Clinical Trials Register

Summary
EudraCT Number:	2021-003273-66
Sponsor's Protocol Code Number:	ENX-CL-02-002
National Competent Authority:	France - ANSM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2022-02-25
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

France - ANSM

A.2

EudraCT number

2021-003273-66

A.3

Full title of the trial

A Phase 2, Multi-Center, Randomized, Placebo-Controlled, Dose-Finding Study Evaluating Efficacy, Safety and Tolerability of Different Doses and Regimens of Allocetra-OTS for the Treatment of Organ Failure in Adult Sepsis Patients

Étude de phase 2, multicentrique, randomisée, contrôlée par placebo, de détermination de la dose évaluant l’efficacité, la sécurité d’emploi et la tolérance de différentes doses et schémas posologiques d’Allocetra-OTS pour le traitement de l’insuffisance organique chez des patients adultes atteints de sepsis

A.3.1

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

Phase 2 study, conducted in few medical centers, patients will be allocated randomly to receive active drug or placebo. The study will evaluate the efficacy and safety of different doses of the drug in patients with organ failure due to sepsis condition.

A.4.1

Sponsor's protocol code number

ENX-CL-02-002

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT04612413

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	Enlivex Therapeutics R&D Ltd.
B.1.3.4	Country	Israel
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	Enlivex Therapeutics R&D Ltd.
B.4.2	Country	Israel
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Accelsiors CRO and Consultancy Services Ltd.
B.5.2	Functional name of contact point	Regulatory unit
B.5.3	Address:
B.5.3.1	Street Address	103 Háros Str
B.5.3.2	Town/ city	Budapest
B.5.3.3	Post code	1222
B.5.3.4	Country	Hungary
B.5.4	Telephone number	+3612990091
B.5.5	Fax number	+3812165 03 380
B.5.6	E-mail	regulatory@accelsiors.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	Allocetra-OTS cells in Ringer's Lactate Solution
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	Allogeneic peripheral blood mononuclear cells induced to apoptotic state
D.3.9.2	Current sponsor code	Allocetra-OTS
D.3.9.3	Other descriptive name	Allogeneic peripheral blood mononuclear cells induced to an apoptotic state
D.3.9.4	EV Substance Code	SUB199514
D.3.10	Strength
D.3.10.1	Concentration unit	Other
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	5000000000
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)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	Yes
D.3.11.3.1	Somatic cell therapy medicinal product	Yes
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	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	Allocetra-OTS cells in Ringer's Lactate Solution
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	Allogeneic peripheral blood mononuclear cells induced to apoptotic state
D.3.9.2	Current sponsor code	Allocetra-OTS
D.3.9.3	Other descriptive name	Allogeneic peripheral blood mononuclear cells induced to apoptotic state
D.3.9.4	EV Substance Code	SUB199514
D.3.10	Strength
D.3.10.1	Concentration unit	Other
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10000000000
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)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	Yes
D.3.11.3.1	Somatic cell therapy medicinal product	Yes
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
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

Sepsis

E.1.1.1

Medical condition in easily understood language

Sepsis is a life-threatening, medical emergency caused by an infection in the blood stream that can affect different organs.

E.1.1.2

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

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	10040047
E.1.2	Term	Sepsis
E.1.2	System Organ Class	10021881 - Infections and infestations

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 safety and efficacy of different doses and regimens of Allocetra-OTS to that of Placebo in the treatment of organ failure in adult sepsis patients

Comparer la sécurité d’emploi et l’efficacité de différentes doses et différents schémas posologiques d’Allocetra-OTS à celles du placebo dans le traitement de la défaillance d’organes chez des patients adultes atteints de sepsis

E.2.2

Secondary objectives of the trial

To compare other clinical manifestations of different doses and regimens of Allocetra-OTS associated with organ failure in sepsis patients and assess long term safety follow up

Comparer d’autres manifestations cliniques de différentes doses et différents schémas posologiques d’Allocetra-OTS associés à une insuffisance organique chez des patients atteints de sepsis et évaluer le suivi de la sécurité d’emploi à long terme

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male or female ≥18 years and ≤90 years of age.
2. Suspected, presumed or documented community-acquired pneumonia by imaging.
3. Treatment with antibiotics after at least one course for the suspected infection.
4. Meets Sepsis 3 criteria: the presence of organ dysfunction as identified by a total SOFA score ≥2 points above pre-admission SOFA.
5. Signed written informed consent by the patient, or his/her legal guardian or delayed patient consent (based on local regulations).
6. Women of childbearing potential and all men must agree to use 2 methods of an adequate contraception: One barrier method (e.g. diaphragm, or condom or sponge, each of which are to be combined with a spermicide) and one hormonal method (e.g. oral, transdermal patch, implanted contraceptives or intrauterine device) prior to study entry and for the duration of study participation through 4 weeks following IP administration. Subjects that are highly unlikely to conceive (e.g.
surgically sterile, postmenopausal, or not heterosexually active) are exempt. For women, post hysterectomy, bilateral oophorectomy, bilateral salpingectomy or bilateral tubal ligation and vasectomy for men at least 6 weeks prior to screening. Documented hysterectomy or oophorectomy
must be confirmed with medical records of the actual procedure or confirmed by ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure.

