TNF previo mediante la evaluación de la reducción de los signos y síntomas de la APS.

E.2.2

Secondary objectives of the trial

- To evaluate the efficacy of guselkumab on additional measures of signs and symptoms of PsA, psoriasis, and patient well-being.
- To evaluate the safety of guselkumab in participants with active PsA.
- To evaluate the pharmacokinetics and immunogenicity of guselkumab in participants with active PsA.

- Evaluar la eficacia de guselkumab en medidas adicionales de los signos y síntomas de la APS, la psoriasis y el bienestar del paciente.
- Evaluar la seguridad de guselkumab en participantes con APS activa.
- Evaluar la farmacocinética y la inmunogenicidad de guselkumab en participantes con APS activa.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Be at least 18 years of age.
- Have a diagnosis of PsA for at least 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: a. At least 3 swollen joints and at least 3 tender joints at screening and at baseline AND b. CRP ≥0.3 mg/dL at screening from the central laboratory. NOTE: A 1-time repeat assessment of CRP level is allowed during the 6-week screening
phase and the investigator may consider the participant eligible if the test result is within acceptable range on repeat testing in 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.
- Have an inadequate response and/or intolerance to anti-TNFα therapy, defined as presence of active PsA despite previous treatment with one prior anti-TNFα agent. Participants may meet either one or both of the following criteria: a. Lack of benefit of no more than one prior anti-TNFα therapy, as documented in the patient history by the treating physician, after at least 12 weeks of etanercept, adalimumab, golimumab, or certolizumab pegol therapy or at least a 14-week dosage regimen of infliximab. Documented lack of benefit may include inadequate improvement in joint counts, physical function, or disease activity AND/OR b. Intolerance to no more than one prior anti-TNFα therapy, as documented in the patient history by the treating physician, to etanercept, adalimumab, golimumab, certolizumab pegol, or infliximab.

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

- Tener por lo menos 18 años
-Contar con un diagnóstico de APs al menos durante 6 meses antes de la primera administración del tratamiento del estudio y cumplir los criterios de clasificación para la artritis psoriásica (CASPAR) en la selección.
- Tener una APs activa, que se define del siguiente modo: a. Al menos 3 articulaciones inflamadas y al menos 3 articulaciones dolorosas a la palpación en la selección y en el momento de referencia Y b. PCR ≥0,3 mg/dl en la selección según los resultados del laboratorio central. NOTA: Se permite repetir la prueba 1 vez para determinar el nivel de PCR durante la fase de selección de 6 semanas, y el investigador puede considerar que el paciente es elegible si el resultado de la prueba se encuentra dentro del rango aceptable de pruebas repetidas en el laboratorio central.
-Tener al menos 1 de los siguientes subconjuntos de APs: afectación de la articulación interfalángica distal, artritis poliarticular con ausencia de nódulos reumatoides, artritis periférica asimétrica o espondilitis con artritis periférica.
- Presentar una respuesta inadecuada y/o intolerancia al tratamiento anti-TNFα, definidas como la presencia de APs activa a pesar del tratamiento previo con solo un agente anti-TNFα. Los pacientes pueden cumplir uno o ambos de los siguientes criterios: a. Ausencia de beneficio de no más de un tratamiento anti-TNFα previo, según lo documentado en la historia del paciente por el médico encargado del tratamiento, después de al menos 12 semanas de tratamiento con etanercept, adalimumab, golimumab o certolizumab pegol (o biosimilares), o al menos una pauta de dosificación de 14 semanas de infliximab (o biosimilares). La ausencia documentada de beneficio puede incluir una mejora inadecuada en el recuento de articulaciones, la función física o la actividad de la enfermedad Y/O b. Intolerancia a no más de un tratamiento anti-TNFα previo, según lo documentado en el historial del paciente por el médico encargado del tratamiento, a etanercept, adalimumab, golimumab, certolizumab pegol o infliximab (o biosimilares).

Para ver el resumen completo de los criterios de inclusión, consulte la sección 5.1 del protocolo

E.4

Principal exclusion criteria

- Has other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy in the treatment of PsA, including but not limited to rheumatoid arthritis, ankylosing spondylitis/non-radiographic axial spondyloarthritis, systemic lupus erythematosus, or Lyme disease.
- Has received more than 1 prior anti-TNFα agent.
- Has received an anti-TNFα agent within the following timeframes: 1. Infliximab or golimumab, within 8 weeks prior to the first administration of study intervention. b. Golimumab SC, adalimumab or certolizumab pegol, within 6 weeks prior to the first administration of study intervention. c. Etanercept within 4 weeks prior to the first administration of study intervention.
- Has previously received any biologic treatment other than an anti-TNFα agent including, but not limited to, guselkumab, ustekinumab, secukinumab, tildrakizumab, ixekizumab,brodalumab, risankizumab or other investigative biologic treatment.

