RhinitisPhase 3Oraltek-58NCT07348302
Efficacy and Safety of SLIT in Patients With Rhinitis/RC With/Without Mild-moderate Asthma, Due to Dpt and/or Df
A Phase 3 study testing Allergen Immunotherapy Extract in people with Rhinitis and Rhinoconjunctivitis, run by Inmunotek S.L. at 19 sites in 4 countries.
Trial summary
The goal of this clinical trial is to learn if MM09 works to treat patients allergic to house mites, displaying rhinitis/rhinoconjunctivitis with or without mild to moderate asthma. It will also learn about the safety of MM09. 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?
- Allergen Immunotherapy Extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 736 participants
- Where
- 19 sitesin 4 countries
- Study dates
- 2 Apr 2025to Jul 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Participants who have signed and dated Informed Consent Form (ICF).
- Female or male aged 12 to 65 years, both included, at the time of signature of ICF.
- Participants with confirmed clinical history of inhalation allergy with intermittent or persistent moderate-severe rhinitis/ rhinoconjunctivitis according to the ARIA classification(1) of at least 1 year of duration (treated with anti-allergic medication) with or without mild-moderate controlled intermittent or persistent asthma according to the definition of GINA 2022(2) caused by Dermatophagoides pteronyssinus and/or Dermatophagoides farinae.
- Participants with positive skin prick test and a wheal major diameter ≥ 5 mm to a standardized allergen extract of Dermatophagoides pteronyssinus and/or Dermatophagoides farinae.
- Women of childbearing age (i.e., following menarche and until postmenopause, defined as no menses for 12 months without an alternative medical cause, or non-subject to permanent sterilisation methods, such as hysterectomy, bilateral salpingectomy and bilateral oophorectomy) must have a serum pregnancy test negative result, and a confirmed menstrual period before enrolling the study.
- Women of childbearing age must commit to using a highly effective contraception method during the trial and up to 1 month after the end of treatment with the investigational medicinal product (IMP). Such methods include: combined (estrogen and progestogen containing) hormonal, contraception. associated with inhibition of ovulation (oral, intravaginal or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable), intrauterine device, intrauterine hormone-releasing system, male condom, diaphragm used with spermicide, bilateral tubal occlusion, vasectomized partner or sexual abstinence.
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- Participants capable of complying with dosage regimen.
- Participants owning a smartphone to register symptoms and medication consumption.
- Participants not sensitized to any other clinically relevant allergen or sensitized with the following characteristics (sensitization to other allergens will be assessed through skin prick test in Europe and LATAM and through IgE levels in China):
- Participants sensitized to dander (with a positive skin prick test for dander or IgE ≥ 0.35 kU/L), provided that they have occasional exposure and symptoms.
- Participants sensitized to endemic pollen (with a positive skin prick test or IgE ≥0.35 kU/L) will be scheduled to be included so that the pollen season does not coincide with the Baseline Evaluation Period nor with one month before and after the Main Evaluation Period. In LATAM, grass sensitized participants will not be included.
- Participants not sensitized to moulds, cockroach, Blomia tropicalis or other geographically relevant mites (negative skin prick test or IgE < 0.7 kU/L).
- Participants with a RCSMS ≥ 3 out of 6 recorded for at least 10 days during the baseline evaluation period, corresponding to moderate-to-severe allergic rhinitis/rhinoconjunctivitis.
- Participants with specific IgE against a complete extract of D. pteronyssinus and / or D. farinae or any of the molecular components of allergenic sources with a value ≥ 3.5kU/L.
Who cannot join
- Participants who have received previous immunotherapy to any of the tested allergen during the last 5 years or any desensitization process in the last 2 years (e.g., oral immunotherapy [OIT], milk, or egg) before the second screening visit (S2), or currently receiving immunotherapy with any other allergen.
