Clinical Trials Register

Summary
EudraCT Number:	2017-005038-53
Sponsor's Protocol Code Number:	FIM-PRU-2018-01
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:	2018-11-23
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

2017-005038-53

A.3

Full title of the trial

Randomized double-blind, placebo-controlled study
evaluate the efficacy and mechanisms involved in immunotherapy
Sublingual specifies with Pru p 3 (Pru p 3-ITSL) in patients with
allergy to nsLTP with severe symptoms in its response to
Peach, peanut, artemisia and olive.

Estudio aleatorizado doble ciego controlado por placebo para
evaluar la eficacia y mecanismos implicados en la inmunoterapia
sublingual especifica con Pru p 3 (Pru p 3-ITSL) en pacientes con
alergia a nsLTP con síntomas graves en su respuesta frente a
melocotón, cacahuete, artemisia y olivo.

A.3.1

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

Study of the efficacy of the LTP allergy (peach, peanut, artemisia and olive) vaccine .

Estudio de la eficacia de la vacuna de la alergia a LTP (melocotón, cacahuete, artemisia y olivo).

A.4.1

Sponsor's protocol code number

FIM-PRU-2018-01

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	Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina Y Salud (FIMABIS)
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	ISCIII
B.4.2	Country	Spain
B.4.1	Name of organisation providing support	ALK-Abelló S.A.
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	Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina Y Salud (FIMABIS)
B.5.2	Functional name of contact point	Plataforma de Estudios Clínicos
B.5.3	Address:
B.5.3.1	Street Address	Hospital Regional Universitario, Avda. Carlos Haya s/n
B.5.3.2	Town/ city	Malaga
B.5.3.3	Post code	29010
B.5.3.4	Country	Spain
B.5.4	Telephone number	34951291977
B.5.6	E-mail	estudios.clinicos@fimabis.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	SLIT-Melocotón
D.2.1.1.2	Name of the Marketing Authorisation holder	ALK
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.3.1	Product name	SLIT Melocotón
D.3.4	Pharmaceutical form	Concentrate for oral solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Sublingual use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Pru p 3
D.3.9.1	CAS number	TSN 24765
D.3.9.3	Other descriptive name	PRUNUS PERSICA
D.3.9.4	EV Substance Code	SUB35015
D.3.10	Strength
D.3.10.1	Concentration unit	µg/µl microgram(s)/microlitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
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	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	Concentrate for oral solution
D.8.4	Route of administration of the placebo	Sublingual use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

LTP syndrome.

Síndrome LTP

E.1.1.1

Medical condition in easily understood language

Alergia a nsLTP con síntomas graves en su respuesta frente a melocotón, cacahuete, artemisia y olivo.

Allergy to nsLTP with severe symptoms in response to peach, peanut, artemisia and olive.

E.1.1.2

Therapeutic area

Body processes [G] - Immune system processes [G12]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10016946
E.1.2	Term	Food allergy
E.1.2	System Organ Class	10021428 - Immune system disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Evaluate the efficacy and safety of specific sublingual immunotherapy with Pru p 3 (SLIT-Prup3) in patients with allergy to nsLTP with severe symptoms in their response to peach, peanut, artemisia and olive trees by conducting controlled double-blind challenge with placebo (CDBCP) and/or specific nasal provocation test.

Evaluar la eficacia y seguridad de la inmunoterapia sublingual especifica con Pru p 3 (ITSL-Prup3) en pacientes con alergia a nsLTP con síntomas graves en su respuesta frente a melocotón, cacahuete, artemisia y olivo mediante la realización de prueba de provocación doble ciego controlada con placebo (PPDCCP) y/oTPNE.

E.2.2

Secondary objectives of the trial

Monitor the immunological changes during the ITSL-Prup3 and after the completion (one year of treatment) of the same at different levels:
a) In vivo: Evaluating changes in sensitization to peach, peanut, artemisia and olive trees, by analyzing the reactivity in intraepidermal tests with allergenic extracts, CDBCP against peach and peanut and by specific nasal provocation test against a p3 p, Art v 3, Ole e 7, artemisia and olive tree.
b) In vitro:
b.1) Humoral. Analyzing changes in the levels of IgE and IgG4 specific to different nsLTPs (Pru p 3, Ara h 9, Art v 3 and Ole e 7) as well as Art v 1 and Ole e 1 (major allergens of artemisia and olive tree) will be used to assess primary awareness of these pollens.
b.2) Cellular. Assessing changes in CD maturation and in the proliferation of different effector and regulatory cell subpopulations specific to the different nsLTPs. The changes in subpopulation apoptosis will be analyzed.

