Clinical Trials Register

Summary
EudraCT Number:	2020-000090-25
Sponsor's Protocol Code Number:	TUC3PII-01
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:	2021-06-07
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

2020-000090-25

A.3

Full title of the trial

A Phase IIa, Multicenter, Randomized, Double-Blind, Parallel- Group, Placebo-Controlled, Proof of Concept Study to Evaluate the Efficacy and Safety of Orally Administered TU2670 in Subjects with Moderate to Severe Endometriosis-Associated Pain.

Studio proof-of-concept di fase IIa, multicentrico, randomizzato, in doppio cieco, a gruppi paralleli, controllato con placebo volto a valutare l’efficacia e la sicurezza di TU2670 somministrato per via orale in soggetti con dolore associato a endometriosi, da moderato a grave.

A.3.1

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

An international Multicenter study to evaluate the efficacy and safety of orally administered TU2670 against placebo in subject with moderate to severe endometriosis -associated Pain.

Uno studio internazionale multicentrico per valutare l'efficacia e la sicurezza di TU2670 somministrato per via orale rispetto al placebo in soggetti con dolore associato a endometriosi, da moderato a grave.

A.3.2

Name or abbreviated title of the trial where available

LUNA

A.4.1

Sponsor's protocol code number

TUC3PII-01

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	TiumBio Co., Ltd.
B.1.3.4	Country	Korea, Republic of
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	TiumBio Co. Ltd.
B.4.2	Country	Korea, Republic of
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	TiumBio
B.5.2	Functional name of contact point	TiumBio General Inquiry
B.5.3	Address:
B.5.3.1	Street Address	49 Daewangpangyo-ro 644 Beon-gil
B.5.3.2	Town/ city	Bundang-gu, Seongnam-si, Gyeonggi-do
B.5.3.3	Post code	1349
B.5.3.4	Country	Korea, Republic of
B.5.6	E-mail	tiumbio@tiumbio.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	TU2670
D.3.2	Product code	[TU2670]
D.3.4	Pharmaceutical form	Capsule, hard
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	TU2670
D.3.9.2	Current sponsor code	TU2670
D.3.9.4	EV Substance Code	SUB194354
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	80
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.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	TU2670
D.3.2	Product code	[TU2670]
D.3.4	Pharmaceutical form	Capsule, hard
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	TU2670
D.3.9.2	Current sponsor code	TU2670
D.3.9.4	EV Substance Code	SUB194354
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	20
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule, hard
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Moderate to Severe Endometriosis-Associated Pain

Dolore associato all'endometriosi da moderato a grave

E.1.1.1

Medical condition in easily understood language

Moderate to Severe Endometriosis-Associated Pain

Dolore associato all'endometriosi da moderato a grave

E.1.1.2

Therapeutic area

Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	LLT
E.1.2	Classification code	10014788
E.1.2	Term	Endometriosis related pain
E.1.2	System Organ Class	100000004872

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 evaluate the efficacy and safety of orally administered TU2670 in the reduction of endometriosis-associated pain compared with placebo after 12 weeks of treatment.

Valutare l'efficacia e la sicurezza di TU2670 somministrato per via orale nella riduzione del dolore correlato all'endometriosi rispetto al placebo dopo 12 settimane di trattamento.

E.2.2

Secondary objectives of the trial

To assess the pharmacokinetics (PK) and pharmacodynamics (PD) of orally administered TU2670 in subjects with endometriosis after 12 weeks of treatment.

Valutare la farmacocinetica (PK) e la farmacodinamica (PD) di TU2670 somministrato per via orale in soggetti con endometriosi dopo 12 settimane di trattamento.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

