Clinical Trials Register

Summary
EudraCT Number:	2019-001734-34
Sponsor's Protocol Code Number:	CLNP023D12201
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:	2019-09-04
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2019-001734-34

A.3

Full title of the trial

A randomized, treatment open-label, dose-blinded, parallel group, three arm, proof-of-concept clinical trial to investigate the efficacy and safety of LNP023 compared with rituximab in the treatment of subjects with idiopathic membranous nephropathy.

Ensayo clínico de prueba de concepto, aleatorizado, con tratamiento abierto, dosis ciega en grupos paralelos y tres brazos para investigar la eficacia y seguridad de LNP023 comparado con rituximab en el tratamiento de sujetos con nefropatía membranosa idiopática.

A.3.1

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

Efficacy and safety of LNP023 compared with rituximab in subjects with idiopathic membranous nephropathy.

Eficacia y seguridad de LNP023 comparado con rituximab en sujetos con nefropatía membranosa idiopática.

A.4.1

Sponsor's protocol code number

CLNP023D12201

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 Vía 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	34900353036
B.5.5	Fax number	34932479903
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	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.3.2	Product code	LNP023
D.3.4	Pharmaceutical form	Capsule, hard
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	not yet established
D.3.9.2	Current sponsor code	LNP023
D.3.9.3	Other descriptive name	LNP023 HYDROCHLORIDE SALT
D.3.9.4	EV Substance Code	SUB180361
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	5
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.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.3.2	Product code	LNP023
D.3.4	Pharmaceutical form	Capsule, hard
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	not yet established
D.3.9.2	Current sponsor code	LNP023
D.3.9.3	Other descriptive name	LNP023 HYDROCHLORIDE SALT
D.3.9.4	EV Substance Code	SUB180361
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	25
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
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.3.2	Product code	LNP023
D.3.4	Pharmaceutical form	Capsule, hard
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	not yet established
D.3.9.2	Current sponsor code	LNP023
D.3.9.3	Other descriptive name	LNP023 HYDROCHLORIDE SALT
D.3.9.4	EV Substance Code	SUB180361
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	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 4
D.1.2 and D.1.3	IMP Role	Comparator
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.2.1.1.2	Name of the Marketing Authorisation holder	Roche Registration GmbH
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	Rituximab
D.3.4	Pharmaceutical form	Concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	RITUXIMAB
D.3.9.1	CAS number	174722-31-7
D.3.9.4	EV Substance Code	SUB12570MIG
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	10
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	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule, hard
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Idiopathic Membranous nephropathy

Nefropatía membranosa idiopática

E.1.1.1

Medical condition in easily understood language

Kidney disease

Enfermedad renal

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	21.1
E.1.2	Level	LLT
E.1.2	Classification code	10027170
E.1.2	Term	Membranous nephropathy
E.1.2	System Organ Class	100000004857

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 assess the efficacy of high dose LNP023 compared with rituximab

Evaluar la eficacia de una dosis alta de LNP023 comparado con rituximab.

E.2.2

Secondary objectives of the trial

- To assess the safety and tolerability of low and high dose of LNP023
- To assess the relationship between LNP023 systemic drug exposure and pharmacodynamics, mode-of-action markers and clinical efficacy
- To assess the difference in response between low (regimen A) and high (regimen B) dose of LNP023
- To assess the effect of LNP023 compared with rituximab on proteinuria remission and renal function
- To assess the pharmacokinetics of LNP023

-Evaluar la seguridad y tolerabilidad de una dosis baja y alta de LNP023.
-Evaluar la relación entre la exposición sistémica al fármaco LNP023 y la farmacodinámica, marcadores del mecanismo de acción y eficacia clínica.
-Evaluar la diferencia en la respuesta entre una dosis baja (pauta A) y alta (pauta B) de LNP023.
-Evaluar el efecto de LNP023 comparado con rituximab en la remisión de proteinuria y la función renal.
-Evaluar la farmacocinética de LNP023.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Female or male adult (≥18 years) subjects at screening visit with a diagnosis of idiopathic (primary) MN confirmed by renal biopsy within 24 months prior to screening. A renal biopsy may be taken at any time during the run-in period to confirm the diagnosis of MN and facilitate subject eligibility, if the most recent biopsy was performed greater than 24 months prior to the screening visit.
• Anti-PLA2R antibody titer of ≥ 100 RU/mL at screening visit (based on the EuroImmun ELISA test)
• Urine protein ≥ 3.5 g/24h at run-in and baseline visits
• ≤50% reduction in both anti-PLA2R level and 24h urine protein between first measurement at screening or run-in visit and baseline
• Estimated GFR (using the CKD-EPI formula) ≥ 45 mL/min per 1.73 m2 at run-in visit
• Receiving stable dose at the maximum recommended dose according to local guidelines or maximum tolerated dose of ACEi and/or ARB and/or statins and/or diuretics for at least 8 weeks prior to Day 1
• Vaccination against Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae (in accordance with local guidelines) at least 28 days prior to Day 1 and no longer than 5 years prior to Day 1