- Those cases in which allergen-specific immunotherapy (AIT) would be a contraindication according to the criteria of European Allergy and Clinical Immunology Immunotherapy Subcommittee.(3)
- Asthmatic participants with forced expiratory volume in the first second (FEV1) <80% (following at least a 6-hour washout of short-acting beta2 agonists [SABA] and 12-hour washout of long-acting beta2 agonists [LABA]) despite pharmacological treatment by the time of enrolment.
- Participants with uncontrolled asthma, according to GINA 2022,(2) asthma with poor symptom control (frequent symptoms or reliever use, activity limited by asthma, night waking due to asthma) and/or frequent exacerbations (≥2/year) requiring oral corticosteroids (OCS), or serious exacerbations (≥1/year) requiring hospitalization.
- Participants with severe asthma, according to GINA 2022,(2) on Step 4 or 5 treatment, who had poor symptom control and had good adherence and inhaler technique.
- Participants on treatment with β-blockers or angiotensin-converting enzyme (ACE) inhibitor.
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- Participants on treatment with immunosuppressive or biological drugs.
- Participants who had not had a long enough washout/withdrawal period at the first screening visit (S1) according to criteria in the study protocol (See Table 6 in section 9.5.3) before undergoing allergen diagnostic tests (skin prick test or IgE analysis).
- Unstable participants who have suffered a respiratory tract infection and/or asthma exacerbation within 4 weeks prior to first screening visit (S1).
- Participants who have suffered chronic urticaria, severe anaphylaxis, or with hereditary angioedema history within 2 years prior to the first screening visit (S1).
- Participants having any contraindication for the use of adrenaline (e.g., hyperthyroidism, heart disease, or hypertension) according to the investigator's criteria.
- Participants with other severe diseases not related to allergic rhinitis or asthma that could interfere with the study treatment or the follow-up.
- Participants with severe and unresponsive to treatment autoimmune diseases (e.g., thyroiditis or lupus), tumoral diseases or immunodeficiencies.
- Participants that could not comply with the study protocol, according to the investigator's criteria, or have a serious mental illness.
- Participants with known allergy to any of the components of the study treatment other than study allergens.
- Participants who had a complication(s) of any nasal disease (including nasal polyp, nasal septal deviation, and hypertrophic rhinitis, drug-induced rhinitis and/or non-allergic rhinitis) affecting an appropriate evaluation of the efficacy and/or safety, according to investigator's criteria.
- Participants who had a nasal surgery within 6 months prior to the first screening visit (S1) or have programmed or anticipated nasal surgery during the trial period.
- Participants with a lesion in the oral cavity that could confound the safety profile of the study treatment, according to the investigator's criteria.
- Participants who required treatment with antihistamines and/or corticosteroids for other purposes than alleviating symptoms of allergic rhinitis (except temporal use for diseases such as common colds).
- Participants with lower respiratory tract diseases different from asthma as emphysema, bronchiectasis, or chronic obstructive pulmonary disease.
- Breastfeeding or pregnant women.
- Participants who are immediate family members of the investigator.
- Concurrent participation in other clinical trials or previous participation within 30 days prior to the first screening visit (S1).
- Participants with history of serious systemic reactions, including food, Hymenoptera venom, medications, etc.
- Participants expected to have marked changes (e.g., moving) in the circumstances of life during the study.
- Participants who plan to start using anti-mite bedding or similar equipment during the study.
- Participants who are considered inappropriate for the study, according to the investigator criteria.
