Clinical Trials Register

Summary
EudraCT Number:	2022-003666-20
Sponsor's Protocol Code Number:	P1606-SUR-O25
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:	2023-02-09
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

2022-003666-20

A.3

Full title of the trial

Phase 2b Single Arm Study of Maveropepimut-S and Low-Dose Cyclophosphamide in Subjects with Platinum-Resistant, Epithelial Ovarian
Cancer (AVALON)

Estudio de fase 2b de un solo grupo de tratamiento de maveropepimut-S y dosis bajas de ciclofosfamida en pacientes con cáncer epitelial de ovario resistente al platino (AVALON)

A.3.1

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

DPX-Survivac and Low-Dose Cyclophosphamide in Participants with Platinum-Resistant, Epithelial Ovarian Cancer (AVALON)

DPX-Survivac y bajas dosis de Cyclofosfamida en participantes con cáncer epitelial de ovario resistente al platino (PROC)

A.3.2

Name or abbreviated title of the trial where available

AVALON

A.4.1

Sponsor's protocol code number

P1606-SUR-O25

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT05243524

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	Immunovaccine Technologies Inc. (IMV Inc.)
B.1.3.4	Country	Canada
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	Immunovaccine Technologies Inc. (IMV Inc.)
B.4.2	Country	Canada
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Immunovaccine Technologies Inc. (IMV Inc.)
B.5.2	Functional name of contact point	Regulatory Affairs
B.5.3	Address:
B.5.3.1	Street Address	130 Eileen Stubbs Avenue, Suite 19
B.5.3.2	Town/ city	Dartmouth, NS
B.5.3.3	Post code	B3B 2C4
B.5.3.4	Country	Canada
B.5.4	Telephone number	+1581741-0519
B.5.5	Fax number	+1902492-0888
B.5.6	E-mail	regulatoryaffairs@imv-inc.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	Yes
D.2.5.1	Orphan drug designation number	EU/3/16/1791
D.3 Description of the IMP
D.3.1	Product name	Maveropepimut-S (formerly DPX- Survivac)
D.3.4	Pharmaceutical form	Powder and solvent for 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	Peptide antigen SurA2.M
D.3.9.3	Other descriptive name	L-leucyl-L-methionyl-L-leucylglycyl-L-a-L-glutamyl-L-phenylalanyl-L-leucyl-L-lysyl-L-leucine
D.3.9.4	EV Substance Code	SUB257492
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	0.8
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Peptide antigen SurA3.K
D.3.9.3	Other descriptive name	L-arginyl-L-isoleucyl-L-seryl-L-threonyl-L-phenylalanyl-L-lysyl-L-asparaginyl-L-tryptophyl-L-prolyl-L-lysine
D.3.9.4	EV Substance Code	SUB257493
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	0.8
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Peptide antigen SurA24
D.3.9.3	Other descriptive name	L-seryl-L-threonyl-L-phenylalanyl-L-lysyl-L-asparaginyl-L-tryptophyl-L-prolyl-L-phenylalanyl-L-leucine
D.3.9.4	EV Substance Code	SUB257494
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	0.8
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Peptide antigen SurB7
D.3.9.3	Other descriptive name	L-leucyl-L-prolyl-L-prolyl-L-alanyl-L-tryptophyl-L-glutaminyl-L-prolyl-L-phenylalanyl-L-leucine
D.3.9.4	EV Substance Code	SUB257495
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	0.8
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Polynucleotide adjuvant (dldC)
D.3.9.3	Other descriptive name	DNA, d(I-C-I-C-I-C-I-C-I-C-I-C-I-C-I-C-I-C-I-C-I-C-I-C-I-C)
D.3.9.4	EV Substance Code	SUB257496
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	0.32
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	T-Helper antigen (A16L)
D.3.9.3	Other descriptive name	L-alanyl-L-glutaminyl-L-tyrosyl-L-isoleucyl-L-lysyl-L-alanyl-L-asparaginyl-L-seryl-L-lysyl-L-phenylalanyl-L-isoleucylglycyl-L-isoleucyl-L-threonyl-L-a-glutamyl-L-leucine
D.3.9.4	EV Substance Code	SUB257497
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	0.4
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Peptide antigen SurA1.T
D.3.9.3	Other descriptive name	L-phenylalanyl-L-threonyl-L-a-glutamyl-L-leucyl-L-threonyl-L-leucylglycyl-L-a-glutamyl-L-phenylalanine
D.3.9.4	EV Substance Code	SUB257491
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	0.8
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	Yes
D.2.1.1.1	Trade name	Cyclophosphamide Tablets 50 mg
D.2.1.1.2	Name of the Marketing Authorisation holder	Baxter Healthcare Ltd
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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	Cyclophosphamide
D.3.4	Pharmaceutical form	Tablet
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	Cyclophosphamide
D.3.9.1	CAS number	6055-19-2
D.3.9.3	Other descriptive name	Cyclophosphamide monohydrate
D.3.9.4	EV Substance Code	SUB16414MIG
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	50
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.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Platinum Resistant Epithelial Ovarian Cancer

