A Phase 3 interventional study of 10,000 MG01 + 10,000 T517 and 30,000 MG01 + 10,000 T517 in Rhinitis, Allergic, Rhinoconjunctivitis and Asthma, Allergic, sponsored by Inmunotek S.L.. Recruiting at 32 sites in Spain. Open to participants aged 12 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-05-07.
Sponsored by Inmunotek S.L. · Phase 3, Interventional, and Treatment
Prospective, multicenter, randomized, double-blind, placebo-controlled clinical trial of efficacy and safety with subcutaneous immunotherapy in patients with mild to moderate rhinitis / rhinoconjunctivitis with or without mild to moderate asthma sensitized to grasses and olive
Double blind, multicenter, parallel, placebo controlled study. It includes 180 subjects sensitised to olea and grass pollen with mild to moderate rhinitis / rhinoconjunctivitis with or without mild to moderate asthma, from 12 to 65 years of age. Medication treatment during 1 year. The main outcome: CSMS
Exclusion Criteria:
10,000 TU/mL of MG01 + 10,000 TU/mL of T517 of subcutaneous immunotherapy
Biological: 10,000 MG01 + 10,000 T517
30,000 TU/mL of MG01 + 10,000 TU/mL of T517 of subcutaneous immunotherapy
Biological: 30,000 MG01 + 10,000 T517
The same solution and presentation as the active treatment, but without active ingredients.
Other: Placebo
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 Olea (Olea europaea), adsorbed on aluminum hydroxide. The other ingredients are: sodium chloride (0.9%), phenol (0.4%) and water for injections
Also known as: Grasses and olea 10,000
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 Olea (Olea europaea), adsorbed on aluminum hydroxide. The other ingredients are: sodium chloride (0.9%), phenol (0.4%) and water for injections
Also known as: Grasses and olea
The same solution and presentation as the active treatment, but without active ingredients
CSMS: Combined Symptoms and Medication Score
Overall score of symptoms and medication throughout the trial. The minimum score is cero and maximum six, per day
Time frame: 12 months
Medication-free days
Number of days that the subjects need no medication
Time frame: 12 months
Symptom-free days
Number of days that the subjects have no symptom
Time frame: 12 months
Asthmatic exacerbations
Time elapsed until the first appearance of asthmatic exacerbations
Time frame: 12 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 very bad and right side very well
Time frame: 12 months
Quality of life rhinitis test
Quality of life rhinitis test (ESPRINT-15)
Time frame: 12 months
Quality of life asthma test
Control of asthma by Asthma Control Quality questionnaire
Time frame: 12 months
Health resources
For each patient, the number of times that due to allergy symptoms has done the following will be counted: Have visited the GP, Have made an unscheduled visit to the specialist, Has gone to the emergency room, Has been hospitalized, Have needed to contact the doctor by phone
Time frame: 12 months
Immunological parameters
Analyses of total and specific IgE, specific Ig G4
Time frame: 12 months
Security parameters
Global rate and severity of AE per administration and per subject
Time frame: 12 months
Adverse Reactions
Local and systemic reactions and any medication administered for the treatment of AR
Time frame: 12 months
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Inmunotek S.L.