Clinical Trial Page

Summary
EudraCT Number:2022-000253-92
Sponsor's Protocol Code Number:EHP-101-MS02
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:2022-10-17
Trial results
A. Protocol Information
A.1Member State ConcernedSpain - AEMPS
A.2EudraCT number2022-000253-92
A.3Full title of the trial
A Phase IIa, Open-label, Multicentre Dose-Finding Trial in Patients with Relapsing Forms of Multiple Sclerosis (RMS) to Evaluate the Safety, Tolerability and Preliminary Efficacy of EHP-101
Ensayo de fase IIa, abierto, multicéntrico, de búsqueda de dosis en pacientes con formas recidivantes de esclerosis múltiple (EMR) para evaluar la seguridad, la tolerabilidad y la eficacia preliminar de EHP-101.
A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
A Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of EHP-101 in Patients with Relapsing Forms of Multiple Sclerosis (RMS)
Estudio para evaluar la seguridad, la tolerabilidad y la eficacia preliminar de EHP-101 en pacientes con formas recidivantes de esclerosis múltiple (EMR)
A.4.1Sponsor's protocol code numberEHP-101-MS02
A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04909502
A.7Trial is part of a Paediatric Investigation Plan No
A.8EMA Decision number of Paediatric Investigation Plan
B. Sponsor Information
B.Sponsor: 1
B.1.1Name of SponsorEmerald Health Pharmaceuticals Inc.
B.1.3.4CountryUnited States
B.3.1 and B.3.2Status of the sponsorCommercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1Name of organisation providing supportEmerald Health Pharmaceuticals Inc.
B.4.2CountryUnited States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1Name of organisationEmerald Health Pharmaceuticals Inc.
B.5.2Functional name of contact pointDirector, Clinical Science
B.5.3 Address:
B.5.3.1Street Address5910 Pacific Center Blvd, Ste 320
B.5.3.2Town/ citySan Diego, CA
B.5.3.3Post code92121
B.5.3.4CountryUnited States
B.5.4Telephone number+34-610-786-932
B.5.6E-mail[email protected]
D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3IMP RoleTest
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation No
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameEHP-101
D.3.2Product code EHP-101
D.3.4Pharmaceutical form Oral solution
D.3.4.1Specific paediatric formulation No
D.3.7Routes of administration for this IMPOral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNN/A
D.3.9.2Current sponsor codeVCE-004.8
D.3.9.4EV Substance CodeSUB192778
D.3.10 Strength
D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
D.3.10.2Concentration typeequal
D.3.10.3Concentration number10
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Yes
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) No
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product No
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product No
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.8 Information on Placebo
E. General Information on the Trial
E.1 Medical condition or disease under investigation
E.1.1Medical condition(s) being investigated
Relapsing Forms of Multiple Sclerosis (RMS)
Formas recidivantes de esclerosis múltiple (EMR)
E.1.1.1Medical condition in easily understood language
Relapsing Forms of Multiple Sclerosis (RMS)
Formas recidivantes de esclerosis múltiple (EMR)
E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
MedDRA Classification
E.1.2 Medical condition or disease under investigation
E.1.2Version 21.0
E.1.2Level PT
E.1.2Classification code 10080700
E.1.2Term Relapsing multiple sclerosis
E.1.2System Organ Class 10029205 - Nervous system disorders
E.1.2 Medical condition or disease under investigation
E.1.2Version 21.1
E.1.2Level PT
E.1.2Classification code 10063400
E.1.2Term Secondary progressive multiple sclerosis
E.1.2System Organ Class 10029205 - Nervous system disorders
E.1.2 Medical condition or disease under investigation
E.1.2Version 21.1
E.1.2Level PT
E.1.2Classification code 10063399
E.1.2Term Relapsing-remitting multiple sclerosis
E.1.2System Organ Class 10029205 - Nervous system disorders
E.1.3Condition being studied is a rare disease No
E.2 Objective of the trial
E.2.1Main objective of the trial
Safety and tolerability of selected doses of EHP-101 in patients with RMS administered for up to 168 days (24 weeks)
Seguridad y tolerabilidad de dosis seleccionadas de EHP-101 en pacientes con EMR administradas durante un máximo de 168 días (24 semanas)
E.2.2Secondary objectives of the trial
To evaluate the treatment effect of selected doses of EHP-101 administered to patients with RMS for up to Day 168 (24 weeks) on:
o Brain lesion activity as measured by MRI;
o Disease progression and disability status;
o Time to first study relapse;
o Annualized relapse rate (ARR);
o Neurofilament light chain (NfL) levels in blood.