For the screening phase:
1. Independent Ethics Committee (IEC)-approved written informed consent/assent and privacy language as per national regulations must
be voluntarily obtained from the subject.
2. Premenopausal female subject, 18 to 45 years, inclusive
3. Subject has moderate to severe endometriosis-related pain likely to meet inclusion criteria 13 and 14 in the opinion of the Investigator.
4. Subject has documented surgically (laparoscopy, laparotomy) diagnosed endometriosis within the last 10 years before signing informed consent and has recurrent or persistent endometriosis symptoms
5. Subject reports regular menstrual cycles of 24 to 38 days inclusive for at least the last 2 years.
6. Subject must agree not to breastfeed starting at screening and throughout the study period, and for 28 days after the final study drug
administration.
7. Subject must agree to use adequate non-hormonal contraceptive method(s) to prevent pregnancy. Contraception must be used
throughout the study starting at screening or before until the end of their study participation. Non-hormonal contraceptive methods are defined as:
A. Subject has undergone surgical sterilization, or B. Subject's sexual partner has been surgically sterilized (at least 12
weeks before signing informed consent), or C. Dual non-hormonal contraception method:
i) Condom with spermicide
ii) Diaphragm with spermicide (with condom)
iii) Cervical cap with spermicide (with condom)
iv) Vaginal sponge impregnated with spermicide, used with a condom
8. Have a body mass index (BMI) between 18 and 36 kg/m2, inclusive
In addition for the randomization:
9. Subject has an mB&B scale total score of =6 with a score of at least 2
for dysmenorrhea and at least 2 for non-menstrual pelvic pain (NMPP).
10. Subject is suffering from endometriosis-associated dysmenorrhea and NMPP (Numeric Rating Scale [NRS] >0 in both domains) with at least 1 of the following:
¿ Moderate to severe dysmenorrhea: Mean NRS pain score =4 (over all menstrual days)
¿ Moderate NMPP: NRS pain score =4 on at least 7 non-menstrual days (not necessarily consecutively)
¿ Severe NMPP: NRS pain score =7 on at least 3 non-menstrual days (not necessarily consecutively)

Per la fase di screening:
1. Il consenso/accordo informato scritto approvato dal Comitato Etico Indipendente (IEC) e il linguaggio della privacy secondo le normative nazionali devono essere acquisiti volontariamente dal soggetto.
2. Soggetto femminile in premenopausa, dai 18 ai 45 anni inclusi.
3. Il soggetto ha dolore correlato all'endometriosi da moderato a grave che probabilmente, secondo lo Sperimentatore, soddisfa i criteri di inclusione 13 e 14.
4. Il soggetto ha documentato chirurgicamente (laparoscopia, laparotomia) endometriosi diagnosticata negli ultimi 10 anni prima di firmare il consenso informato e ha sintomi di endometriosi ricorrenti o persistenti.
5. Il soggetto riferisce cicli mestruali regolari da 24 a 38 giorni inclusi almeno negli ultimi 2 anni.
6. Il soggetto deve accettare di non allattare al seno a partire dallo screening, per tutto il periodo di studio e per 28 giorni dopo la somministrazione finale del farmaco in studio.
7. Il soggetto deve accettare di utilizzare metodi contraccettivi non ormonali adeguati al fine di evitare una gravidanza. La contraccezione deve essere utilizzata durante lo studio a partire dallo screening o in precedenza fino alla fine della partecipazione allo studio. I metodi contraccettivi non ormonali sono così definiti:
A. Il soggetto è stato sottoposto a sterilizzazione chirurgica, o
B. Il partner sessuale del soggetto è stato sterilizzato chirurgicamente (almeno 12 settimane prima della firma del consenso informato), o
C. Doppio metodo di contraccezione non ormonale:
i) Preservativo con spermicida
ii) Diaframma con spermicida (con preservativo)
iii) Cappuccio cervicale con spermicida (con preservativo)
iv) Spugna vaginale impregnata di spermicida, usata con un preservativo
8. Avere un indice di massa corporea (BMI) compreso tra 18 e 36 kg/m2 compresi.
Inoltre, per la randomizzazione:
9. Il soggetto presenta in scala mB&B =6 punti complessivi, con un almeno 2 punti per la dismenorrea e almeno 2 punti per il dolore pelvico non correlato al ciclo mestruale (NMPP).
10. Il soggetto soffre di dismenorrea associata a endometriosi e NMPP (scala numerica di valutazione [NRS] >0 in entrambi i domini) con almeno 1 dei seguenti disturbi:
- Dismenorrea da moderata a grave: Punti medi del dolore NRS =4 (durante tutti i giorni delle mestruazioni)
- NMPP moderato: Punti del dolore NRS =4 in almeno 7 giorni in cui non sono presenti le mestruazioni (non necessariamente consecutivi)
- NMPP grave: Punti del dolore NRS =7 in almeno 3 giorni in cui non sono presenti le mestruazioni
(non necessariamente consecutivi)

