ClinicalTrials.gg
RecruitingNCT07412990GRASSUpdated Mar 20, 2026

GRASS (Grass MATA MPL Real-world Assessment Study)

An observational study in Grass Pollen Allergy, sponsored by Allergy Therapeutics. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-20.

Sponsored by Allergy Therapeutics · Observational

From the registry’s dates

  • Started Mar 2026; still recruiting 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years and older
Sex
All
01

Study summary

Objective of this non-interventional study (NIS) is to collect data on the use of Grassmuno® in routine clinical practice.

02

Conditions studied

  • Grass Pollen Allergy

Browse trials for

Keywords

  • Allergy, Grass-pollen, AIT, SCIT
03

In context

Hypersensitivity

1,055 studies on the registry are indexed under Hypersensitivity; 149 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 166 across 327 observational studies indexed under Hypersensitivity.

Browse Hypersensitivity studies →

Lead sponsor

Allergy Therapeutics is the lead sponsor of 27 studies on the registry; 1 is open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Eligibility criteria

At the physician's discretion and based on the current Summary of Product Characteristics (SmPC), study participation may be offered to patients who

  • are male and female patients
  • are 18 years of age or older
  • treated in accordance with the SmPC of Grassmuno® for IgE-mediated moderate to severe allergic rhinitis and/or rhinoconjunctivitis (without asthma or with well-controlled asthma) triggered by grass pollen.
  • Patients will only be enrolled in the study after the treatment decision has been made

Exclusion Criteria:

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 listed in the current Summary of Product Characteristics (SmPC) are present.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

    Drug: Grassmuno®

Interventions

  • DrugGrassmuno®

    SCIT for grass pollen allergy, observational study

06

What researchers measure

Primary outcomes

  1. Treatment adherence

    Absolute number and percentage of treatment adherent patients after the first treatment year

    Time frame: once a year for one year

Secondary outcomes

  1. Injection intervals

    Analysis of dosing and injection intervals of Grassmuno®

    Time frame: ~6 injection visits (visit 1 to visit 6) per treatment year

  2. Treatment adherence

    Absolute number an percentage of treatment adherent patients after the second treatment year and for first and second treatment year (total).

    Time frame: once for a year for 2 years

  3. Combined symptom and medication score (CSMS)

    Combined symptom and medication score (CSMS) after the first and second year of treatment

    Time frame: once a year for 2 years

  4. Medications Score (dMS)

    Medication scores (dMS) after the first and second year of treatment

    Time frame: once a year for 2 years

  5. Symptom Score (dSS)

    Symptom score (dSS) after the first and second year of treatment

    Time frame: once a year for two years

  6. Rhinitis Quality of Life

    Change in quality of life as assessed by the standardized Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ\[s\])

    Time frame: three times a year (fist year), twice for 2nd year

  7. Rhinitis and Rhinoconjunctivitis Score

    Change from baseline in retrospectively collected data on rhinitis-, conjunctivitis-, and asthma-related symptoms (severity and frequency)

    Time frame: once in two years

  8. 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

    Time frame: once a year for two years

  9. 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

    Time frame: once a year for two years

  10. 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

    Time frame: all year for two years

07

Study locations

1 of 1 sites recruiting
  • Dr. Kasche
    Hamburg, Germany
    Recruiting
    • Daniela Kasche, Dr. med. · Contact
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2026 (actual). Primary completion is estimated for Oct 2028, 30 months after the start.

Of 124 observational studies under Hypersensitivity, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 136. This study's planned 30 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 28, 2026
First posted
Feb 17, 2026
StartActual
Mar 11, 2026
Primary completionEst.
Oct 2, 2028
CompletionEst.
Oct 2, 2028
Last update
Mar 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07412990
Collaborators
Bencard Allergie GmbH, ClinCompetence Cologne GmbH
Responsible party
Sponsor
First posted
Feb 17, 2026
Start date
Mar 11, 2026
Primary completion
Oct 2, 2028 (estimated)
Completion
Oct 2, 2028 (estimated)
Last update
Mar 20, 2026

Study contacts

Ralph Mösges, Univ. Prof. Dr. med. Dipl.-Ing
Contact
Ralph.Moesges@Uni-Koeln.de
+49 172 2056 230

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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