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

- Tener otras enfermedades inflamatorias que podrían dificultar la interpretación de las evaluaciones del beneficio de la terapia con guselkumab en el tratamiento de la APs, que incluyen, entre otras, artritis reumatoide, espondilitis anquilosante/espondiloartritis axial no radiográfica, lupus eritematoso sistémico o enfermedad de Lyme.
- Haber recibido más de 1 agente anti-TNFα previo (o biosimilares).
- Haber recibido un agente anti-TNFα dentro de los siguientes plazos: a. Infliximab (o biosimilares) o golimumab en las 8 semanas anteriores a la primera administración del tratamiento del estudio. b. Golimumab s.c., adalimumab o certolizumab pegol (o biosimilares), en las 6 semanas anteriores a la primera administración del tratamiento del estudio. c. Etanercept (o biosimilares) en las 4 semanas anteriores a la primera administración del tratamiento del estudio.
- Haber recibido previamente algún tratamiento biológico (distinto a un agente anti-TNFα) que incluya, entre otros, guselkumab, ustekinumab, secukinumab, tildrakizumab, ixekizumab, brodalumab, risankizumab u otro tratamiento biológico en investigación.

Para ver el resumen completo de los criterios de exclusión, consulte la sección 5.2 del protocolo

E.5 End points

E.5.1

Primary end point(s)

Proportion of participants who achieve an ACR 20 response at Week 24

Proporción de participantes que logran una respuesta ACR 20 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 a psoriasis response of IGA psoriasis score of 0 or 1 AND ≥2-grade reduction from baseline at Week 24 among the participants with ≥3% BSA psoriatic involvement and an IGA score of ≥2 at baseline
- Proportion of participants who achieve PASI 90 response at Week 24 among the participants with ≥3% BSA psoriatic involvement and an IGA score of ≥2 at baseline
- Change from baseline in HAQ-DI at Week 24
- Change from baseline in the SF-36 PCS at Week 24
- Change from baseline in Functional Assessment of Chronic Illness Therapy – fatigue score at Week 24
- Proportion of participants achieving minimal disease activity at Week 24
- Proportion of participants who achieve ACR 20 response at Week 16
Proportion of participants who achieve ACR 50 response at Week 16
- Proportion of participants who achieve ACR 50 response at Week 24
- Proportion of participants who achieve ACR 70 response at Week 24

- Proporción de participantes que logran una respuesta a la psoriasis con una puntuación de IGA de 0 o 1 y una reducción de ≥2 grados con desde la visita basal en a la semana 24 entre los participantes con una afectación psoriásica de ≥3% de la BSA y una puntuación de IGA de ≥2 en la visita basal
- Proporción de participantes que logran una respuesta PASI 90 en la semana 24 entre los participantes con ≥3% de afectación psoriásica de la BSA y una puntuación IGA de ≥2 en la visita basal
- Cambio con respecto al valor de visita basal en el HAQ-DI en la semana 24
- Cambio con respecto a la visita basal en el SF-36 PCS en la semana 24
- Cambio respecto al valor de visita basal en la puntuación de la Evaluación Funcional de la Terapia de Enfermedades Crónicas - fatiga en la Semana 24
- Proporción de participantes que logran una actividad mínima de la enfermedad en la semana 24
- Proporción de participantes que logran una respuesta ACR 20 en la semana 16
- Proporción de participantes que logran una respuesta ACR 50 en la semana 16
- Proporción de participantes que logran una respuesta ACR 50 en la semana 24
- Proporción de participantes que logran una respuesta ACR 70 en la semana 24

E.5.2.1

Timepoint(s) of evaluation of this end point

Week 16 and 24

Semanas 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

Yes

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

Immunogenicity and Biomarker assessments

Evaluaciones de inmunogenicidad y biomarcadores

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

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)

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

Argentina

Australia

Israel

Malaysia

United States

Poland

Bulgaria

Spain

Czechia

Italy

Hungary

Russian Federation

Turkey

Ukraine

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

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:

405

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

338

F.4.2.2

In the whole clinical trial

450

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

Ninguno

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

2022-10-06

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-09-19

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

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