GRASS (Grass MATA MPL Real-world Assessment Study) (GRASS)

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.

Study Overview

• Status: Recruiting
• Conditions: Grass Pollen Allergy
• Intervention / Treatment: Drug: Grassmuno®

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Ralph Mösges, Univ. Prof. Dr. med. Dipl.-Ing; Phone Number: +49 172 2056 230; Email: Ralph.Moesges@Uni-Koeln.de

Study Locations

• Germany
  • Hamburg, Germany
    • Recruiting
    • Dr. Kasche
    • Contact: Daniela Kasche, Dr. med.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• 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.

Description

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 contraindications listed in the current Summary of Product Characteristics (SmPC) are present.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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®; SCIT for grass pollen allergy, observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment adherence	Absolute number and percentage of treatment adherent patients after the first treatment year	once a year for one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Injection intervals	Analysis of dosing and injection intervals of Grassmuno®	~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).	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	once a year for 2 years
Medications Score (dMS)	Medication scores (dMS) after the first and second year of treatment	once a year for 2 years
Symptom Score (dSS)	Symptom score (dSS) after the first and second year of treatment	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])	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)	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	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	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	all year for two years

Collaborators and Investigators

• Sponsor: Allergy Therapeutics
• Collaborators: Bencard Allergie GmbH; ClinCompetence Cologne GmbH

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2026
• Primary Completion (Estimated): October 2, 2028
• Study Completion (Estimated): October 2, 2028

Study Registration Dates

• First Submitted: January 28, 2026
• First Submitted That Met QC Criteria: February 9, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 19, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Allergy, Grass-pollen, AIT, SCIT
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: GRASS-NIS; DRKS00039005 (Other Identifier: DRKS - Deutsches Register Klinischer Studien)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No