Clinical Trials Register

Summary
EudraCT Number:	2019-004770-25
Sponsor's Protocol Code Number:	D7310C00001
National Competent Authority:	Poland - Office for Medicinal Products
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2020-10-28
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

Poland - Office for Medicinal Products

A.2

EudraCT number

2019-004770-25

A.3

Full title of the trial

A Phase 3 Randomized, Double-blind, Multicenter, Global Study of Monalizumab or Placebo in Combination with Cetuximab in Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Previously Treated With an Immune Checkpoint Inhibitor

Międzynarodowe, randomizowane, prowadzone metodą podwójnie ślepej próby, wieloośrodkowe badanie fazy III, oceniające terapię monalizumabem lub placebo w skojarzeniu z cetuksymabem u pacjentów z nawrotowym lub przerzutowym rakiem płaskonabłonkowym regionu głowy i szyi uprzednio leczonych inhibitorem punktu kontrolnego układu odpornościowego

A.3.1

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

Study of Monalizumab Given With Cetuximab or Placebo Given with Cetuximab in Patients With Head and Neck Cancer that has come back or spread to other parts of the body

Badanie terapii monalizumabem podawanym w skojarzeniu z cetuksymabem lub placebo podawanym w skojarzeniu z cetuksymabem prowadzonej u pacjentów z nawracającym lub przerzutowym rakiem okolicy głowy i szyi

A.3.2

Name or abbreviated title of the trial where available

INTERLINK-1

A.4.1

Sponsor's protocol code number

D7310C00001

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT04590963

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	AstraZeneca AB
B.1.3.4	Country	Sweden
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	AstraZeneca AB
B.4.2	Country	Sweden
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	AstraZeneca AB
B.5.2	Functional name of contact point	Clinical Trial Transparency
B.5.3	Address:
B.5.3.1	Street Address	Karlebyhus, Astraallén
B.5.3.2	Town/ city	Södertälje
B.5.3.3	Post code	SE 151 85
B.5.3.4	Country	Sweden
B.5.6	E-mail	ClinicalTrialTransparency@astrazeneca.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	Monalizumab
D.3.2	Product code	IPH2201
D.3.4	Pharmaceutical form	Powder for 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	Monalizumab
D.3.9.1	CAS number	1228763-95-8
D.3.9.2	Current sponsor code	IPH2201
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	50
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	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	Cetuximab
D.2.1.1.2	Name of the Marketing Authorisation holder	Merck Europe B.V.
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Cetuximab
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	Cetuximab
D.3.9.1	CAS number	205923-56-4
D.3.9.3	Other descriptive name	Cetuximab
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	5
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: 3
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	Cetuximab
D.2.1.1.2	Name of the Marketing Authorisation holder	Merck Europe B.V.
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Cetuximab
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	Cetuximab
D.3.9.1	CAS number	205923-56-4
D.3.9.3	Other descriptive name	Cetuximab
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	5
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
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Previously Treated With an Immune Checkpoint Inhibitor

Pacjenci z nawracającym lub przerzutowym rakiem płaskonabłonkowym okolicy głowy i szyi wcześniej leczeni inhibitorem punktu kontrolnego układu odpornościowego

E.1.1.1

Medical condition in easily understood language

Patients who had received prior immunotherapy treatment for specific type of head and neck cancer that has come back or spread to other parts of the body

Pacjenci, którzy otrzymywali uprzednio leczenie immunoterapią w odniesieniu do określonego rodzaju raka głowy i szyi, który powrócił lub rozprzestrzenił się na inne części ciała

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	21.1
E.1.2	Level	PT
E.1.2	Classification code	10067821
E.1.2	Term	Head and neck 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

To compare the effect of monalizumab and cetuximab (Arm A) relative to placebo and cetuximab (Arm B) in terms of overall survival (OS) in HPV unrelated participants.

Porównanie wpływu monalizumabu i cetuksymabu (grupa terapeutyczna A) oraz placebo i cetuksymabu (grupa terapeutyczna B) poprzez ocenę ogólnego przeżycia (OS) u pacjentów niepowiązanych z HPV.