Trial locations and contacts
19 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
19 sites in 4 countries
China9 sites, 9 recruiting
- Recruiting
Beijing Tongren Hospital
Beijing, Beijing Municipality, 100730
Luo Zhang, +86 13 911 189 954, dr.luozhang@139.com
- Recruiting
Changzhou Third People's Hospital
Changzhou, Jiangsu, 213003
Meiping Lu, +86 13 776 683 366, entlmp@126.com
- Recruiting
The Third Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangzhou, 510080
Qintai Yang, +86 18 922 103 352, yang.qt@163.com
gzxur2708@163.com
- Recruiting
Union Hospital Tongji Medical College of HUST
Huangzhou
Jianjun Chen, +86 13 659 851 719, jj-c@tom.com
- Recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266005
Yan Jiang, +86 13 256 875 886, jiangyanoto@163.com
- Recruiting
Eye & ENT Hospital of Fudan University
Shanghai, Shanghai Municipality, 20032
Hongfei Lou, +86 15 210 295 496, 1371445013@qq.com
- Recruiting
Tongji Hospital Tongji Medical College of HUST
Tongji, Wuhan, 430033
Rongfei Zhu, +86 18 986 292 602, zrf13092@163.com
- Recruiting
The Third Xiangya Hospital of Central South University
Xiangya, Hunan, 410013
Guolin Tan, +86 13 873 187 823, guolintan@163.com
- Not yet recruiting
The First Affiliated Hospital, Sun Yat-sen University
Zhongshan, Guangzhou, 510080
Rui Xu, +86 13 802 509 090, gzxur2708@163.com
Argentina6 sites, 5 recruiting
- Active, not recruiting
Fundación CIDEA
Buenos Aires, 1121
- Recruiting
Hospital Italiano de Buenos Aires
Buenos Aires, 1199
Claudio A Parisi, +54 911 5765 4081, claudio.parisi@hospitalitaliano.org.ar
- Recruiting
Centro de Educación Medica de Investigaciones Clinicas "Norberto Quirno" (CEMIC)
Buenos Aires, 1431
Esteban I Garramone, +54 9 11 5299-0100, eigarramone@gmail.com
- Recruiting
Centro Médico Vitae
Nueve de Julio, Buenos Aires, 1650
Iris V Medina, +54 9 2317 47 4535, irisvmedina@gmail.com
- Recruiting
Centro de Investigaciones Clínicas - Instituto de Especialidades de la Salud Rosario
Rosario, Santa Fe Province, 2000
Ledit R Ardusso, +54 9 341 6426843, cic-iesr@hotmail.com
- Recruiting
Centro Respiratorio Infantil
Rosario, Santa Fe Province, 2000
Gabriel Gattolin, +54 9342 473 6908, gabrielgattolin@gmail.com
Portugal2 sites, 2 recruiting
- Not yet recruiting
Unidade de Local de Saúde de Santo António, E.P.E.
Porto, 4050-651
Diana Pinto, +351 222 077 500, diana.pinto@chporto.min-saude.pt
- Not yet recruiting
ULS Lezíria- Hospital Distrital de Santarém
Santarém, 2005-177
José M Onofre, +351 243 300 200, josemanuelonofre@gmail.com
Spain2 sites, 1 recruiting
- Active, not recruiting
Hospital General Universitario Dr. Balmis
Alicante, 03010
- Recruiting
Hospital IMED Benidorm
Benidorm, Alicante, 03503
Ana M Olano Rocha, +34 673 876 059, olano.melissa@gmail.com
About this study
Official title: Prospective, Randomised, DBPC, Multicenter Clinical Trial to Evaluate Efficacy and Safety of Sublingual Immunotherapy in Patients With Rhinitis/Rhinoconjunctivitis With or Without Mild to Moderate Asthma, Allergic to Dpt and/or Df
The goal of this clinical trial is to learn if MM09 works to treat patients allergic to house mites, displaying rhinitis/rhinoconjunctivitis with or without mild to moderate asthma. It will also learn about the safety of MM09. The main questions it aims to answer are:
Does MM09 reduce the symptoms and the need of rescue medication? What medical problems do participants have when inhaling MM09? Researchers will compare MM09 to a placebo (a look-alike substance that contains no drug) to see if MM09 works to treat rhinitis/rhinoconjunctivitis.
