Clinical Trials Register

Summary
EudraCT Number:	2020-002713-17
Sponsor's Protocol Code Number:	GA42469
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2020-07-20
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

2020-002713-17

A.3

Full title of the trial

A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OF
MSTT1041A OR UTTR1147A IN PATIENTS WITH SEVERE COVID-19 PNEUMONIA

ESTUDIO DE FASE II, MULTICÉNTRICO, ALEATORIZADO,
DOBLE CIEGO Y CONTROLADO CON PLACEBO, PARA
EVALUAR LA SEGURIDAD Y LA EFICACIA DE MSTT1041A
O UTTR1147A EN PACIENTES CON NEUMONÍA GRAVE
CAUSADA POR COVID-19

A.3.1

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

A Study to Evaluate the Safety and Efficacy of MSTT1041A or UTTR1147A in Patients with Severe Covid-19 Pneumonia

Estudio para evaluar la seguridad y la eficacia de MSTT1041A o UTTR1147A en pacientes con neumonía grave causada por Covid-19

A.3.2

Name or abbreviated title of the trial where available

COVASTIL

A.4.1

Sponsor's protocol code number

GA42469

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	Genentech, Inc.
B.1.3.4	Country	United States
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	Genentech Inc. c/o F. Hoffmann-La Roche Ltd
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Genentech Inc. c/o F. Hoffmann-La Roche Ltd
B.5.2	Functional name of contact point	Trial Information Support Line-TISL
B.5.3	Address:
B.5.3.1	Street Address	Grenzacherstrasse 124
B.5.3.2	Town/ city	Basel
B.5.3.3	Post code	4070
B.5.3.4	Country	Switzerland
B.5.4	Telephone number	+34913257300
B.5.5	Fax number	+34913248196
B.5.6	E-mail	spain.start_up_unit@roche.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	n/a
D.3.2	Product code	RO7021610/F01 (Active)
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	n/a
D.3.9.2	Current sponsor code	RO7021610
D.3.9.3	Other descriptive name	UTTR1147A, IL22-Fc, IL-22Fc
D.3.9.4	EV Substance Code	SUB179397
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	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	Yes
D.3.11.13.1	Other medicinal product type	Human interleukin-22 (IL-22) fusion protein
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.3.1	Product name	Astegolimab
D.3.2	Product code	RO7187807/F01
D.3.4	Pharmaceutical form	Solution for injection/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	Astegolimab
D.3.9.2	Current sponsor code	RO7187807
D.3.9.3	Other descriptive name	MSTT1041A, anti- ST2 (IgG2) human monoclonal antibody
D.3.9.4	EV Substance Code	SUB182263
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	70
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	Yes
D.3.11.13.1	Other medicinal product type	human immunoglobulin (Ig) G2 monoclonal antibody

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for infusion
D.8.4	Route of administration of the placebo	Intravenous use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for injection/infusion
D.8.4	Route of administration of the placebo	Intravenous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Severe coronavirus disease 2019 (COVID-19) pneumonia

Enfermedad coronavirus grave 2019 (COVID-19) neumonía

E.1.1.1

Medical condition in easily understood language

Coronaviruses are a family of viruses that typically cause the common cold. SARS-CoV 2 is a strain of coronavirus that can cause pneumonia (a severe lung infection) and respiratory failure.

Los coronavirus son una familia de virus q típicamente causan el resfriado común. SARS-CoV 2 es una cepa de coronavirus q puede causar neumonía (infección pulmonar grave) e insuficiencia respiratoria.

E.1.1.2

Therapeutic area

Diseases [C] - Virus Diseases [C02]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	23.0
E.1.2	Level	LLT
E.1.2	Classification code	10084383
E.1.2	Term	Novel COVID-19-infected pneumonia
E.1.2	System Organ Class	100000004862

E.1.2 Medical condition or disease under investigation

E.1.2	Version	23.0
E.1.2	Level	LLT
E.1.2	Classification code	10084270
E.1.2	Term	SARS-CoV-2 acute respiratory disease
E.1.2	System Organ Class	100000004862

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 MSTT1041A compared with placebo and of UTTR1147A compared with placebo in combination with standard of care (SOC) on the basis of clinical status assessed using a 7-category ordinal scale at Day 28

Evaluar la eficacia de MSTT1041A en comparación con el placebo y de UTTR1147A en comparación con el placebo en combinación con el tratamiento habitual basándose en el estado clínico evaluado mediante una escala ordinal de 7 categorías el día 28

E.2.2

Secondary objectives of the trial

• To evaluate the efficacy of MSTT1041A compared with placebo and of UTTR1147A compared with placebo in combination with SOC on the basis of time to clinical improvement, time to improvement of at least 2 categories relative to baseline on a 7-category ordinal scale of clinical status, incidence of mechanical ventilation, ventilator-free days to Day 28, incidence and duration of intensive care unit (ICU) stay, time to clinical failure, mortality rate, time to hospital discharge or “ready for discharge”, duration of supplemental oxygen, duration of hypoxemia, and proportion of patients alive and free of respiratory failure
• To evaluate the safety of MSTT1041A compared with placebo and of UTTR1147A compared with placebo in combination with SOC for the treatment of severe COVID-19 pneumonia
• To characterize the pharmacokinetic profile of MSTT1041A and UTTR1147A
• To evaluate the immune response to UTTR1147A and MSTT1041A

