Grass Pollen AllergyGRASSNCT07412990
GRASS (Grass MATA MPL Real-world Assessment Study)
An observational study of Grass Pollen Allergy, run by Allergy Therapeutics at 1 site in Germany.
Trial summary
Objective of this non-interventional study (NIS) is to collect data on the use of Grassmuno® in routine clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Grass Pollen Allergy
- What is being tested?
- Grassmuno®
- Type of treatment
- Injection or infusion
- How many people
- 1,000 participants
- Where
- 1 siteGermany
- Study dates
- 11 Mar 2026to 2 Oct 2028
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients for whom a pre-seasonal subcutaneous allergen immunotherapy (AIT) with Grassmuno® for the treatment of IgE-mediated moderate to severe allergic rhinitis and/or rhinoconjunctivitis, without asthma or with well-controlled asthma elicicited by grass pollen is indicated.
Who may be able to join
None listed.
Who cannot join
- At the physician's discretion, the study should not be offered to the following patients:
- Patients who are not sufficiently proficient in or do not adequately understand the German language, as this would prevent adequate comprehension of study-relevant documents.
- In addition, patients should not be included if any of the contraindications listed in the current Summary of Product Characteristics (SmPC) are present.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Dr. Kasche
Hamburg
Daniela Kasche, Dr. med.
About this study
Official title: Eine Prospektive, Offene, Multizentrische, Nicht-interventionelle Studie Zur Erhebung Von Daten Zur Anwendung Von Grass MATA MPL 27 600 SU Und Compliance in Der täglichen Klinischen Praxis Bei Erwachsenen Gräserpollen- Allergikern
Objective of this non-interventional study (NIS) is to collect data on the use of Grassmuno® in routine clinical practice.
- Conditions
- Grass Pollen Allergy
- Being tested
- Grassmuno®
- Keywords
- Allergy, Grass-pollen, AIT, SCIT
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grassmuno®Drug
SCIT for grass pollen allergy, observational study
| Study group | Role | What they receive |
|---|---|---|
| Grass Allergic adults | Adult patients aged ≥ 18 for whom pre-seasonal subcutaneous allergen immunotherapy (AIT) with Grassmuno ® is indicated for the treatment of IgE-mediated moderate to severe allergic rhinitis and/or rhinoconjunctivitis with no asthma or with well-controlled asthma elicited by grass pollen allergy Receives: Drug: Grassmuno® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment adherence
Absolute number and percentage of treatment adherent patients after the first treatment year
Measured: once a year for one year
Secondary outcomes (10)
Injection intervals
Analysis of dosing and injection intervals of Grassmuno®
Measured: ~6 injection visits (visit 1 to visit 6) per treatment year
Treatment adherence
Absolute number an percentage of treatment adherent patients after the second treatment year and for first and second treatment year (total).
Measured: once for a year for 2 years
Combined symptom and medication score (CSMS)
Combined symptom and medication score (CSMS) after the first and second year of treatment
Measured: once a year for 2 years
Medications Score (dMS)
Medication scores (dMS) after the first and second year of treatment
Measured: once a year for 2 years
Symptom Score (dSS)
Symptom score (dSS) after the first and second year of treatment
Measured: once a year for two years
Rhinitis Quality of Life
Change in quality of life as assessed by the standardized Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ[s])
Measured: three times a year (fist year), twice for 2nd year
Rhinitis and Rhinoconjunctivitis Score
Change from baseline in retrospectively collected data on rhinitis-, conjunctivitis-, and asthma-related symptoms (severity and frequency)
Measured: once in two years
Patient Satisfaction
Absolute numbers and percentage of patients with a satisfaction grade (likert scale (very satisfied, satisfied, less satisfied, not satisfied), measured after the first and second year of treatment
Measured: once a year for two years
Physican Satisfaction
Absolute numbers and percentage of physicians with a satisfaction grade (likert scale (very satisfied, satisfied, less satisfied, not satisfied), measured after the first and second year of treatment
Measured: once a year for two years
Incidence of Treatment-emergent adverse events (safety and tolerability)
Type, frequency, and severity of adverse drug reactions (ADRs) occurring in association with treatment including frequency of ADRs leading to premature discontinuation of therapy
