Clinical Trials Register

Summary
EudraCT Number:	2018-003080-56
Sponsor's Protocol Code Number:	1368-0025
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-12-14
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

2018-003080-56

A.3

Full title of the trial

An open-label, long term extension study to assess the safety and
efficacy of BI 655130 treatment in patients with Generalized
Pustular Psoriasis (GPP)

Estudio de extensión abierto y a largo plazo para evaluar la eficacia y seguridad del tratamiento con BI 655130 en pacientes con Psoriasis Pustulosa Generalizada (PPG).

A.3.1

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

A 5-year study to test BI 655130 in patients with Generalized
Pustular Psoriasis who took part in previous studies with BI
655130

Estudio de 5 años para evaluar BI 655130 en pacientes con Psoriasis Pustulosa Generalizada que participaron en estudios previos con BI 655130

A.4.1

Sponsor's protocol code number

1368-0025

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	Boehringer Ingelheim España 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	Boehringer Ingelheim España S.A.
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Boehringer Ingelheim Pharma GmbH & Co KG
B.5.2	Functional name of contact point	CT Disclosure & Data Transparency
B.5.3	Address:
B.5.3.1	Street Address	Binger Strasse 173
B.5.3.2	Town/ city	Ingelheim am Rhein
B.5.3.3	Post code	55216
B.5.3.4	Country	Germany
B.5.4	Telephone number	+34 (93) 404 5100
B.5.5	Fax number	+34 (93) 404 5580
B.5.6	E-mail	clintriage.rdg@boehringer-ingelheim.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	BI 655130
D.3.4	Pharmaceutical form	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	Spesolimab
D.3.9.2	Current sponsor code	BI 655130
D.3.9.3	Other descriptive name	MONOCLONAL ANTIBODY ANTI-IGG1
D.3.9.4	EV Substance Code	SUB31544
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	60
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.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	BI 655130
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Spesolimab
D.3.9.2	Current sponsor code	BI 655130
D.3.9.3	Other descriptive name	MONOCLONAL ANTIBODY ANTI-IGG1
D.3.9.4	EV Substance Code	SUB31544
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	150
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Generalized Pustular Psoriasis

Psoriasis Pustulosa Generalizada

E.1.1.1

Medical condition in easily understood language

Generalized Pustular Psoriasis

Psoriasis Pustulosa Generalizada

E.1.1.2

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.0
E.1.2	Level	LLT
E.1.2	Classification code	10037159
E.1.2	Term	Psoriasis pustular
E.1.2	System Organ Class	100000004858

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 evaluate the long-term safety and efficacy of BI 655130 in patients with GPP, who have
completed previous BI 655130 trials and are qualified for entry in this trial

Evaluar la seguridad y eficacia largo plazo de BI 655130 en pacientes con PPG, que hayan completado estudios previos con BI 655130 y estén cualificados para entrar en el estudio.

E.2.2

Secondary objectives of the trial

The primary endpoint is the occurrence of treatment emergent adverse events (TEAEs) up to
week 252 of maintenance treatment

La variable principal de eficacia es la aparición de acontecimientos adversos aparecidos durante el tratamiento (AAAT) hasta la semana 252 del tratamiento de mantenimiento

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male or female patients who have completed the treatment period without premature
discontinuation in the previous BI 655130 trial (1368-0013 or 1368-0027) and are willing
and able to continue treatment in the current trial
2. Women of childbearing potential must be ready and able to use highly effective methods
of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year
when used consistently and correctly. A list of contraception methods meeting these
criteria is provided in Section 4.2.2.3 as well as in the patient information. Note: A
woman is considered of childbearing potential, i.e. fertile, following menarche and until
becoming postmenopausal unless permanently sterile. Permanent sterilisation methods
include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Tubal ligation
is not a method of permanent sterilization. A postmenopausal state is defined as no
menses for 12 months without an alternative medical cause.
3. Signed and dated written informed consent for the current trial 1368-0025, in accordance
with ICH-GCP and local legislation prior to admission to the current trial

1. Pacientes varones o mujeres que han completado el periodo de tratamiento sin interrupción prematura de los ensayos anteriores con BI 655130 (1368-0013 o 1368-0027) y están dispuestos y son capaces de poder continuar el tratamiento en el ensayo actual.
2. Las mujeres potencialmente fértiles deben estar preparadas y ser capaces de utilizar métodos anticonceptivos altamente eficaces según la directriz ICH M3 (R2), es decir, aquellos con una tasa de fracaso inferior al 1% anual cuando se utilizan de forma consistente y correcta. Una lista de métodos anticonceptivos que cumplen estos criterios se proporcionan en la sección 4.2.2.3 así como en la información al paciente. Nota: se considera que la mujer tiene capacidad de gestación, es decir es fértil, después de la menarquia y hasta la postmenopausia a menos que sea permanentemente estéril. Los métodos de esterilización permanente incluyen histerectomía, salpingectomía bilateral y ooforectomía bilateral. La ligadura de trompas no es un método de esterilización permanente. Un estado posmenopáusico se define como la ausencia de menstruaciones durante 12 meses sin una causa médica alternativa.
3. Consentimiento y asentimiento informado por escrito firmado y fechado por escrito para el ensayo 1368-0025, de conformidad con las normas de BPD del ICH y la legislación local antes de la inclusión en el estudio.