• Sujetos de ambos sexos (>/=18 años) en la visita de selección con diagnóstico de NM idiopática (primaria) confirmada mediante biopsia renal durante los 24 meses anteriores a la selección. Si la biopsia más reciente se ha realizado más de 24 meses antes de la visita de selección, se podrá realizar una biopsia renal en cualquier momento durante el periodo de preinclusión para confirmar el diagnóstico de NM y facilitar la elegibilidad del sujeto.
• Título de anticuerpos anti-PLA2R >/=100 UR/ml en la visita de selección (basándose en la prueba ELISA de EuroImmun).
• Proteína en orina >/=3,5 g/24 h en las visitas de preinclusióny basal.
• Disminución </= 50 % tanto en el nivel anti-PLA2R como en la proteína en orina de 24 horas entre la primera medición en la visita de selección o de preinclusión y la basal.
• TFG estimada (mediante la fórmula del CKD-EPI) >/= 45 ml/min/1,73 m2 en la visita de preinclusión.
• Sujetos que estén recibiendo una dosis estable de la dosis máxima recomendada de acuerdo con las directrices locales o la dosis máxima tolerada de IECA y/o ARAII y/o estatinas y/o diuréticos durante al menos 8 semanas antes del día 1.
• Vacunación contra Neisseria meningitidis, Streptococcus pneumoniae y Haemophilus influenzae (de acuerdo con las directrices locales) al menos 28 días antes del día 1 y no más de 5 años antes del día 1.

E.4

Principal exclusion criteria

• Secondary causes of MN, e.g. systemic autoimmune diseases, solid or haematological malignancies, infections or chronic intake of drugs (e.g. gold salts, NSAIDs, penicillamines)
• Diagnostic renal biopsy showing evidence of crescent formation in glomeruli, suggestive of an alternative or additional diagnosis to primary idiopathic MN
• Previous treatment with B-cell depleting or B-cell modifying agents such as, but not limited to rituximab, belimumab, daratumomab or bortezomib
• Previous treatment with immunosuppressive agents such as cyclophosphamide, chlorambucil, mycophenolate mofetil (or equivalent), cyclosporine, tacrolimus or azathioprine within 90 days prior to Day 1. Low dose systemic corticosteroid therapy is permitted, though the subject should have been on stable dose equivalent to ≤10 mg prednisolone for at least 90 days prior to Day 1
• Previous treatment with gemfibrozil or strong CYP2C8 inhibitors such as clopidogrel within 7 days prior to Day 1
• Presence or suspicion (based on judgment of the investigator) of active infection within 30 days prior to Day 1, or history of severe recurrent bacterial infections

• Causas secundarias de NM, p. ej., enfermedades autoinmunes sistémicas, tumores sólidos o hematológicos malignos, infecciones o consumo crónico de fármacos (p. ej., sales de oro, AINE y penicilaminas).
• Biopsia renal de diagnóstico que muestre evidencia de formación semilunar en glomérulos, indicativa de un diagnóstico alternativo o adicional a la NM idiopática primaria.
• Tratamiento previo con fármacos depletivos de células B o modificadores de células B como rituximab, belimumab, daratumumab o bortezomib, entre otros.
• Tratamiento previo con fármacos inmunosupresores como ciclofosfamida, clorambucilo, micofenolato de mofetilo (o equivalente), ciclosporina, tacrolimus o azatioprina durante los 90 días anteriores al día 1. Se permite administrar una terapia con corticosteroides sistémicos a dosis bajas,
aunque el sujeto deberá haber recibido una dosis estable equivalente a ≤10 mg de prednisolona durante al menos los 90 días anteriores al día 1.
• Tratamiento previo con gemfibrozilo o inhibidores potentes de CYP2C8 como clopidogrel durante los 7 días anteriores al día 1.
• Presencia o sospecha (basándose en el criterio del investigador) de infección activa durante los 30 días anteriores al día 1, o antecedentes de infecciones
bacterianas recurrentes graves.

