Rhinitis, AllergicPhase 3NCT04891237
Efficacy and Safety Evaluation for the Treatment of Allergy Against Grass and Olive Pollen
A Phase 3 study testing 10,000 MG01 + 10,000 T517 and 30,000 MG01 + 10,000 T517 in people with Rhinitis, Allergic and Rhinoconjunctivitis, run by Inmunotek S.L. at 32 sites in Spain.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Rhinitis, Allergic, Rhinoconjunctivitis, Asthma, Allergic
- What is being tested?
- 10,000 MG01 + 10,000 T517 and 30,000 MG01 + 10,000 T517
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 32 sitesSpain
- Study dates
- 14 Jun 2021to Jan 2027
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subject who has signed the informed consent.
- Subjects of both sexes aged between 12 and 65 years.
- Subjects with confirmed clinical history of inhalational allergy (rhinitis and / or moderate-severe intermittent or persistent rhinoconjunctivitis according to the ARIA classification with or without intermittent or persistent controlled mild-moderate asthma according to the GEMA 5.0 classification caused by grass and olive allergy. The diagnosis of asthma will be valid from 12 months prior to signing the informed consent
- Subjects with a positive prick test (higher papule diameter ≥ 5 mm) to a standardized extract of pollen from grasses (Phleum pratense, Holcus lanatus, Dactylis glomerata, Poa pratensis, Festuca elatior, Lolium perenne), or one of the components of the mixture and an olive extract.
- Specific IgE (CAP or Immulite) against a mixture of grasses or against one of the components of the mixture of grasses, preferably Phleum pratense and olive or one of the molecular components of allergenic sources with a value > 3,5 KU / L.
- Women of childbearing age (from menarche) should submit a urine pregnancy test with a negative result at the time of joining the trial.
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- 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 capable of complying with the dosage regimen.
- Subjects who have a smartphone to record symptoms and medication.
- Subjects with a negative prick test to coestational pollens. In the case specific IgE is available, the result should be <3,5 kU/L and without relevant symptomatology
- Subjects with a negative prick test to other aeroallergens (dust mites, epitheliums and fungus). In the case specific IgE is available, the result should be <3,5 kU/L and without relevant symptomatology
Who cannot join
- Subjects polysensitized to other aeroallergens with the exception of epithelia with occasional exposure and symptoms
- Subjects polysensitized to other aeroallergens with the exception non-seasonal pollens with grasses and olive
- Subjects who have received prior immunotherapy in the preceding 5 years to any aeroallergens.
- 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 with severe or uncontrolled 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 presented a serious secondary reaction during the performance of diagnostic skin tests using the prick test.
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- Subjects under treatment with ß-blockers.
- Clinically unstable subjects at the time of enrolment in the trial (acute asthma exacerbation, respiratory infection, feverish process, acute urticaria, etc.).
- Subjects with active chronic urticaria, severe dermographism, severe atopic dermatitis, sunburns, 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 the administration of adrenaline is contraindicated (hyperthyroidism, HT, heart disease, etc.).
- Subjects with some other disease not related to moderate rhinoconjunctivitis or asthma, but of potential severity and that may interfere with treatment and follow-up (epilepsy, psychomotor disorder, uncontrolled diabetes, malformations, multiple operations, kidney disease,).
- Subjects with autoimmune disease (thyroiditis, lupus, etc.), tumor diseases or with a diagnosis of immunodeficiencies.
- Subject whose condition prevents him / her from offering cooperation and who has severe psychiatric disorders.
- Subjects with a known allergy to other investigational drug components other than the allergen.
- Subjects with diseases of the lower respiratory tract other than asthma such as emphysema or bronchiectasis.
- Subjects who are direct relatives of the researchers.
- Pregnant or lactating women.
Trial locations and contacts
32 sites in 1 country. Contact the study team or a site near you to ask about taking part.
32 sites in 1 country
Spain32 sites, 22 recruiting
- Withdrawn
Private Practice
Albacete, 02003
- Completed
Hospital Universitario Principe de Asturias
Alcalá de Henares, Madrid, 28805
- Recruiting
Hospital Ntra. Sra. de Sonsoles
Ávila, 05004
Sara Acero, MD
- Recruiting
Clinica Dermatologica Y Alergia
Badajoz, 06001
Irán Sánchez Ramos, MD
- Recruiting
Hospital Quironsalud Clideba
Badajoz, 06011
Silvia Sánchez, MD
- Recruiting
Hospital Universitario Dexeus
Barcelona, 08028
Elena Botey Faraudo, MD
- Withdrawn
Clínica privada Barcelona
Barcelona, 08172
- Recruiting
Hospital General Universitario Ciudad Real
Ciudad Real, 13005
Carmen García, MD
- Recruiting
Hospital Quironsalud Córdoba
Córdoba, 14004
Ignacio García Nuñez, MD
- Recruiting
Hospital Clínico Universitario Virgen de Arrixaca
El Palmar, Murcia, 30120
PAOLA CARRILLO, DM
- Active, not recruiting
Hospital Universitario Clínico San Cecilio
Granada, 18016
- Recruiting
Hospital Universitario de Jaén
Jaén, 23007
Manuel Alcántara Villar, MD
Carmen Laura Cañada Porta, MD
- Recruiting
Hospital Universitari Santa María
Lleida, 25198
Eva Alcoceba Borrás, MD
- Withdrawn
Private practice
Madrid, 28001
- Recruiting