-Evaluar la eficacia de MSTT1041A en comparación con el placebo y de UTTR1147A en comparación con el placebo en combinación con el tto habitual basándose en Tiempo hasta la mejoría clínica, tiempo hasta la mejoría de al menos 2 categorías con respecto al momento basal en una escala ordinal de 7 categorías del estado clínico, Incidencia de ventilación mecánica, Días sin respirador hasta el día 28, Incidencia y duración de estancia en la UCI, Tiempo hasta el fracaso clínico, Tasa de mortalidad, Tiempo hasta el alta hospitalaria o “listo para el alta”, Duración de la oxigenoterapia, Duración de la hipoxemia y Proporción de pacientes vivos y sin insuficiencia respiratoria.
- Evaluar la seguridad de MSTT1041A en comparación con el placebo y de UTTR1147A en comparación con el placebo en combinación con el tto habitual para la neumonía grave por el virus de la covid-19
- Caracterizar los perfiles FC de MSTT1041A y UTTR1147A
- Evaluar la respuesta inmunitaria a UTTR1147A y MSTT1041A

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Age >=18 years
• Hospitalized with COVID-19 pneumonia confirmed per WHO criteria and evidenced by chest X-ray or CT scan
• Peripheral capillary oxygen saturation (SpO2) <= 93% or partial pressure of oxygen/fraction of inspired oxygen <= 300 mmHg or requiring supplemental oxygen to maintain SpO2 > 93%

-Edad>=18 years
-Hospitalización debida a neumonía por el virus de la covid-19 confirmada según los criterios de la OMS y demostrada por radiografía de tórax o TC
-Saturación de oxígeno capilar periférica (SpO2) <= 93 % o presión parcial de oxígeno (PaO2)/fracción de oxígeno inspirado (FiO2) <= 300 mm Hg o necesidad de oxigenoterapia para mantener la SpO2> 93 %

E.4

Principal exclusion criteria

• Any serious medical condition or abnormality of clinical laboratory tests that, in the investigator’s judgment, precludes the patient’s safe participation in and completion of the study
• In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments
• Participating in another clinical drug trial
• Treatment with investigational therapy (other than for COVID-19) within 5 half-lives or 30 days prior to initiation of study drug
• Use of Janus kinase inhibitor within 30 days or 5 drug elimination half-lives prior to screening
• Have received high-dose systemic corticosteroids within 72 hours prior to Day 1
• Known HIV infection with CD4< 200 cells/micro liter or <14% of all lymphocytes
• Alanine aminotransferase and aspartate aminotransferase >10× upper limit of normal (ULN) detected at screening
• History of anaplastic large-cell lymphoma or mantle-cell lymphoma
• History of cancer within the previous 5 years unless it has been adequately treated and considered cured or remission-free in the investigator's judgment
• Clinical evidence of active or unstable cardiovascular disease (e.g., acute myocardial ischemia or decompensated heart failure) as assessed by the investigator assessment, ECG, laboratory assessment, or echocardiographic data
• History of moderate or severe allergic, anaphylactic, or anaphylactoid reactions or hypersensitivity to any component of study treatment

-Cualquier enfermedad grave o anomalía analítica que, en opinión del investigador, descarte la
participación segura del paciente en el estudio y su finalización.
- En opinión del investigador, la progresión a la muerte es inminente e inevitable en las 24 horas siguientes, con independencia de la administración de tratamientos
- Participación en otro ensayo clínico con fármacos
- Tratamiento con un fármaco en investigación (que no sea para la COVID-19) en el plazo de
5 semividas o 30 días (lo que dure más tiempo) antes del inicio del fármaco del estudio.
- Uso de un inhibidor de la cinasa Jano (JAK) en los 30 días previos a la selección o el equivalente a 5 semividas de eliminación del fármaco
-Haber recibido corticosteroides sistémicos en dosis altas en las 72 horas previas al día 1.
- Infección conocida por el VIH con CD4 < 200 células/micro litro o < 14 % de todos los linfocitos
- ALT o AST > 10 x el límite superior de la normalidad (LSN) detectado en la selección
- Antecedentes de linfoma anaplásico de células grandes o linfoma de células del manto
- Antecedentes de cáncer en los 5 años anteriores a menos que se haya tratado adecuadamente y se considere curado o sin remisión según el criterio del investigador
-Signos clínicos de enfermedad cardiovascular activa o inestable (p. ej., isquemia miocárdica aguda o insuficiencia cardíaca descompensada) según la evaluación del investigador, ECG, evaluación de laboratorio, o datos ecocardiográficos
- Antecedentes de reacciones alérgicas, anafilácticas o anafilactoides moderadas o intensas o de hipersensibilidad a cualquiera de los componentes del tratamiento del estudio

E.5 End points

E.5.1

Primary end point(s)

