Efficacy and Safety Evaluation of the Treatment of Allergy Against Cupressaceae and Grasses.

Sponsor

Inmunotek S.L. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04898283

Collaborator

(none)

180

Enrollment

Locations

Arms

Anticipated Duration (Months)

12.9

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A Randomized, Double-Blinded, Placebo-Controlled, Prospective, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of Subcutaneous Immunotherapy in Patients With Rhinitis With or Without Mild to Moderate Asthma Sensitized to cupressaceae and grasses.

Condition or Disease	Intervention/Treatment	Phase
Rhinitis, Allergic Rhinoconjunctivitis Asthma, Allergic	Biological: 10,000 MG01 +10,000 T521 Biological: 30,000 MG01 +10,000 T521 Other: Placebo subcutaneous	Phase 3

Detailed Description

Double blind, multicenter, parallel, placebo controlled study. It includes 150 subjects sensitised to cupressaceae and grass pollen, from 14 to 65 years of age. Medication treatment during 1 year. The main outcome: CSMS

Study Design

Study Type:

Interventional

Anticipated Enrollment :

180 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized, double-blind, placebo-controlled, multicentre, parallel-group studyRandomized, double-blind, placebo-controlled, multicentre, parallel-group study

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

During the trial, both the investigator and the included subjects will be unaware of the treatment each subject is receiving. The person in charge of data analysis will also not know the treatment assigned to each subject until the database has been closed. So that neither the subject nor the investigator knows what treatment each subject is receiving, all the trial medication is identical in terms of outer packaging and appearance.

Primary Purpose:

Treatment

Official Title:

A RDPC, Prospective, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of SCIT in Patients With Rhinitis With or Without Mild to Moderate Asthma Sensitized to Cupressaceae and Grasses.

Actual Study Start Date :

May 31, 2021

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 10,000 MG01 + 10,000 T521 10,000 TU/mL of MG01 + 10,000 TU/mL of T521 of subcutaneous immunotherapy	Biological: 10,000 MG01 +10,000 T521 Purified and polymerized with glutaraldehyde allergen extract, from a mixture of grasses (Phleum pratense, Holcus lanatus, Poa pratensis, Festuca pratensis, Lolium perenne and Dactylis glomerata) and cupresaceae (Juniperus oxycedrus), adsorbed on aluminum hydroxide. The other ingredients are: sodium chloride (0.9%), phenol (0.4%) and water for injections
Experimental: 30,000 MG01 + 10,000 T521 30,000 TU/mL of MG01 + 10,000 TU/mL of T521 of subcutaneous immunotherapy	Biological: 30,000 MG01 +10,000 T521 Purified allergen extract polymerized with glutaraldehyde, from a mixture of grasses (Phleum pratense, Holcus lanatus, Poa pratensis, Festuca pratensis, Lolium perenne and Dactylis glomerata) and cupresaceae (Juniperus oxycedrus), adsorbed on aluminum hydroxide. The other ingredients are: sodium chloride (0.9%), phenol (0.4%) and water for injections.
Placebo Comparator: Placebo subcutaneous The same solution and presentation as the active treatment, but without active ingredients.	Other: Placebo subcutaneous The same solution and presentation as the active treatment, but without active ingredients

Arm

Intervention/Treatment

Experimental: 10,000 MG01 + 10,000 T521

10,000 TU/mL of MG01 + 10,000 TU/mL of T521 of subcutaneous immunotherapy

Biological: 10,000 MG01 +10,000 T521

Purified and polymerized with glutaraldehyde allergen extract, from a mixture of grasses (Phleum pratense, Holcus lanatus, Poa pratensis, Festuca pratensis, Lolium perenne and Dactylis glomerata) and cupresaceae (Juniperus oxycedrus), adsorbed on aluminum hydroxide. The other ingredients are: sodium chloride (0.9%), phenol (0.4%) and water for injections

Experimental: 30,000 MG01 + 10,000 T521

30,000 TU/mL of MG01 + 10,000 TU/mL of T521 of subcutaneous immunotherapy

Biological: 30,000 MG01 +10,000 T521

Purified allergen extract polymerized with glutaraldehyde, from a mixture of grasses (Phleum pratense, Holcus lanatus, Poa pratensis, Festuca pratensis, Lolium perenne and Dactylis glomerata) and cupresaceae (Juniperus oxycedrus), adsorbed on aluminum hydroxide. The other ingredients are: sodium chloride (0.9%), phenol (0.4%) and water for injections.

Placebo Comparator: Placebo subcutaneous

The same solution and presentation as the active treatment, but without active ingredients.

Other: Placebo subcutaneous

The same solution and presentation as the active treatment, but without active ingredients

Outcome Measures

Primary Outcome Measures

CSMS: Combined Symptoms and Medication Score, asthma and rhinitis. [12 months]
Evaluation of the number of symptoms and the consumption of medication necessary for the control of such symptoms in asthma and rhinitis / rhinoconjunctivitis of each subject during the trial, of the groups with each other and with respect to placebo.

