Clinical Trials Register

Summary
EudraCT Number:	2016-003726-17
Sponsor's Protocol Code Number:	M16-289
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2019-01-04
Trial results	View results

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

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2016-003726-17

A.3

Full title of the trial

A Randomized, Open-Label, Multicenter, Phase 3 Study of Rovalpituzumab Tesirine Compared with Topotecan for Subjects with Advanced or Metastatic DLL3high Small Cell Lung Cancer (SCLC) who have First Disease Progression During or Following Front-Line Platinum-Based Chemotherapy (TAHOE)

Sperimentazione Multicentrica di Fase 3, Randomizzata e in Aperto per Valutare Rovalpituzumab Tesirine rispetto a Topotecan in Soggetti con Carcinoma Polmonare a Piccole Cellule (SCLC) Metastatico o in Fase Avanzata e ad Elevata Espressione di DLL3 (DLL3high) che Presentano la Prima Progressione di Malattia Durante o Dopo un Regime Chemioterapico di Prima Linea a Base di Platino (TAHOE)

A.3.1

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

A randomized, open-label, multicenter study comparing the efficacy, safety and tolerability of rovalpituzumab tesirine versus topotecan for DLL3high SCLC subjects with first relapse/recurrence following front-line platinumbased chemotherapy.

Sperimentazione multicentrica randomizzata e in aperto per valutare l'efficacia, la sicurezza e la tollerabilità di rovalpituzumab tesirine rispetto a topotecan in Soggetti con Carcinoma Polmonare a Piccole Cellule (SCLC) e ad Elevata Espressione di DLL3 (DLL3high) con la prima ricaduta/ricorrenza dopo un regime chemioterapico di prima linea a base di platino.

A.3.2

Name or abbreviated title of the trial where available

TAHOE

A.4.1

Sponsor's protocol code number

M16-289

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT03061812

A.5.4

Other Identifiers

Name:

Number:

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	ABBVIE DEUTSCHLAND GMBH & CO. KG
B.1.3.4	Country	Germany
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	AbbVie Inc.
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	AbbVie Ltd.
B.5.2	Functional name of contact point	EU Clinical Trials Helpdesk
B.5.3	Address:
B.5.3.1	Street Address	AbbVie House, Vanwall Business Park, Vanwall Road
B.5.3.2	Town/ city	Maidenhead, Berkshire
B.5.3.3	Post code	SL6 4UB
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	00441628561090
B.5.5	Fax number	00441628461153
B.5.6	E-mail	eu-clinical-trials@abbvie.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	Rovalpituzumab tesirine
D.3.2	Product code	SC16LD6.5
D.3.4	Pharmaceutical form	Powder for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ROVALPITUZUMAB TESIRINE
D.3.9.1	CAS number	1613313-09-9
D.3.9.2	Current sponsor code	SC16LD6.5
D.3.9.4	EV Substance Code	SUB181948
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	30
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)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	NA
D.2.1.1.2	Name of the Marketing Authorisation holder	NA
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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.3.4	Pharmaceutical form	Powder for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	TOPOTECAN HYDROCHLORIDE
D.3.9.1	CAS number	119413-54-6
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	TOPOTECAN HYDROCHLORIDE
D.3.9.4	EV Substance Code	SUB04921MIG
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	1
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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

Small Cell Lung Cancer

Carcinoma Polmonare a Piccole Cellule

E.1.1.1

Medical condition in easily understood language

Small Cell Lung Cancer

Carcinoma Polmonare a Piccole Cellule

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	20.0
E.1.2	Level	PT
E.1.2	Classification code	10041067
E.1.2	Term	Small cell lung cancer
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

E.2 Objective of the trial

E.2.1

Main objective of the trial

The primary objective is to assess treatment with rovalpituzumab tesirine imrpoves objective response rate (ORR) and overall survival rate
(OS) compared to topotecan in subjects with DLL3high SCLC who have first disease progression during or following front-line platinum based chemotherapy.

L'obiettivo primario è valutare se il trattamento con rovalpituzumab tesirine sia in grado di migliorare il tasso di risposta oggettiva (objective response rate, ORR) e della sopravvivenza globale (overall survival, OS) rispetto a topotecan in soggetti affetti da SCLC con DLL3high che hanno presentato la prima progressione di malattia durante o dopo un regime chemioterapico di prima linea a base di platino.

E.2.2

Secondary objectives of the trial

1) Assess if treatment with rovalpituzumab tesirine improves progression free survivial (PFS) compared to topotecan in subjects with
advanced or metastatic DLL3high SCLC who have first disease progression during or following front-line platinum based chemotherapy,
2) Compare the duration of object response between two arms,
3) To assess the pharmacokinetics (PK) and immunogenicity of rovalpituzumab tesirine,
4) Assess the effect on patient reported outcomes (i.e. health-related quality of life and symptom assessment) due to treatment with rovalpituzumab tesirine compared to topotecan in subects with DLL3high SCLC who have first disease progression during or following front-line
platinum based chemotherapy.