E.5 End points

E.5.1

Primary end point(s)

Ratio between baseline UPCR and UPCR at 24 weeks of treatment (from 24h urine collection)

Relación entre el CPCO basal y el CPCO a las 24 semanas de tratamiento (de la recogida de muestras de orina de 24 horas).

E.5.1.1

Timepoint(s) of evaluation of this end point

Baseline, Day 113 and Day 169

Basal, Día 113 y Dia 169

E.5.2

Secondary end point(s)

• ECG parameters, vital signs, safety laboratory data, physical exam and collection of AEs
• Plasma levels of Bb and sC5b-9
• UPCR measured in first morning void
• Ratio between baseline UPCR and UPCR at 24 weeks of treatment (from 24h urine collection)
• Proportion of subjects with a complete remission, defined as proteinuria ≤0.3 g/day at 24 weeks of treatment, derived from 24h urine collection
• Proportion of subjects with a partial remission, defined as reduction of proteinuria from baseline ≥50% plus final UP ≤ 3.5 g/24h but >0.3 g/24h at 24 weeks of treatment, derived from 24h urine collection.
• Change in eGFR applying the Chronic Kidney Disease Epidemiology Collaboration (CKD- EPI) equation from baseline to 24 weeks of treatment
• Plasma: non-compartmental parameters in plasma related to total parent drug, including, but not limited, to Tmax, Cmax, AUClast and AUCtau will be calculated for each dose level.
• Urine: renal plasma clearance derived from 24h urine at week 16.

• ECG, constantes vitales, datos analíticos de seguridad, exploración física y recogida de AA.
• Niveles plasmáticos de Bb y sC5b-9.
• CPCO medido en la primera orina de la mañana.
• Relación entre el UPCR basal y el UPCR a las 24 semanas de tratamiento (de la recogida de muestras de orina de 24 horas).
• Proporción de sujetos con remisión completa, definida como proteinuria </=0,3 g/día a las 24 semanas de tratamiento, derivada de la recogida de orina de 24 horas.
• Proporción de sujetos con remisión parcial, definida como disminución ≥50 % de la proteína en orina respecto a la basal más nivel de proteína en orina final </=3,5 g/24 h, pero >0,3 g/24 h, derivado de la recogida de orina de 24 horas.
• El cambio en la TFGe se calcula mediante la ecuación desarrollada por el grupo Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) desde la basal hasta las 24 semanas de tratamiento.
• Plasma: Para cada nivel de dosis se calcularán los parámetros no
compartimentales en plasma relacionados con el fármaco original total, que incluyen Cmax, Tmax, AUClast y AUCtau, entre otros.
• Orina: aclaramiento plasmático y renal derivado de la orina de
24 horas en la semana 16.

E.5.2.1

Timepoint(s) of evaluation of this end point

• Baseline, Day 1, Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 266, EOS. Collection of AEs is continuous.
• Baseline, Day 15, Day 29, Day 57, Day 113, Day 169, Day 266, EOS
• Baseline, Day 15, Day 29, Day 57, Day 85, Day 113, Day 169, Day 266, EOS
• Baseline, Day 113 and Day 169
• Baseline, Day 113 and Day 169
• Baseline, Day 113 and Day 169
• Baseline, Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 266, EOS
• Day 15, Day 29, Day 57, Day 113, Day 169
• Day 113

• Basal, Dia 1, Dia 15, Dia 29, Dia 57, Dia 85, Dia 113, Dia 141, Dia 169, Dia 266, Fin de studio. REcogida de RE es continua
• Basal, Dia 15, Dia 29, Dia 57, Dia 113, Dia 169, Dia 266, Fin de studio
• Basal, Dia 15, Dia 29, Dia 57, Dia 85, Dia 113, Dia 169, Dia 266, Fin de studio
• Basal, Dia 113 y Dia 169
• Basal, Dia 113 y Dia 169
• Basal, Dia 113 y Dia 169
• Baseline, Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 266, EOS
• Day 15, Day 29, Day 57, Day 113, Day 169
• Day 113

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

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

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)

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

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

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)

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

Argentina

Czech Republic

France

Germany

India

Netherlands

Russian Federation

Singapore

Spain

United Kingdom

United States

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

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

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)

None

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

2019-11-12

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-10-24

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2023-01-20

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