1. Hommes ou femmes âgé(e)s de ≥ 18 ans et ≤ 90 ans.
2. Pneumonie communautaire suspectée, présumée ou documentée par imagerie.
3. Traitement par antibiotiques après au moins un cycle pour l’infection suspectée.
4. Répond aux critères de la sepsis 3 : présence d’un dysfonctionnement organique identifié par un score SOFA total ≥ 2 points au-dessus du score SOFA avant l’admission.
5. Consentement éclairé écrit signé par le patient ou son tuteur légal, ou consentement différé du patient (selon les réglementations locales).
6. Les femmes en âge de procréer et tous les hommes doivent accepter d’utiliser 2 méthodes de contraception adéquates : une méthode barrière (par ex. diaphragme, préservatif ou éponge, chacun d’entre eux devant être associé à un spermicide) et une méthode hormonale (par ex. patch transdermique oral, contraceptifs implantés ou dispositif intra-utérin) avant l’entrée dans l’étude, pendant toute la durée de la participation à l’étude et jusqu’à 4 semaines après l’administration du PE. Les patientes qui sont très peu susceptibles de concevoir (par ex.,chirurgicalement stériles, ménopausées ou non hétérosexuellement actives) sont exemptées.
L’incapacité à avoir des enfants est définie par les critères suivants (en l’absence de raisons médicales) :
• Âge ≥ 45 ans et absence de menstruations depuis plus de 2 ans.
• Âge < 45 ans et aménorrhée depuis > 2 ans sans hystérectomie ni ovariectomie et taux d’hormone folliculo-stimulante (FSH) dans la plage post-ménopausique lors de l’évaluation avant l’étude (sélection).
Pour les femmes, post-hystérectomie, ovariectomie bilatérale, salpingectomie bilatérale ou ligature bilatérale des trompes et vasectomie pour les hommes au moins 6 semaines avant la sélection. L’hystérectomie ou l’ovariectomie documentée doit être confirmée avec les dossiers médicaux de la procédure réelle ou confirmée par échographie. La ligature des trompes doit être confirmée avec les dossiers médicaux de la procédure proprement dite.

E.4

Principal exclusion criteria

1. Sepsis due to infection other than lung infection, or sepsis patients where site of infection is unclear or unknown.
2. On chronic dialysis.
3. Invasive ventilated patient and PaO2/FiO2 < 100 mmHg.
4. Weight <50 kg or >120 kg or Body Mass Index (BMI) >40 kg/m2.
5. SOFA score ≥ 10 at screening (Day -1).
6. Patients with Septic shock; requiring persisting hypotension treated with vasopressors to maintain MAP ≥65 mmHg AND having a serum lactate level >4 mmol/L (36 mg/dL) despite adequate volume resuscitation at screening and on Day 1 prior to IP administration.
7. Surgical intervention within 30 days prior to diagnosis of sepsis, plan for surgical intervention (not including percutaneous procedure needed for the current treatment of the sepsis and its complications such as chest drain, Peripherally Inserted Central Catheter (PICC) line or central line insertion among others).
8. Patients with risk of nosocomial infection due to hospitalization within 30 days prior to diagnosis of sepsis.
9. A known malignancy that is progressing or has required active treatment within the past 3 months.
10. Patient with end-stage disease (unrelated to sepsis) defined as patients who prior to the current hospitalization are expected to live < 6 months (as assessed by the study physician).
11. Known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or chronic viral infections, such as, hepatitis B virus (HBV) or hepatitis C virus (HCV), human immunodeficiency virus (HIV) or other chronic infections.
12. Chronic respiratory disease requiring home oxygen therapy on a regular basis for > 6 h/day.
13. Known active upper gastrointestinal (GI) tract ulceration or hepatic dysfunction including but not limited to biopsy-proven cirrhosis; Endstage cirrhosis (Child Pugh Class C); portal hypertension; episodes of past upper GI bleeding attributed to portal hypertension; or prior episodes of hepatic failure, encephalopathy, or coma.
14. Known New York Heart Association (NYHA) class IV heart failure or unstable angina, ventricular arrhythmias, acute coronary disease, or myocardial infarction within six months prior to diagnosis of sepsis.
15. Known immunocompromised state or medications known to be immunosuppressive as follows:
• Hydrocortisone (for the treatment of septic shock) > 300 mg /d Prednisone or equivalent to a dose ≥10 mg/day, for more than 14 days within the last 28 days.
• Methotrexate, cyclophosphamide, cyclosporine A (unless as ophthalmic formulation), leflunomide/teriflunomide (unless as monotherapy), tacrolimus (unless as a topical formulation), sirolimus, everolimus, temsirolimus, mycophenolate mofetil or azathioprine, in the last 60 days;
• Chemotherapy in the last 3 months;
• Mycophenolate mofetil (MMF) or sirolimus for solid organ transplant or bone marrow transplant with no time limitation.
• Thalidomide within the last 72 hours.
• Anti-tumor necrosis factor (TNF) agents, interleukin (IL)-1 receptor antagonists (IL-1-RA), CTLA-4 fusion proteins, anti-CD20, anti-CD52, anti-IL-2, anti-IL-6R, anti-IL-12/23, anti-B-cell activation factor (BAFF) or integrin inhibitor agents within the last 8 weeks.
16. Organ allograft or previous history of stem cell transplantation.
17. Women who are pregnant or breastfeeding. Child-bearing potential females must have a negative serum ß-hCG or hCG blood test at screening. Pregnancy testing is not required for postmenopausal or surgically sterilized women.
18. Participation in an interventional investigational study within 30 days prior to diagnosis of sepsis.
19. Likely to be non-compliant or uncooperative during the study (e.g. substance abuse such as drug or alcohol abuse, uncontrolled psychiatric disorder or any chronic condition that may interfere with study conduct).

