Clinical Trials Register

Summary
EudraCT Number:	2020-003611-10
Sponsor's Protocol Code Number:	213744
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:	2021-07-05
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

2020-003611-10

A.3

Full title of the trial

A 52-week, randomised, double-blind, placebo-controlled, parallel-group, multi-centre study of the efficacy and safety of GSK3511294 adjunctive therapy in adult and adolescent participants with severe uncontrolled asthma with an eosinophilic phenotype

Estudio de 52 semanas, aleatorizado, doble ciego, controlado con placebo, de grupos paralelos y multicéntrico de la eficacia y la seguridad del tratamiento
complementario con GSK3511294 en participantes adultos y adolescentes con asma grave no controlada con fenotipo eosinofílico

A.3.1

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

Placebo-controlled efficacy and safety study of GSK3511294 in participants with severe asthma with an eosinophilic phenotype

Estudio controlado con placebo de la eficacia y la seguridad de GSK3511294 en participantes con asma grave con fenotipo eosinofílico

A.4.1

Sponsor's protocol code number

213744

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	GlaxoSmithKline Research & Development Limited
B.1.3.4	Country	United Kingdom
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	GlaxoSmithKline Research & Development Limited
B.4.2	Country	United Kingdom
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	GlaxoSmithKline Research & Development Limited
B.5.2	Functional name of contact point	Clinical Support Help Desk
B.5.3	Address:
B.5.3.1	Street Address	980 Great West Road
B.5.3.2	Town/ city	Brentford, Middlesex
B.5.3.3	Post code	TW8 9GS
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	+34902202700
B.5.6	E-mail	GSKClinicalSupportHD@gsk.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	GSK3511294
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	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Not available
D.3.9.1	CAS number	2243274-14-6
D.3.9.3	Other descriptive name	GSK3511294
D.3.9.4	EV Substance Code	SUB187908
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	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
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

Severe uncontrolled asthma with an eosinophilic phenotype

Asma grave no controlada con fenotipo eosinofílico

E.1.1.1

Medical condition in easily understood language

Severe asthma

Asma grave

E.1.1.2

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

MedDRA Classification

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	10003553
E.1.2	Term	Asthma
E.1.2	System Organ Class	10038738 - Respiratory, thoracic and mediastinal 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 GSK3511294 100 mg (SC) every 26 weeks versus placebo in participants with severe uncontrolled asthma with an eosinophilic phenotype on top of existing asthma therapy

Evaluar la eficacia de GSK3511294 100 mg (s.c.) cada 26 semanas en
comparación con el placebo en participantes con asma grave no controlada con
fenotipo eosinofílico además del tratamiento del asma actual

E.2.2

Secondary objectives of the trial

To evaluate GSK3511294 100 mg (SC) every 26 weeks versus placebo on health-related quality of life (HRQoL) and additional efficacy assessments on top of existing asthma therapy

Evaluar GSK3511294 100 mg (s.c.) cada 26 semanas frente a placebo sobre la
calidad de vida relacionada con la salud (CVRS) y las evaluaciones de la eficacia
adicionales además del tratamiento del asma actual

