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RhinitisPhase 2MM09NCT02661854

Dose Finding for the Treatment of Rhinitis/Rhinoconjunctivitis Against Mite Allergy

A Phase 2 study testing MM09 Mannosylated 5.000 subcutaneous, MM09 Mannosylated 10.000 subcutaneous and MM09 Mannosylated 30.000 subcutaneous in people with Rhinitis and Rhinoconjunctivitis, run by Inmunotek S.L. at 14 sites in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of the study is to evaluate the more efficient dose for the treatment of rhinitis/rhinoconjunctivitis against mite allergy Read more about this study

Who is it for?
Ages 12 to 65 years
Conditions the study is for
Rhinitis, Rhinoconjunctivitis
What is being tested?
MM09 Mannosylated 5.000 subcutaneous, MM09 Mannosylated 10.000 subcutaneous and MM09 Mannosylated 30.000 subcutaneous
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
186 participants
Where
14 sitesSpain
Study dates
21 Jun 2016to Jul 2020
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Written informed consent
  • Positive suggestive clinical history of intermittent or persistent moderate to severe rhinitis /rhinoconjunctivitis, with or without moderate asthma, due to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae allergy
  • Subjects with a positive skin prick-test (wheal sixe >6 mm diameter)
  • Specific immunoglobulin E against house dust mites >10 kU/L and whose determination does not exceed 6 months prior to the inclusion visit
  • Age between 12 and 65 years
  • Both genders
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  • Subjects capable of giving informed consent
  • Subjects capable of complying with the dosing regimen
  • Subjects that have not received immunotherapy in the last 5 years
  • Subjects presenting sensitization to another aeroallergens, but that is considered clinically not relevant or no clinical interference with the nasal provocation test.

Who cannot join

  • Subjects outside of the age range.
  • Subjects who have previously received immunotherapy for the treatment of the allergic rhinitis/rhinoconjunctivitis due to mites and other allergens in the last 5 years.
  • Subjects that immunotherapy may be an absolute contraindication according to the criteria of the immunotherapy Committee of the Spanish society of Allergy and Clinical Immunology, and of the European Allergy and Clinical Immunology Immunotherapy Subcommittee may also include.
  • Subjects with important symptoms of rhinoconjunctivitis /bronchial asthma in which the suspension of the systemic antihistamine treatment is contraindicated.
  • Subjects with persistent severe or not controlled asthma , with a forced expiratory volume (FEV) < 70 respect to the reference value in spite of the appropriate pharmacological treatment at the time of the inclusion in the trial.
  • Subjects that have required oral corticosteroids in the 12 weeks previous to the inclusion in the trial.
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  • Subjects that have previously submitted a serious secondary reaction during the skin prick test
  • Subjects in treatment with beta blockers.
  • Unstable subjects from the clinical point of view (respiratory infection, febrile, acute urticaria, etc.) at the time of the inclusion in the clinical trial
  • Subject with chronic urticaria in the last 2 years or hereditary angioedema.
  • Subjects that have some pathology (hyperthyroidism, hypertension, heart disease, etc.) is contraindicated.
  • Subjects with any other disease not associated with the rhinitis/rhinoconjunctivitis, but of potential severity and that could interfere with treatment and follow-up (epilepsy, psychomotor deterioration, diabetes, malformations, multi-operated, kidney diseases,...).
  • Subjects with autoimmune disease (lupus, thyroiditis, etc.), tumor or with diagnosis of immunodeficiency diseases.
  • Subject whose status prevents him from providing cooperation and or which present severe psychiatric disorders.
  • Subject with known allergy to other components of the vaccine different from mites allergen extract.
  • Subjects with lower airway diseases other than asthma such as emphysema or bronchiectasis.
  • Direct investigator's relatives.
  • Pregnant or women at risk of pregnancy and breastfeeding women.

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

Spain14 sites

  • Hospital General Universitario de Alicante

    Alicante, 03010

  • Hospital Vithas Internacional Medimar

    Alicante, 03016

  • Hospital Universitari de Castelló

    Castellon, Castellón, 12004

  • Hospital General Universitario de Elche

    Elche, Alicante, 03203

  • Hospital Del Vinalopo

    Elche, Alicante, 03293

  • Hospital General Universitario de Elda-Virgen de La Salud

    Elda, Alicante, 03600

  • Hospital de Manises

    Manises, Valencia, 46940

  • Hospital Vega Baja Orihuela

    Orihuela, Alicante, 03314

  • Hospital Arnau de Vilanova

    Valencia, 46015

  • Hospital Universitario Doctor Peset

    Valencia, 46017

  • HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE Adults

    Valencia, 46026

  • HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE child

    Valencia, 46026

  • Hospital de La Plana

    Vila-real, Castellón, 12540

  • Hospital Lluis Alcanyis de Xátiva

    Xátiva, Valencia, 46800

Other trials in Spain

About this study

Official title: Double Blind, Placebo-controlled, Dose Finding, Prospective, Multicenter Clinical Trial for the Treatment of Rhinitis/Rhinoconjunctivitis Against a Mixture of Dermatophagoides Pteronyssinus and Dermatophagoides Farinae Allergen Extract

The purpose of the study is to evaluate the more efficient dose for the treatment of rhinitis/rhinoconjunctivitis against mite allergy

Read the detailed description

Double blind placebo-controlled study. The subjects will receive medication during 4 months.

