A Phase 3 interventional study of 10,000 MG01 +10,000 T521 and 30,000 MG01 +10,000 T521 in Rhinitis, Allergic, Rhinoconjunctivitis and Asthma, Allergic, sponsored by Inmunotek S.L.. Recruiting at 27 sites in Spain. Open to participants aged 12 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-05-13.
Sponsored by Inmunotek S.L. · Phase 3, Interventional, and Treatment
A Randomized, Double-Blinded, Placebo-Controlled, Prospective, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of Subcutaneous Immunotherapy in Patients With Rhinitis/Rhinoconjunctivitis With or Without Mild to Moderate Asthma Sensitized to cupressaceae and grasses.
The multicenter study includes 180 subjects sensitised to cupressaceae and grass pollen, both male and female aged 12 to 65 years.
The double-blinded and placebo controlled treatment will last 18 months for each subject.
The primary endpoint of the trial will be the combined rhinitis/rhinoconjunctivitis symptom and medication score (RCSMS) which will be assessed using data collected in the Subject electronic Diary during the cupressaceae (January, February and March) and grass (May and June) pollen seasons.
717 studies on the registry are indexed under Rhinitis, Allergic; 94 are open to participants now.
This study's planned enrollment of 180 is above the median of 68 across 552 interventional studies indexed under Rhinitis, Allergic.
Browse Rhinitis, Allergic studies →Inmunotek S.L. is the lead sponsor of 26 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
10,000 TU/mL of MG01 + 10,000 TU/mL of T521 of subcutaneous immunotherapy
Biological: 10,000 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
The same solution and presentation as the active treatment, but without active ingredients.
Other: Placebo subcutaneous
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 cupressaceae (Juniperus oxycedrus), adsorbed on aluminum hydroxide. The other ingredients are: sodium chloride (0.9%), phenol (0.4%) and water for injections
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 cupressaceae (Juniperus oxycedrus), adsorbed on aluminum hydroxide. The other ingredients are: sodium chloride (0.9%), phenol (0.4%) and water for injections.
The same solution and presentation as the active treatment, but without active ingredients
RCSMS: Combined Symptoms and Medication Score of rhinitis. Combined symptom and medication score in rhinitis/rhinoconjunctivitis (RCSMS)
Evaluation of the number of symptoms and the consumption of medication necessary for the control of such symptoms in rhinitis / rhinoconjunctivitis of each subject during the pollen season and pollen peak of cupressaceae (January, February and March) and grasses (May and June), of the groups with each other and with respect to placebo.
Time frame: 18 months
Symptom free days
The number of days during the trial period that the subject was free of symptoms related to the study pathologies (both rhinitis/rhinoconjunctivitis and asthma) shall be counted for each subject.
Time frame: 18 months
Medication free days
The number of days during the trial period that the subject has not taken any medication for symptom (both rhinitis/rhinoconjunctivitis and asthma) relief shall be counted for each subject.
Time frame: 18 months
Symptom score in rhinitis/rhinoconjunctivitis (RSS) during pollen season and pollen peak of grasses and cupressaceae
The rhinitis/rhinoconjunctivitis-related symptom score shall be counted throughout the trial period for each subject.
Time frame: 18 months
Medication score in rhinitis/rhinoconjunctivitis (RMS) during pollen season and pollen peak of grasses and cupressaceae
The rhinitis/rhinoconjunctivitis-related medication score will be counted throughout the trial period for each subject.
Time frame: 18 months
Combined symptom and medication score (ACSMS) during pollen season and pollen peak of grasses and cupressaceae
The combined asthma-related symptom score (ASS) and asthma-related medication score (AMS) shall be counted throughout the trial period for each subject. The ACSMS shall range from 0 to 6.
Time frame: 18 months
Asthma symptom score (ASS) during pollen season and pollen peak of grasses and cupressaceae
The asthma-related symptom score shall be counted throughout the trial period for each subject. The symptoms are as follows: coughing, wheezing or whistling, choking or suffocating sensation, chest tightness The assessment criteria for each symptom shall be as follows: 0 = No symptoms (no obvious symptoms). 1. = Mild (trivial; the symptom is clearly present but not bothersome). 2. = Moderate (annoying, but not disabling or intolerable). 3. = Severe (disabling and/or intolerable). The asthma symptom score (ASS) will be the sum of the 4 asthma symptoms divided by 4. The final score will vary from 0 to 3.
Time frame: 18 months
Asthma Medication Score (AMS) during pollen season and pollen peak of grasses and cupressaceae
The asthma-related medication score will be counted throughout the trial period for each subject. The medication will be scored based on the therapeutic step in which the drugs are included in the GEMA 5.0 and GINA 2020 guidelines. The scoring approach is detailed in the article entitled 'Combination of Allergic Asthma Symptom and Medication Scores in Allergen Immunotherapy Trials: A Proposal'
Time frame: 18 months
Asthma and rhinitis/rhinoconjunctivitis symptom score (ARSS) during pollen season and pollen peak of grasses and cupressaceae
The asthma-related (ASS) and rhinitis/rhinoconjunctivitis (RSS) symptom scores shall be counted throughout the trial period for each subject. The ARSS shall range from 0 to 6.
Time frame: 18 months
Asthma and rhinitis/rhinoconjunctivitis medication score (ARMS) during pollen season and pollen peak of grasses and cupressaceae
The asthma-related medication score (AMS) and rhinitis/rhinoconjunctivitis score (RMS) shall be counted throughout the trial period for each subject. The ARMS shall range from 0 to 6.
Time frame: 18 months
Combined symptom and medication score in asthma and rhinitis/rhinoconjunctivitis (ARCSMS) during pollen season and pollen peak of grasses and cupressaceae
The combined asthma-related symptom and medication score (ACSMS) and rhinitis/rhinoconjunctivitis (RCSMS) shall be counted throughout the trial period for each subject. The ARCSMS shall range from 0 to 12.
Time frame: 18 months
Asthmatic exacerbations
Time to first occurrence of asthmatic exacerbation, number, duration and severity will be analysed.
Time frame: 18 months
Visual Analogue Scale (VAS)
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
Time frame: 18 months
Immunological parameters
Total IgE, specific IgE and specific IgG4 are analysed during screening and final visit. The determination of grasses shall be carried out on Phleum pratense. The determination of immunological parameters shall be carried out by analysis of the whole or total extract and not by molecular components.
Time frame: 18 months
Quality of life associated with asthma (ACQ-6)
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
Time frame: 18 months
Quality of life associated with rhinitis (ESPRINT-15)
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).
Time frame: 18 months
Health resource consumption
Counting the Health resource consumption related to the study pathology: visits to specialists, telephone calls, test and analyses. Recording of health resource consumption will be carried out at all study visits, from screening to final visit or additional final visit, if applicable.
Time frame: 18 months
Safety parameters
Number of participants with treatment-related adverse events as assessed by T521+MG01-SIT026. Comparison between the beginning and end of the trial and among active groups and placebo
Time frame: 18 months
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Plan to share: No
Started May 2021 (actual). Primary completion is estimated for Oct 2026, 65 months after the start.
Of 31 industry-sponsored phase 3 interventional studies under Rhinitis, Allergic, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 41. This study's planned 65 months is above that.
Counting every sponsor, half of 41 studies reached it within 13 months; a quarter within 6 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
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