Clinical Trials Register

Summary
EudraCT Number:	2016-002714-45
Sponsor's Protocol Code Number:	FJD-MET-2016-01
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2016-11-17
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

Spain - AEMPS

A.2

EudraCT number

2016-002714-45

A.3

Full title of the trial

"Pilot study to assess the efficacy of treatment with metformin in patients with Hidradenitis suppurativa refractory to standard treatment "

“Estudio piloto para evaluar la eficacia del tratamiento con Metformina en pacientes con Hidradenitis supurativa refractaria al tratamiento estándar”

A.3.1

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

"Pilot study to assess the efficacy of treatment with metformin in patients with Hidradenitis suppurativa refractory to standard treatment "

“Estudio piloto para evaluar la eficacia del tratamiento con Metformina en pacientes con Hidradenitis supurativa refractaria al tratamiento estándar”

A.3.2

Name or abbreviated title of the trial where available

Metfomin for Hidradenitis Suppurativa

Metformina para Hidradenitis supurativa

A.4.1

Sponsor's protocol code number

FJD-MET-2016-01

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	Instituto de Investigación Sanitaria Fundación Jiménez Díaz
B.1.3.4	Country	Spain
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	Sociedad Española de Dermatología
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Instituto de Investigación Sanitaria Fundación Jiménez Díaz
B.5.2	Functional name of contact point	Raquel Muñoz
B.5.3	Address:
B.5.3.1	Street Address	Avda. Reyes Católicos 2
B.5.3.2	Town/ city	Madrid
B.5.3.3	Post code	28040
B.5.3.4	Country	Spain
B.5.4	Telephone number	+349155048003214
B.5.6	E-mail	rmunozs@fjd.es

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	Metformina
D.2.1.1.2	Name of the Marketing Authorisation holder	KernPharma
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	Tablet
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	METFORMIN
D.3.9.1	CAS number	657-24-9
D.3.9.2	Current sponsor code	Metformin
D.3.9.3	Other descriptive name	Metformin
D.3.9.4	EV Substance Code	SUB08831MIG
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	850
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Hidradenitis suppurativa

Hidradenitis supurativa

E.1.1.1

Medical condition in easily understood language

Hidradenitis suppurativa

Hidradenitis supurativa

E.1.1.2

Therapeutic area

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

MedDRA Classification

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 of metformin in the treatment of patients with refractory hidradenitis suppurativa treatment

E.2.2

Secondary objectives of the trial

Evaluar la eficacia de metformina en el tratamiento de pacientes con Hidradenitis Supurativa refractaria a tratamiento.

•Evaluar la seguridad y tolerabilidad de dicho tratamiento.
•Evaluar la mejoría de la calidad de vida de los pacientes.
•Evaluar la prevalencia del Síndrome Metabólico y resistencia a la insulina en pacientes con HS.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Men or women over 14 years (in case of minors with parental consent or guardians)
2. Clinical diagnosis of hidradenitis suppurativa (defined by the presence of a) typical lesions: multiple deep inflammatory nodules, comedones, fistulas, sinus tracts, abscesses and / or fibrotic scars, b) in typical locations: armpits, English, inframammary regions, neck c) with chronic course with exacerbations and remissions) of moderate to severe (stage II-III Hurley)
3. That is refractory or recurrent oral antibiotics and / or topical and / or the patient does not tolerate, at the discretion of the investigator
4. In the case of women of childbearing age who are not planning pregnancy in the next 6 months and agree to use effective contraception during the treatment period (6 months) and until one month after the last dose of study medication.
5. are willing and able to participate in the study, comply with established procedures and to give his written consent after receiving appropriate information

1. Hombres o mujeres mayores de 14 años (en caso de menores de edad con consentimiento de los padres o tutores)
2. Diagnóstico clínico de Hidradenitis Supurativa (definida por la presencia de a) lesiones típicas: nódulos inflamatorios profundos múltiples, comedones, fístulas, tractos sinuosos, abscesos y/o cicatrices fibróticas, b) en localizaciones típicas: axilas, ingles, regiones inframamarias, cuello y c) con curso crónico con exacerbaciones y remisiones), de grado moderado a grave (estadio II-III de Hurley)
3. Que sea refractaria o recurrente a antibioterapia oral y/o tópica y/o el paciente no la tolere, a criterio del investigador
4. En el caso de mujeres en edad fértil, que no estén planificando quedarse embarazadas en los próximos 6 meses y que acepten usar un método anticonceptivo eficaz durante el período de tratamiento (6 meses) y hasta un mes de haber tomado la última dosis de la medicación en estudio.
5. Que estén dispuestos y sean capaces de participar en el estudio, cumplir con los procedimientos establecidos y a dar su consentimiento por escrito tras haber recibido la información adecuada

E.4

Principal exclusion criteria

Pregnant or breastfeeding
2. Contraindications to the use of metformin hypersensitivity to the active substance or to any of the excipients, diabetic ketoacidosis, diabetic pre-coma, renal failure or renal dysfunction (creatinine clearance <60 mL / min), acute disease that poses a risk of impaired capable of causing chronic tissue hypoxia (cardiac or respiratory failure, myocardial infarction in the last month- recently, shock), liver failure, kidney function alcohol intoxication (dehydration, severe infection, shock), acute illness or acute (which has stated income), chronic alcoholism.
3. Patients pretreatment with metformin
4. medical or surgical history that the investigator's discretion not allow participation in the study.
5. Refusal to participate in the study and sign the consent.
6. are participating or have completed their participation in another clinical trial with drug or medical device within the last 30 days before the start of study treatment.