Monitorizar los cambios inmunológicos durante la ITSL-Prup3 y tras la finalización (un año de tratamiento) de la misma a diferentes niveles:
a) In vivo: Evaluando cambios en la sensibilización a melocotón, cacahuete, artemisia y olivo, mediante el análisis de la reactividad en pruebas intraepidérmicas con extractos alergénicos, PPDCCP frente a melocotón y cacahuete y mediante TPNE frente aPru p 3, Art v 3, Ole e 7, artemisia y olivo.
b) In vitro:
b.1) Humoral. Analizando cambios en los niveles de IgE e IgG4 especificas a diferentes nsLTPs (Pru p 3, Ara h 9, Art v 3 y Ole e 7) así como a Art v 1 y Ole e 1 (alérgenos mayores de artemisia y olivo) que se utilizarán para valorar sensibilización primaria a estos pólenes.
b.2) Celular. Evaluando cambios en la maduración de CD y en la proliferación de diferentes subpoblaciones celulares efectoras y reguladoras específicas a las diferentes nsLTPs. Se analizarán los cambios en apoptosis de subpoblaciones.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Informed Consent (IC) for the study and for the Biobank signed
2. Men or women ≥5 and ≤55 years of age.
3. Moderate/severe allergic reaction after ingestion of peach, with or without peanut, confirmed by PPDCCP with peach.

1. Consentimiento informado (CI) del estudio y de Biobanco firmado
2. Hombres o mujeres entre 5 y 55 años de edad.
3. Reacción alérgica moderada/grave tras la ingestión de melocotón acompañado o no de cacahuete, confirmado por PPDCCP con melocotón.

E.4

Principal exclusion criteria

1. Pregnancy and lactation.
2. Immunological diseases, treatments with immunomodulators and/or blockers.
3. Mental illness.
4. Severe atopic dermatitis according to SCORAD (53)
5. FEV1 <70%.
6. Inflammation in the oral cavity with severe symptoms, oral surgery in the previous 7 days.

1. Embarazo y lactancia
2. Enfermedades inmunológicas, tratamientos con inmunomoduladores y/o bloqueantes.
3. Enfermedad mental.
4. Dermatitis atópica grave según SCORAD (53)
5. FEV1<70%.
6. Inflamación en cavidad oral con síntomas severos, cirugía oral en los 7 días previos.
7. IT con pólenes en los 2 años anteriores o cualquier otra condición que contraindique la IT.
8. Alergia a coco.
9. Sujetos incapaces de realizar el tratamiento.

E.5 End points

E.5.1

Primary end point(s)

Evaluation of the in vivo response
- Skin tests
- Specific nasal provocation test
- CDBCP with Peach and Peanut

Evaluación de la respuesta in vivo
- Pruebas cutáneas
- Test de provocación nasal específica (TPNE)
- PPDCCP con Melocotón y Cacahuete

E.5.1.1

Timepoint(s) of evaluation of this end point

- Skin tests: Screening period, 1, 6 and 12 months of treatment.
- Specific nasal provocation test & CDBCP with Peach and Peanut: Screening period and 12 months.

- Pruebas cutáneas: Periodo de selección (V0), al mes de inicio del tratamiento (V2), A los 6 meses (V3) y a los 12 meses de tratamiento (V4).
- Test de provocación nasal específica (TPNE) y PPDCCP con Melocotón y Cacahuete: Periodo de selección (V0) y a los 12 meses de tratamiento (V4).

E.5.2

Secondary end point(s)

Sensibilización in vitro frente a Pru p 3, Ara h 9, Art v3, Ole e 7, Ole e 1 y Art v 1.

E.5.2.1

Timepoint(s) of evaluation of this end point

V0, V1, V2, V3 y V4
Visit 0 (Screening) , V1 (start of treatment) , V2 (1 month of treatment), V3 (6 months of treatment) and V4 (12 months of treatment)

V0, V1, V2, V3 y V4
Periodo de selección (V0), al inicio del tratamiento (V1), al mes del inicio del tratamiento (V2), a los 6 meses del inicio del tratamiento (V3) y a los 12 meses del inicio del tratamiento (V4).

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

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)

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

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

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

LVLS
Última visita del último sujeto.

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)

Yes

F.1.1.5.1

Number of subjects for this age range:

F.1.1.6

Adolescents (12-17 years)

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

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)

Once subject’s participation in the study is finished, he/she will be offered the best treatment available for his/her condition.

Una vez finalizada la participación del sujeto en el estudio, se le ofrecerá el mejor tratamiento disponible para su condición.

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

2019-05-16

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-02-01

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

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