E.4

Principal exclusion criteria

1. Evidence of flare symptoms of moderate/severe intensity at screening
2. Treatment with any restricted medication as specified in Table 4.2.2.1:1, or any drugs considered by the investigator likely to interfere with the safe conduct of the study since the last visit of the previous BI 651330 trial and during the screening period for the current trial.
3. Severe, progressive, or uncontrolled hepatic disease, defined as >3-fold Upper Limit of Normal (ULN) elevation in AST or ALT or alkaline phosphatase, or >2-fold ULN elevation in total bilirubin.
4. Patients with congestive heart disease, as assessed by the investigator.
5. Relevant chronic or acute infections including human immunodeficiency virus (HIV) or viral hepatitis. A patient can be re-screened if the patient was treated and is cured from acute infection.
6. Active or Latent tuberculosis (TB):
- Patients with active tuberculosis should be excluded
- Patients will be screened with Interferon Gamma Release Assay (IGRA) such as QuantiFERON®-TB-Gold Plus or T-spot®. Patients with positive IGRA (indicating active or latent tuberculosis) are excluded unless they have completed treatment for active or latent tuberculosis per investigator discretion, at the time of screening.
- Patients with indeterminate QuantiFERON®-TB-Gold Plus or invalid/borderline T-spot® may be retested with IGRA (once) or Tuberculin Skin test (TST).
- TST or any alternative test/procedure (as per local standards) to rule out TB can be performed if IGRA is not available or indeterminate. A TST reaction ≥10mm (≥5mm if receiving ≥15mg/d prednisone or other immunosuppressant) is considered positive. Patients with a positive TST are excluded unless they have completed treatment as above.

7. History of allergy/hypersensitivity to a systemically administered trial medication agent or its excipients.
8. Any documented active or suspected malignancy at screening, except appropriately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix.
9. Women who are pregnant, nursing, or who plan to become pregnant while in the trial. Women who stop nursing before the study drug administration do not need to be excluded from participating; they should refrain from breastfeeding up to 16 weeks after the study drug administration (see Section 4.2.2).
10. Major surgery (major according to the investigator’s assessment) performed since the last visit of previous BI 655130 trial or planned during the current trial, e.g. hip replacement, aneurysm removal, stomach ligation), as assessed by the investigator.
11. Evidence of a current or previous disease, medical condition (including chronic alcohol or drug abuse or any condition) other than GPP, surgical procedure, psychiatric or social problems, medical examination finding (including vital signs and electrocardiogram [ECG]), or laboratory value at the screening outside the reference range that in the opinion of the investigator is clinically significant and would make the study participant unreliable to adhere to the protocol, comply with all study visits/procedures or to complete the trial, compromise the safety of the patient or compromise the quality of the data.

12. Patients with a confirmed active infection with SARS-CoV-2 (as confirmed by PCR test). A patient may be enrolled once recovered from SARS-CoV-2 infection according to the investigator’s assessment.

1. Presencia de síntomas de un brote de intensidad moderada o grave en la selección.
2. Tratamiento con cualquier medicamento restringido como se especifica en la Tabla 4.2.2.1:1, o cualquier medicamento que el investigador considere que pueda interferir con la realización segura del estudio desde la última visita del ensayo BI 651330 anterior y durante el período de selección para el ensayo actual.
3. Enfermedad hepática grave, progresiva o no controlada, definida como > 3 veces el Límite Superior de Normalidad (LSN) de AST o ALT o fosfatasa alcalina, o > 2 veces el LSN para bilirrubina total.
4. Pacientes con cardiopatía congestiva, a criterio del investigador.
5. Infecciones crónicas o agudas relevantes, incluidas las causadas por el virus de la inmunodeficiencia humana (VIH) o una hepatitis vírica. Un paciente puede ser seleccionado de nuevo si ha sido tratado y ha superado la infección aguda.
6. Tuberculosis (TB) activa o latente:
- Pacientes con tuberculosis activa deben ser excluidos.
- Se examinará a los pacientes con el Ensayo de Liberación de Interferón Gamma (IGRA) como QuantiFERON®-TB-Gold Plus o T-spot®. Los pacientes con IGRA positivo (indicando tuberculosis activa o latente) estarán excluidos a menos que hayan completado el tratamiento para la tuberculosis activa o latente a juicio del investigador, en el momento de la selección.
- Pacientes con resultado indeterminado en QuantiFERON®-TB-Gold Plus o T-spot® inválido/límite pueden volver a someterse a una prueba con IGRA (una vez) o a una prueba cutánea de la tuberculina (TST).
- Se puede realizar una TST o cualquier prueba/procedimiento alternativo (según las normas locales) para descartar la TB si el IGRA no está disponible o su resultado es indeterminado. Una reacción de TST ≥ 10 mm (≥ 5 mm si se reciben ≥ 15 mg/d de prednisona u otro inmunosupresor) se considera positiva. Se excluyen los pacientes con una TST positiva a menos que hayan completado el tratamiento, como se indica anteriormente.