1) Valutare se il trattamento con rovalpituzumab tesirine sia in grado di migliorare la sopravvivenza libera da progressione (progression free survival, PFS) rispetto a topotecan in soggetti con SCLC metastatico o in fase avanzata e con DLL3high che hanno presentato la prima progressione di malattia durante o dopo un regime chemioterapico di prima linea base di platino.
2) Confrontare la durata della risposta oggettiva fra i due bracci.
3) Valutare la farmacocinetica (PK) e l'immunogenicità di rovalpituzumab tesirine,
4) Valutare l’effetto sugli esiti segnalati dai pazienti (ovvero sulla qualità di vita correlata alla salute e sulla valutazione dei sintomi) prodotto dal trattamento con rovalpituzumab tesirine rispetto a topotecan in soggetti affetti da SCLC con DLL3high che hanno presentato la prima progressione di malattia durante o dopo un regime chemioterapico di prima linea base di platino.

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

Optional Tumor Tissue at Time of Progression for Exploratory Research

Raccolta di tessuto tumorale opzionale al momento della progressione per la ricerca esplorativa

E.3

Principal inclusion criteria

1) Subjects must be an age of 18 years or older, providing written informed consent
2) Histologically or cytologically confirmed advanced or metastatic SCLC with documented first disease progression after or during front-line platinum-based systemic regimen.
3) Tumor must have high DLL3 expression (DLL3high) defined as having > 75% tumor cells staining positive according to the VENTANA DLL3 (SP347) IHC Assay. Archived or fresh tumor material can be used for the DLL3 testing.
4) Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
5) Females of childbearing potential must have a negative serum pregnancy test result at Screening, and a negative urine pregnancy test at randomization. Females of non-childbearing potential (either postmenopausal or permanently surgically sterile) at Screening do not require pregnancy testing.

1) I soggetti devono avere un'età di 18 anni o più, e aver rilasciato il proprio consenso informato per iscritto.
2) Conferma istologica o citologica di SCLC metastatico o in fase avanzata con evidenza di prima progressione di malattia durante o dopo un regime sistemico di prima linea a base di platino.
3) Il tumore deve presentare espressione elevata di DLL3 (DLL3high). Per DLL3high si intende la positività alla colorazione di ≥ 75% di cellule tumorali mediante dosaggio VENTANA DLL3 (SP347) IHC. Per la determinazione dell’espressione di DLL3 potrà essere usato un campione di tessuto tumorale conservato oppure ottenuto mediante esecuzione di biopsia.
4) Punteggio dello stato funzionale ECOG (Eastern Cooperative Oncology Group) pari a 0 o 1.
5) I soggetti di sesso femminile in età fertile dovranno avere un risultato negativo al test di gravidanza eseguito su siero allo Screening e su urine alla randomizzazione. Il test di gravidanza non dovrà essere eseguito nei soggetti di sesso femminile non in età fertile (ovvero in presenza di menopausa oppure sterilità chirurgica permanente).

E.4

Principal exclusion criteria

1) Any significant medical condition that, in the opinion of the investigator or Sponsor, may place the subject at undue risk from the study, including but not necessarily limited to uncontrolled hypertension and/or diabetes, clinically significant pulmonary disease or neurological disorder (e.g., seizure disorder active within 6 months)
2) Documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac
symptoms consistent with New York Heart Association (NYHA) Class III– IV within 6 months prior to their first dose of study drug.
3) Subject has known leptomeningeal metastases
4) Subject has Isolated CNS disease progression with no evidence of progression outside of CNS
5) Subject has more than one prior systemic therapy regimen for SCLC (prior systemic maintenance therapy following front-line platinum based regimen, administered as part of clinical trial is allowed)

1) Presenza di qualsiasi patologia medica significativa, che a giudizio dello sperimentatore o del Promotore porrebbero il soggetto a un rischio eccessivo in caso di partecipazione alla sperimentazione, fra cui a titolo esemplificativo ma non necessariamente esaustivo, ipertensione e/o diabete non controllato, malattia polmonare o disturbo neurologico (ad esempio episodi ripetuti di convulsione negli ultimi 6 mesi) clinicamente significativi
2) Storia documentata di evento cerebrovascolare (ictus o attacco ischemico transitorio), angina instabile, infarto miocardico oppure sintomi cardiaci indicativi di classe NYHA III – IV (New York Heart Association) nei 6 mesi precedenti la prima dose del medicinale sperimentale.
3) Il soggetto ha note metastasi leptomeningee.
4) Il soggetto ha la progressione isolata di malattia a carico del SNC senza evidenza di progressione al di fuori del SNC.
5) Il soggetto ha più di un regime terapeutico sistemico per SCLC (è permessa una pregressa terapia sistemica di mantenimento successiva al regime di prima linea a base di platino somministrata nell’ambito di una sperimentazione clinica)

E.5 End points

E.5.1

Primary end point(s)

- Objective response rate (ORR)
- Overall survival (OS)

- Tasso di risposta oggettiva (ORR)
- Sopravvivenza Globale (OS)

E.5.1.1

Timepoint(s) of evaluation of this end point

- Objective Response Rate will be performed in the response-evaluable set, defined as all randomized subjects with measureable disease at baseline who have had a minimum follow-up of 5 months at the time of analysis.
- Overall Survival is defined as the time from the date of randomization to the date of death form any cause (i.e., date of subject's death - date of randomization +1).