1. Sepsis due à une infection autre qu’une infection pulmonaire, ou sepsis chez les patients dont le site d’infection n’est pas clair ou inconnu.
2. Sous dialyse chronique.
3. Patient sous ventilation invasive et PaO2 / FiO2 < 100 mmHg.
4. Poids < 50 kg ou > 120 kg ou indice de masse corporelle (IMC) > 40 kg/m2.
5. Score SOFA ≥ 10 à la sélection (Jour -1).
6. Patients présentant un choc septique ; hypotension persistante nécessitant un traitement par vasopresseurs pour maintenir une PAM ≥ 65 mmHg ET ayant un taux de lactate sérique > 4 mmol/l (36 mg/dl) malgré une réanimation volémique adéquate à la sélection et le Jour 1 avant l’administration du PE.
7. Intervention chirurgicale dans les 30 jours avant le diagnostic de sepsis, planification d’intervention chirurgicale (à l’exclusion d’une procédure percutanée nécessaire pour le traitement actuel de la sepsis et de ses complications, telle que mise en place d’un drain thoracique, d’une ligne de cathéter central inséré par voie périphérique (CCIP) ou d’une ligne centrale, entre autres).
8. Patients présentant un risque d’infection nosocomiale due à une hospitalisation dans les 30 jours précédant le diagnostic de sepsis.
9. Tumeur maligne connue qui progresse ou qui a nécessité un traitement actif au cours des 3 derniers mois.
10. Patients présentant une maladie au stade terminal (non liée à une sepsis) définie par les patients dont l’espérance de vie est < 6 mois avant l’hospitalisation actuelle (telle qu’évaluée par le médecin de l’étude).
11. Infection active connue active par le coronavirus 2 du syndrome respiratoire aigu (severe acute respiratory syndrome coronavirus 2, SARS-CoV-2) ou infections virales chroniques, comme le virus de l’hépatite B (VHB) ou le virus de l’hépatite C (VHC), le virus de l’immunodéficience humaine (VIH) ou d’autres infections chroniques.
12. Maladie respiratoire chronique nécessitant une oxygénothérapie à domicile de façon régulière pendant plus de 6 heures par jour.
13. Ulcération active du tractus gastro-intestinal (GI) ou dysfonctionnement hépatique, qui inclut, mais sans s’y limiter, une cirrhose confirmée par biopsie ; une cirrhose au stade terminal (classe C de Child-Pugh) ; une hypertension portale ; des épisodes d’hémorragie GI supérieure passée attribuée à une hypertension portale ; ou des épisodes antérieurs d’insuffisance hépatique, d’encéphalopathie ou de coma.
14. Insuffisance cardiaque de classe IV de la New York Heart Association (NYHA) ou angor instable, arythmies ventriculaires, cardiopathie ischémique ou infarctus du myocarde dans les 6 mois précédant le diagnostic de sepsis.
15. État immunodéprimé avéré ou prise de médicaments connus pour être immunosuppresseurs comme suit :
• Hydrocortisone (pour traiter un choc septique) > 300 mg/j Prednisone ou équivalent à une dose ≥10 mg/jour pendant plus de 14 jours au cours des 28 derniers jours ;
• Méthotrexate, cyclophosphamide, cyclosporine A (sauf en formulation ophtalmique), léflunomide/tériflunomide (sauf en monothérapie), tacrolimus (sauf en formulation topique, sirolimus, évérolimus, temsirolimus, mycophénolate mofétil ou azathioprine au cours des 60 derniers jours ;
• Chimiothérapie au cours des 3 derniers mois ;
• Mycophénolate mofétil (MMF) ou sirolimus pour une transplantation d’organe solide ou transplantation de moelle osseuse sans limitation de temps ;
• Thalidomide au cours des dernières 72 heures ;
• Agents inhibiteurs du facteur de nécrose tumorale (TNF)), antagonistes des récepteurs de l'interleukine IL-1 (IL-1-RA), protéines de fusion CTLA-4, facteur d’activation anti-CD20, anti-CD52, anti-IL-2, anti-IL-6R, anti-IL-12/23, anti-lymphocytes B (BAFF) ou agents inhibiteurs de l’intégrine au cours des 8 dernières semaines.
16. Antécédents d’allogreffe d’organe ou de greffe de cellules souches.
17. Femmes enceintes ou qui allaitent. Les femmes en âge de procréer doivent présenter à la sélection un test sanguin négatif à l’hormone ß-hCG ou hCG dans le sérum. Un test de grossesse n’est pas nécessaire pour les femmes ménopausées ou les femmes stérilisées par voie chirurgicale.
18. Participation à une étude expérimentale interventionnelle dans les 30 jours précédant le diagnostic de sepsis.
19. Patient susceptible d’être non observant ou non coopératif pendant l’étude (par ex., abus de substances telle que toxicomanie ou alcoolisme, trouble psychiatrique non contrôlé ou toute affection chronique pouvant interférer avec la conduite de l’étude).