1. Mujeres embarazadas o en período de lactancia
2. Contraindicaciones para el uso de metformina: hipersensibilidad al principio activo o a alguno de los excipientes, cetoacidosis diabética, precoma diabético, Insuficiencia renal o disfunción renal (aclaramiento de creatinina < 60 mL/min), patología aguda que implique un riesgo de alteración de la función renal (deshidratación, infección grave, shock), enfermedad aguda o crónica capaz de provocar una hipoxia tisular (insuficiencia cardiaca o respiratoria, infarto de miocardio reciente- en el último mes-, shock), insuficiencia hepática, intoxicación alcohólica aguda (que haya precisado ingreso), alcoholismo crónico.
3. Pacientes en tratamiento previo con metformina
4. Antecedentes médicos o quirúrgicos que a criterio del investigador no permitan la participación en el estudio.
5. Negativa a participar en el estudio y a firmar el consentimiento.
6. Que estén participando o hayan finalizado su participación en otro ensayo clínico con medicamento o producto sanitario en los últimos 30 días antes del inicio del tratamiento en estudio.

E.5 End points

E.5.1

Primary end point(s)

The mean difference in the score Sartorius Scale property at the end of treatment (24 weeks) compared to baseline.

la diferencia media en la puntuación de la Escala de Sartorius Modificada al final del tratamiento (24 semanas) respecto de la basal.

E.5.1.1

Timepoint(s) of evaluation of this end point

24 weeks

24 semanas

E.5.2

Secondary end point(s)

Descriptive analysis of baseline characteristics of the patients included
 average difference in score Sartorius Scale modified at 6 and 12 weeks of treatment compared to baseline.
 average difference in score Sartorius Scale at 6, 12 and 24 weeks of treatment compared to baseline.
% of patients responding to treatment (defined as those who achieved ≥30% reduction in the score Sartorius Modified) at 6, 12 and 24 weeks.
% of responders according to the change in the HS-PGA scale, defined as patients with a score of cleared, minimal or mild with at least two degrees of improvement over baseline score at week 24 of treatment.
% of patients who respond to treatment according HiSCR (Hidradenitis Suppurativa Clinical Response) (reduction of at least 50% of nodules + abscesses, without increasing the number of abscesses without increasing the number of draining fistulas compared to baseline) to 6, 12 and 24 weeks.
 Mean improvement in the quality of life according to the DLQI at 6, 12 and 24 weeks of treatment
% of patients achieving a decrease of 4 points DLQI at 6,12 and 24 weeks
 Mean improvement of pain according to EVA in the most painful injury chosen by the patient at 6, 12 and 24 weeks of treatment
% means of compliance
% of patients with adverse reactions to treatment (and description thereof)
% of patients who have to abandon treatment by poor tolerability at the same
 Descriptive analysis of laboratory parameters at each visit and comparing relative to baseline.

 Análisis descriptivo de las características basales de los pacientes incluidos
 Diferencia media en la puntuación de la Escala de Sartorius modificada a las 6 y 12 semanas de tratamiento respecto de la basal.
 Diferencia media en la puntuación de la Escala de Sartorius a las 6, 12 y 24 semanas de tratamiento respecto de la basal.
 % de pacientes que responden al tratamiento (definidos como aquellos que alcanzan una reducción ≥30% en el score Sartorius Modificado) a las 6, 12 y 24 semanas.
 % de pacientes respondedores de acuerdo al cambio en la escala HS-PGA, definido como pacientes con un score de despejado, mínimo o leve con al menos dos grados de mejora respecto al score basal a la semana 24 de tratamiento.
 % de pacientes que responden al tratamiento según HiSCR (Hidradenitis Suppurativa Clinical Response) (reducción de al menos el 50% de nódulos + abscesos, sin aumento del número de abscesos y sin aumento del número de fístulas drenantes en relación a la basal) a las 6, 12 y 24 semanas.
 Mejoría media en la calidad de vida de acuerdo al DLQI a las 6, 12 y 24 semanas de tratamiento
 % de pacientes que alcanzan una disminución del DLQI de 4 puntos a las 6,12 y 24 semanas
 Mejoría media del dolor según la EVA en la lesión más dolorosa elegida por el paciente a las 6, 12 y 24 semanas de tratamiento
 % medio de cumplimiento
 % de pacientes que presentan reacciones adversas al tratamiento (y descripción de las mismas)
 % de pacientes que tienen que abandonar el tratamiento por mala tolerabilidad al mismo
 Análisis descriptivo de los parámetros analíticos en cada visita y comparación respecto a los valores basales.

E.5.2.1

Timepoint(s) of evaluation of this end point

6, 12 and 24 weeks

6, 12 y 24 semanas

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

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.8.3

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

Last patient, last visit

Última visita, último paciente

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

Yes

F.1.1

Number of subjects for this age range:

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)

Yes

F.1.1.6.1

Number of subjects for this age range:

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

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

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)

Patients will be managed according to clinical practice after the end of the trial

Los pacientes serán tratados según práctica clínica habitual después del ensayo

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

2017-01-13

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-12-30

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

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