E.4

Principal exclusion criteria

1. used hormonal contraceptives or other drugs with effects on gynecological endocrinology within 12 weeks prior to the start of e-diary
completion, depot medroxyprogesterone acetate (DMPA) or danazol within 12 weeks prior to the start of e-diary completion, GnRH-agonists
or antagonists within 12 weeks prior to the start of e-diary completion, GnRH-agonist or antagonist depot-products within 24 weeks prior to the
start of e-diary completion, or is using a non-hormonal (copper) intrauterine device. 2. has been nonresponsive to GnRH-agonist or antagonist therapy for the management of endometriosis. 3. has had a pregnancy within 12 weeks prior to signing informed consent, is currently breastfeeding, or has the intention to become pregnant during the study. 4. has had surgery (including diagnostic laparoscopy) for endometriosis
within the 8 weeks prior to screening visit. 5. has a known concurrent uterine myoma or other pelvic lesions >3 cm diameter.
6. has undiagnosed abnormal vaginal bleeding. 7. has concurrent or previous pelvic infection within 8 weeks before signing informed consent.
8. has documented, concurrent disease with chronic abdominal pain of non-endometriosis origin (eg, irritable bowel syndrome [IBS], interstitial
cystitis, adenomyosis) or any concurrent condition requiring evaluation or therapy during the course of the study that may induce abdominal
pain. 9. Have had a hysterectomy or oophorectomy. 10. Have pelvic pain that is not caused by endometriosis. 11. Have a previous or current history of thyroid dysfunction. 12. has a pituitary adenoma. 13. has used drugs with negative effects on BMD within 12 weeks prior to start of e-diary completion including use of systemic steroids on a chronic or regular basis. 14. has concurrent or previous osteoporosis, bone loss, other metabolic bone diseases, parathyroid disease or abnormalities of the spine or hip that may affect BMD measurement, or spine or femur BMD T-scores below -1.5 by DXA performed at screening. 15. has active malignancy or history of malignancy during the 5 years before signing informed consent. A history of cutaneous squamous cell
carcinoma or a basal cell carcinoma is allowed if considered cured at the time of informed consent. 16. has severe renal function deterioration: estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2 (Modification of Diet in Renal Disease [MDRD], based on serum creatinine).
17. has an aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2×upper limit of normal (ULN), or total bilirubin >1.5×ULN.
18. has any unstable medical condition or chronic disease, investigation or laboratory abnormality, which in the Investigator's opinion, makes
the subject unsuitable for study participation. 19. Screening 12-lead ECG showing clinically significant abnormalities and/or QT interval corrected using Fridericia's formula (QTcF) >470 msec. 20. has a chronic condition that requires the regularly use of analgesics and/or corticosteroids (such as rheumatoid arthritis) that may influence the assessment of endometriosis pelvic pain. 21. has a contraindication or known allergy for study drug or ibuprofen
or any components (eg, lactose or galactose) of these. 22. Have a clinically significant cardiovascular disease or uncontrollable hypertension. 23. Have a previous or current history of hypersensitivity or allergy to gelatin-containing formulations or food containing gelatin (including lifestyle and/or dietary restrictions that preclude the consumption of products containing gelatin), or have a previous or current history of severe hypersensitivity or severe allergy to other drugs. 24. is currently receiving (or unable to stop use at least 3 weeks prior to receiving the first dose of TU2670) medications or herbal supplements known to be inducers of P-glycoprotein (P-gp) or inhibitors of P-gp. [...] For the complete list, please refer to the Study protocol.

1.Ha utilizzato contraccettivi ormonali o altri farmaci con effetti sull'endocrinologia ginecologica entro 12 settimane prima dell'inizio del completamento del diario elettronico, depot di medrossiprogesterone acetato (DMPA) o danazolo entro 12 settimane prima dell'inizio del completamento del diario elettronico, agonisti o antagonisti del GnRH entro 12 settimane prima dell'inizio del completamento del diario elettronico, prodotti di depot agonisti o antagonisti del GnRH entro 24 settimane prima dell'inizio del completamento del diario elettronico o sta utilizzando un dispositivo intrauterino non ormonale (rame).
2.Non ha risposto alla terapia con agonisti o antagonisti del GnRH per la gestione dell'endometriosi. 3.Ha avuto una gravidanza nelle 12 settimane antecedenti alla firma del consenso informato, sta attualmente allattando o ha intenzione di rimanere incinta durante lo studio. 4.Ha subito un intervento chirurgico (inclusa la laparoscopia diagnostica) per endometriosi nelle 8 settimane antecedenti alla visita di screening. 5.Ha un mioma uterino concomitante noto o altre lesioni pelviche >3 cm di diametro. 6.Ha sanguinamento vaginale anormale non diagnosticato. 7.Ha un'infezione pelvica concomitante o pregressa entro 8 settimane prima della firma del consenso informato. 8.Ha una malattia concomitante documentata con dolore addominale cronico di origine non endometriosica (p. es., sindrome dell'intestino irritabile [IBS], cistite interstiziale, adenomiosi) o qualsiasi patologia concomitante che richieda valutazione o terapia durante il corso dello studio che può provocare dolore addominale. 9.Ha subito un'isterectomia o un'ovariectomia. 10.Ha dolore pelvico non causato dall'endometriosi. 11.Ha una pregressa o attuale storia di disfunzione tiroidea. 12.Ha un adenoma pituitario. 13.Ha utilizzato farmaci con effetti negativi sulla BMD entro 12 settimane prima dell'inizio del completamento del diario elettronico, compreso l'uso di steroidi sistemici su base cronica o regolare. 14.Ha osteoporosi concomitante o pregressa, perdita ossea, altre malattie metaboliche delle ossa, malattie paratiroidee o anomalie della colonna vertebrale o dell'anca che possano influenzare la misurazione della BMD, o punti inferiori a -1,5 T della BMD della colonna vertebrale o del femore secondo la DXA eseguita allo screening. 15.Ha un tumore maligno attivo o una storia di tumore maligno nei 5 anni antecedenti alla firma del consenso informato. È ammessa una storia di carcinoma cutaneo a cellule squamose o di carcinoma a cellule basali se il soggetto si considera guarito al momento del consenso informato. 16.Ha un grave deterioramento della funzione renale: velocità di filtrazione glomerulare stimata (eGFR) <30 mL/min/1,73 m2 (Modifica della dieta nelle malattie renali [MDRD], basata sulla creatinina sierica). 17.Ha un aspartato aminotransferasi (AST) o alanina aminotransferasi (ALT) >2 × limite superiore alla norma (ULN), o bilirubina totale >1,5 × ULN. 18.Presenta qualsiasi condizione medica instabile o malattia cronica, indagine o anomalia di laboratorio che, secondo il Sperimentatore, rende il soggetto inadatto alla partecipazione allo studio. 19.Screening dell'ECG a 12 derivazioni che mostra anomalie clinicamente significative e/o intervallo QT corretto utilizzando la formula di Fridericia (QTcF) >470 msec. 20.Presenta una condizione cronica che richiede l'uso regolare di analgesici e/o corticosteroidi (come l'artrite reumatoide) che può influenzare la valutazione del dolore pelvico da endometriosi. 21.Presenta una controindicazione o un'allergia nota al farmaco in studio, all'ibuprofene o a qualsiasi componente (ad esempio, lattosio o galattosio) di questi medicinali. 22.Soffre di una malattia cardiovascolare clinicamente significativa o di ipertensione incontrollabile. [...] Per la lista completa si prega di fare riferimento al Protocollo di studio.

E.5 End points

E.5.1

Primary end point(s)

Change from baseline to 12 weeks of treatment of the mean dysmenorrhea score (defined as mean overall pelvic pain [OPP] pain score on menstrual bleeding days) as measured by the Numeric Rating Scale (NRS) over the past month.

Modifica dal basale a 12 settimane di trattamento del punteggio medio della dismenorrea (definito come punteggio medio del dolore pelvico complessivo [OPP] nei giorni di sanguinamento mestruale) rilevati dalla scala numerica di valutazione (NRS) nell'ultimo mese.

E.5.1.1

Timepoint(s) of evaluation of this end point

NRS will be self-assessed through entry into an e-diary. Subjects will complete e-diary entries on a daily basis. At last Visit during the follow up period, NRS will be assessed in the clinic.

L'NRS sarà autovalutata attraverso l'inserimento in un diario elettronico. I soggetti completeranno le voci del diario elettronico su base giornaliera. All'ultima visita durante il periodo di follow-up, l'NRS sarà valutata in clinica.

E.5.2

Secondary end point(s)

•Change from baseline to 12 weeks of treatment of the mean NRS pain score for non-menstrual pelvic pain (NMPP) (mean NRS pain score on
non-menstrual bleeding days)
• Change from baseline to 12 weeks of treatment of signs and symptoms scores
• Plasma concentration of TU2670 at scheduled assessments during the treatment period
• In a subset of approximately 10 subjects/arm calculation of TU2670 PK parameters

• Modifica dal basale a 12 settimane di trattamento del punteggio medio del dolore NRS per il dolore pelvico non correlato al ciclo mestruale (NMPP) (punteggio medio del dolore NRS nei giorni di sanguinamento non correlato con il ciclo mestruale)
• • Variazione dal basale a 12 settimane di trattamento dei punti dei segni e dei sintomi
• • Concentrazione plasmatica di TU2670 alle valutazioni programmate durante il periodo di trattamento
• • In un sottogruppo di circa 10 soggetti/calcolo della divisione dei parametri PK TU2670

E.5.2.1

Timepoint(s) of evaluation of this end point

12 weeks

12 settimane

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

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

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

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

Russian Federation

Ukraine

Italy

Poland

Czechia

E.8.7

Trial has a data monitoring committee

E.8.8

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

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)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

None

Nessuno

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

2021-06-23

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-06-23

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2024-01-22

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:
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