E.5 End points

E.5.1

Primary end point(s)

Efficacy: Change from baseline in SOFA score throughout 28 days.
Safety: Number and severity of AEs and Serious Adverse Events (SAEs) throughout 28 days follow up period.

Efficacité : Variation par rapport à la référence du score SOFA tout au long des 28 jours.
Sécurité d’emploi : Nombre et sévérité des EI et des événements indésirables graves (EIG) pendant la période de suivi de 28 jours.

E.5.1.1

Timepoint(s) of evaluation of this end point

28 days

28 jours

E.5.2

Secondary end point(s)

Ventilator-free days over 28 days
Vasopressor-free days over 28 days
All-cause mortality at Day 28 following first dose
Days without renal replacement therapy (dialysis) (evaluation up to 12 months)
Time in ICU and time in hospital (evaluation up to 12 months)
Number of days with creatinine ≤ Baseline levels +20% (evaluation up to 12 months)
Changes from baseline in C-reactive protein (CRP) levels (evaluation up to 12 months)
Detection of autoimmune and human leukocyte antigen (HLA) antibodies (evaluation up to 12 months)
Number and severity of AEs and SAEs throughout 12 months follow-up period (evaluation up to 12 months)

• Jours sans ventilation sur 28 jours
• Jours sans vasopresseur sur 28 jours
• Jours sans traitement de remplacement rénal (dialyse)
• Temps passé en USI et temps passé à l’hôpital
• Nombre de jours avec créatinine ≤ taux de référence +20 %
• Mortalité toutes causes confondues au Jour 28 après la première dose
• Variations par rapport à la référence des taux de protéine C réactive (CRP)
• Nombre et sévérité des EI et des EIG pendant la période de suivi de 12 mois
• Détection d’anticorps auto-immuns et anti-antigènes leucocytaires humains (HLA)

E.5.2.1

Timepoint(s) of evaluation of this end point

28 days and throughout 12 months follow-up period

28 jours et tout au long de la période de suivi de 12 mois

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

Yes

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

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

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

France

Greece

Israel

Spain

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

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

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

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

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

Yes

F.3.3.6

Subjects incapable of giving consent personally

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Some subjects may be in a medical condition where they cannot give consent. Legal rep. may provide consent on their behalf, or a delayed consenting will be performed, in a matter that fully complies with local competent authority requirements.

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

160

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)

No additional treatment or follow up is planned following study end.

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

2022-05-10

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-06-21

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2025-01-16

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials