Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled, Efficacy and Safety Clinical Trial With SCIT in Patients With Rhinitis/Rhinoconjunctivitis With or Without Mild to Moderate Asthma Sensitized to Dpt. and/or D. Farinae

Who is this study for? Child to adult patients with Allergic Rhinitis
Status: Recruiting
Location: See all (32) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

A double-blinded, placebo-controlled, prospective, multicenter randomized of 2 active treatment groups, compared to 1 placebo group, for the determination of the efficacy and safety of subcutaneous immunotherapy in patients with rhinitis/rhinoconjunctivitis with or without asthma, sensitised to Dermatophagoides pteronyssinus and /or Dermatophagoides farinae.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 65
Healthy Volunteers: f
View:

• Written informed consent.

• Age between 12 and 65, both genders.

• Subjects with a confirmed clinical history of inhalant allergy (intermittent or persistent moderate-severe rhinitis and/or rhinoconjunctivitis according to the ARIA classification with or without intermittent or persistent mild-moderate controlled asthma according to the GEMA 5.0 definition) caused by allergy to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae. The diagnosis of asthma will be valid from 12 months prior to signing the informed consent.

• Subjects with a positive skin prick-test wheal size \>5 mm higher diameter due to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae. The positive and negative control of the test should give consistent results. The results will be valid 12 months prior to the signing of the informed consent.

• Specific immunoglobulin E against house dust mites \>3,5 KU/mL (InmunoCAP® o Immulite), for the complete extract of Dermatophagoides pteronyssinus and / or for Dermatophagoides farinae or for some of the molecular components of these allergenic sources

• Subjects should preferably be monosensitized to the study allergens. In case of subjects sensitized to other aeroallergens, only those with the following characteristics may be included in the study:

‣ Subjects with positive skin test to Blomia tropicalis and Lepidoglyphus destructor, whose specific IgE values do not exceed or equal the values for the study allergens. The maximum specific IgE value for these allergens is 3.5 KU/L.

⁃ Subjects with positive skin tests to epithelia, as long as they present occasional exposure and symptomatology.

⁃ Subjects with positive skin tests to pollens, whose specific IgE values do not exceed or equal the values of the allergens in the study and who do not present exacerbations during the pollen season. The maximum value of specific IgE for these allergens is 17.5 KU/L.

• Subjects with negative skin test for fungi

• Women of childbearing age (from menarche) must present a urine pregnancy test with a negative result at the time of joining the trial, before the first administration of the IMP.

• Women of childbearing age participating in the trial must agree to use an appropriate method of contraception, meaning any act, device, or medication to prevent conception or viable pregnancy, during the trial if they are sexually active.

• Subjects with a diagnosis of asthma according to the GEMA 5.0 guideline.

• Subjects capable of complying with the dosing regimen.

• Subjects who own an smartphone for symptom registration and medication

Locations
Other Locations
Spain
Clinica Virgen del Rosario
ACTIVE_NOT_RECRUITING
Algeciras
Hospital General Universitario Dr. Balmis
RECRUITING
Alicante
Hospital Universitario San Juan de Alicante
RECRUITING
Alicante
Clínica Dermatológica y Alergia
RECRUITING
Badajoz
Hospital Quironsalud Clideba
RECRUITING
Badajoz
Allergocenter
ACTIVE_NOT_RECRUITING
Barcelona
Cenvi Medic
RECRUITING
Barcelona
Clínica Corachan
RECRUITING
Barcelona
Hospital Sant Pere Claver
RECRUITING
Barcelona
Hospital Universitari Dexeus
RECRUITING
Barcelona
Clinica privada
WITHDRAWN
Bilbao
Centro Médico ASISA Dr. Lobatón
RECRUITING
Cadiz
Centro Médico Puerto
RECRUITING
Cadiz
Hospital General Universitario Santa Maria de Rosell
WITHDRAWN
Cartagena
Hospital Quiron Salud Córdoba
RECRUITING
Córdoba
IMED Elche
RECRUITING
Elche
Hospital HLA Jerez Puerta Sur
WITHDRAWN
Jerez De La Frontera
Hospital Polusa
RECRUITING
Lugo
Clinica privada
RECRUITING
Málaga
Hospital Comarcal de Melilla
RECRUITING
Melilla
Clinica Privada
NOT_YET_RECRUITING
Murcia
Alergocantabria
RECRUITING
Santander
Hospital Provincial de Conxo
RECRUITING
Santiago De Compostela
Hospital Quiron Infanta Luisa
RECRUITING
Seville
Hospital Universitario de Torrevieja
RECRUITING
Torrevieja
Clinica IMED
WITHDRAWN
Valencia
Clinica Lanuza
RECRUITING
Valencia
Clinica Tecma
COMPLETED
Valencia
Hospital de Sagunto
WITHDRAWN
Valencia
Hospital Dr. Peset
RECRUITING
Valencia
Hospital Universitario Y Politecnico La Fe
RECRUITING
Valencia
Hospital Rivera Povisa
ACTIVE_NOT_RECRUITING
Vigo
Contact Information
Primary
Miguel Casanovas, MD PhD
mcasanovas@inmunotek.com
+34916510010
Backup
Raquel Caballero, MD
rcaballero@inmunotek.com
+34607600638
Time Frame
Start Date: 2020-10-06
Estimated Completion Date: 2026-12
Participants
Target number of participants: 150
Treatments
Experimental: Experimental:10,000 MM09
10,000 TU/mL of subcutaneous immunotherapy
Experimental: Experimental: 30,000 MM09
30,000 TU/mL of subcutaneous immunotherapy
Placebo_comparator: Placebo subcutaneous
The same solution and presentation as the active treatment, but without any active ingredients.
Authors
Related Therapeutic Areas
Sponsors
Leads: Inmunotek S.L.
Collaborators: BioClever 2005 S.L.

This content was sourced from clinicaltrials.gov

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