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Age: Adults and adolescents ≥12 years of age, at the time of signing the informed consent/assent. [For countries where local regulations or the regulatory status of study medication permit enrolment of adults only, participants recruited will be ≥18 years of age]
2. Asthma: Participants must have a documented physician diagnosis of asthma for ≥2 years that meets the National Heart, Lung, and Blood Institute guidelines [NHLBI, 2007] or GINA guidelines [GINA, 2020]
AND
a) Eosinophilic phenotype: Have, or with high likelihood of having, asthma with an eosinophilic phenotype as per Randomisation Criteria 1 and 2 (see Section 5.3 of the protocol)
AND
b) Exacerbation history: Have previously confirmed history of ≥2 exacerbations requiring treatment with systemic corticosteroids ( CS) (IM, IV, or oral), in the 12 months prior to Visit 1, despite the use of medium to high-dose inhaled corticosteroids (ICS) (see criterion 4). For participants receiving maintenance CS, the CS treatment for the exacerbations must have been a two-fold dose increase or greater.
3. Airflow obstruction: Persistent airflow obstruction as indicated by:
a) For participants ≥18 years of age at Visit 1, a pre-bronchodilator FEV1 <80% predicted (NHANES III) recorded at Visit 1
b) For participants 12-17 years of age at Visit 1:
• A pre-bronchodilator FEV1 <90% predicted (NHANES III) recorded at
Visit 1 OR
• FEV1:Forced Vital Capacity (FVC) ratio <0.8 recorded at Visit 1
4. Inhaled Corticosteroid: A well-documented requirement for regular treatment with medium to high dose ICS (in the 12 months prior to Visit 1 with or without maintenance OCS). The maintenance ICS dose must be ≥440 mcg FP HFA daily, or clinically comparable [GINA, 2020; see Appendix 10 of the protocol]. Participants who are treated with medium dose ICS will also need to be treated with Long-acting beta-agonist (LABA) to qualify for inclusion.
5. Additional Controller Medication: Current treatment with at least one additional controller medication, besides ICS, for at least 3 months [e.g., LABA, long-acting muscarinic antagonist (LAMA), leukotriene receptor antagonist (LTRA), or theophylline].
6. Male or eligible female.
• A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:
o Is a woman of non-childbearing potential (WONCBP) as defined in Section 10.4.1 of the protocol
OR
Is a woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective, with a failure rate of <1%, as described in Section 10.4.2 of the protocol from at least 14 days prior to the first dose of study intervention until at least 30 weeks after the last administered dose of study intervention.
•A WOCBP must have a negative highly sensitive serum pregnancy test at screening Visit 1 and a negative highly sensitive urine pregnancy test within 24 hours before the first dose of study intervention. Additional requirements for pregnancy testing during and after study intervention are located in Section 8.3.5. of the protocol
•Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• The investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated in relationship to the first dose of study intervention).
• The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a
woman with an early undetected pregnancy.
7. Informed Consent: Capable of giving signed informed consent/assent as described in Section 10.1 of the protocol which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.
French participants: In France, a participant will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.

1.Edad: adultos y adolescentes de #12 años de edad, en el momento de firmar el
consentimiento informado/asentimiento. [En países donde la normativa local o el
estado normativo de la medicación del estudio permite únicamente la inscripción de
adultos, los participantes serán de #18 años de edad] 2. Asma: Los participantes
deben tener un diagnóstico médico de asma documentado durante #2 años que
cumpla con las directrices del National Heart, Lung and Blood Institute (NHLBI,
2007) o las directrices GINA [GINA, 2020] Y a)Fenotipo eosinofílico: Sufrir, o con
alta probabilidad de sufrir, asma con un fenotipo eosinofílico según los criterios de
aleatorización 1 y 2 (consulte la sección 5.3 ) Y b)Antecedentes de exacerbaciones:
tener antecedentes confirmados previos de #2 exacerbaciones que requieran
tratamiento con CS sistémicos (por vía i.m., i.v. u oral) en los 12 meses anteriores a
la visita 1, a pesar del uso de media a alta de corticosteroides inhalados (CSI)
(consulte el criterio 4). Para los participantes que reciben CS de mantenimiento, el
tratamiento de CS para las exacerbaciones debe haber sufrido un aumento de la
dosis del doble o mayor. 3. Obstrucción del flujo de aire: obstrucción del flujo de
aire persistente, indicada por: a) Para los participantes #18 años de edad en la
visita 1, un VEF1 previo al broncodilatador <80 % del valor previsto (NHANES III)
registrado en la visita 1 b) Para los participantes de 12-17 años de edad en la visita
1: • Un VEF1 previo al broncodilatador <90 % del valor previsto (NHANES III)
registrado en la visita 1 O • VEF1: tasa de capacidad vital forzada (CVF) <0,8 de la
registrada en la visita 1 4. Corticosteroide inhalado: un requisito bien documentado
para el tratamiento regular con dosis de media a alta de CSI (en los 12 meses
previos a la visita 1 con o sin CSO de mantenimiento). La dosis de CSI debe ser de
mantenimiento #440 μg PF HFA al día, o clínicamente comparable [GINA, 2020;
consulte el Apéndice 10]. Los participantes que son tratados con dosis medias de
CSI también tendrán que ser tratados con LABA para ser aptos para su inclusión. 5.
Medicación de control adicional: tratamiento actual con al menos un medicamento
de control adicional, aparte de los CSI, durante al menos 3 meses (p. ej., LABA,
antagonista muscarínico de acción prolongada [LAMA], antagonista del receptor de
leucotrienos [LTRA] o teofilina). 6. Hombre o mujer apta. Mujeres participantes: •
Una mujer es apta para participar si no está embarazada ni en período de lactancia
y si se cumple por lo menos uno de los siguientes requisitos: o No es una mujer en
edad fértil (NO MEF) como se define en la sección 10.4.1 O BIEN o Es una mujer
en edad fértil (MEF) y usa un método anticonceptivo que es muy eficaz, con una
tasa de fracaso de <1 %, como se describe en la sección 10.4.2 desde al menos 14
días antes de la primera dosis de la intervención del estudio hasta al menos 30
semanas después de la última dosis administrada de la intervención del estudio. •
Las MEF deben presentar una prueba de embarazo en suero de alta sensibilidad
negativa en la visita 1 de selección y una prueba de embarazo en orina de alta sensibilidad negativa en el plazo de 24 horas antes de la primera dosis de la
intervención del estudio. Los requisitos adicionales para las pruebas de embarazo
durante y después de la intervención del estudio se encuentran en la sección 8.3.5.
• El uso de anticonceptivos por las mujeres debe ser coherente con las normativas
locales relativas a los métodos anticonceptivos para las participantes en estudios
clínicos. • El investigador debe evaluar el potencial de fracaso del método
anticonceptivo (p. ej., incumplimiento, iniciado recientemente en relación a la
primera dosis de la intervención del estudio). • El investigador es responsable de la
revisión de los antecedentes médicos, los antecedentes menstruales y la actividad
sexual reciente para reducir el riesgo de incluir a una mujer con un embarazo
temprano no detectado. 7. Consentimiento informado: con capacidad de dar su
consentimiento informado firmado según lo establecido en la sección #10.1, lo que
incluye el cumplimiento de los requisitos y las restricciones enumerados en el
formulario de consentimiento informado (FCI) y en este protocolo. Participantes
franceses: en Francia, un participante será apto para su inscripción en este estudio
únicamente si está afiliado o es beneficiario de una categoría de seguridad social.