1. Clinical status assessed using a 7-category ordinal scale at Day 28

1. Estado clínico evaluado mediante una escala ordinal de 7 categorías el día 28

E.5.1.1

Timepoint(s) of evaluation of this end point

1. At Day 28

1. En el día 28

E.5.2

Secondary end point(s)

1. Time to clinical improvement, defined as a National Early Warning Score 2 (NEWS2) of <= 2 maintained for 24 hours
2. Time to improvement of at least 2 categories relative to baseline on a 7-category ordinal scale of clinical status
3. Incidence of mechanical ventilation
4. Ventilator-free days to Day 28
5. Incidence of ICU stay
6. Duration of ICU stay
7. Time to clinical failure
8. Mortality rate at Days 7, 14, 21, 28, and 60
9. Time to hospital discharge or “ready for discharge”
10. Duration of supplemental oxygen
11. Duration of hypoxemia (<= 93% on room air)
12. Proportion of patients alive and free of respiratory failure at Day 28
13. Incidence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0
14. Change from baseline in targeted vital signs, targeted clinical laboratory test results, and targeted ECG parameters
15. Serum concentration of MSTT1041A at specified timepoints
16. Serum concentration of UTTR1147A at specified timepoints
17. Prevalence of anti-drug antibodies (ADAs) at baseline and incidence of ADAs during the study

1. Tiempo hasta la mejoría clínica (THMC), definido como una puntuación en la Escala pronóstica de gravedad nacional (NEWS2) 2 mantenida durante 24 horas.
2. Tiempo hasta la mejoría de al menos 2 categorías con respecto al momento basal en una escala ordinal de 7 categorías del estado clínico
3. Incidencia de ventilación mecánica
4. Días sin respirador hasta el día 28
5. Incidencia de estancia en la UCI
6. Duración de la estancia en la UCI
7. Tiempo hasta el fracaso clínico
8. Tasa de mortalidad los días 7, 14, 21, 28 y 60
9. Tiempo hasta el alta hospitalaria o “listo para el alta”
10. Duración de la oxigenoterapia
11. Duración de la hipoxemia (93 % con aire ambiente)
12. Proporción de pacientes vivos y sin insuficiencia respiratoria el día 28
13. Incidencia e intensidad de los acontecimientos adversos, con determinación de la intensidad conforme a los Criterios terminológicos comunes para acontecimientos adversos del National Cancer Institute, versión 5.0
14. Variación con respecto al momento basal de las constantes vitales de interés, los resultados analíticos de interés y los parámetros ECG de interés.
15. Concentración sérica de MSTT1041A en momentos especificados
16. Concentración sérica de UTTR1147A en momentos especificados
17. Prevalencia de anticuerpos contra el fármaco (ACF) en el momento basal e incidencia de ACFdurante el estudio.

E.5.2.1

Timepoint(s) of evaluation of this end point

1-3 Up to Day 60
4. Up to Day 28
5-7. Up to Day 60
8. At Days 7, 14, 21, 28, and 60
9-11. Up to Day 60
12. At Day 28
13. Up to Day 60
14. From baseline to Day 60
15-16. Day 1-3, 7, 15, 21, 28, 60 or at early discontinuation visit
17. Day 1, 15, 28, 60 or at early discontinuation visit

1-3 Hasta el día 60
4. Hasta el día 28
5-7. Hasta el día 60
8. En los días 7, 14, 21, 28 y 60
9-11. Hasta el día 60
12. En el día 28
13. Hasta el día 60
14. Desde la línea de base hasta el día 60
15-16. Día 1-3, 7, 15, 21, 28, 60 o en la visita de interrupción temprana
17. Día 1, 15, 28, 60 o en la visita de interrupción temprana

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

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

immunogenicity, predictive biomarkers, prognostic biomarkers, PD biomarkers

Inmunogenicidad, biomarcadores predictivos, biomarcadores pronósticos y biomarcadores FD

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

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

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

Mexico

Spain

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

The end of this study is defined as the date when the last patient, last visit, occurs or the date at which the last data point required for statistical analysis or safety follow-up is received from the last patient, whichever occurs later.

El final del estudio se define como la fecha en que tenga lugar la última visita del último paciente o la fecha en que se reciban los últimos datos necesarios para el análisis estadístico o el seguimiento de seguridad del último paciente, lo que suceda más tarde.

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:

195

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

105

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

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Patients who are on a ventilator or who have altered mental status will not be able to give consent.

Los pacientes que están en un respirador o que tienen un estado mental alterado no podrán dar su consentimiento.

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

300

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)

Currently, the Sponsor (Genentech, a member of the Roche Group) does not have any plans to provide Genentech IMPs (MSTT1041A or UTTR1147A) or any other study treatments to patients who have completed the study.

Actualmente, el promotor (Genentech, miembro del Grupo Roche) no tiene planes de proporcionar Genentech IMPs (MSTT1041A o UTTR1147A) o cualquier otro tratamiento del estudio a los pacientes que han completado el estudio.

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

2020-07-13

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-07-09

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2021-02-12

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