Trial · NCT07904052
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
NCT07904052, Phase 3, Recruiting, Inmunotek S.L.
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063. Trials, record NCT07904052. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07904052
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
- NCT number
- NCT07904052
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 250 participants, estimated
- Lead sponsor
- Inmunotek S.L.
- Conditions
- Allergic Rhinitis, Allergic Rhinoconjunctivitis, Allergic Asthma
- Interventions
- EP-088_MM09, Placebo
- First posted
- 2026-10-29
- Last updated
- 2026-10-29
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rhinitis/Rhinoconjunctivitis Combined Symptom and Medication Score (RCSMS) by means of the Subject's Diary | Baseline Visit or Additional Baseline visit (2 weeks), visit 3 (2 weeks), visit 6 (2 weeks), visit 9 (2 weeks) and visit 12 (4 weeks) | The combination score of symptoms and medication required for symptom control in rhinitis/rhinoconjunctivitis for each subject during the trial will be obtained by means of the Subject's diary. RCSMS corresponds to the sum of Rhinitis/rhinoconjunctivitis Symptom Score (RSS) and Rhinitis/rhinoconjunctivitis Medication Score (RMS). The assessment criteria for each symptom shall be as follows: * 0 = No symptoms * 1 = Mild symptoms * 2 = Moderate * 3 = Severe The RSS will correspond to the sum of the six rhinitis/rhinoconjunctivitis symptoms (itchy/red eyes, watery eyes, sneezing, itchy nose, runny nose, blocked nose), divided by six: The final score will range from 0 to 3. RMS will correspond to the highest level of medication taken on this day. The final RMS score will range from 0 to 3. The daily RCSMS is calculated as RCSMS (0-6) = RSS (0-3) + RMS (0-3). |
| Secondary | Rhinitis/Rhinoconjunctivitis Symptom Score (RSS) | Baseline Visit or Additional Baseline visit (2 weeks), visit 3 (2 weeks), visit 6 (2 weeks), visit 9 (2 weeks) and visit 12 (4 weeks) | The RSS will correspond to the sum of the six rhinitis/rhinoconjunctivitis (itchy/red eyes, watery eyes, sneezing, itchy nose, runny nose, blocked nose), symptoms divided by six: (SS1+SS2+SS3+SS4+SS5+SS6) /6. The final score will range from 0 to 3. The assessment criteria for each symptom shall be 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 Rhinitis/Rhinoconjunctivitis Symptom Score (RSS) will be obtained throughout the different trial periods for each subject by means of the Subject's Diary. |
| Secondary | Rhinitis/Rhinoconjunctivitis Medication Score (RMS) | Baseline Visit or Additional Baseline visit (2 weeks), visit 3 (2 weeks), visit 6 (2 weeks), visit 9 (2 weeks) and visit 12 (4 weeks) | RMS will correspond to the highest level of medication taken on this day. The final RMS score will range from 0 to 3. Medication to assess rhinitis/rhinoconjunctivitis: * Oral and/or topical (eyes or nose) non-sedative H1 antihistamines (H1A). * Intranasal corticosteroids (INS) with/ without H1A. * Oral corticosteroids (OCS) with/without INS, with/without H1A. The Rhinitis/Rhinoconjunctivitis Medication Score (RMS) will be obtained throughout the different trial periods for each subject by means of the Subject's Diary |
| Secondary | Asthma Combined Symptom and Medication Score (ACSMS) | Baseline Visit or Additional Baseline visit (2 weeks), visit 3 (2 weeks), visit 6 (2 weeks), visit 9 (2 weeks) and visit 12 (4 weeks) | The Asthma-Combined Symptom and Medication Score (ACSMS) will be obtained throughout the different trial periods for each subject with asthma using the data from the Subject's Diary. The ACSMS will correspond to the sum of ASS and AMS and will be calculated as follows: ACSMS (0-6) = ASS (0-3) + AMS (0-3) The final score will range from 0 to 6 |
