Clinical Trials Register

Summary
EudraCT Number:	2022-003562-20
Sponsor's Protocol Code Number:	2018-018
National Competent Authority:	France - ANSM
Clinical Trial Type:	EEA CTA
Trial Status:	Trial now transitioned
Date on which this record was first entered in the EudraCT database:	2022-12-02
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

2022-003562-20

A.3

Full title of the trial

A Multicentric Randomized Double-Blind Phase 3 Trial Evaluating the Efficacy of an Adapted Antibiotherapy in Hurley Stage 2 Active Hidradenitis Suppurativa Patients versus Tetracycline Derivative

Traitement de l’Hidrosadénite Suppurée de stade 2 de Hurley active: un essai de phase 3 multicentrique randomisé en double insu évaluant l’efficacité d’un traitement par antibiothérapie adaptée versus un dérivé de tétracycline

A.3.1

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

A Multicentric Randomized Double-Blind Phase 3 Clinical Trial Evaluating the Efficacy of an Adapted Antibiotherapy in Hurley Stage 2 Active Hidradenitis Suppurativa Patients versus Tetracycline Derivative

Traitement de l’Hidrosadénite Suppurée de stade 2 de Hurley active: un essai clinique de phase 3 multicentrique randomisé en double insu évaluant l’efficacité d’un traitement par antibiothérapie adaptée versus un dérivé de tétracycline

A.3.2

Name or abbreviated title of the trial where available

ABCESS2

A.4.1

Sponsor's protocol code number

2018-018

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	INSTITUT PASTEUR
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	INSTITUT PASTEUR
B.4.2	Country	France
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	CRT-CC
B.5.2	Functional name of contact point	JOLLY nathalie
B.5.3	Address:
B.5.3.1	Street Address	25-28 rue du Docteur Roux
B.5.3.2	Town/ city	Paris
B.5.3.3	Post code	75015
B.5.3.4	Country	France
B.5.5	Fax number	33140613977
B.5.6	E-mail	sponsor@pasteur.fr

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	ROCEPHINE 1 g/3,5 ml pdre/solv p sol inj IM
D.2.1.1.2	Name of the Marketing Authorisation holder	ROCHE
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.3.4	Pharmaceutical form	Powder and solvent for solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP
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	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	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	Métronidazole
D.3.2	Product code	Métronidazole
D.3.4	Pharmaceutical form	Capsule
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
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	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	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: 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	Rifadine 300mg
D.2.1.1.2	Name of the Marketing Authorisation holder	Sanofi-Aventis
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.3.4	Pharmaceutical form	Capsule
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP
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	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	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: 4
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	IZILOX 400mg
D.2.1.1.2	Name of the Marketing Authorisation holder	Bayer Healthcare
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.3.4	Pharmaceutical form	Capsule
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP
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	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	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: 5
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	Tétralysal 150mg
D.2.1.1.2	Name of the Marketing Authorisation holder	Galderma
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.3.4	Pharmaceutical form	Capsule
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP
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	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	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	Powder and solution for solution for injection
D.8.4	Route of administration of the placebo	Intramuscular use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 3
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 4
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 5
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule
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

Hidradenitis Suppurativa

Hidrosadénite Suppurée

E.1.1.1

Medical condition in easily understood language

Verneuil's Disease

Maladie de Verneuil

E.1.1.2

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10020041
E.1.2	Term	Hidradenitis suppurativa
E.1.2	System Organ Class	100000004858

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 demonstrate the superiority of a 3-week course of a ceftriaxone+metronidazole treatment followed by 3 weeks of a rifampicin+moxifloxacin+metronidazole combination, then 6 weeks of rifampicin+moxifloxacin (experimental treatment) over a 12-week course of tetracycline-derivative (control treatment) in patients with Hurley stage 2 HS (Hidradenitis suppurativa) at week 12.

Démontrer la supériorité d'un traitement de 3 semaines par ceftriaxone + métronidazole suivi de 3 semaines d'une association rifampicine + moxifloxacine + métronidazole, puis de 6 semaines de traitement par rifampicine + moxifloxacine (traitement expérimental) versus un traitement de 12 semaines par un dérivé de tétracycline chez des patients HS (Hidrosadénite Suppurée) de stade 2 de Hurley à la 12ème semaine (S12)

E.2.2

Secondary objectives of the trial

Efficacy of the experimental treatment:
- To measure the clinical efficacy at week 6, week 24 and week 52
- To measure microbiological efficacy at week 12
- To evaluate the impact on pain and quality of life
- To quantify the use of additional treatments
- To characterize the number of HS flares after clinical remission
- To identify prognosis markers of response to treatments
Safety of the experimental treatment:
- To evaluate clinical and biological tolerance
- To identify emergence of multidrug resistance in the gut microflora