Evaluar el efecto terapéutico de dosis seleccionadas de EHP-101 administradas a pacientes con EMR durante un máximo de 168 días (24 semanas) sobre:
o Actividad de las lesiones cerebrales medida mediante resonancia magnética (RM).
o Progresión de la enfermedad y estado de discapacidad.
o Tiempo transcurrido hasta la primera recidiva en el estudio.
o Tasa anualizada de recidivas (TAR).
o Concentración sanguínea de cadenas ligeras de los neurofilamentos
(NfL).
E.2.3Trial contains a sub-study Yes
E.2.3.1Full title, date and version of each sub-study and their related objectives
Pharmacokinetics sub-study per section 7.3.2 of the protocol
Subestudio de farmacocinética según la sección 7.3.2 del protocolo
E.3Principal inclusion criteria
1. Male and female adults aged 18 to 55 years at the time of consent;
2. Confirmed diagnosis of MS according to the revised 2017 McDonald criteria;
3. Relapsing forms of MS (RMS) including Relapsing-Remitting MS (RRMS) and active Secondary Progressive MS (SPMS);
4. Patients must have experienced at least 1 of the following within 12 months prior to Visit 1: an acute clinical relapse, gadolinium-enhancing T1 lesions on brain or spinal cord magnetic resonance imaging (MRI), or new T2 lesion(s) on brain or spinal cord MRI;
5. Neurologically stable with no evidence of clinical relapse of MS or corticosteroid treatment within 28 days prior to the first investigational product administration;
6. Naïve to prior MS treatment or discontinuing current MS treatment due to (1) intolerability, (2) laboratory abnormalities, (3) current treatment perceived by the patient to be ineffective, (4) patient preference, or (5) based on investigator judgement to switch MS therapy;
7. An EDSS score of 0 to 6.0 (inclusive) at screening and enrolment visit;
8. Willing and able to provide informed consent and capable of understanding and complying with the protocol.
1. Varón o mujer de entre 18 a 55 años en el momento de obtener el consentimiento.
2. Diagnóstico confirmado de EM según los criterios revisados de McDonald de 2017.
3. Forma recidivante de EM (EMR), incluida EM remitente-recidivante (EMRR) y EM secundaria progresiva (EMSP) activa.
4. Presencia de al menos una de las circunstancias siguientes en los 12 meses previos a la visita 1: recidiva clínica aguda, lesiones en T1 realzadas con gadolinio en una RM cerebral o medular o nuevas lesiones en T2 en una RM cerebral o medular.
5. Neurológicamente estable sin signos de recidiva clínica de la EM ni tratamiento con corticosteroides en los 28 días previos a la primera administración del producto en investigación.
6. Ausencia de tratamiento previo para la EM o suspensión del tratamiento actual para la EM por (1) intolerancia, (2) anomalías analíticas, (3) tratamiento actual percibido como ineficaz por parte del paciente, (4) preferencia del paciente o (5) criterio del investigador de cambiar el tratamiento para la EM.