| Secondary | Asthma Symptom Score (ASS) | Baseline Visit or Additional Baseline visit (2 weeks), visit 3 (2 weeks), visit 6 (2 weeks), visit 9 (2 weeks) and visit 12 (4 weeks) | The Asthma Symptom Score (ASS) will be obtained throughout the different trial periods (See Flow-chart in 9.1) for each subject with asthma by means of the Subject's Diary. Asthma symptoms are the following: * Cough. * Wheezing. * Shortness of breath or feeling of choking. * Chest tightness. The endpoint for each symptom will be 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 four asthma symptoms (cough, wheezing, shortness of breath or feeling of choking, and chest tightness) divided by four: (SS1+SS2+SS3+SS4) /4. The final score will range from 0 to 3. |
| Secondary | Asthma Medication Score (AMS) | Baseline Visit or Additional Baseline visit (2 weeks), visit 3 (2 weeks), visit 6 (2 weeks), visit 9 (2 weeks) and visit 12 (4 weeks) | The asthma medication will be scored based on the therapeutic step in which the drugs are included in the GEMA 5.0 and GINA 2023 guidelines. The scoring method is detailed in the article entitled "Combination of Allergic Asthma Symptom and Medication Scores in Allergen Immunotherapy Trials: A Proposal." In the present study, the asthma medication will be scored as follows: * Score 0.5: SABA as needed. * Score 1: Low dose ICS with/without SABA as needed. * Score 1.5: Low dose ICS + LABA or medium dose ICS with/without SABA as needed. * Score 2: Medium dose ICS+LABA with/without SABA as needed. * Score 2.5: High dose ICS+LABA with/without SABA as needed. * Score 3: High dose ICS+LABA + systemic corticosteroids with/without LTRA with/without SABA as needed. The AMS will correspond to the highest level of medication taken on this day. The final score will range from 0 to 3. |
| Secondary | Asthma and Rhinitis/Rhinoconjunctivitis Symptom Score (ARSS) | Baseline Visit or Additional Baseline visit (2 weeks), visit 3 (2 weeks), visit 6 (2 weeks), visit 9 (2 weeks) and visit 12 (4 weeks) | The Asthma and Rhinitis/Rhinoconjunctivitis Symptom Score (ARSS) will be obtained throughout the different trial periods (See Flow-chart in 9.1) for each subject with asthma using the data from the Subject's Diary. The ARSS will correspond to the sum of RSS and ASS and will be calculated as follows: ARSS (0-6) = RSS (0-3) + ASS (0-3) The final score will range from 0 to 6. |
| Secondary | Asthma and Rhinitis/Rhinoconjunctivitis Medication Score (ARMS) | Baseline Visit or Additional Baseline visit (2 weeks), visit 3 (2 weeks), visit 6 (2 weeks), visit 9 (2 weeks) and visit 12 (4 weeks) | The Asthma and Rhinitis/Rhinoconjunctivitis Medication Score (ARMS) will be obtained throughout the different trial periods (See Flow-chart in 9.1) for each subject with asthma using the data from the Subject's Diary. The ARMS will correspond to the sum of RMS and AMS and will be calculated as follows: ARMS (0-6) = RMS (0-3) + AMS (0-3) The final score will range from 0 to 6. |
| Secondary | Asthma and Rhinitis/Rhinoconjunctivitis Combined Symptom and Medication Score | Baseline Visit or Additional Baseline visit (2 weeks), visit 3 (2 weeks), visit 6 (2 weeks), visit 9 (2 weeks) and visit 12 (4 weeks) | The Asthma and Rhinitis/Rhinoconjunctivitis Combined Symptom and Medication Score (ARCSMS) will be counted throughout the different trial periods (See Flow-chart in 9.1) for each subject with asthma using the data from the Subject's Diary. The ARCSMS will correspond to the sum of RCSMS and ACSMS and will be calculated as follows: ARCMS (0-12) = RCSMS (0-6) + ACSMS (0-6) The final score will range from 0 to 12. |
| Secondary | Asthma exacerbations | From visit 1 to the end of treatment at 12 months | Time to first asthma exacerbation, number, duration, and severity |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07904052
GET https://conductscience.org/api/trials/v1/NCT07904052/registered