cáncer epitelial de ovario resistente al platino

E.1.1.1

Medical condition in easily understood language

Platinum Resistant Ovarian Cancer

cáncer de ovario resistente al platino

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.0
E.1.2	Level	PT
E.1.2	Classification code	10033160
E.1.2	Term	Ovarian epithelial cancer recurrent
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.3

Condition being studied is a rare disease

Yes

E.2 Objective of the trial

E.2.1

Main objective of the trial

To determine the antitumor activity of MVP-S plus low-dose CPA in subjects with platinum-resistant ovarian cancer (PROC)

Determinar la actividad antitumoral de maveropepimut-S más dosis bajas de CPA en pacientes con cáncer de ovario resistente al platino (PROC, por sus siglas en inglés)

E.2.2

Secondary objectives of the trial

To further characterize the antitumor activity of MVP-S plus low-dose CPA in subjects with PROC
To characterize the safety and tolerability of MVP-S plus low-dose CPA in subjects with PROC

Ampliar la caracterización de la actividad antitumoral de maveropepimut-S más dosis bajas de CPA en pacientes con PROC
Caracterizar la seguridad y la tolerabilidad de maveropepimut-S más dosis bajas de CPA en pacientes con PROC

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer, histologically diagnosed high-grade serous
Platinum-resistant disease, meeting one of the following definitions.
a. Relapsing within 3-6 months after completion of initial platinum-based
treatment, OR
b. Progressing while on treatment with ≥ 2nd platinum-based therapy,
OR
c. Progressing within 6 months after the completion of ≥ 2nd platinum-based treatment
Received ≤ 4 prior lines of anti-cancer therapy for ovarian cancer, including at least one platinum-based therapy
Evidence of progressive disease
Measurable disease (RECIST v1.1) with at least one non-target lesion accessible by image-guided biopsy. No single lesion may be larger than 4
cm in diameter.

cáncer epitelial de ovario, de trompa de Falopio o peritoneal primario en estadio III o IV, diagnosticado histológicamente como carcinoma seroso de alto grado resistente a Platino, que reúna alguno de las siguientes definiciones.
a. Recaída en los 3 a 6 meses posteriores a la finalización del tratamiento inicial basado en platino

Ó

b. Progresión durante el 2.o tratamiento o uno posterior basado en platino,

o bien

c. Progresión en los 6 meses posteriores a la finalización del 2.o tratamiento o uno posterior basado en platino
Haber recibido menos de 4 líneas de tratamiento anteriores contra el cáncer de ovario, incluido al menos un tratamiento basado en platino.
Evidencia de progresión de la enfermedad.
Enfermedad medible (RECIST v1.1), con al menos 1 lesión no diana accesible mediante biopsia guiada por imagen. Ninguna lesión individual puede tener más de 4 cm de diámetro

E.4

Principal exclusion criteria

Concurrent chemotherapy drugs, anti-cancer therapy or anti-neoplastic hormonal therapy, or radiotherapy
Prior receipt of survivin-based vaccines/therapy, immune checkpoint inhibitors, IDO inhibitor, or cell-based therapy
Non-epithelial tumor origin of the ovary, fallopian tube, or peritoneum
Clinical ascites
Concurrent second malignancy other than basal or squamous cell skin cancer, cervical carcinoma in situ, or Stage I or II cancer in complete remission
GI condition that might limit absorption of oral agents
Recent history of thyroiditis
History of autoimmune disease requiring treatment within the last two years (except paraneoplastic syndrome, vitiligo, or diabetes)
History of bowel obstruction related to the disease
Presence of a serious acute infection or chronic infection
Uncontrolled concurrent illness or history of significant cardiac or pulmonary dysfunction
Myocardial infarction or cerebrovascular event within past 6 months
Known central nervous system (CNS) or leptomeningeal metastasis (brain metastases)
Clinically significant illness or major surgery within past 28 days or anticipated need for major surgery during study treatment
Ongoing treatment with steroid therapy or other immunosuppressive
Receipt of live attenuated vaccines
Edema or lymphedema in the lower limbs > grade 2
Acute or chronic skin and/or microvascular disorders

