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A Study in Children and Adolescents With Birch Pollen-induced Rhinoconjunctivitis (TreeTop Trial)

Phase 3
Waitlist Available
Led By Monika Gappa, Prof. Dr. Med.
Research Sponsored by ALK-Abelló A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Pivotal Trial

Summary

This trial tests a tablet with small amounts of tree pollen in children and adolescents aged 5-17 who are allergic to birch or related tree pollen. The tablet helps their bodies get used to the pollen, reducing allergy symptoms. The SQ tree SLIT-tablet has been shown to be highly effective and well tolerated in previous studies.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pharmaceutical Preparations
Secondary study objectives
Average daily medication score during the birch pollen season
Average daily medication score during the tree pollen season
Average daily symptom score during the birch pollen season
+2 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Intervention/treatmentExperimental Treatment1 Intervention
Sublingual allergy immunotherapy tablet, for daily administration SQ tree SLIT-tablet
Group II: PlaceboPlacebo Group1 Intervention
Gelatine (fish source), mannitol and sodium hydroxide
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SQ tree SLIT-tablet
2015
Completed Phase 3
~1140

Find a Location

Who is running the clinical trial?

ALK-Abelló A/SLead Sponsor
76 Previous Clinical Trials
327,493 Total Patients Enrolled
ParexelIndustry Sponsor
313 Previous Clinical Trials
95,769 Total Patients Enrolled
Monika Gappa, Prof. Dr. Med.Principal InvestigatorEvangelisches Krankenhaus Düsseldorf
Monika Gappa, Prof. MDPrincipal InvestigatorEvangelisches Krankenhaus Düsseldorf
~196 spots leftby Dec 2025
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