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SQ tree SLIT-tablet for Allergy (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
A documented, physician diagnosed, clinically relevant history of moderate to severe AR/C induced by birch pollen (with or without asthma) despite having received treatment with symptom-relieving medication during at least 1 previous tree pollen season for ages 4 through 6 years at screening or at least 2 previous tree pollen seasons for ages 7 through 17 years at screening
Presence of 1 or more of the following Allergic Rhinitis Impact on Asthma (ARIA) quality of life items due to AR/C during the previous BPS: Sleep disturbance, Impairment of daily activities, leisure and/or sport, Impairment of school or work, Troublesome symptoms
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

TreeTop Trial Summary

This trial is testing whether the medication is effective and safe to treat birch/tree pollen allergy in children and adolescents.

TreeTop Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have a history of moderate to severe allergic rhinitis caused by birch pollen, even after trying medication to relieve symptoms during past tree pollen seasons.
Select...
Your daily life is significantly affected by symptoms like trouble sleeping, difficulty doing regular activities, problems with school or work, and bothersome symptoms related to your allergies and asthma.

TreeTop Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pharmaceutical Preparations
Secondary outcome measures
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

TreeTop 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
327,390 Total Patients Enrolled
ParexelIndustry Sponsor
301 Previous Clinical Trials
99,725 Total Patients Enrolled
Monika Gappa, Prof. Dr. Med.Principal InvestigatorEvangelisches Krankenhaus Düsseldorf

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research program looking for more participants?

"The information on clinicaltrials.gov suggests that this trial is looking for patients at this time. The trial was first announced on April 7th, 2021 and was last updated on August 12th, 2022."

Answered by AI

Is there a potential for SQ tree SLIT-tablet to have negative side effects for users?

"Data from Phase 3 clinical trials provides evidence of SQ tree SLIT-tablet's efficacy and safety, thus it received a score of 3 from our team."

Answered by AI

How many individuals are being given the chance to try this new treatment?

"The clinical trial is recruiting patients and the information is available on clinicaltrials.gov. The trial was first posted on 4/7/2021. It was last edited on 8/12/2022. They are looking for 1000 participants between 3 locations."

Answered by AI

Are elderly patients eligible to participate in this experiment?

"In order to take part in this clinical trial, potential patients must fall between the ages of 5 and 17. Out of the 242 total trials, 80 are for those under 18 and 162 are for seniors."

Answered by AI
~234 spots leftby Mar 2025