Hospital Universitario Cruz Roja
Madrid, 28003
JOSE JULIO LAGUNA, MD
Cosmin Boteau, MD
- Recruiting
Clínica de Asma y Alergia en Madrid | CLÍNICA OJEDA
Madrid, 28006
Pedro Ojeda, MD
David Baquero, MD
- Recruiting
Clínica Subiza
Madrid, 28006
Javier Subiza Garrido-Lestache, MD
Concepción Barjau Buj, MD
- Completed
Hospital Carlos Iii
Madrid, 28029
- Withdrawn
Hospital Universitario Rey Juan Carlos
Madrid, 28933
- Recruiting
Hospital Quirónsalud Málaga
Málaga, 29004
Leticia Herrero, DM
- Recruiting
Private Practice
Málaga
Manuel Barceló, DM
- Recruiting
Private Practice
Murcia
Antonio Carbonell, MD
Yulia Petryk Petryk, MD
- Completed
Private Practice
Palencia, 34001
- Recruiting
Hospital Universitario Infanta Cristina
Parla, 28981
Aurora Losada, MD
- Withdrawn
Clínica privada Sevilla
Seville, 41005
- Recruiting
Hospital Virgen Del Rocío
Seville, 41013
Joaquín Quiralte Enriquez, MD
Yolanda Puente Crespo, MD
- Recruiting
Hospital Viamed Santa Ángela de La Cruz
Seville, 41014
MÓNICA DONADO NORTES, MD
- Recruiting
Cedt de Tarancón
Tarancón, Cuenca, 16400
ANTONIO MORENO FERNÁNDEZ, MD
- Withdrawn
Private Practice
Toledo, 45005
- Recruiting
Centro Médico Iza
Tres Cantos, Madrid, 28760
Diana Pérez Alzate
Diana Pérez Alzate, MD
- Recruiting
Hospital Infanta Elena
Valdemoro, Madrid, 28342
FRANCISCO JAVIER RUIZ HORNILLOS, DM
- Recruiting
Hospital Recoletas Felipe Ii
Valladolid, 47003
Alicia Alonso, DM
About this study
Official title: A Randomized, Double-Blinded, Placebo-Controlled, Prospective, Multicenter CT to Evaluate Efficacy and Safety of Subcutaneous Immunotherapy in Subjects With Rhinitis With/Without Mild to Moderate Asthma Sensitized to Olive and Grass Pollen
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
Read the detailed description
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
- Conditions
- Rhinitis, Allergic, Rhinoconjunctivitis, Asthma, Allergic
- Being tested
- 10,000 MG01 + 10,000 T517, 30,000 MG01 + 10,000 T517, Placebo
- Keywords
- Rhinitis/ Rhinoconjunctivitis, Mild to moderate asthma, Allergy, Grasses, Olea
- Medical subject headings
- Rhinitis, Allergic, Asthma, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10,000 MG01 + 10,000 T517Biological
Also called 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
30,000 MG01 + 10,000 T517Biological
Also called Grasses and olea
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
PlaceboOther
The same solution and presentation as the active treatment, but without active ingredients
| Study group | Role | What they receive |
|---|---|---|
| 10,000 MG01 + 10,000 T517 | Experimental | 10,000 TU/mL of MG01 + 10,000 TU/mL of T517 of subcutaneous immunotherapy Receives: Biological: 10,000 MG01 + 10,000 T517 |
| 30,000 MG01 + 10,000 T517 | Experimental | 30,000 TU/mL of MG01 + 10,000 TU/mL of T517 of subcutaneous immunotherapy Receives: Biological: 30,000 MG01 + 10,000 T517 |
| Placebo subcutaneous | Placebo comparator | The same solution and presentation as the active treatment, but without active ingredients. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (10)
Medication-free days
Number of days that the subjects need no medication
Measured: 12 months
Symptom-free days
Number of days that the subjects have no symptom
Measured: 12 months
Asthmatic exacerbations
Time elapsed until the first appearance of asthmatic exacerbations
Measured: 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
Measured: 12 months
Quality of life rhinitis test
Quality of life rhinitis test (ESPRINT-15)
Measured: 12 months
Quality of life asthma test
Control of asthma by Asthma Control Quality questionnaire
Measured: 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
Measured: 12 months
Immunological parameters
Analyses of total and specific IgE, specific Ig G4
Measured: 12 months
Security parameters
Global rate and severity of AE per administration and per subject
Measured: 12 months
Adverse Reactions
Local and systemic reactions and any medication administered for the treatment of AR
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study start14 Jun 2021
- Primary completionJan 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Rhinitis, AllergicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, double-blind, placebo-controlled, multicentre, parallel-group study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inmunotek S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Irán Sánchez, Study chair, Private Site
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04891237
- Sponsor's protocol ID
- DMV03-SIT-027
- Status last verified
- May 2025
- First submitted
- 30 Apr 2021
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Subiza J, Feliu A, Subiza JL, Uhlig J, Fernandez-Caldas E. Cluster immunotherapy with a glutaraldehyde-modified mixture of grasses results in an improvement in specific nasal provocation tests in less than 2.5 months of treatment. Clin Exp Allergy. 2008 Jun;38(6):987-94. doi: 10.1111/j.1365-2222.2008.02995.x. Epub 2008 Apr 25.
PubMed 18445082Klimek L, Uhlig J, Mosges R, Rettig K, Pfaar O. A high polymerized grass pollen extract is efficacious and safe in a randomized double-blind, placebo-controlled study using a novel up-dosing cluster-protocol. Allergy. 2014 Dec;69(12):1629-38. doi: 10.1111/all.12513. Epub 2014 Oct 6.
PubMed 25130503Guzman-Fulgencio M, Caballero R, Lara B, Mena M, Tejera M, Sastre A, Subiza JL, Fernandez-Caldas E, Casanovas M. Safety of immunotherapy with glutaraldehyde modified allergen extracts in children and adults. Allergol Immunopathol (Madr). 2017 Mar-Apr;45(2):198-207. doi: 10.1016/j.aller.2016.08.008. Epub 2016 Dec 7.
PubMed 27939406