Clinical Trials Register

Summary
EudraCT Number:	2021-001256-34
Sponsor's Protocol Code Number:	CAIN457X12301
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2021-11-19
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

2021-001256-34

A.3

Full title of the trial

A randomized, parallel-group, double-blind, placebo-controlled, multicenter phase III study to investigate the efficacy and safety of secukinumab (Cosentyx) 300 mg administered subcutaneously in patients with active peripheral spondyloarthritis (pSpA)

Estudio de fase 3, multicéntrico, aleatorizado, doble ciego, controlado con placebo y de grupos paralelos para evaluar la eficacia y la seguridad de secukinumab 300 mg administrado por vía subcutánea a pacientes con espondiloartritis periférica activa

A.3.1

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

study to demonstrate the efficacy and safety of secukinumab up to 224 weeks in subjects with active peripheral spondyloathritis (pSpA).

Estudio para demostrar la eficacia y seguridad de secukinumab durante un máximo de 224 semanas en pacientes con espondiloartritis periférica (EspAp) activa.

A.4.1

Sponsor's protocol code number

CAIN457X12301

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	Novartis Farmacéutica, S.A.
B.1.3.4	Country	Spain
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	Novartis Pharma AG
B.4.2	Country	Switzerland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Novartis Farmacéutica, S.A.
B.5.2	Functional name of contact point	Trial Monitoring Organization (TMo)
B.5.3	Address:
B.5.3.1	Street Address	Gran Via de les Corts Catalanes, 764
B.5.3.2	Town/ city	Barcelona
B.5.3.3	Post code	08013
B.5.3.4	Country	Spain
B.5.4	Telephone number	+3493 3064464
B.5.6	E-mail	eecc.novartis@novartis.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	Cosentyx
D.2.1.1.2	Name of the Marketing Authorisation holder	Novartis Europharm Limited
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.3.4	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	secukinumab
D.3.9.1	CAS number	1229022-83-6
D.3.9.2	Current sponsor code	AIN457
D.3.9.3	Other descriptive name	SECUKINUMAB
D.3.9.4	EV Substance Code	SUB33242
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	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	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 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

Peripheral Spondyloarthritis

Espondiloartritis periférica

E.1.1.1

Medical condition in easily understood language

Peripheral Spondyloarthritis

Espondiloartritis periférica

E.1.1.2

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	HLT
E.1.2	Classification code	10052775
E.1.2	Term	Spondyloarthropathies
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

The primary objective and clinical question of interest of this study is to demonstrate the superiority of secukinumab compared to placebo based on Modified Peripheral SpondyloArthritis Response Criteria 40 (mPSpARC40) response at Week 16 in participants with active pSpA

El objetivo principal y la cuestión clínica principal de interés de este estudio es demostrar la superioridad de secukinumab comparado con placebo basándose en la respuesta de los criterios de respuesta 40 modificados de la espondiloartritis periférica (mPSpARC40)) en la semana 16 en participantes con EspAp activa.

E.2.2

Secondary objectives of the trial

To demonstrate the superiority of secukinumab compared to placebo based on:
-Analysis Plan A (At Week 16):
In participants with undifferentiated pSpA: mPSpARC40 response
In participants with active pSpA: mPSpARC50 response, ACR 50
response, physician's global assessment of disease activity, SF-36 PCS, HAQ-DI, enthesitis count for enthesitis
subset ; patient global assessment of disease activity & pain
-Analysis Plan B (Week 16 and Week 52):
In participants with undifferentiated pSpA: mPSpARC40 response at week 16 & 52
In participants with active pSpA:
At week 52: mPSpARC40 response
At week 16 & 52: ACR 50 response
At week 16: mPSpARC50 response ; physician's global
assessment of disease activity, SF-36 PCS, HAQ-DI, enthesitis count for enthesitis subset, patient global assessment of disease activity & pain
The overall safety and tolerability of secukinumab compared to placebo as assessed by AEs, vital signs, clinical laboratory values, and adverse events monitoring.