E.4

Principal exclusion criteria

1. Concurrent Respiratory Disease: Presence of a known pre-existing, clinically important lung condition other than asthma. This includes (but is not limited to) current infection, bronchiectasis, pulmonary fibrosis, bronchopulmonary aspergillosis, or diagnoses of emphysema or chronic bronchitis (chronic obstructive pulmonary disease other than asthma) or a history of lung cancer.
2. Eosinophilic Diseases: Participants with other conditions that could lead to elevated eosinophils such as hyper-eosinophilic syndromes including (but not limited to) Eosinophilic Granulomatosis with Polyangiitis (EGPA, formerly known as Churg-Strauss Syndrome) or Eosinophilic Esophagitis.
3. Parasitic infection: Participants with a known, pre-existing parasitic infestation within 6 months prior to Visit 1.
4. Immunodeficiency: A known immunodeficiency (e.g. human immunodeficiency virus – HIV), other than that explained by the use of CSs taken as therapy for asthma.
5. Malignancy: A current malignancy or previous history of cancer in remission for less than 12 months prior to screening (Participants that had localised carcinoma of the skin which was resected for cure will not be excluded).
6. Liver Disease: Cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, persistent jaundice.
NOTE: Stable non-cirrhotic chronic liver disease (including Gilbert’s syndrome, asymptomatic gallstones, and chronic stable hepatitis B or C) are acceptable if participant otherwise meets entry criteria.
7. Other Concurrent Medical Conditions: Participants who have known, preexisting, clinically significant cardiac, endocrine, autoimmune, metabolic, neurological, renal, gastrointestinal, hepatic, haematological or any other system abnormalities that are uncontrolled with standard treatment.
8. Vasculitis: Participants with current diagnosis of vasculitis. Participants with high clinical suspicion of vasculitis at screening will be evaluated and current vasculitis must be excluded prior to enrolment.
9. COVID-19: Participants that, according to the investigator's medical judgment, are likely to have active COVID-19 infection should be excluded. Participants with known COVID-19 positive contacts within the past 14 days should be excluded for at least 14 days following the exposure during which the participant should remain symptom-free.
10. Monoclonal antibodies targeting IL-5/5R: Participants who have received mepolizumab (Nucala), reslizumab (Cinqair/Cinqaero), or benralizumab (Fasenra) within 12 months prior to Visit 1 or who have a previous documented failure with anti-IL-5/5R therapy.
11. Other mAbs in the treatment of asthma: Participants who have received omalizumab (Xolair) or dupilumab (Dupixent) within 130 days prior to Visit 1.
12. Other mAbs not used for the treatment of asthma: Participants who have received any mAb within 5 half-lives of Visit 1.
13. Investigational Medications: Participants who have received treatment with an investigational drug within the past 30 days or five terminal phase half-lives of the drug whichever is longer, prior to Visit 1 (this also includes investigational formulations of marketed products).
14. Previous participation: Previously participated in any study with mepolizumab, reslizumab, or benralizumab and received study intervention (including placebo) within 12 months prior to Visit 1.
15. ECG Assessment: QTcF ≥450 msec or QTcF ≥480 msec for participants with Bundle Branch Block at screening Visit 1.
16. Smoking history: Current smokers or former smokers with a smoking history of ≥10 pack years (number of pack years = (number of cigarettes per day / 20) x number of years smoked). A former smoker is defined as a participant who quit smoking at least 6 months prior to Visit 1.
17. Alcohol/Substance Abuse: A history (or suspected history) of alcohol misuse or substance abuse within 2 years prior to Visit 1.
18. Hypersensitivity: Participants with allergy/intolerance to a mAb or biologic.
19. Pregnancy: Participants who are pregnant or breastfeeding. Participants should not be enrolled if they plan to become pregnant during the time of study participation. Requirements for pregnancy testing are located in Section 8.3.5 of the protocol.
20. Adherence: Participants who have known evidence of lack of adherence to controller medications and/or ability to follow physician’s recommendations.