Efficacité traitement expérimental:
- Mesurer l’efficacité clinique du traitement aux semaines 3, 6 et 52
- Mesurer l’efficacité microbiologique à la semaine 12
- Evaluer l’impact des traitements sur la douleur et la qualité de vie
- Quantifier la nécessité de traitements supplémentaires
- Caractériser des rechutes d’HS après rémission clinique (délai après rémission, nombre et évolution)
- Identifier les marqueurs pronostiques de réponse au traitement

• Sécurité :
- Evaluer la tolérance clinique et biologique des traitements
- Identifier l’émergence d'une multirésistance dans la flore intestinale

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Adults < 60 years old
Diagnosis of HS according to European Dermatology guidelines:
Recurrent inﬂammation occurring more than 2 times in the past 6 months in the inverse regions of the body, presenting with nodules, sinus-tracts and/or scarring.
Signs: Involvement of axilla, genitofemoral area, perineum, gluteal area (and infra-mammary areafor women). Presence of nodules (inﬂamed or noninﬂamed), sinus tracts (inﬂamed or noninﬂamed), abscesses, scarring (atrophic, mesh-like, red, hypertrophic or linear)
Active HS with i) ≥ 1 year of evolution and ii) ≥ 4 flares during the previous year
Clinical severity of HS at inclusion: Hurley stage 2
BMI < 35
Written informed consent from patient
Patient able to complete DLQI
Patients affiliated to the French health system (Assurance Maladie), except French state medical aid beneficiaries (Aide Médicale d’Etat)
Active compatible contraception for men and women of childbearing or inability to procreate
Available laboratory blood test performed within the last 2-months

Adultes < 60 ans
Diagnostic d’HS selon les recommandations européennes en dermatologie:
Récurrence d’inflammation survenue plus de 2 fois au cours des 6 derniers mois dans les régions des grands plis du corps présentant des nodules, tractus sinusaux et/ou des cicatrices.
Signes: Atteinte des zones axillaires, génito-fémorales, périnéale, fessières ou infra-mammaire des femmes. Présence de nodules (inﬂammatoires ou non-inflammatoires). Présence de tractus sinueux (inﬂammatoires ou non-inflammatoires), abcès, cicatrices (atrophique, en maille, rouge, hypertrophique ou linéaire).
HS actif avec i) ≥ 1 an d'évolution et ii) ≥ 4 poussées au cours de l'année écoulée
Gravité clinique de l’HS à l’inclusion: stade 2 de Hurley
IMC < 35
Consentement éclairé écrit du patient
Patient capable de compléter le questionnaire de qualité de vie (DLQI)
Patients affiliés à la sécurité sociale française (Assurance Maladie) a l’exception de l’Aide Médicale d’Etat
Contraception active compatible chez les femmes et les hommes en âge de procréer ou impossibilité de procréer

E.4

Principal exclusion criteria

Person < 18 and ≥ 60 years old
Former stage 3 HS
Previous use of the experimental treatment
Unauthorized drugs for the study during the month preceding the inclusion
Any contra-indication to study treatments or excipient (e.g. lactose, corn starch, riboflavin notably)
pregnancy, breastfeeding,
known allergy to experimental or reference drugs, wheat allergy,
tendinopathy,
QT prolongation, bradycardia, heart failure, heart rhythm disturbances,
hydroelectrolytic disorders, hypokalemia,
coagulation disorders,
severe liver/kidney dysfunction,
porphyria,
mandatory use of nonsteroidal anti-inflammatory drugs (NSAIDs) for other medical conditions
Unbalanced diabetes (ie HbA1c above 7%)
Dysphagia, untreated gastro-oesophageal reflux/ulcer,
BMI ≥ 35
Immune suppression, inflammatory disease, including gastroenterologic and rheumatologic inflammatory conditions,
Lactase deficiency, lactose and galactose intolerance
Malabsorption syndrome
Person living in the same household as another patient
Person under guardianship or curatorship
Individuals with any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives (e.g patient unable to complete DLQI, or poor predictable observance
Participation in another interventional research on health products studies
Patients requiring repeated (more than 3/year) use of antibiotics for a chronic disease other than HS