Demostrar la superioridad de secukinumab comparado con placebo basándose en:
- Plan de analisis A (semana 16):
En participantes con EspAp indiferenciada: la tasa de respuesta mPSpARC40 .
En participantes con EspAp activa: la tasa de respuesta mPSpARC50, la respuesta 50 del American College of Rheumatology (ACR), la evaluación global de la actividad de la enfermedad por parte del médico, el resumen de los componentes físicos (PCS) del SF-36, la mejora (cambio) el Health Assessment Questionnaire - Disability Index (HAQ-DI), el recuento de entesitis para el subgrupo de entesitis, la evaluación global de la actividad de la enfermedad y del dolor por parte del paciente.
-Plan de Análisis B (semanas 16 y 52):
En participantes con EspAp indiferenciada: la tasa de respuesta mPSpARC40 en las semanas 16 y 52 .
En participantes con EspAp activa:
En la semana 52: la tasa de respuesta mPSpARC40

Para mas información ver protocolo

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Participant meets ASAS criteria for classification of pSpA:
· Participant must have current arthritis (asymmetric or predominantly in the lower limbs) or enthesitis (except for enthesitis only along the spine, sacroiliac joints and/or chest wall) or dactylitis.
AND at least one of the following SpA features:
· Anterior uveitis in the past confirmed by a qualified medical professional (participants with current ongoing uveitis are excluded from participation in the study).
· Evidence of preceding infection (acute diarrhea or non-gonococcal urethritis or cervicitis less than 1 month before arthritis).
· Human Leukocyte Antigen -B27 (HLA-B27) positivity.
· Sacroiliitis on imaging; based on prior magnetic resonance imaging (MRI) or X-ray.
OR at least 2 of the following SpA features:
· Arthritis (past or present diagnosis), adequately documented and identified, or diagnosed by a qualified medical professional.
· Enthesitis (any location, past or present diagnosis), adequately documented and identified, or diagnosed by a qualified medical professional.
· Dactylitis (past or present diagnosis) adequately documented and identified, or diagnosed by a qualified medical professional.
· Inflammatory back pain (past or present).
· Family history for SpA.

Diagnosis of pSpA with evidence of active disease as manifested by
· Patient’s global assessment of disease activity (0-100 VAS) ≥ 40 mm, and
· Patient’s global assessment of pain (0-100 VAS) ≥ 40 mm, and
· At least one of the following:
· ≥ 2 joints that are both tender and swollen
· ≥ 2 sites of severe enthesitis as assessed by the investigator and ≥ 1 joint that is both tender and swollen
· ≥ 2 digits with dactylitis and ≥1 joint that is both tender and swollen not associated with dactylitis

Participant should have been on at least 2 different non-steroidal anti-inflammatory drugs (NSAIDs) at the highest recommended dose for at least 4 weeks in total prior to randomization with an inadequate response or failure to respond, or less if therapy had to be withdrawn due to intolerance, toxicity or contraindications.

Participant taking methotrexate (≤ 25 mg/week), or sulfasalazine (≤ 3 g/day), and/or hydroxychloroquine (≤ 400 mg/day) are allowed to continue their medication and must have taken it for at least 3 months and must be on a stable dose and route of administration for at least 4 weeks prior to randomization. Only one of these csDMARDs can continue during the study.

Participant taking systemic corticosteroids must be on a stable dose of ≤ 10 mg/day prednisone or equivalent for at least 2 weeks before randomization.

Participantes que cumplan los criterios de clasificación ASAS sobre EspAp:
· Participantes que actualmente tengan artritis (asimétrica o predominantemente en las extremidades inferiores) o entesitis (excepto entesitis solo a lo largo de la médula espinal, articulaciones sacroilíacas o pared torácica) o dactilitis.
Y al menos una de las siguientes características de EspA:
· Uveítis anterior en el pasado, confirmada por un médico cualificado (los participantes que actualmente presenten uveítis en curso quedan excluidos de la participación en el estudio).
· Evidencia de infección previa (diarrea aguda o uretritis o cervicitis no gonocócicas menos de un mes antes de la artritis).
· Resultado positivo en una prueba de antígeno leucocitario humano B27 (HLA-B27).
· Sacroileitis en pruebas de diagnóstico por imagen basadas en resonancias magnéticas (RM) o radiografías.
O al menos 2 de las siguientes características de EspA:
· Artritis (diagnóstico pasado o presente), adecuadamente documentada e identificada, o diagnosticada por un médico cualificado.
· Entesitis (en cualquier punto, con diagnóstico pasado o presente), adecuadamente documentada e identificada, o diagnosticada por un médico cualificado.
· Dactilitis (diagnóstico pasado o presente) adecuadamente documentada e identificada, o diagnosticada por un médico cualificado.
· Dolor de espalda inflamatorio (pasado o presente).
· Antecedentes familiares de EspA.