Being tested
MM09 Mannosylated 5.000 subcutaneous, MM09 Mannosylated 10.000 subcutaneous, MM09 Mannosylated 30.000 subcutaneous, MM09 Mannosylated 50.000 subcutaneous, MM09 Mannosylated 5.000 sublingual
Keywords
Rhinitis / Rhinoconjunctivitis, Vaccine, Immunotherapy, Mite, Allergy
Medical subject headings
Rhinitis, Hypersensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MM09 Mannosylated 5.000 subcutaneousBiological

    Also called Manano

    Mixture of the following mites: Dermatophagoides pteronyssinus and Dermatophagoides farinae, allergen extract with a concentration of 5.000 MTU (Mannosylated Therapeutic Units)/ml subcutaneous

  • MM09 Mannosylated 10.000 subcutaneousBiological

    Mixture of the following mites: Dermatophagoides pteronyssinus and Dermatophagoides farinae, allergen extract with a concentration of 10.000 MTU (Mannosylated Therapeutic Units)/ml subcutaneous

  • MM09 Mannosylated 30.000 subcutaneousBiological

    Mixture of the following mites: Dermatophagoides pteronyssinus and Dermatophagoides farinae, allergen extract with a concentration of 30.000 MTU (Mannosylated Therapeutic Units)/ml subcutaneous

  • MM09 Mannosylated 50.000 subcutaneousBiological

    Mixture of the following mites: Dermatophagoides pteronyssinus and Dermatophagoides farinae, allergen extract with a concentration of 50.000 MTU (Mannosylated Therapeutic Units)/ml subcutaneous

  • MM09 Mannosylated 5.000 sublingualBiological

    Mixture of the following mites: Dermatophagoides pteronyssinus and Dermatophagoides farinae, allergen extract with a concentration of 5.000 MTU (Mannosylated Therapeutic Units)/ml sublingual

  • MM09 Mannosylated 10.000 sublingualBiological

    Mixture of the following mites: Dermatophagoides pteronyssinus and Dermatophagoides farinae, allergen extract with a concentration of 10.000 MTU (Mannosylated Therapeutic Units)/ml sublingual

  • MM09 Mannosylated 30.000 sublingualBiological

    Mixture of the following mites: Dermatophagoides pteronyssinus and Dermatophagoides farinae, allergen extract with a concentration of 30.000 MTU (Mannosylated Therapeutic Units)/ml sublingual

  • MM09 Mannosylated 50.000 sublingualBiological

    Mixture of the following mites: Dermatophagoides pteronyssinus and Dermatophagoides farinae, allergen extract with a concentration of 50.000 MTU (Mannosylated Therapeutic Units)/ml sublingual

  • Subcutaneous placeboBiological

    Comparison between placebo and active group

  • Sublingual placeboBiological

    Comparison between placebo and active group

Study groups in NCT02661854
Study groupRoleWhat they receive
MM09 Mannosylated 5.000 subcutaneousExperimental5.000 MTU/ml of subcutaneous immunotherapy and sublingual placebo.
Receives: Biological: MM09 Mannosylated 5.000 subcutaneous; Biological: Sublingual placebo
MM09 Mannosylated 10.000 subcutaneousExperimental10.000 MTU/ml of subcutaneous immunotherapy and sublingual placebo.
Receives: Biological: MM09 Mannosylated 10.000 subcutaneous; Biological: Sublingual placebo
MM09 Mannosylated 30.000 subcutaneousExperimental30.000 MTU/ml of subcutaneous immunotherapy and sublingual placebo.
Receives: Biological: MM09 Mannosylated 30.000 subcutaneous; Biological: Sublingual placebo
MM09 Mannosylated 50.000 subcutaneousExperimental50.000 MTU/ml of subcutaneous immunotherapy and sublingual placebo.
Receives: Biological: MM09 Mannosylated 50.000 subcutaneous; Biological: Sublingual placebo
MM09 Mannosylated 5.000 sublingualExperimental5.000 MTU/ml of sublingual immunotherapy and subcutaneous placebo.
Receives: Biological: MM09 Mannosylated 5.000 sublingual; Biological: Subcutaneous placebo
MM09 Mannosylated 10.000 sublingualExperimental10.000 MTU/ml of sublingual immunotherapy and subcutaneous placebo.
Receives: Biological: MM09 Mannosylated 10.000 sublingual; Biological: Subcutaneous placebo
MM09 Mannosylated 30.000 sublingualExperimental30.000 MTU/ml of sublingual immunotherapy and subcutaneous placebo.
Receives: Biological: MM09 Mannosylated 30.000 sublingual; Biological: Subcutaneous placebo
MM09 Mannosylated 50.000 sublingualExperimental50.000 MTU/ml of sublingual immunotherapy and subcutaneous placebo.
Receives: Biological: MM09 Mannosylated 50.000 sublingual; Biological: Subcutaneous placebo
Placebo Sublingual Placebo subcutaneousPlacebo comparatorSublingual and subcutaneous placebo.
Receives: Biological: Subcutaneous placebo; Biological: Sublingual placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Concentration required to elicit a positive response after nasal provocation test (NPT)