1. Enfermedad respiratoria concurrente: presencia de una enfermedad pulmonar
clínicamente importante preexistente conocida distinta al asma. Esto incluye (entre
otros) infección actual, bronquiectasia, fibrosis pulmonar, aspergilosis
broncopulmonar, o diagnósticos de enfisema o bronquitis crónica (enfermedad
pulmonar obstructiva crónica aparte del asma) o antecedentes de cáncer de
pulmón. 2. Enfermedades eosinofílicas: participantes con otras afecciones que
podrían dar lugar a aumento de eosinófilos como síndromes hipereosinofílicos,
incluidos (entre otros) granulomatosis eosinofílica con poliangeítis (GEPA,
anteriormente conocida como síndrome de Churg-Strauss) o esofaguitis
eosinofílica. 3. Infección parasitaria: participantes con una infestación parasitaria
conocida, preexistente en los 6 meses anteriores a la visita 1. 4. Inmunodeficiencia:
inmunodeficiencia conocida (por ejemplo, virus de la inmunodeficiencia humana,
VIH), excepto la que se explique por el uso de los CS tomados como tratamiento
para el asma. 5. Neoplasia maligna: neoplasia maligna actual o antecedentes de
cáncer en remisión durante menos de 12 meses antes de la selección (los
participantes que presentaron carcinoma localizado de la piel que se extirpó para
su curación no se excluirán). 6. Enfermedad hepática: cirrosis o enfermedad
hepática o biliar actual inestable según la evaluación del investigador definida por la presencia de ascitis, encefalopatía, coagulopatía, hipoalbuminemia, varices
esofágicas o gástricas, ictericia persistente. NOTA: la hepatopatía crónica no
cirrótica estable (incluidos el síndrome de Gilbert, los cálculos biliares asintomáticos
y la hepatitis B o C estable crónica) es aceptable si el participante cumple el resto
de los criterios de inclusión. 7. Otras afecciones médicas simultáneas: participantes
que tengan anomalías conocidas, preexistentes clínicamente significativas del
sistema cardíaco, endocrino, autoinmunitario, metabólico, neurológico, renal,
gastrointestinal, hepático, hematológico o de cualquier otro sistema que no estén
controladas con tratamiento estándar. 8. Vasculitis: participantes con diagnóstico
actual de vasculitis. Los participantes con sospecha clínica alta de vasculitis en el
momento de la selección se evaluarán y vasculitis actual debe excluirse antes de la
inscripción. 9. COVID-19: los participantes que, según el criterio del investigador, es
probable que tengan infección activa de COVID-19 deben ser excluidos. Los
participantes con contactos positivos de COVID-19 conocidos en los últimos 14
días deben excluirse durante al menos 14 días después de la exposición durante
los cuales el participante debe seguir estando sin síntomas. 10. Anticuerpos
monoclonales dirigidos a IL-5/5R: participantes que recibieron mepolizumab
(Nucala), reslizumab (Cinqair/Cinqaero) o benralizumab (Fasenra) en los 12 meses
anteriores a la visita 1 o que tengan un fallo documentado anterior del tratamiento
anti-IL-5/5R. 11. Otros ACM en el tratamiento del asma: participantes que han
recibido omalizumab (Xolair) o dupilumab (Dupixent) en los 130 días previos a la
visita 1. 12. Otros ACM no usados para el tratamiento del asma: participantes que
hayan recibido cualquier ACM en el plazo de 5 semividas antes de la visita 1. 13.
Productos en investigación: participantes que hayan recibido tratamiento con un
fármaco en investigación en los últimos 30 días o cinco semividas de fase terminal,
lo que sea más prolongado, antes de la visita 1 (esto también incluye las
formulaciones en investigación de productos comercializados). 14. Participación
anterior: haber participado previamente en cualquier estudio con mepolizumab,
reslizumab o benralizumab y haber recibido la intervención del estudio (incluido el
placebo) en los 12 meses anteriores a la visita 1. 15. Evaluaciones de ECG: QTcF
#450 ms o QTcF #480 ms para los participantes con bloqueo de rama en la visita 1
de selección. 16. Antecedentes de tabaquismo: fumadores actuales o exfumadores
con antecedentes de tabaquismo de #10 años-paquete (número de años-paquete =
(número de cigarrillos por día / 20) x número de años fumando). Un exfumador se
define como un participante que dejó de fumar al menos 6 meses antes de la visita
1. 17. Abuso de alcohol/sustancias: antecedentes (o sospecha de antecedentes) de
alcoholismo o abuso de sustancias en los 2 años anteriores a la visita 1. 18.
Hipersensibilidad: participantes con alergia/intolerancia a un ACM o fármaco
biológico. 19. Embarazo: mujeres participantes que estén embarazadas o
amamantando. No deben inscribirse participantes que tienen previsto quedarse
embarazadas durante el tiempo de la participación en el estudio. Los requisitos
para las pruebas de embarazo se encuentran en la sección 8.3.5. 20.
Cumplimiento: participantes que tengan indicios conocidos de falta de cumplimiento
con los medicamentos de control y/o capacidad para seguir las recomendaciones
médico.

