Clinical Trials Register

Summary
EudraCT Number:	2019-002271-34
Sponsor's Protocol Code Number:	GINECO-CE108b
National Competent Authority:	France - ANSM
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-01-20
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

France - ANSM

A.2

EudraCT number

2019-002271-34

A.3

Full title of the trial

A multicenter, pilot study evaluating immune impact and safety of nivolumab in combination with ipilimumab (immune combination) before initial RT-CT treatment for cervix cancer. COLIBRI Study

Etude pilote multicentrique évaluant l’impact immunitaire et la sécurité de la combinaison nivolumab et ipilimumab avant le traitement initial par radio-chimiothérapie dans le cancer du col de l’utérus. Etude COLIBRI

A.3.1

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

A multicenter, pilot study evaluating immune impact and safety of nivolumab in combination with ipilimumab (immune combination) before initial RT-CT treatment for cervix cancer. COLIBRI Study

Il s’agit d’une étude pilote multicentrique, simple bras, évaluant l’impact immunitaire et la sécurité de la combinaison nivolumab et ipilimumab avant le traitement initial par radio-chimiothérapie dans le cancer du col de l’utérus.

A.3.2

Name or abbreviated title of the trial where available

COLIBRI

A.4.1

Sponsor's protocol code number

GINECO-CE108b

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	ARCAGY-GINECO
B.1.3.4	Country	France
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Bristol Myers Squibb (BMS)
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	ARCAGY-GINECO
B.5.2	Functional name of contact point	Project Manager, Sidonie ADAM
B.5.3	Address:
B.5.3.1	Street Address	8 Rue Lamennais
B.5.3.2	Town/ city	PARIS
B.5.3.3	Post code	75008
B.5.3.4	Country	France
B.5.4	Telephone number	33184 85 20 18
B.5.5	Fax number	33143 26 26 73
B.5.6	E-mail	reglementaire@arcagy.org

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	Yes
D.2.1.1.1	Trade name	OPDIVO
D.2.1.1.2	Name of the Marketing Authorisation holder	Bristol-Myers Squibb (BMS)
D.2.1.2	Country which granted the Marketing Authorisation	France
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	nivolumab
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	NIVOLUMAB
D.3.9.3	Other descriptive name	NIVOLUMAB
D.3.9.4	EV Substance Code	SUB122750
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	10
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Yervoy
D.2.1.1.2	Name of the Marketing Authorisation holder	Bristol-Myers Squibb (BMS)
D.2.1.2	Country which granted the Marketing Authorisation	France
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	ipilimumab
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	IPILIMUMAB
D.3.9.3	Other descriptive name	IPILIMUMAB
D.3.9.4	EV Substance Code	SUB29397
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Patients with cervical squamous cell carcinoma stage IB3 to IVa

Patientes atteintes d'un carcinome épidermoïde du col de l'utérus au stade IB3 à IVa

E.1.1.1

Medical condition in easily understood language

Patients with cervical squamous cell carcinoma stage IB3 to IVa

Patientes atteintes d'un carcinome épidermoïde du col de l'utérus au stade IB3 à IVa

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	LLT
E.1.2	Classification code	10008233
E.1.2	Term	Cervical cancer stage I
E.1.2	System Organ Class	100000004864

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	10008234
E.1.2	Term	Cervical cancer stage II
E.1.2	System Organ Class	100000004864

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	10008235
E.1.2	Term	Cervical cancer stage III
E.1.2	System Organ Class	100000004864

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	10008236
E.1.2	Term	Cervical cancer stage IV
E.1.2	System Organ Class	100000004864

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 evolution of the CD8+/FOXP3+ ratio of lymphocytes in pre- versus post-treatment biopsies in patients treated with a combination of Nivolumab and Ipilimumab in a window study, just before starting standard RT-CT.

Evaluer l’évolution du rapport CD8+/FOXP3+ dans les lymphocytes avant et après traitement, chez les patientes ayant reçu la combinaison nivolumab + ipilimumab, avant la radio-chimiothérapie qui est le traitement standard.

E.2.2

Secondary objectives of the trial

To assess tolerability, Objective Response Rate, clinical activity and biological (dynamic) changes of the immune micro environment.