7. Puntuación EDSS de 0 a 6,0 (ambos inclusive) en las visitas de selección e inclusión.
8. Disposición y capacidad para otorgar el consentimiento informado y capacidad para comprender y cumplir el protocolo.
E.4Principal exclusion criteria
1. Primary progressive MS or non-active secondary progressive MS
2. Relapse during the 28 days prior to first investigational product (IP) administration
3. Total lymphoid irradiation, T-cell or T-cell receptor vaccination, total body irradiation, or total lymphoid irradiation at any time
4. Treatment with alemtuzumab, mitoxantrone, cyclophosphamide or cladribine at any time
5. MS treatment that may impact the efficacy or safety assessment defined as follows:
a. 52 weeks or less prior to first IP administration:
• Immunosuppressant agents (e.g., cyclosporine, methotrexate, mycophenolate)
b. 36 weeks or less prior to first IP administration:
• CD20 depletion therapies such as rituximab, ocrelizumab, ofatumumab or others.
• Condition for inclusion of patients who had CD20 depletion therapies more than 36 weeks prior to the first IP administration: may only be included if there is no clinically relevant B cell depletion and possible safety risk to patients based on the Investigator’s opinion
c. 12 weeks or less prior to first IP administration:
• natalizumab
d. 8 weeks or less prior to first IP administration:
• dimethyl-fumarate • fingolimod
e. 4 weeks or less prior to first IP administration:
• corticosteroids • intravenous immunoglobulin • ozanimod, siponimod, or ponesimod • glatiramer acetate • interferons
f. 2 weeks or less prior to first IP administration:
• teriflunomide. Subject must exhibit no active agent in serum levels; cholestyramine or activated charcoal washout may be used to achieve this
6. Concomitant treatment with dalfampridine or fampridine is acceptable if patient is on a stable dose for ≥ 4 weeks
7. Concomitant medication that could cause drug-interactions as defined in the protocol
8. Clinically significant and uncontrolled cardiovascular, pulmonary, gastrointestinal, dermatologic, psychiatric, neurologic (other than MS, such as transverse myelitis), other autoimmune diseases (lupus, rheumatoid arthritis, Sjogren’s) and/or other major disease that would preclude participation in this clinical trial
9. Type 1 and Type 2 Diabetes mellitus
10.Gilbert’s syndrome
11.History of malignancy with the following exceptions: basal cell carcinoma, cutaneous squamous cell carcinoma or cervical carcinoma in situ resolved > 1 year prior to screening
12.Has a clinically significant medical condition or observed abnormality at screening
13.History of heart failure, abnormal left ventricular ejection fraction <53% at the screening visit, myocardial infarction including a silent myocardial infarction identified on ECG or unstable angina
14.Any clinically significant cardiac conduction abnormalities or abnormal, clinically relevant ECG result
15.Contraindication to MRI examination or gadolinium-based contrast agents
16.Use of cannabis products up to 28 days prior to dosing and during the study
17.Suspected hypersensitivity to any of the inactive ingredients of EHP-101: corn oil and Maisine® CC
18.Confirmed diagnosis of albinism
19.Moderate or severe drug or alcohol abuse within the past year and during the study (as defined by the investigator)
20.Positive serology test for hepatitis B panel (surface antigen positive, or core antibody positive with surface antibody negative), hepatitis C antibody (except treated/resolved HCV infection confirmed by negative HCV RNA PCR at screening), or human immunodeficiency virus antibody at screening
21.Positive tuberculosis test at screening
22.Participant has abnormal blood test values as defined in the protocol
23. Clinically significant history of suicidal ideation or suicidal behaviour as defined in the protocol
24. Current or prior participation in a clinical trial or 5 times the half-life of the prior IP as defined by the protocol
25. Female participant is pregnant or breastfeeding or plans to become pregnant or begin breastfeeding or not willing to follow the guidance for contraception as defined in protocol