E.2.2

Secondary objectives of the trial

To compare the effect of monalizumab and cetuximab (arm A) relative to placebo and cetuximab (arm B) by:
1. assessment of OS in all randomized participants
2. assessment of PFS, ORR, DoR;
3. assessment of disease-related symptoms, functioning and quality of life;
4. characterization of the association between clinical outcome and protein expression in the tumor;
5. assessment of safety and tolerability.

To investigate PK and immunogenicity of monalizumab.

Porównanie wpływu monalizumabu i cetuksymabu (grupa terapeutyczna A) oraz placebo i cetuksymabu (grupa terapeutyczna B) poprzez:
1. ocenę przeżycia całkowitego (OS) u wszystkich pacjentów zrandomizowanych
2. ocenę czas przeżycia bez progresji choroby (PFS), wskaźnika odpowiedzi obiektywnej (ORR), czasu odpowiedzi (DoR)
3. ocenę objawów związanych z chorobą, funkcjonowania i jakości życia związanej ze zdrowiem fizycznym (HRQoL)
4. charakterystykę powiązania wyników klinicznych i ekspresji białek w mikrośrodowisku guza
5. ocenę bezpieczeństwa i tolerancji
Ocena farmakokinetyki (PK) i immunogeniczności monalizumabu

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Are aged 18 years and over
2. Recurrent or metastatic SCCHN (oral cavity, oropharynx, hypopharynx, or larynx)
3. Received treatment using a PD-(L)1 inhibitor
4. Prior platinum failure
5. Received 1 or 2 prior systemic regimens for recurrent or metastatic SCCHN
6. At least one measurable lesion at baseline that qualifies RECIST 1.1
7. A fresh or recently acquired tumor tissue for the purpose of biomarker testing
8. WHO/ECOG PS of 0 or 1

1. Uczestnik musi być w wieku ≥18 lat
2. Histologicznie lub cytologicznie potwierdzony R/M SCCHN jamy ustnej, części ustnej gardła, części krtaniowej gardła lub krtani
3. Konieczność uprzedniego odbycia leczenia z zastosowaniem ogólnoustrojowego inhibitora PD-(L)1
4. Niepowodzenie uprzedniego leczenia związkami platyny
5. Wcześniejsze otrzymanie 1 lub 2 schematów ogólnoustrojowego leczenia R/M SCCHN
6. Co najmniej jedna zmiana kwalifikująca się jako zmiana mierzalna TL wg kryteriów RECIST 1.1
7. Dostarczenie świeżej lub ostatnio pozyskanej tkanki guza w celu wykonania badań biomarkerów
8. Ocena WHO/ECOG PS wynosząca 0 lub 1 w momencie włączenia do badania

E.4

Principal exclusion criteria

1. Head and neck cancer of any primary anatomic location in the head and neck not specified in the inclusion criteria, including participants with SCCHN of unknown primary or non-squamous histologies
2. Had prior cetuximab therapy (unless it was administered in curative LA setting with radiotherapy and no disease progression for at least 6 months following the last cetuximab dose)
3. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn’s disease], diverticulitis
4. Any concurrent anticancer treatment, except for hormonal therapy for non-cancer-related conditions (eg, hormone replacement therapy)

1. Histologicznie lub cytologicznie potwierdzony rak okolicy głowy i szyi lub umiejscowiony w innej głównej lokalizacji anatomicznej w rejonie głowy i szyi nieokreślony w kryteriach włączenia, w tym uczestnicy z rakiem płaskonabłonkowym o nieznanym ognisku początkowym lub cechach niepłaskonabłonkowych
2. Uprzednie leczenie cetuksymabem (chyba że stosowane w przypadku lokalnie zaawansowanej choroby w terapii z intencją wyleczenia w skojarzeniu z radioterapią i nie obserwowano progresji choroby przez co najmniej 6 miesięcy po otrzymaniu ostatniej dawki cetuksymabu)
3. Aktywne lub wcześniej udokumentowane zaburzenia autoimmunologiczne lub zapalne (w tym zapalna choroba jelit (np. zapalenie okrężnicy lub choroba Leśniowskiego-Crohna), zapalenie uchyłków
4. Równoczesne stosowanie jakiegokolwiek leczenia przeciwnowotworowego. Terapia hormonalna stosowana równocześnie w leczeniu chorób innych niż nowotworowa (np. hormonalna terapia zastępcza) jest dozwolona

E.5 End points

E.5.1

Primary end point(s)

Overall survival, defined as the time from the date of randomization until date of death due to any cause.