- Il Tasso di Risposta Oggettivo sarà effettuato nel set di valutazione di risposta, definito come tutti i soggetti randomizzati con malattia misurabile al baseline, che hanno avuto un follow-up minimo di 5 mesi al momento dell'analisi.
- La Sopravvivenza Globale è definita come il tempo dalla data di randomizzazione alla data della morte per qualsisasi causa (ovvero la data della morte del soggetto - la data della randomizzazione +1).

E.5.2

Secondary end point(s)

- Progression-free survival (PFS) based on the CRAC per RECIST v1.1.
- Duration of objective response (DOR) based on the CRAC per RECIST v1.1.
- Patient reported outcomes (PROs)

- Sopravvivenza Libera da Progressione (Progression-Free Survival, PFS) basata sul CRAC secondo i criteri RECIST versione 1.1.
- Durata della risposta oggettiva (DOR) basata sul CRAC secondo i criteri RECIST versione 1.1.
- Esiti Segnalati dai Pazienti

E.5.2.1

Timepoint(s) of evaluation of this end point

- PFS is based on independent review of tumor assessment, defined as the time from randomization to documented CRAC-assessed disease progression or death from any cause (whichever occurs earlier).
- DOR is defined as the time between the date of first response (CR or PR, whichever is recorded first) to the date of the first documented tumor progression (per RECIST 1.1) or death due to any cause, whichever comes first.

- La PFS si basa sulla revisione indipendente della valutazione tumorale, definita come il tempo dalla randomizzazione alla progressione della malattia documentata dal CRAC o dalla morte per qualsiasi causa (a seconda di quale si verifichi prima).
- DOR è definito come il tempo compreso tra la data della prima risposta (CR o PR, qualunque sia registrata prima) alla data della prima progressione tumorale documentata (per RECIST 1.1) o della morte dovuta a qualsiasi causa, a seconda di quale avviene prima.

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

Yes

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Performance status Quality of Life

Qualità di vita Performance Status

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)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

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

100

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

Information not present in EudraCT

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

Brazil

Canada

China

Japan

Korea, Republic of

Mexico

Singapore

Taiwan

Turkey

United States

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

The end-of-study is defined as the date of the last subject's last visit, or the date of the last subject's last survival follow-up contact, whichever is later.

La fine dello studio è definita come la data dell'ultima visita dell'ultimo soggetto o la data dell'ultimo contatto di follow-up di sopravvivenza dell'ultimo soggetto, a seconda di quale sia il momento successivo.

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

Number of subjects for this age range:

F.1.1.1

In Utero

Information not present in EudraCT

F.1.1.2

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

Information not present in EudraCT

F.1.1.3

Newborns (0-27 days)

Information not present in EudraCT

F.1.1.4

Infants and toddlers (28 days-23 months)

Information not present in EudraCT

F.1.1.5

Children (2-11years)

Information not present in EudraCT

F.1.1.6

Adolescents (12-17 years)

Information not present in EudraCT

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

206

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

205

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

Yes

F.3.3.2

Women of child-bearing potential using contraception

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

250

F.4.2.2

In the whole clinical trial

411

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)

Sponsor has no current plans to provide Rovalpituzumab Tesirine (Rova-T) or other study interventions to patients after conclusion of the study (unless required by country specific regulations) or any earlier patient withdrawal. Sponsor will evaluate the appropriateness of continuing to provide Rova-T to study patients after evaluating the primary efficacy outcome measure and safety data gathered in the study; these analyses may be conducted prior to completion of the study.

Lo Sponsor non ha piani attuali per fornire Rovalpituzumab Tesirine (Rova-T) o altre sperimentazioni interventistiche ai pazienti dopo la conclusione della sperimentazione (a meno che non sia richiesto dalle normative nazionali specifiche) o qualsiasi ritiro prematuro del paziente. Lo Sponsor valuterà l'appropriatezza di continuare a fornire Rova-T ai pazienti della sperimentazione dopo aver valutato la misura del risultato dell'efficacia primaria e i dati di sicurezza raccolti nella sperimentaz

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

2017-07-05

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-06-13

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2020-02-12

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IMP with orphan designation in the indication
Orphan Designation Number:
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