    Change in the threshold concentration of mite allergen extract, measured in Histamine Equivalent Prick per ml (HEP/ml), needed to trigger a positive response after nasal provocation test (NPT) assessed by acoustic rhinometry.

    This will be compared between the beginning and end of the trial and among active groups and placebo.

    Measured: 4 months

Secondary outcomes (2)

  1. Dose finding skin prick test

    Comparison between the beginning and end of the trial and among active groups and placebo

    Measured: 4 months

  2. Number of participants with treatment-related adverse events as assessed by MM09-SIT-013

    Comparison between the beginning and end of the trial and among active groups and placebo

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2016 (estimated)
  2. Study start21 Jun 2016
  3. Primary completionJul 2020 (estimated)
  4. Study completionJul 2020 (estimated)

Resources

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 2
Primary purpose
Screening
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
186 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02661854
Sponsor's protocol ID
MM09-SIT-013
Other IDs
2015-000820-27, 2015
Acronym
MM09
Status last verified
Mar 2020
First submitted
20 Jan 2016
Last updated
11 Mar 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Soria I, Lopez-Relano J, Vinuela M, Tudela JI, Angelina A, Benito-Villalvilla C, Diez-Rivero CM, Cases B, Manzano AI, Fernandez-Caldas E, Casanovas M, Palomares O, Subiza JL. Oral myeloid cells uptake allergoids coupled to mannan driving Th1/Treg responses upon sublingual delivery in mice. Allergy. 2018 Apr;73(4):875-884. doi: 10.1111/all.13396. Epub 2018 Jan 31.

    PubMed 29319882

  • Manzano AI, Javier Canada F, Cases B, Sirvent S, Soria I, Palomares O, Fernandez-Caldas E, Casanovas M, Jimenez-Barbero J, Subiza JL. Structural studies of novel glycoconjugates from polymerized allergens (allergoids) and mannans as allergy vaccines. Glycoconj J. 2016 Feb;33(1):93-101. doi: 10.1007/s10719-015-9640-4. Epub 2015 Nov 25.

    PubMed 26603537

  • Sirvent S, Soria I, Cirauqui C, Cases B, Manzano AI, Diez-Rivero CM, Reche PA, Lopez-Relano J, Martinez-Naves E, Canada FJ, Jimenez-Barbero J, Subiza J, Casanovas M, Fernandez-Caldas E, Subiza JL, Palomares O. Novel vaccines targeting dendritic cells by coupling allergoids to nonoxidized mannan enhance allergen uptake and induce functional regulatory T cells through programmed death ligand 1. J Allergy Clin Immunol. 2016 Aug;138(2):558-567.e11. doi: 10.1016/j.jaci.2016.02.029. Epub 2016 Apr 13.

    PubMed 27177779

  • Soria I, Alvarez J, Manzano AI, Lopez-Relano J, Cases B, Mas-Fontao A, Canada FJ, Fernandez-Caldas E, Casanovas M, Jimenez-Barbero J, Palomares O, Vinals-Florez LM, Subiza JL. Mite allergoids coupled to nonoxidized mannan from Saccharomyces cerevisae efficiently target canine dendritic cells for novel allergy immunotherapy in veterinary medicine. Vet Immunol Immunopathol. 2017 Aug;190:65-72. doi: 10.1016/j.vetimm.2017.07.004. Epub 2017 Jul 23.

    PubMed 28778325

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MM09 Mannosylated 5.000 subcutaneous, MM09 Mannosylated 10.000 subcutaneous and MM09 Mannosylated 30.000 subcutaneous in people with Rhinitis and Rhinoconjunctivitis, run by Inmunotek S.L. at 14 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Concentration required to elicit a positive response after nasal provocation test (NPT) (time frame: 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02661854, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2020.

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