Diagnóstico de EspAp con evidencia de enfermedad activa según se manifiesta mediante:
· evaluación global de la actividad de la enfermedad por parte del paciente (EVA 0-100) >/=40 mm y
· evaluación global del dolor por parte del paciente (EVA 0-100) >/=40 mm y
· al menos una de las siguientes opciones:
· >/=2 articulaciones que sean tanto dolorosas como tumefactas;
· >/=2 puntos de entesitis grave según la evaluación del investigador y >/=1 articulación que sea tanto dolorosa como tumefacta;
· >/=2 dedos con dactilitis y >/=1 articulación que sea tanto dolorosa como tumefacta no asociada a la dactilitis.

Participantes que hayan tomado al menos dos fármacos antiinflamatorios no esteroideos (AINE) diferentes en la dosis más alta recomendada durante al menos 4 semanas en total antes de la aleatorización con una respuesta inadecuada o ninguna respuesta, o menos si se ha tenido que retirar el tratamiento por intolerancia, toxicidad o contraindicaciones.

Los participantes que tomen metotrexato (</=25 mg/semana), o sulfasalazina (</=3 g/día) o hidroxicloroquina (</=400 mg/día) pueden continuar con su medicación y deben haberla tomado durante al menos 3 meses. Asimismo, su dosis y vía de administración deben ser estables durante al menos las 4 semanas anteriores a la aleatorización. Solo uno de estos FAME sintéticos convencionales puede continuar tomándose durante el estudio.

Los participantes que tomen corticosteroides sistémicos deben recibir una dosis estable de prednisona </= 10 mg/día o equivalente durante al menos las 2 semanas anteriores a la aleatorización.

E.4

Principal exclusion criteria

Current or previous diagnosis of any of the following:
· Psoriasis (PsO) and/or nail changes consistent with PsO diagnosed by a qualified medical professional.
· PsA diagnosed by a qualified medical professional.
· Inflammatory bowel disease (IBD) diagnosed by a qualified medical professional.
· axSpA by a qualified medical professional.

Meets ASAS Axial Spondyloarthritis (axSpA) criteria.

Score of ≥2 on numerical rating scale (NRS)-score for total back pain and nocturnal back pain. (score 0–10).

History of a confirmed diagnosis of any inflammatory joint disorder other than pSpA (e.g., rheumatoid arthritis, gouty arthritis, other crystalline arthritis, systemic lupus erythematosus, or any arthritis with onset prior to age 16 years such as juvenile idiopathic arthritis).

Prior exposure to Tumor Necrosis Factor inhibitors (TNF-i’s) or other biologics, immunomodulating agents, investigational or approved.

Active ongoing inflammatory diseases other than pSpA that might confound the evaluation of the benefit of secukinumab therapy (e.g., uveitis).

Diagnóstico pasado o presente de alguna de las siguientes:
· Psoriasis (PsO) o cambios en las uñas que coincidan con la PsO diagnosticada por un médico cualificado.
· AP diagnosticada por un médico cualificado.
· Enfermedad intestinal inflamatoria (EII) diagnosticada por un médico cualificado.
· EspA axial diagnosticada por un médico cualificado.

Participantes que cumplan los criterios de clasificación ASAS sobre la espondiloartritis (EspA) axial.

Puntuación >/=.2 en una escala de clasificación numérica (NRS) para el dolor de espalda total y el dolor de espalda nocturno (puntuación 0-10).

Antecedentes de un diagnóstico confirmado de cualquier trastorno inflamatorio de las articulaciones salvo EspAp (p. ej., artritis reumatoide, artritis gotosa, otras artritis cristalinas, lupus eritematoso sistémico o cualquier artritis con aparición antes de los 16 años de edad, como la artritis idiopática juvenil).

Exposición previa a inhibidores del factor de necrosis tumoral (iTNF) u otros productos biológicos o fármacos inmunomoduladores, en investigación o aprobados.

Enfermedades inflamatorias activas en curso, salvo EspAp que puedan confundir en la evaluación del beneficio del tratamiento con secukinumab (p. ej., la uveítis).