Read the detailed description
Sublingual MM09 is being investigated as an etiological treatment for moderate-to-severe allergic rhinitis and/or rhinoconjunctivitis (as classified by ARIA), with or without mild-to-moderate controlled allergic asthma (as defined by GINA 2022), caused by Dermatophagoides pteronyssinus and/or Dermatophagoides farinae. This prospective, randomized, double-blind, placebo-controlled, multicenter phase III clinical trial aims to assess the efficacy of sublingual MM09 at a dose of 30,000 TU/mL compared to placebo, administered over 12 months, in participants aged 12 to 65 years.
- Conditions
- Rhinitis, Rhinoconjunctivitis
- Being tested
- Allergen Immunotherapy Extract
- Keywords
- immunotherapy, sublingual, Quality of live, dust mites, Dermatophagoides pteronyssinus, Dermatophagoides farinae, moderate asthma, allergic rhinitis, Allergic asthma, House dust mite allergy, efficacy, safety
- Medical subject headings
- Rhinitis, Rhinitis, Allergic, Dust Mite Allergy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allergen Immunotherapy ExtractBiological
Also called ORALTEK®
Sublingual spray, solution
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Is a solution identical in composition to the active treatment, but without active ingredients Receives: Biological: Allergen Immunotherapy Extract |
| Sublingual MM09 | Experimental | Active substance Receives: Biological: Allergen Immunotherapy Extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
RCSMS : Rhinitis/Rhinoconjunctivitis Combined Symptom and Medication Score
The RCMS corresponds to the sum of Rhinitis/Rhinoconjunctivitis Symptom Score (RSS) and Rhinitis/Rhinoconjunctivitis Medication Score (RMS).
The daily RCSMS will be calculated as RCSMS (0-6) = RSS (0-3) + RMS (0-3)
Higher scores mean a worse outcome.
Measured: last 4 weeks of IMP treatment
Secondary outcomes (5)
RSS : Rhinitis/Rhinoconjunctivitis Symptom Score
The RSS will correspond to the sum of the grade of the six Rhinitis Rhinoconjunctivitis symptoms score (SS) divided by six:
RSS (0-3) = (SS1+SS2+SS3+SS4+SS5+SS6) /6. The final RSS will range from 0 to 3.
Each symptom will be graded 0-3 as follows:
- 0 = No symptoms (no obvious symptoms).
- 1 = Mild symptoms (trivial; the symptom is clearly present but not bothersome).
- 2 = Moderate (annoying but not disabling or intolerable).
- 3 = Severe (disabling and/or intolerable).
Measured: last 4 weeks of IMP treatment
RMS : Rhinitis/Rhinoconjunctivitis Medication Score
The rhinitis/rhinoconjunctivitis rescue medication will be provided to the participants with the instruction to use them according to a specific stepwise standardised procedure (See section 8.6.2):
- 0= no medication.
- 1= if symptoms occur, first take an oral antihistamine (desloratadine) with or without ocular antihistamine (olopatadine)
- 2= if symptoms are insufficiently controlled, add intranasal corticosteroid (INS) with or without oral antihistamine (fluticasone furoate).
- 3= if symptoms persist and are insufficiently controlled add an oral corticosteroid (OCS) (methylprednisolone) (with or without intranasal corticosteroid [INS] and antihistamine)
Measured: last 4 weeks of IMP treatment
ASS : Asthma Symptom Score
The score is obtained by the collection on the occurrence of following asthma symptoms:
- Cough
- Wheezing
- Shortness of breath or feeling of choking
- Chest tightness
Each asthma symptom will be graded as follows:
- 0= No symptoms (no obvious symptoms).
- 1= Mild symptoms (trivial; the symptom is clearly present but not bothersome).
- 2= Moderate (annoying but not disabling or intolerable).
- 3= Severe (disabling and/or intolerable).
The ASS will correspond to the sum of the grades of the four asthma symptoms score (SS) divided by four:
ASS (0-3) = (SS1+SS2+SS3+SS4) /4. The final score will range from 0 to 3.
Measured: last 4 weeks of IMP treatment
AMS: Asthma Medication Score
The AMS will be scored based on the therapeutic step in which the drugs are included in the GEMA 5.0 (90) and GINA 2020 guidelines.(91) The scoring method is detailed in the article entitled "Combination of Allergic Asthma Symptom and Medication Scores in Allergen Immunotherapy Trials: A Proposal."