Measured: all year for two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start11 Mar 2026
- Primary completion2 Oct 2028 (estimated)
- Study completion2 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Grass Pollen AllergyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Allergy Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bencard Allergie GmbH, ClinCompetence Cologne GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07412990
- Sponsor's protocol ID
- GRASS-NIS
- Other IDs
- DRKS00039005
- Acronym
- GRASS
- Status last verified
- Mar 2026
- First submitted
- 28 Jan 2026
- Last updated
- 20 Mar 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 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eine Prospektive, Offene, Multizentrische, Nicht-interventionelle Studie Zur Erhebung Von Daten Zur Anwendung Von Grass MATA MPL 27 600 SU Und Compliance in Der täglichen Klinischen Praxis Bei Erwachsenen Gräserpollen- Allergikern
- ClinicalTrials.gov ID
- NCT07412990
- Acronym / sponsor ID
- GRASS / GRASS-NIS
- Conditions
- Grass Pollen Allergy
- Keywords
- Allergy, Grass-pollen, AIT, SCIT
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Allergy TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Bencard Allergie GmbH, ClinCompetence Cologne GmbH
- Study start
- 11 Mar 2026 (actual)
- Primary completion
- 2 Oct 2028 (estimated)
- Study completion
- 2 Oct 2028 (estimated)
- First posted
- 17 Feb 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.
Objective of this non-interventional study (NIS) is to collect data on the use of Grassmuno® in routine clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Grass Allergic adults | – | Drug: Grassmuno®Adult patients aged ≥ 18 for whom pre-seasonal subcutaneous allergen immunotherapy (AIT) with Grassmuno ® is indicated for the treatment of IgE-mediated moderate to severe allergic rhinitis and/or rhinoconjunctivitis with no asthma or with well-controlled asthma elicited by grass pollen allergy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients for whom a pre-seasonal subcutaneous allergen immunotherapy (AIT) with Grassmuno® for the treatment of IgE-mediated moderate to severe allergic rhinitis and/or rhinoconjunctivitis, without asthma or with well-controlled asthma elicicited by grass pollen is indicated.
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Patients who are not sufficiently proficient in or do not adequately understand the German language, as this would prevent adequate comprehension of study-relevant documents.
- In addition, patients should not be included if any of the contraindications listed in the current Summary of Product Characteristics (SmPC) are present.
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 |
|---|---|---|
| Grassmuno®SCIT for grass pollen allergy, observational study | Drug | Grass Allergic adults |
Primary outcome
Treatment adherence
Time frame: once a year for one year
Absolute number and percentage of treatment adherent patients after the first treatment year
10 secondary outcomes
Injection intervals
Time frame: ~6 injection visits (visit 1 to visit 6) per treatment year
Treatment adherence
Time frame: once for a year for 2 years
Combined symptom and medication score (CSMS)
Time frame: once a year for 2 years
Medications Score (dMS)
Time frame: once a year for 2 years
Symptom Score (dSS)
Time frame: once a year for two years
Rhinitis Quality of Life
Time frame: three times a year (fist year), twice for 2nd year
Rhinitis and Rhinoconjunctivitis Score
Time frame: once in two years
Patient Satisfaction
Time frame: once a year for two years
Physican Satisfaction
Time frame: once a year for two years
Incidence of Treatment-emergent adverse events (safety and tolerability)
Time frame: all year for two years
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 20 Mar 2026.
- Individual participant dataSharing planned: No
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Tyrosine Allergoid Paediatric and Adult Study
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Grass Pollen Allergy, run by Allergy Therapeutics at 1 site in Germany.
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 0 inclusion and 3 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 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Ralph Mösges, Univ. Prof. Dr. med. Dipl.-Ing (+49 172 2056 230, Ralph.Moesges@Uni-Koeln.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment adherence (time frame: once a year for one year). 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 20 Mar 2026.