E.5 End points

E.5.1

Primary end point(s)

Proportion of participants with active pSpA who achieve a mPSpARC40 response at Week 16 defined as meeting the following:
● ≥ 40% improvement as well as a ≥ 20 mm absolute improvement from baseline in the VAS scores for patient’s global assessment of disease activity and patient’s global assessment of pain
AND
● ≥ 40% improvement in at least one of the following domains and no concurrent worsening in the other domains:
1. SJC (76 joints assessed) and TJC (78 joints assessed) or
2. Enthesitis count as measured by the SPARCC Enthesitis Index
3. Dactylitis count as measured by LDI

Proporción de participantes con EspAp activa que alcanzaron una respuesta mPSpARC40 en la semana 16 definida como el cumplimiento de lo siguiente:
-Una mejora >/=40 % así como una mejora absoluta >/=20 mm respecto a la basal en las puntuaciones de EVA en la evaluación global del paciente de la actividad de la enfermedad y la evaluación global del paciente del dolor.
Y
-Una mejora >/=40 % en al menos uno de los siguientes dominios y ningún empeoramiento concurrente en los otros dominios:
1. SJC (evaluación de 76 articulaciones) y TJC (evaluación de 78 articulaciones) o
2. recuento de entesitis según el SPARCC Enthesitis Index;
3. recuento de dactilitis según el LDI.

E.5.1.1

Timepoint(s) of evaluation of this end point

16 weeks

16 semanas

E.5.2

Secondary end point(s)

Objectives associated with Analysis Plan A (Week 16)
-Proportion of participants with undifferentiated pSpA achieving mPSpARC≥40 response at Week 16
-Proportion of participants with active pSpA achieving mPSpARC≥50 at Week 16
-Proportion of participants with active pSpA achieving ACR 50 at Week 16
-Change in physician’s global assessment of disease activity (0-100 mm VAS) from -Baseline to Week 16 in participants with active pSpA
-Change in SF-36 PCS from Baseline to Week 16 in participants with active pSpA
-Change in HAQ-DI improvement (change) from Baseline to Week 16 in participants with active pSpA
-Change in enthesitis count from Baseline to Week 16 utilizing the SPARCC enthesitis index in participants with active pSpA.
-Change in patient’s global assessment of pain (0–100 mm VAS) from Baseline to Week 16 in participants with active pSpA
-Change in patient’s global assessment of disease activity (0-100 mm VAS) from Baseline to Week 16 in participants with active pSpA
-Assessment of Treatment Emergent Adverse Events (TEAEs) and changes in physical exams, Electrocardiogram (ECG)s, vital signs, laboratory assessments.

Objectives associated with Analysis Plan B (Week 16 and Week 52)
-Proportion of participants with active pSpA achieving mPSpARC>40 response at Week 52
-Proportion of participants with active undifferentiated pSpA achieving mPSpARC≥40 response at Week 16
-Proportion of participants with active undifferentiated pSpA achieving mPSpARC≥40 response at Week 52
-Proportion of participants with active pSpA achieving mPSpARC≥50 at Week 16
-Proportion of participants with active pSpA achieving ACR 50 at Week 16
-Proportion of participants with active pSpA achieving ACR 50 at Week 52
-Change in physician’s global assessment of disease activity (0-100 mm VAS) from Baseline to Week 16 in participants with active pSpA
-Change in SF-36 PCS from Baseline to Week 16 in participants with active pSpA
-Change in HAQ-DI from Baseline to Week 16 in participants with active pSpA
-Change in enthesitis count from Baseline to Week 16 utilizing the SPARCC enthesitis index in participants with active pSpA.
-Change in patient’s global assessment of pain (0–100 mm VAS) from Baseline to Week 16 in participants with active pSpA
-Change in patient’s global assessment of disease activity (0-100 mm VAS) from Baseline to Week 16 in participants with active pSpA
-Assessment of TEAEs, and changes in physical exams, ECGs, vital signs, laboratory assessments.