Evaluer la tolérance, le taux de réponse objective, l’activité clinique et les modifications biologiques du micro-environnement de la tumeur.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Histologically confirmed diagnosis of cervical squamous cell carcinoma stage IB3 to IVA, (FIGO 2018)
• Patients requiring RT-CT therapy as standard of care
• Age ≥18
• Patient accepting to undergo a new cervix biopsy
• Adequate marrow function:
 White blood cell (WBC) >2000/mm3 (stable off any growth factor within 4 weeks of first study drug administration)
 Neutrophils >1500/ mm3 (stable off any growth factor within 4 weeks of first study drug administration)
 Platelets > 100× 103/mm3 (transfusion to achieve this level is not permitted within 2 weeks of first study drug administration)
 Hemoglobin > 8 g/dL (transfusion to achieve this level is not permitted within 2 weeks of first study drug administration)
• Adequate other organ functions:
 ALT and AST < 3× institutional ULN
 Total bilirubin < 1.5× institutional ULN (except subjects with Gilbert’s Syndrome who must have normal direct bilirubin)
 Normal thyroid function, subclinical hypothyroidism (thyroid-stimulating hormone [TSH] < 10 mIU/mL) or have controlled hypothyroidism on appropriate thyroid supplementation
 Serum creatinine < 2× ULN or creatinine clearance (CrCl) > 40 mL/min (measured using the Cockcroft-Gault formula or the MDRD formula for patients older than 65 years-old)
• General Health as evidenced by PS ≤2
• Covered by a medical insurance
• Signed and dated informed consent form prior to any study-specific procedure.
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Women of childbearing potential must have a negative serum or urine pregnancy test
For females of reproductive potential: use of highly effective contraception and for at least 5 months after administration of the last dose of nivolumab. A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmeno-pausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries, fallopian tubes, and/or uterus).
• All subjects must consent to allow the acquisition of blood samples, FFPE tumor tissue, either a block or 15 to 20 unstained slides, and fresh tumor for performance of correlative studies.

• Diagnostic confirmé histologiquement du carcinome épidermoïde cervical de stade IB3 à IVa (FIGO 2018)
• Patientes devant bénéficier d’un traitement par radio-chimiothérapie, qui est le traitement standard
• Age ≥18
• Patientes acceptant d’avoir une nouvelle biopsie du col de l’utérus
• Fonctions adéquates de la moelle osseuse :
 Globules blancs ≥ 2000/mm3 (valeurs stables - hors facteurs de croissance – pendant les 4 semaines précédant la première administration du traitement à l’étude)
 Neutrophiles ≥ 1500/ mm3 (valeurs stables - hors facteurs de croissance – pendant les 4 semaines précédant la première administration du traitement à l’étude)
 Plaquettes ≥ 100× 103/mm3 (aucune transfusion n’est permise dans les 2 semaines précédant la première administration du traitement)
 Hémoglobine ≥ 8 g/dL (aucune transfusion n’est permise dans les 2 semaines précédant la première administration du traitement)
• Fonctions adéquates d’autres organes :
 ALT et AST ≤ 3× LSN
 Bilirubine Totale ≤ 1.5× LSN (sauf les patientes ayant le syndrome de GILBERT qui doivent avoir une bilirubine directe normale)
 Fonction thyroïdienne normale, hypothyroïdie subclinique (hormone stimulant la thyroïde [TSH] <10 mIU / mL) ou ayant une hypothyroïdie contrôlée avec une supplémentation thyroïdienne appropriée
 Créatinine sérique ≤ 2 × LSN ou Clairance de la créatinine (CrCl) ≥ 40 mL / min (mesurée à l'aide de la formule de Cockcroft-Gault ou de la formule MDRD pour les patientes âgées de plus de 65 ans)
• Bon état général avec PS ≤ 2
• Couverte par l’assurance maladie
• Formulaire de consentement signé et daté avant toute procédure spécifique à l’étude
• Capable de suivre toutes les procédures de la recherche et disponibilité pendant la durée de l’étude
• Test de grossesse négatif (sanguin ou urinaire) pour les femmes en âge de procréer
Les femmes en capacité de procréer doivent utiliser une contraception hautement efficace et ce pendant au moins 5 mois après l’arrêt de la dernière dose du nivolumab. Une femme est considérée comme étant en âge de procréer si elle est postménarchique, si elle n’a pas atteint un état postménopause (≥ 12 mois consécutifs d’aménorrhée sans autre cause identifiée que la ménopause) et si elle n’a pas subi de stérilisation chirurgicale (ablation des ovaires, tubes, et / ou de l'utérus).
• Les patientes doivent donner leur consentement pour permettre le prélèvement d'échantillons de sang et de tissu tumoral (fraiches ou FFPE).

E.4

Principal exclusion criteria

• Pregnant or breastfeeding women.
• Patient concurrently using other approved or investigational antineoplastic agents.
• Patient candidate for neo adjuvant CT before RT-CT
• Any contraindication to nivolumab or ipilimumab treatments as per Nivolumab and Ipilimumab Investigator's Brochure
• Prior therapy with an immune checkpoint inhibitor
• Prior history of other malignancies other than study disease (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix) unless the patient has been free of the disease for at least 3 years.
• Immune-deficient status (patients with HIV, immunosuppressive treatment, haematological malignancies, and previous organ transplantation)
• History of any chronic hepatitis as evidenced by:
 Positive test for hepatitis B surface antigen
 Positive test for qualitative hepatitis C viral load (by polymerase chain reaction [PCR])
Note: Subjects with positive hepatitis C antibody and negative quantitative hepatitis C by PCR are eligible. History of resolved hepatitis A virus infection is not an exclusion criterion
• Uncontrolled or significant cardiovascular disease including, but not limited to, any of the following:
 Myocardial infarction or stroke/transient ischemic attack within the past 6 months
 Uncontrolled angina within the past 3 months
 History of other clinically significant heart disease (eg, cardiomyopathy, congestive heart failure with New York Heart Association functional classification III-IV, pericarditis, significant pericardial effusion, or myocarditis)
 Any history of clinically significant arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or torsades de pointes)
 QT interval corrected for heart rate using Fridericia’s formula (QTcF) prolongation > 480 msec
 Cardiovascular disease-related requirement for daily supplemental oxygen therapy
• Subjects with known or suspected CNS metastases, untreated CNS metastases, are excluded.
Note: However, subjects with controlled brain metastases will be allowed to enroll. Controlled brain metastases are defined as no radiographic progression for at least 4 weeks following radiation and/or surgical treatment (or 4 weeks of observation if no intervention is clinically indicated), and off of steroids for at least 2 weeks, and no new or progressive neurological signs and symptoms.
• Patients requiring concomitant treatment with therapeutic doses of anticoagulants will not be eligible for this clinical trial.
Note: Patients treated with low dose of anticoagulants for thrombo-embolic events prophylaxis are allowed.
• Any major surgery within 4 weeks of study drug administration. Subjects must have recovered from the effects of major surgery or significant traumatic injury at least 14 days before the first dose of study drug.
Note: Pelvic and aortic dissection is not considered as traumatic surgery, and therefore can be performed if clinically indicated.
• Subjects with active, known or suspected autoimmune disease.
Note: Subjects with skin disorders (such as vitiligo, psoriasis or alopecia), type I diabetes mellitus, hypothyroidism only requiring hormone replacement or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
• Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration.
Note: Inhaled or topical steroids, and adrenal replacement doses are permitted in the absence of active autoimmune disease.)