E.5 End points

E.5.1

Primary end point(s)

Annualised rate of clinically significant exacerbations over 52 weeks

Tasa anualizada de exacerbaciones clínicamente significativas a a lo largo de 52
semanas

E.5.1.1

Timepoint(s) of evaluation of this end point

Week 0 through Week 52

Semana 0 hasta Semana 52

E.5.2

Secondary end point(s)

1.Change from baseline in St. George's Respiratory Questionnaire (SGRQ) total score at Week 52
2.Change from baseline in Asthma Control Questionnaire-5 (ACQ-5) score at Week 52
3.Change from baseline in pre-bronchodilator forced expiratory volume in one second (FEV1) at Week 52
4.Annualised rate of exacerbations requiring hospitalisation and/or Emergency Department (ED) visit over 52 weeks

1. Cambio desde el inicio en la puntuación total del cuestionario respiratorio de St.
George (St. George's Respiratory Questionnaire, SGRQ) en la semana 52 2.
Cambio desde el inicio en el la puntuación del cuestionario sobre control del asma 5
(Asthma Control Questionnaire-5, ACQ-5) en la semana 52 3. Cambio desde el
inicio en el volumen espiratorio forzado en un segundo (VEF 1 ) previo al
broncodilatador en la semana 52 4. Tasa anualizada de exacerbaciones que
requieran hospitalización y/o visita al servicio de urgencias (SU) a lo largo de 52
semanas

E.5.2.1

Timepoint(s) of evaluation of this end point

1.Baseline ( Week 0) and Week 52
2.Baseline ( Week 0) and Week 52
3.Baseline ( Week 0) and Week 52
4.Week 0 through Week 52

1. (Semana 0) y Semana 52 2.(Semana 0) y Semana 52 3.(Semana 0) y Semana
52 4.Semana 0 hasta Semana 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

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

Yes

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

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

Canada

Japan

United States

France

Italy

Poland

Spain

Czechia

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 último sujeto

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

Yes

F.1.1

Number of subjects for this age range:

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)

Yes

F.1.1.6.1

Number of subjects for this age range:

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

322

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

152

F.4.2.2

In the whole clinical trial

375

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)

The investigator is responsible for ensuring that consideration has been given to the post-study care of the participant's medical condition. At the end of study, participants may be eligible to screen for the Open Label Extension (OLE) Study 212895 and have continued access to open-label GSK3511294 if they meet the criteria. Participants who do not enter the OLE will complete a follow-up visit/call and be prescribed alternative asthma therapy if needed and as determined by the Investigator.

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

2021-06-23

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-04-08

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

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Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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