Safety, Tolerability and Efficacy of the Depigmented Modified Allergen Extract of Two Mites in Subjects With Allergic Rhinitis or Rhinoconjunctivitis, With Controlled Allergic Asthma

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02340130
• Date of registration: 13/01/2015
• Prospective Registration: No
• Primary sponsor: Laboratorios Leti, S.L.
• Public title: Safety, Tolerability and Efficacy of the Depigmented Modified Allergen Extract of Two Mites in Subjects With Allergic Rhinitis or Rhinoconjunctivitis, With Controlled Allergic Asthma
• Scientific title: A Multicentre, Open Label, Phase IIb Clinical Trial to Evaluate Safety, Tolerability and Efficacy of the Depigmented Modified Allergen Extract of Two Mites Mixes at 200 DPP/ml (DP/MG/14-1 Dermatophagoides Pteronyssinus / Lepidoglyphus Destructor and DP/MG/14-2 Dermatophagoides Pteronyssinus /Blomia Tropicalis) in Subjects With Allergic Rhinitis or Rhinoconjunctivitis, With Controlled Allergic Asthma
• Date of first enrolment: September 2014
• Target sample size: 57
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02340130
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Spain

Contacts

• Name: Jaime Sanchez
• Affiliation: Laboratorios Leti, S.L.U

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Subject has provided appropriately signed and dated written informed consent.

2. Men and women aged 18 years and 70 years of age at Visit 1.

3. Has an FEV1 value 80% of predicted normal value at Visit 1.

4. Individuals suffering from perennial allergic rhinitis or rhinoconjunctivitis
moderate-severe for at least the preceding year, with controlled asthma, caused by
double sensitization against Dermatophagoides pteronyssinus (DPT) and Lepidoglyphus
destructor or Dermatophagoides pteronyssinus and Blomia tropicalis.

5. Patients sensitized to co-allergens such as tree pollen, grasses or weeds, fungi or
animal epithelials cannot participate in the study if they are symptomatic.

6. If a female is of non-childbearing potential, the subject must be postmenopausal for
at least 1 year or surgically sterile.

7. If a female is of childbearing potential, the subject must be non-lactating and
non-pregnant and must correctly use an effective method of contraception during the
study.

Exclusion Criteria:

1. Any contraindication for treatment with allergen specific immunotherapy.

2. Subjects with a previous history of anaphylaxis.

3. Patients with hospital admission due to asthma exacerbations within 1 year prior to
V1.

4. Has uncontrolled asthma, according to Global Initiative for Asthma Guidelines (GINA
2010).

5. Acute or chronic infectious conjunctivitis.

6. Has acute or chronic inflammatory or infectious airways disease.

7. Has chronic structural diseases of the affected organ (e.g. eye, nose, lung).

8. History or presence of confirmed or potential diseases of the immune system including
autoimmune diseases and immune deficiencies of actual clinical relevance.

9. Has any disease that prohibits the use of adrenaline (e.g., hyperthyroidism).

10. Has a severe uncontrolled disease that could increase the risk to the subjects while
participating in the study, including but not limited to, the following:
cardiovascular insufficiency, any severe or unstable lung diseases, endocrine
diseases, clinically significant renal or hepatic diseases or haematological disord



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Rhinitis

Rhinoconjunctivitis

Asthma

Intervention(s)

Biological: DP/MG/14-1

Biological: DP/MG/14-2

Primary Outcome(s)

Subjects (%) suffering from immediate or delayed systemic grade 2 reactions [Time Frame: Safety: local and systemic adverse reactions (EAACI classification) within 24 and 48 hours after the treatment.]

Secondary ID(s)

1301-PG-PSC-203

Source(s) of Monetary Support

Please refer to primary and secondary sponsors