Ogólne przeżycie zdefiniowane jako czas od daty randomizacji do daty zgonu z dowolnej przyczyny

E.5.1.1

Timepoint(s) of evaluation of this end point

Assessments of survival status must be made periodically from enrollment.

Ocena statusu przeżycia musi być przeprowadzania okresowo począwszy od włączenia do badania

E.5.2

Secondary end point(s)

- Overall survival, defined as the time from the date of randomization until date of death due to any cause

- PFS is defined as time from randomization until disease progression, per RECIST 1.1 as assessed by the investigator at local site or death due to any cause, whichever occurs first.

- ORR is defined as the proportion of participants with measurable disease who have a confirmed CR or PR, as determined by the investigator at local site per RECIST 1.1.

- DoR is defined as the time from the date of first documented response until date of documented disease progression or death in the absence of disease progression.

- Patient questionnaires regarding wellbeing and symptom change in baseline scores across visits

- Concentration of monalizumab in the blood

- Presence of antibodies to monalizumab in the blood

- Measurement of specific biomarkers in the tumor sample(s)

- AEs, vital signs, clinical laboratory results, ECGs

• Ogólne przeżycie zdefiniowane jako czas od daty randomizacji do daty zgonu z dowolnej przyczyny
• PFS definiuje się jako czas od randomizacji do progresji choroby wg kryteriów RECIST 1.1, na podstawie oceny badacza w ośrodku lokalnym, lub do zgonu z dowolnej przyczyny, zależnie od tego, co nastąpi wcześniej.
• ORR definiuje się jako odsetek pacjentów z mierzalną chorobą, u których potwierdzono CR lub PR, według oceny badacza w lokalnym ośrodku na podstawie kryteriów RECIST 1.1.
• DoR definiuje się jako czas od daty uzyskania pierwszej udokumentowanej odpowiedzi do daty udokumentowanej progresji choroby lub zgonu w przypadku braku progresji choroby.
• Kwestionariusze pacjenta dotyczące oceny samopoczucia i objawów zmiany wyników od badania wyjściowego obserwowana podczas wizyty
• Stężenie monalizumabu we krwi
• Obecność przeciwciał przeciwko lekowi (ADA) we krwi
• Ekspresja specyficznych biomarkerów w próbkach guza
• Zdarzenia niepożądane (AE), parametry życiowe, wyniki badań laboratoryjnych, EKG

E.5.2.1

Timepoint(s) of evaluation of this end point

Periodically from enrollment

Okresowo począwszy od włączenia do badania

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

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

Yes

E.6.11

Pharmacogenomic

Yes

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)

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

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)

Yes

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

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

Argentina

Australia

Brazil

Canada

Japan

Korea, Democratic People's Republic of

Peru

Philippines

Taiwan

United States

Austria

France

Poland

Bulgaria

Netherlands

Romania

Spain

Switzerland

Germany

Greece

Italy

Belgium

Portugal

Russian Federation

United Kingdom

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

„LVLS” (Last Visit Last Subject)

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

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:

416

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

208

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

Caregiver

opiekun ustawowy

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

263

F.4.2.2

In the whole clinical trial

624

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 end of treatment with study drug, patients may be managed according to local standard of care or may continue study treatment for as long as receiving benefit.

Po zakończeniu leczenia badanym lekiem pacjenci mogą być leczeni zgodnie z lokalnymi standardami opieki lub mogą otrzymywać leczenie przewidziane protokołem tak długo, jak długo odnosić będą korzyści z leczenia.

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

2021-01-07

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-11-12

P. End of Trial
P.	End of Trial Status	Completed

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Clinical trials