The steps of medication shown in the Figure 6 (above) correspond to the medication stepping of GEMA 5.0. In asthma participants AMS will be score as follows:
- 0.5= SABA as needed.
- 1= Low dose ICS with/without SABA as needed.
- 1.5= Low dose ICS + LABA or medium dose ICS with/without SABA as needed.
- 2= Medium dose ICS+LABA with/without SABA as needed.
- 2.5= High dose ICS+LABA with/without SABA as needed.
- 3= High dose ICS+LABA + systemic corticosteroids with/without SABA as needed. The AMS will correspond to the highest level of medication taken on a day. The score will range from 0 to 3.
Measured: last 4 weeks of IMP treatment
ARSS: Asthma and Rhinitis/Rhinoconjunctivitis Symptom Score
The ARSS ranges from 0 to 6, corresponds to the sum of RSS and ASS, and is calculated as follows: ARSS (0-6) = RSS (0-3) + ASS (0-3)
Higher scores mean a worse outcome.
Measured: last 4 week of IMP treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start2 Apr 2025
- Primary completion27 Apr 2029 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RhinitisStudies of the same condition, open and under way.
- More trials run by Inmunotek S.L.The sponsor's other registered studies.
- 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, randomised, double-blind, placebo-controlled
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 736 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inmunotek S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Raquel Caballero, Study chair, Inmunotek S.L.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07348302
- Sponsor's protocol ID
- MM09-SLG-058
- Acronym
- Oraltek-58
- Status last verified
- Jan 2026
- First submitted
- 5 Dec 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomised, DBPC, Multicenter Clinical Trial to Evaluate Efficacy and Safety of Sublingual Immunotherapy in Patients With Rhinitis/Rhinoconjunctivitis With or Without Mild to Moderate Asthma, Allergic to Dpt and/or Df
- ClinicalTrials.gov ID
- NCT07348302
- Acronym / sponsor ID
- Oraltek-58 / MM09-SLG-058
- Conditions
- Rhinitis, Rhinoconjunctivitis
- Keywords
- immunotherapy, sublingual, Quality of live, dust mites, Dermatophagoides pteronyssinus, Dermatophagoides farinae, moderate asthma, allergic rhinitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 736 participants (estimated)
- Lead sponsor
- Inmunotek S.L.Industry (pharma, biotech, devices)
- Study start
- 2 Apr 2025 (actual)
- Primary completion
- 27 Apr 2029 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if MM09 works to treat patients allergic to house mites, displaying rhinitis/rhinoconjunctivitis with or without mild to moderate asthma. It will also learn about the safety of MM09. The main questions it aims to answer are:
Does MM09 reduce the symptoms and the need of rescue medication? What medical problems do participants have when inhaling MM09? Researchers will compare MM09 to a placebo (a look-alike substance that contains no drug) to see if MM09 works to treat rhinitis/rhinoconjunctivitis.
Detailed description
Sublingual MM09 is being investigated as an etiological treatment for moderate-to-severe allergic rhinitis and/or rhinoconjunctivitis (as classified by ARIA), with or without mild-to-moderate controlled allergic asthma (as defined by GINA 2022), caused by Dermatophagoides pteronyssinus and/or Dermatophagoides farinae. This prospective, randomized, double-blind, placebo-controlled, multicenter phase III clinical trial aims to assess the efficacy of sublingual MM09 at a dose of 30,000 TU/mL compared to placebo, administered over 12 months, in participants aged 12 to 65 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Prospective, randomised, double-blind, placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Biological: Allergen Immunotherapy ExtractIs a solution identical in composition to the active treatment, but without active ingredients |
| Sublingual MM09 | Experimental | Biological: Allergen Immunotherapy ExtractActive substance |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- Participants who have signed and dated Informed Consent Form (ICF).