26. Male participant does not agree to use acceptable contraception as defined in the protocol.
27. Any finding that in the view of the investigator would compromise the safety of the patient or affect his/her ability to adhere to the protocol
1. EM progresiva primaria o EM progresiva secundaria no activa
2. Recidiva durante los 28 días previos a la primera administración del producto en investigación (PI)
3. Vacunación basada en el uso de linfocitos T o receptores de linfocitos T, irradiación corporal total o irradiación linfática total en cualquier momento
4. Tratamiento con alemtuzumab, mitoxantrona, ciclofosfamida o cladribina en cualquier momento
5. Tratamiento para la EM que pueda influir en la evaluación de la eficacia o la seguridad, definida por:
a. 52 semanas o menos antes de la primera dosis del PI: Inmunodepresores(ej:ciclosporina, metotrexato o micofenolato)
b. 36 semanas o menos antes de la primera dosis del PI: •Tratamientos anti-CD20, como rituximab, ocrelizumab, ofatumumab u otros
•Condicion para la inclusión de pacientes que hayan recibido tratamientos anti-CD20 por más de 36 semanas antes de la primera dosis del PI: solo podrán ser incluidos si no existe una disminución clínicamente importante de los linfocitos B ni un posible riesgo para la seguridad de los pacientes, según la opinión del investigador
c. 12 semanas o menos antes de la primera dosis del PI: Natalizumab
d. 8 semanas o menos antes de la primera dosis del PI:
Dimetilfumarato, Fingolimod
e. 4 semanas o menos antes de la primera administración del PI:
Corticosteroides,Inmunoglobulina intravenosa, Ozanimod, siponimod o ponesimod, Acetato de glatirámero,Interferones
f. 2 semanas o menos antes de la primera dosis del PI:
Teriflunomida. El paciente no debe presentar fármaco activo en las determinaciones de concentración sérica; para lograrlo se puede utilizar colestiramina o carbón activado
6. Tratamiento concomitante con dalfampridina o fampridina es aceptable si el paciente recibe una dosis estable durante ≥4 semanas
7. Medicación concomitante que pueda causar interacciones farmacológicas como se define en el protocolo
8. Enfermedad cardiovascular, pulmonar, digestiva, dermatológica, psiquiátrica, neurológica (aparte de la EM, como mielitis transversa), autoinmune (lupus, artritis reumatoide, síndrome de Sjögren) o importante de otro tipo clínicamente significativa y no controlada que impediría la participación en el ensayo clínico
9. Diabetes mellitus de tipo 1 o 2
10. Síndrome de Gilbert
11. Antecedentes de neoplasia maligna, con las siguientes excepciones: carcinoma basocelular, carcinoma espinocelular cutáneo o carcinoma cervicouterino in situ resueltos >1 un año antes de la selección
12. Presencia de una enfermedad clínicamente significativa o una anomalía observada en el período de selección
13. Antecedentes de insuficiencia cardíaca, fracción de eyección del ventrículo izquierdo anormal <53% en la visita de selección, infarto de miocardio, incluido un infarto de miocardio asintomático identificado en el ECG, o angina de pecho inestable
14. Cualquier anomalía clínicamente significativa de la conducción cardíaca o resultado anormal del ECG clínicamente importante
15. Contraindicación de la RM o el uso de medios de contraste a base de gadolinio
16. Uso de productos derivados del cannabis hasta 28 días antes de la administración y durante el estudio
17. Sospecha de hipersensibilidad a cualquiera de los componentes inactivos de EHP-101: aceite de maíz y Maisine® CC
18. Diagnóstico confirmado de albinismo
19. Abuso moderado o grave de drogas o alcohol en el último año y durante el estudio (según la evaluación del investigador)
20. Serología positiva para hepatitis B (antígeno de superficie positivo o anticuerpos anti core positivo con anticuerpos de superficie negativo), anticuerpos contra el virus de la hepatitis C (excepto infección por el VHC tratada o resuelta confirmada por un resultado negativo en una PCR para ARN del VHC en el período de selección) o anticuerpos contra el virus de la inmunodeficiencia humana en el período de selección
21. Prueba de tuberculosis positiva en el período de selección
22. El participante tiene valores de análisis de sangre anormales como se define en el protocolo
23. Antecedentes clínicamente significativos de ideación o comportamiento suicida según lo definido en el protocolo
24. Participación actual o previa en un ensayo clínico o 5 veces la semivida del PI previo según lo definido por el protocolo
25. Mujeres embarazadas, en período de lactancia o que tengan
previsto quedarse embarazadas o comenzar la lactancia o no esten dispuestas a seguir las recomendaciones sobre metodos anticonceptivos recogidos en el protocolo
26. Varones que no se comprometan a utilizar métodos anticonceptivos aceptables recogidos en el protocolo
27. Cualquier hallazgo que, en opinión del investigador, pueda comprometer la seguridad del paciente o afectar a su capacidad de cumplir con el protocolo
E.5 End points
E.5.1Primary end point(s)
Incidence and severity of treatment-emergent adverse events (TEAEs)
Incidencia e intensidad de los acontecimientos adversos surgidos durante el tratamiento (AAST)
E.5.1.1Timepoint(s) of evaluation of this end point
from baseline for up to 168 days / 24 weeks.