7. Antecedentes de alergia/hipersensibilidad a un medicamento del ensayo administrado de forma sistémica o a sus excipientes.
8. Cualquier tumor maligno activo o con diagnóstico de sospechosa documentado en la selección, excepto un carcinoma basocelular de la piel, un carcinoma de células escamosas en la piel o un carcinoma in situ de cuello uterino tratados adecuadamente.
9. Mujeres embarazadas o en periodo lactancia, o que prevean quedarse embarazadas durante el ensayo. No es necesario excluir de la participación a las mujeres que dejan la lactancia antes de la administración del medicamento en estudio; deben interrumpir la lactancia hasta 16 semanas después de la administración del fármaco en estudio (ver sección 4.2.2).
10. Cirugía mayor (según la evaluación del investigador) realizada desde la última visita del ensayo anterior con BI 655130 o prevista durante el ensayo actual, por ejemplo reemplazo de cadera, extirpación de aneurismas, cirugía bariátrica), según criterio del investigador.
11. Evidencia de enfermedad actual o previa, afección médica (incluido abuso crónico de alcohol, drogas u otras afecciones) distinta de la PPG, procedimiento quirúrgico, problemas psiquiátricos o sociales, hallazgos médicos (incluidos signos vitales y electrocardiograma [ECG]), o valores de laboratorio en la selección fuera de los límites de referencia que, bajo criterio del investigador, sean clínicamente significativos y harían que el participante del estudio no fuera fiable para adherirse al protocolo, cumplir con todas las visitas/procedimientos del estudio o completar el ensayo, comprometer la seguridad del pacientes o la calidad de los datos.

12. Pacientes con infección activa confirmada por SARS-CoV-2 (confirmada mediante PCR). Una vez recuperado de la infección por SARS-CoV-2, se puede volver a incluir al paciente en el estudio de acuerdo con la evaluación del investigador.

E.5 End points

E.5.1

Primary end point(s)

1) occurrence of treatment emergent adverse events (TEAEs) up to week 252 of maintenance treatment

1) aparición de acontecimientos adversos aparecidos durante el tratamiento (AAAT) hasta la semana 252 del tratamiento de mantenimiento.

E.5.1.1

Timepoint(s) of evaluation of this end point

1) 252 weeks

1) 252 semanas

E.5.2

Secondary end point(s)

1) The reoccurrence of a GPP flare defined by GPPGA (as defined in Section 3.1)
2) Time to first achievement of a GPPGA score of 0 or 1 (Patients received flare rescue Treatment)
3) A GPPGA pustulation sub-score of 0 indicating no visible pustules, by visit (Patients received flare rescue treatment)
4)Change from baseline in Psoriasis Symptom Scale (PSS) score, by visit (Patients received flare rescue treatment)

1) Reaparición de un brote de PPG definida por GPPGA (como se define en la sección 3.1).
2) Tiempo hasta la primera vez que se alcanza una puntuación GPPGA de 0 o 1 (los pacientes recibieron tratamiento de rescate para el brote).
3) Subpuntación de la GPPGA de 0 que indica que no hay pústulas visibles, por visita (los pacientes recibieron tratamiento de rescate para el brote).
4)Cambio desde el inicio en la puntuación de la escala de síntomas de psoriasis (PSS), por visita (los pacientes recibieron tratamiento de rescate para el brote).

E.5.2.1

Timepoint(s) of evaluation of this end point

1) 252 weeks
2) 252 weeks
3) 252 weeks
4) 252 weeks

1) 252 semanas
2) 252 semanas
3) 252 semanas
4) 252 semanas

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

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

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.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the 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

Chile

Colombia

Egypt

Georgia

Mexico

Philippines

Singapore

South Africa

Thailand

Tunisia

Turkey

Argentina

Belgium

Brazil

Bulgaria

China

Croatia

Czechia

Germany

Greece

Israel

Italy

Japan

Korea, Republic of

Malaysia

Netherlands

Poland

Russian Federation

Spain

Taiwan

Ukraine

United States

Vietnam

France

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

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

LVLS

Última visita del último paciente.

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

Yes

F.1.1

Number of subjects for this age range:

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

140

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

150

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

Ninguno.

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

2022-02-07

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-12-15

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

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IMP with orphan designation in the indication
Orphan Designation Number:
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