• Femmes enceintes ou allaitantes
• Patientes utilisant simultanément d’autres agents antinéoplasiques expérimentaux ou approuvés
• Patientes pouvant bénéficier d’une chimiothérapie néoadjuvante avant la radio-chimiothérapie
• Toute contre-indication à l’utilisation du nivolumab et de l’ipilimumab, conformément à la brochure investigateur
• Traitement préalable avec un inhibiteur de contrôle immunitaire
• Antécédents de tumeurs malignes autres que la maladie à l'étude (sauf carcinome basocellulaire ou épidermoïde de la peau ou carcinome in situ du col de l'utérus), sauf si la patiente est indemne de la maladie depuis au moins 3 ans.
• Patientes immunodéprimées (VIH, sous immunosuppresseurs, tumeurs hématologiques et antécédents de transplantation d’organes)
• Antécédents d’hépatite chronique :
 Test positif à l’antigène de surface de l’hépatite B
 Test positif de la charge virale qualitative de l’hépatite C (par réaction en chaine de la polymérase (PCR)
Remarque : Les sujets positifs aux anticorps anti-hépatite C et négatifs à l’hépatite C par PCR sont éligibles. Les antécédents d'infection par le virus de l'hépatite A qui sont résolus ne constituent pas un critère d'exclusion.
• Maladies cardiovasculaires significatives ou non contrôlées incluant, mais ne se limitant pas à une des caractéristiques suivantes :
 Infarctus du myocarde ou accident vasculaire cérébral/ attaque ischémique transitoire au cours des 6 derniers mois
 Angor non contrôlé au cours des 3 derniers mois
 Antécédents d’autres maladies cardiaques cliniquement significatives (par exemple cardiomyopathie, insuffisance cardiaque congestive avec classification fonctionnelle III-IV de la New York Heart Association, péricardite, épanchement péricardique important, myocardite)
 Tout antécédent d’arythmie cliniquement significative (tels que tachycardie ventriculaire, fibrillation ventriculaire ou torsades de pointes)
 Intervalle QT corrigé pour la fréquence cardiaque en utilisant la formule de Friderica (QTcF) > 480 msec
 Oxygénothérapie journalière liée à une maladie cardiovasculaire
• Les sujets avec métastases connues ou suspectées du SNC, métastases non traitées du SNC, sont exclus
Remarque : Cependant, les sujets avec des métastases cérébrales contrôlées seront autorisés à participer à l’étude. Les métastases cérébrales contrôlées sont définies par l'absence de progression radiographique au moins 4 semaines après la radiothérapie et / ou un traitement chirurgical (ou 4 semaines d'observation si aucune intervention n'est cliniquement indiquée), et l'absence de corticostéroïdes pendant au moins 2 semaines, et pas de nouveaux signes et symptômes neurologiques ou pas de progression des signes et symptômes neurologiques.
• Les patients nécessitant un traitement concomitant avec des doses thérapeutiques d'anticoagulants ne seront pas admissibles à cet essai clinique.
Remarque : Les patientes traitées avec une faible dose d'anticoagulants pour une prophylaxie d'événements thromboemboliques sont autorisées.
• Toute intervention chirurgicale majeure survenant dans les 4 semaines précédant l’administration du traitement de l’étude. Les sujets doivent avoir guéri des effets de l’intervention chirurgicale majeure ou d'une lésion traumatique importante au moins 14 jours avant la première dose du médicament à l'étude.
Remarque : La dissection pelvienne et aortique ne sont pas considérées comme une chirurgie traumatique et peuvent donc être effectuées si elles sont cliniquement indiquées.
• Patientes atteintes d’une maladie auto-immune active, connue ou soupçonnée.
Remarque : Les sujets présentant des troubles de la peau (tels que le vitiligo, le psoriasis ou l'alopécie), le diabète sucré de type I, l'hypothyroïdie ne nécessitant qu'un traitement hormonal de substitution ou des affections qui ne devraient pas se reproduire en l'absence d'un déclencheur externe sont autorisés.
• Sujets atteints d'une affection nécessitant un traitement systémique avec des corticoïdes (prednisone > 10 mg par jour) ou d'autres médicaments immunosuppresseurs dans les 14 jours précédant l'administration du médicament à l'étude.
Remarque : Les stéroïdes inhalés ou topiques et les doses de substitution d’hormones surrénales sont autorisés en l'absence de maladie auto-immune.

E.5 End points

E.5.1

Primary end point(s)

The CD8+/FOXP3+ relative change of lymphocytes from pre to post treatment biopsies.

Variation relative du rapport CD8+/FOXP3+ dans les lymphocytes avant et après traitement, à partir des biopsies prélevées avant et après traitement

E.5.1.1

Timepoint(s) of evaluation of this end point

1 month after the first injection of nivolumab and ipilimumab; and just before the radio-chemiotherapy

1 mois après la première administration du nivolumab /ipilimumab; et juste avant la radiochimiothérapie

E.5.2

Secondary end point(s)

Clinical endpoints:
- Safety
- Objective Response Rate (ORR) before and after RT-CT
- 1-year Progression Free Survival (1-year PFS)
- 3-years Overall Survival (3-years OS)
Biological endpoints:
- Assessment of the dynamic changes of the immune microenvironment using various approaches.

Critères de jugement cliniques :
- Tolérance
- Taux de réponse objective
-Survie sans progression
- Survie globale

Critère de jugement biologique :
- Modifications dynamiques du micro-environnement immunitaire de la tumeur en utilisant différentes approches biologiques.

E.5.2.1

Timepoint(s) of evaluation of this end point

ORR : before and after RT-CT
PFS : 1-year
OS : 3-years

Taux de réponse objective avant et après la radio-chimiothérapie
Survie sans progression à 1 an
Survie globale à 3 ans

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

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Immune impact of the combination nivolumab and ipilimumab

Impact immunitaire de la combinaison nivolumab et ipilimumab

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

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

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

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

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

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.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)

Normal treatment according to clinical practice

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

2019-10-23

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-02-13

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

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IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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