desde el inicio hasta 168 días / 24 semanas.
E.5.2Secondary end point(s)
• Brain lesion activity endpoint evaluations including:
- Percentage change from baseline in the number of new gadolinium (Gd)-enhancing lesions on brain MRI scans at Day 169;
- Volume change from baseline of new or enlarging hyperintense lesions on T2-weighted images at Day 169;
- Change from baseline in T1 hypointense lesion volume at Day 169;
- Proportion of patients free from MRI disease activity (absence of new Gd-enhancing and new/enlarging T2 lesions) between baseline and Day 169;
• Disease progression and disability status endpoints to be evaluated include changes from baseline in:
- MS Functional Composite (MSFC) Score at Day 169;
- Expanded Disability Status Scale (EDSS) at Day 169;
- Symbol Digit Modalities Test (SDMT) at Day 169;
• Time to first relapse from baseline;
• Preliminary Annualized Relapse Rate (ARR) data at the Week 24 (Day 169) endpoint to be evaluated include:
- Percent of patients who experience a relapse;
• Proportion of patients who remain qualified as relapse-free;
• NfL blood levels over time from baseline.
•Evaluaciones de criterios de valoración relacionados con la actividad de las lesiones cerebrales, tales como:
- Variación porcentual del número de lesiones realzadas con gadolinio (Gd) nuevas en las RM cerebrales entre el momento basal y el día 169;
- Variación del volumen de lesiones hiperintensas nuevas o que aumenten de tamaño en las imágenes ponderadas en T2 entre el momento basal y el día 169;
- Variación del volumen de lesiones hipointensas en T1 entre el momento basal y el día 169;
- Proporción de pacientes sin actividad de la enfermedad en la RM (ausencia de lesiones nuevas realzadas con Gd y de lesiones nuevas o que aumenten de tamaño en T2) entre el momento basal y el día 169.
• Entre los criterios de valoración relacionados con la progresión de la enfermedad y el estado de discapacidad que se evaluarán figuran las variaciones del momento basal en:
- Puntuación en la Escala funcional compuesta para la EM (MSFC) en el día 169;
- Puntuación en la Escala ampliada del estado de discapacidad (EDSS) en el día 169;
- Test de símbolos y dígitos (SDMT) en el día 169;
• Tiempo transcurrido hasta la primera recidiva desde el momento basal.
• Entre los datos preliminares relacionados con la tasa anualizada de recidivas (TAR) en el momento final de la semana 24 (día 169) que se evaluarán figuran:
- Porcentaje de pacientes que presenten una recidiva;
• Proporción de pacientes que siguen cumpliendo los requisitos de ausencia de recidivas.
• Concentración sanguínea de NfL a lo largo del tiempo con respecto al momento basal.