Personnes < 18 et ≥ 60 ans
Ancien stade 3 de Hurley
Utilisation antérieure de la stratégie expérimentale de l’étude
Tout médicament non autorisé dans le cadre de l’étude pendant le mois précédant l'inclusion
Toute contre-indication aux traitements de l'étude ou excipients (lactose, amidon de maïs, riboflavine notamment)
grossesse, allaitement,
allergie connue aux médicaments expérimentaux ou de référence, allergie au blé,
tendinopathie,
Allongement de l'intervalle QT, bradycardie, insuffisance cardiaque, troubles du rythme cardiaque,
troubles hydroélectrolytiques, hypokaliémie,
troubles de la coagulation,
dysfonctionnement hépatique/rénal sévère,
porphyrie,
utilisation obligatoire d'anti-inflammatoires non stéroïdiens (AINS) pour d'autres conditions médicales
Diabète déséquilibré (HbA1 au dessus de 7%)
Dysphagie, reflux / ulcère gastro-œsophagien non traité,
Obésité sévère (IMC ≥ 35)
Immuno-suppression, maladie inflammatoire notamment gastroentérologique et rhumatologique
Déficit en lactase, intolérance en lactose et galactose
Syndrome de malabsorption
Personne vivant dans le même foyer qu’un patient à l’étude
Personne sous tutelle ou curatelle
Personne présentant une condition qui, selon l'investigateur, pourrait interférer avec l'évaluation des objectifs de l'étude (par exemple patient incapable de compléter le DLQI, ou mauvaise observance prévisible)
Patients nécessitant une utilisation répétée (plus de 3/an) d'antibiotiques pour une maladie chronique autre que l'HS

E.5 End points

E.5.1

Primary end point(s)

Percentage of patients reaching clinical remission at week 12, défined by an improvement of 90% of the IHS4 score from the baseline (IHS4 (1))

Pourcentage de patients en rémission clinique a la semaine 12, définie par une amélioration de 90% du score de gravité international de l’HS (IHS4 (1)) par rapport à l’inclusion.

E.5.1.1

Timepoint(s) of evaluation of this end point

Week 12

Semaine 12

E.5.2

Secondary end point(s)

Efficacy:
- Physician HS evaluation: Physician Global Assessment (PGA), modified Sartorius score, HS clinical Response (HiSCR), International Hidradenitis Suppurativa Severity Score (IHS4) at each visit
- Normalization of the worst lesion microbiome at W12 compared to baseline at inclusion
- Patient’s HS evaluation: Pain (visual analogic scale, number of painful days per month); Dermatology Life Quality Index (DLQI)
- Number of pain killers and antibiotic treatments prescribed for flares (acute worsening of one or more HS lesions), number of surgical drainages
- Time without flare of HS after remission, number of flares using a patient journal
- Identification of prognosis markers of response to treatments:
Patient’s personal and familial history, lesions localization and characteristics, clinical examination, Body Mass Index (BMI)
Past antimicrobial treatments
Microbiome of the worst lesion at baseline
Microbiome of relapsing or resistant lesions
Observance of the study treatment
CRP, CBC, blood glucose

Safety:
Description of adverse events related to treatments
Description of adverse events related to protocol procedures other than treatments
Emergence of extended spectrum betalactamase and carbapenemase producing enterobacteriaceae as well as vancomycin resistant enterococci in the gut microflora

Efficacité:
- Évaluation HS par le médecin: PGA, score de Sartorius modifié, HiSCR, IHS4, à chaque visite
- Normalisation du microbiome de la lésion la plus sévère à S12 à comparer au microbiome de cette lésion à l'inclusion
- Evaluation du patient: douleur: échelle analogique visuelle, nombre de jours douloureux par mois; Indice de qualité de vie en dermatologie (DLQI)
- Utilisation d’analgésiques, nombre de cures d’antibiotiques de rechute nécessaires, et de drainages chirurgicaux
- Délai sans rechute d’HS après rémission, nombre de rechutes à l'aide d'un journal patient
Identification des marqueurs pronostiques de réponse aux traitements:
Antécédents personnels et familiaux du patient, localisation et caractéristiques des lésions, examen clinique, indice de masse corporelle (IMC)
Traitements antibiotiques antérieurs
Flore microbienne initiale et flore associée aux lésions résistantes
Observance des traitements de l’étude
VS, CRP, leucocytes, glycémie

• Sécurité:
- Description des événements indésirables liés aux traitements
- Description des événements indésirables liés à d'autres procédures du protocole que les traitements
- Emergence d'entérobactéries productrices de bétalactamase à spectre étendu ou de carbapénémase, ainsi que d'entérocoques résistants à la vancomycine dans la flore intestinale

E.5.2.1

Timepoint(s) of evaluation of this end point

At weeks 6, 12, 24 and 52

Aux semaines 6, 12, 24 et 52

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

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)

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

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

3 months after last patient last visit. This date corresponds to the database lock. This will take into account the time to perfom biological analysis and will allow the writing of the final report 1 year after database lock.

3 mois après la dernière visite du dernier patient. Cette date correspond au gel de base. Elle prend en compte la durée des analyses biologiques et permettra ainsi de produire un rapport final de l’étude 1 an après le gel de base.

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)

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

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)

none

aucun

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

2023-03-07

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2023-02-09

P. End of Trial
P.	End of Trial Status	Trial now transitioned

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