- Female or male aged 12 to 65 years, both included, at the time of signature of ICF.
- Participants with confirmed clinical history of inhalation allergy with intermittent or persistent moderate-severe rhinitis/ rhinoconjunctivitis according to the ARIA classification(1) of at least 1 year of duration (treated with anti-allergic medication) with or without mild-moderate controlled intermittent or persistent asthma according to the definition of GINA 2022(2) caused by Dermatophagoides pteronyssinus and/or Dermatophagoides farinae.
- Participants with positive skin prick test and a wheal major diameter ≥ 5 mm to a standardized allergen extract of Dermatophagoides pteronyssinus and/or Dermatophagoides farinae.
- Women of childbearing age (i.e., following menarche and until postmenopause, defined as no menses for 12 months without an alternative medical cause, or non-subject to permanent sterilisation methods, such as hysterectomy, bilateral salpingectomy and bilateral oophorectomy) must have a serum pregnancy test negative result, and a confirmed menstrual period before enrolling the study.
Key exclusion criteria (27 listed)
- Participants who have received previous immunotherapy to any of the tested allergen during the last 5 years or any desensitization process in the last 2 years (e.g., oral immunotherapy [OIT], milk, or egg) before the second screening visit (S2), or currently receiving immunotherapy with any other allergen.
- Those cases in which allergen-specific immunotherapy (AIT) would be a contraindication according to the criteria of European Allergy and Clinical Immunology Immunotherapy Subcommittee.(3)
- Asthmatic participants with forced expiratory volume in the first second (FEV1) <80% (following at least a 6-hour washout of short-acting beta2 agonists [SABA] and 12-hour washout of long-acting beta2 agonists [LABA]) despite pharmacological treatment by the time of enrolment.
- Participants with uncontrolled asthma, according to GINA 2022,(2) asthma with poor symptom control (frequent symptoms or reliever use, activity limited by asthma, night waking due to asthma) and/or frequent exacerbations (≥2/year) requiring oral corticosteroids (OCS), or serious exacerbations (≥1/year) requiring hospitalization.
- Participants with severe asthma, according to GINA 2022,(2) on Step 4 or 5 treatment, who had poor symptom control and had good adherence and inhaler technique.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allergen Immunotherapy ExtractAlso: ORALTEK®Sublingual spray, solution | Biological | Control, Sublingual MM09 |
Primary outcome
RCSMS : Rhinitis/Rhinoconjunctivitis Combined Symptom and Medication Score
Time frame: last 4 weeks of IMP treatment
The RCMS corresponds to the sum of Rhinitis/Rhinoconjunctivitis Symptom Score (RSS) and Rhinitis/Rhinoconjunctivitis Medication Score (RMS). The daily RCSMS will be calculated as RCSMS (0-6) = RSS (0-3) + RMS (0-3) Higher scores mean a worse outcome.
5 secondary outcomes
RSS : Rhinitis/Rhinoconjunctivitis Symptom Score
Time frame: last 4 weeks of IMP treatment
RMS : Rhinitis/Rhinoconjunctivitis Medication Score
Time frame: last 4 weeks of IMP treatment
ASS : Asthma Symptom Score
Time frame: last 4 weeks of IMP treatment
AMS: Asthma Medication Score
Time frame: last 4 weeks of IMP treatment
ARSS: Asthma and Rhinitis/Rhinoconjunctivitis Symptom Score
Time frame: last 4 week of IMP treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Raquel Caballero study chair
Inmunotek S.L.
19 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Allergen Immunotherapy Extract in people with Rhinitis and Rhinoconjunctivitis, run by Inmunotek S.L. at 19 sites in 4 countries.
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 14 inclusion and 27 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: looking for participants now, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in China, Argentina, Portugal, 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Raquel Caballero (+34 912 908 94, rcaballero@inmunotek.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RCSMS : Rhinitis/Rhinoconjunctivitis Combined Symptom and Medication Score (time frame: last 4 weeks of IMP treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jan 2026.