Secondary Outcome Measures

Medication free days [12 months]
Both rhinitis/rhinoconjuntivitis and asthma
Symptom free days [12 months]
Both rhinitis/rhinoconjuntivitis and asthma
Number of participants with treatment-related adverse events as assessed by T521+MG01-SIT026 [12 months]
Comparison between the beginning and end of the trial and among active groups and placebo
Quality of life associated with asthma [12 months]
The quality of life associated with asthma will be measured following the ACQ questionnaire. The ACQ questionnaire consists of 6 questions (ACQ-6). In questions 1-6, patients recall their experience during the last 7 days and answer using a scale of 7 points (from 0 = fully controlled to 6 = extremely poorly controlled). The questionnaire score is the mean of the 6 responses (ACQ-6). The interpretation of the scores is as follows: Less than or equal to 0.75: Adequate control of asthma From 0.75 to 1.50: Partially controlled asthma More than 1.50: Inadequate asthma control
VAS [12 months]
Visual Analogue Scale in which the subject has to indicate in a straight line of 10cm how he/she feels regarding to his allergy symptoms. Being left side (0) = very bad and right side (10) = very well
Asthmatic exacerbations [12 months]
Time elapsed until the first appearance of asthmatic exacerbations, number, duration and severity.
Health resource consumption [12 months]
Counting the Health resource consumption: visits to specialists, telephone calls, test and analyses.
Quality of life associated with rhinitis [12 months]
The quality of life associated with rhinitis will be measured following the test ESPRINT-15. The scoring of the questionnaire will be carried out as follows: The global sum of the scores (ranging from "0 = nothing has bothered me" to "6 = it has bothered me a lot") of the 14 items plus the score given in the general questionnaire (ranging from "0 = Excellent" to "4 = Bad"). This sum is divided by the total number of items (15 items). The interpretation of the scores is between 0 (low impact) and 6 (high impact).

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Written informed consent.
Aged between 14 and 65, both genders
Positive suggestive clinical history of intermittent or persistent moderate to severe rhinitis /rhinoconjunctivitis, with or without moderate intermittent or persistent asthma,according to GEMA 5.0, due to grass and cupressaceae pollen.
Subjects with a positive skin prick-test (wheal sixe >5 mm diameter). The positive and negative control of the test should give consistent results and whose determination does not exceed 1 year prior to the baseline visit.
Specific immunoglobulin E ≥ class 3 , against grass and cupressaceae pollen (InmunoCAP® o Immulite) and whose determination does not exceed 1 year prior to the inclusion visit.
Women of childbearing age (from menarche) must present a urine pregnancy test with a negative result at the time of joining the trial.
Women of childbearing potential, and men participating in the trial, should commit to using an appropriate method of contraception. Medically acceptable methods of contraception are intrauterine devices placed at least 3 months in advance, surgical sterilization (for example, tubal ligation), barrier methods, or the use of oral contraceptives.
Subjects with asthma must be diagnosed according to the GEMA 5.0 guideline.
Subjects capable of complying with the dosing regimen.
Subjects who own a smartphone for symptom registration and medication

Exclusion Criteria:

Subjects polisensitised to other aeroallergens but sensitisation to epithelia with exposure and occasional symptoms or sensitisation to pollen noncoseasonal with cupressus or grasses.
Subjects who have received prior immunotherapy in the preceding 5 years for any of the allergens tested or a cross-reactive allergen or are currently receiving immunotherapy with any allergen.
Subjects in which immunotherapy may be subject to an absolute general contraindication according to the criteria of the Immunotherapy Committee of the Spanish Society of Allergy and Clinical Immunology and the European Allergy and Clinical Immunology Immunotherapy Subcommittee.
Subjects have not granted written informed consent.
Subjects with severe or uncontrolled intermittent or persistent asthma, with an FEV1 <70% with respect to the reference value despite adequate pharmacological treatment at the time of inclusion in the trial. Likewise, subjects with intermittent or persistent rhinitis / rhinoconjunctivitis with severe symptoms in which the suspension of oral or systemic antihistamine treatment is contraindicated.
Subjects who have previously had a severe secondary reaction during the prick test diagnostic skin test.
Subjects treated with beta-blockers.
Clinically unstable subjects at the time of inclusion in the trial (acute asthmatic exacerbation, respiratory infection, febrile process, acute urticaria, etc.).
Subjects with active chronic urticaria, severe dermographism, severe atopic dermatitis, sunburn, active psoriasis with lesions in areas where skin tests will be performed, or a history of hereditary angioedema.
Subjects who have any pathology in which adrenaline administration is contraindicated (hyperthyroidism, HTN, heart disease, etc.).
Subjects with any other disease not related to moderate rhinoconjunctivitis or asthma, but potentially serious and that may interfere with treatment and follow-up (epilepsy, psychomotor disorder, uncontrolled diabetes, malformations, multioperated patients, kidney disease,).
Subjects with autoimmune disease (thyroiditis, lupus, etc.), tumor diseases or with a diagnosis of immunodeficiencies.
Subject whose condition prevents from offering cooperation and/ or who has severe psychiatric disorders.
Subjects with a known allergy to components of the investigational medicinal product other than the allergen.
Subjects with lower respiratory diseases other than asthma such as emphysema or bronchiectasis.
Subjects who are direct relatives of the researchers.
Pregnant or lactating women.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cedt de Tarancon	Tarancon	Cuenca	Spain	16400
2	Hospital U. Fundación Alcorcón	Alcorcón	Madrid	Spain	28922
3	Fundación Hospital Sant Pere Claver	Barcelona		Spain	08004
4	Clinica privada Burgos	Burgos		Spain	09006
5	Hospital Universitario de Burgos	Burgos		Spain	09006
6	Clinica privada	León		Spain	24001
7	Clínica Subiza	Madrid		Spain	28006
8	CAP José Marva	Madrid		Spain	28020
9	Clínica Privada	Madrid		Spain	28035
10	Clinica privada	Palencia		Spain	34002
11	Clinica privada	Pamplona		Spain	31006
12	Hospital Clínico de Salamanca	Salamanca		Spain	37007
13	Clinica Privada Soria	Soria		Spain	42002
14	Clínica Privada Zaragoza	Zaragoza		Spain	50004