E.5.2.1Timepoint(s) of evaluation of this end point
Time points as noted per Section E.5.2
Medidas de tiempo como se indica en la Sección E.5.2
E.6 and E.7 Scope of the trial
E.6Scope of the trial
E.6.1Diagnosis No
E.6.2Prophylaxis No
E.6.3Therapy Yes
E.6.4Safety Yes
E.6.5Efficacy Yes
E.6.6Pharmacokinetic Yes
E.6.7Pharmacodynamic Yes
E.6.8Bioequivalence No
E.6.9Dose response Yes
E.6.10Pharmacogenetic No
E.6.11Pharmacogenomic No
E.6.12Pharmacoeconomic No
E.6.13Others Yes
E.6.13.1Other scope of the trial description
Tolerability
Tolerabilidad
E.7Trial type and phase
E.7.1Human pharmacology (Phase I) No
E.7.1.1First administration to humans No
E.7.1.2Bioequivalence study No
E.7.1.3Other No
E.7.1.3.1Other trial type description
E.7.2Therapeutic exploratory (Phase II) Yes
E.7.3Therapeutic confirmatory (Phase III) No
E.7.4Therapeutic use (Phase IV) No
E.8 Design of the trial
E.8.1Controlled No
E.8.1.1Randomised No
E.8.1.2Open Yes
E.8.1.3Single blind No
E.8.1.4Double blind No
E.8.1.5Parallel group No
E.8.1.6Cross over No
E.8.1.7Other No
E.8.2 Comparator of controlled trial
E.8.2.1Other medicinal product(s) No
E.8.2.2Placebo No
E.8.2.3Other No
E.8.2.4Number of treatment arms in the trial2
E.8.3 The trial involves single site in the Member State concerned No
E.8.4 The trial involves multiple sites in the Member State concerned Yes
E.8.4.1Number of sites anticipated in Member State concerned11
E.8.5The trial involves multiple Member States Yes
E.8.5.1Number of sites anticipated in the EEA15
E.8.6 Trial involving sites outside the EEA
E.8.6.1Trial being conducted both within and outside the EEA Yes
E.8.6.2Trial being conducted completely outside of the EEA No
E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
Australia
Italy
Spain
United States
E.8.7Trial 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
La última visita del último sujeto reclutado
E.8.9 Initial estimate of the duration of the trial
E.8.9.1In the Member State concerned years1
E.8.9.1In the Member State concerned months4
E.8.9.1In the Member State concerned days0
E.8.9.2In all countries concerned by the trial years1
E.8.9.2In all countries concerned by the trial months9
E.8.9.2In all countries concerned by the trial days0
F. Population of Trial Subjects
F.1 Age Range
F.1.1Trial has subjects under 18 No
F.1.1.1In Utero No
F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
F.1.1.3Newborns (0-27 days) No
F.1.1.4Infants and toddlers (28 days-23 months) No
F.1.1.5Children (2-11years) No
F.1.1.6Adolescents (12-17 years) No
F.1.2Adults (18-64 years) Yes
F.1.2.1Number of subjects for this age range: 50
F.1.3Elderly (>=65 years) No
F.2 Gender
F.2.1Female Yes
F.2.2Male Yes
F.3 Group of trial subjects
F.3.1Healthy volunteers No
F.3.2Patients Yes
F.3.3Specific vulnerable populations Yes
F.3.3.1Women of childbearing potential not using contraception No
F.3.3.2Women of child-bearing potential using contraception Yes
F.3.3.3Pregnant women No
F.3.3.4Nursing women No
F.3.3.5Emergency situation No
F.3.3.6Subjects incapable of giving consent personally No
F.3.3.7Others No
F.4 Planned number of subjects to be included
F.4.1In the member state22
F.4.2 For a multinational trial
F.4.2.1In the EEA 24
F.4.2.2In the whole clinical trial 50
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)
Prior to the End of Study Visit, patient may be offered to participate in an open label extension trial under a separate protocol.
Antes de la visita de final del estudio podrá ofrecerse a cada paciente la posibilidad de participar en un ensayo de extensión abierto con un protocolo aparte.
G. Investigator Networks to be involved in the Trial
N. Review by the Competent Authority or Ethics Committee in the country concerned
N.Competent Authority Decision Authorised
N.Date of Competent Authority Decision2022-10-14
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2022-06-28
P. End of Trial
P.End of Trial StatusOngoing