Objetivos asociados al plan de análisis A (semana 16).
-Proporción de participantes con EspAp no diferenciada que alcancen una respuesta mPSpARC >/=40 en la semana 16.
-Proporción de participantes con EspAp activa que alcancen una respuesta mPSpARC >/=50 en la semana 16.
-Proporción de participantes con EspAp activa que alcancen una respuesta ACR 50 en la semana 16.
-Cambio en la evaluación global del médico de la actividad de la enfermedad (puntuación EVA 0-100 mm) desde la basal hasta la semana 16 en los participantes con EspAp activa.
-Cambio en el PCS del SF-36 desde la basal hasta la semana 16 en participantes con EspAp activa.
-Cambio en la mejora (cambio) del HAQ-DI desde la basal hasta la semana 16 en participantes con EspAp activa.
-Cambio en el recuento de entesitis desde la basal hasta la semana 16 según el SPARCC Enthesitis Index en participantes con EspAp activa.
-Cambio en la evaluación global del paciente del dolor (puntuación EVA 0-100 mm) desde la basal hasta la semana 16 en los participantes con EspAp activa.
-Cambio en la evaluación global del paciente de la actividad de la enfermedad (puntuación EVA 0-100 mm) desde la basal hasta la semana 16 en los participantes con EspAp activa.
-Evaluación de acontecimientos adversos que han aparecido con el tratamiento (AAAT) y cambios en las exploraciones físicas, electrocardiogramas (ECG), constantes vitales y pruebas analíticas.
Objetivos asociados al plan de análisis B (semana 16 y semana 52).
-Proporción de participantes con EspAp activa que alcancen una respuesta mPSpARC >40 en la semana 52.
-Proporción de participantes con EspAp no diferenciada activa que alcancen una respuesta mPSpARC >/=40 en la semana 16.
-Proporción de participantes con EspAp no diferenciada activa que alcancen una respuesta mPSpARC >/=40 en la semana 52.
-Proporción de participantes con EspAp activa que alcancen una respuesta mPSpARC >/=50 en la semana 16.
-Proporción de participantes con EspAp activa que alcancen una respuesta ACR 50 en la semana 16.
-Proporción de participantes con EspAp activa que alcancen una respuesta ACR 50 en la semana 52.
-Cambio en la evaluación global del médico de la actividad de la enfermedad (puntuación EVA 0-100 mm) desde la basal hasta la semana 16 en los participantes con EspAp activa.
-Cambio en el PCS del SF-36 desde la basal hasta la semana 16 en participantes con EspAp activa.
-Cambio en la el HAQ-DI desde la basal hasta la semana 16 en participantes con EspAp activa.
-Cambio en el recuento de entesitis desde la basal hasta la semana 16 según el SPARCC Enthesitis Index en participantes con EspAp activa.
-Cambio en la evaluación global del paciente del dolor (puntuación EVA 0-100 mm) desde la basal hasta la semana 16 en los participantes con EspAp activa.
-Cambio en la evaluación global del paciente de la actividad de la enfermedad (puntuación EVA 0-100 mm) desde la basal hasta la semana 16 en los participantes con EspAp activa.
-Evaluación de AAAT, y cambios en las exploraciones físicas, ECG, constantes vitales y pruebas analíticas.

E.5.2.1

Timepoint(s) of evaluation of this end point

End point for Analysis plan A is Week 16;
End points for Analysis plan B are Week 16 and Week 52

La variable de evaluación para en plan de análisis A es la semana 16;
Las variables de evaluación para en plan de análisis B son las semanas 16 y 52;

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

Tolerability

Tolerabilidad

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

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

Australia

Brazil

Canada

China

Colombia

Guatemala

India

Philippines

Russian Federation

South Africa

Thailand

Turkey

United States

Vietnam

Belgium

Estonia

Germany

Hungary

Italy

Poland

Slovakia

Spain

Czechia

Argentina

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

Último paciente, última visita

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:

292

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

170

F.4.2.2

In the whole clinical trial

324

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 on open-label secukinumab who the investigator believes are continuing to receive benefit from treatment, may also have post-trial access until secukinumab is available for peripheral SpA following product launch and subsequent reimbursement (where applicable), treatment discontinuation, or the benefit-risk profile is no longer positive.

Los participantes que tomen secukinumab en abierto, en caso de que el investigador considere que continúan beneficiándose del tratamiento, podrían tener acceso posterior al ensayo hasta que secukinumab esté disponible para EspAp periférica después de su comercialización y el reembolso posterior (si procede), hasta la discontinuación del tratamiento o hasta que el perfil de beneficio-riesgo ya no sea positivo.

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

2022-01-17

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-12-29

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2022-08-23

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