GRASS (Grass MATA MPL Real-world Assessment Study)

NCT07412990 | Recruiting

• 2 other identifiers: GRASS-NISDRKS00039005
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Grass Pollen Allergy

Keywords

Allergy, Grass-pollen, AIT, SCIT

Outcome Measures

Primary Outcomes (1)

• Treatment adherence

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

  once a year for one year

Secondary Outcomes (10)

• Injection intervals

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

• Treatment adherence

  once for a year for 2 years

• Combined symptom and medication score (CSMS)

  once a year for 2 years

• Medications Score (dMS)

  once a year for 2 years

• Symptom Score (dSS)

  once a year for two years

Study Arms (1)

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

Grassmuno® DRUG

SCIT for grass pollen allergy, observational study

Grass Allergic adults

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Allergy Therapeutics: lead
• Bencard Allergie GmbH: collaborator
• ClinCompetence Cologne GmbH: collaborator

Study Sites (1)

Dr. Kasche

Hamburg, Germany

RECRUITING

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Central Study Contacts

Ralph Mösges, Univ. Prof. Dr. med. Dipl.-Ing

CONTACT

+49 172 2056 230; Ralph.Moesges@Uni-Koeln.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2026
• First Posted: February 17, 2026
• Study Start: March 11, 2026
• Primary Completion (Estimated): October 2, 2028
• Study Completion (Estimated): October 2, 2028
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)