quimioterapias concurrentes, terapia anti-cáncer terapia hormonal anti-neoplásica o radioterapia.
Haber recibido previamente terapias/vacunas basadas en survivina, inhibidores de puntos de control inmunitario, inhibidores IDO o terapia basada en células.
Origen tumoral no epitelial del ovario, las trompas de Falopio o el peritoneo.
Ascitis clínica
Neoplasia maligna concurrente, excepto por lo siguiente: cáncer de piel de células basales o escamosas, cáncer de cuello uterino in situ, cáncer en estadio I o II en remisión completa
Condición gastrointestinal que pueda limitar la absorción de agentes orales.
Historia reciente de tiroiditis
Historia de enfermedad autoinmune que haya requerido tratamiento dentro de los dos últimos años (excepto síndrome paraneoplásico, el vitíligo o la diabetes.
Antecedentes de obstrucción intestinal relacionada con la enfermedad.
Presencia de infección severa aguda o infección crónica
Enfermedad concurrente, no controlada o historia cardíaca significativa o disfunción pulmonar
Infarto de miocardio o evento cerebrovascular en los pasados seis meses
Metástasis conocida del sistema nervioso central (SNC ) o leptomeningea (metástasis cerebral)
Enfermedad clínicamente significativa o cirugía mayor en los 28 días anteriores al día 0 ó necesidad prevista de cirugía mayor durante el tratamiento del estudio.
Tratamiento con terapia esteroidea u otros inmunosupresores
Administración de una vacuna viva atenuada
Edema o linfedema en las extremidades inferiores > grado 2
Trastorno cutáneo y/o microvascular agudo o crónico

E.5 End points

E.5.1

Primary end point(s)

Overall Response Rate (ORR) per Response Evaluation Criteria in Solid
Tumours

Tasa de remisión objetiva (TRO) según los criterios de evaluación de respuesta en tumores sólidos, versión 1.1 (RECIST 1.1)1

E.5.1.1

Timepoint(s) of evaluation of this end point

Approximately 12 months

aproximadamente 12 meses

E.5.2

Secondary end point(s)

ORR per modified Response Evaluation Criteria in Solid Tumours 1.1 for immune-based therapeutics (iRECIST)
Duration of Response (DOR)
Disease Control Rate (DCR)
Time to Progression (TTP)
Progression Free Survival (PFS)
6-month PFS
Overall Survival (OS)
CA-125 Response
AEs and SAEs, assessed using NCI CTCAE v5.0
Laboratory Parameters
Physical exam, vital signs & performance status

TRO según los criterios modificados de evaluación de la respuesta en tumores sólidos 1.1 para terapias inmunológicas (iRECIST2)
Duración de la remisión (DR)
Tasa de control de la enfermedad (TCE)
Tiempo hasta la progresión (THP)
Supervivencia sin progresión (SSP)
SSP a los 6 meses
Supervivencia global (SG)
Respuesta de CA-1253

E.5.2.1

Timepoint(s) of evaluation of this end point

Approximately 12 months

aproximadamente 12 meses

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

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

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

Simon's Two-Stage Design

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Australia

Canada

United States

France

Romania

Spain

Georgia

United Kingdom

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

Completion of the Survival Follow-up period for the last patient treated in the study. Completion of follow-up for the last patient will occur when the last patient in the study has been followed for up to 5 years after their End of Treatment Visit, has withdrawn consent, has been withdrawn from the study by the Investigator, has died, or has been lost to follow-up, whichever occurs first.

Completar el periodo de supervivencia para el último paciente tratado en el estudio. La finalización del seguimiento para el último paciente ocurrirá cuando el último paciente en el estudio haya sido seguido por hasta cinco años después de su visita de fin de tratamiento, haya retirado el consentimiento, o haya sido retirado del estudio por el investigador, haya fallecido, o haya sido perdido para el seguimiento, lo que ocurra primero.

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 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

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

Legally authorized representative will consent on behalf of subject
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)

After completion of final study visit, subjects will each be followed every 3 months for 1 year post-treatment. The follow-up period will include collection of response status performed per standard of care. Collection of information on the next line of therapy, time to second objective progression, and survival will be captured by phone call or similar method of contact. During the next 4 years, response status and survival information will be collected every 6 months or until subject's death.

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

2023-06-01

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2023-05-23

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

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