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A Study in Children and Adolescents With Birch Pollen-induced Rhinoconjunctivitis

Study Purpose

This is a clinical study in children and adolescents (5-17 years) with allergy to pollen from birch (or related trees). It compares the tree SLIT-tablet with placebo in relieving rhinoconjunctivitis symptoms during the birch/tree pollen season based on the average allergic rhinoconjunctivitis daily total combined score. The study will also collect health-related quality of life information in the groups treated with the tree SLIT-tablet or with placebo during the pollen season. The trial medication used is already approved to treat allergic rhinitis caused by birch/tree pollen in adults in several countries?.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 5 Years - 17 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Male or female of any race/ethnicity aged ≥4 to <18 years on the day informed consent is obtained from the parent/caregiver; the subject must be ≥5 to <18 years old at the randomisation visit.
  • - 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.
  • - Positive skin prick test (SPT) to Betula verrucosa at screening.
  • - Positive specific IgE to Bet v 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: 1.
Sleep disturbance. 2. Impairment of daily activities, leisure and/or sport. 3. Impairment of school or work. 4. Troublesome symptoms.

Exclusion Criteria:

  • - A clinically relevant history of symptomatic seasonal AR/C caused by an allergen source, other than tree pollen from the birch homologous group, with a season overlapping the TPS.
  • - A clinically relevant history of symptomatic perennial AR/C caused by an allergen source such as animal hair and dander to which the subject is exposed during the TPS.
  • - Any clinical deterioration of asthma (i.e. asthma exacerbation) that resulted in emergency treatment, hospitalisation or treatment with systemic corticosteroids within 3 months prior to randomisation.
  • - Reduced lung function at randomisation defined as forced expiratory volume in 1 second (FEV1) <70% of predicted value.
For subjects with asthma, this is assessed on subject's usual asthma medication following at least a 6-hour wash-out of SABA. This criterion does not need to be fulfilled if the subject is <7 years old, cannot perform reproducible FEV1 manoeuvres despite coaching and is not considered as having a diagnosis of asthma.
  • - Ongoing treatment with any allergy immunotherapy product.
  • - Severe chronic oral inflammation.
  • - A diagnosis of eosinophilic oesophagitis.
  • - A relevant history of systemic allergic reaction e.g. anaphylaxis with cardiorespiratory symptoms, generalised urticaria or severe facial angioedema that in the opinion of the investigator may constitute an increased safety concern.
- Immunosuppressive treatment (ATC code L04 or L01) within 3 months prior to the screening visit

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04878354
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

ALK-Abelló A/S
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Monika Gappa, Prof. Dr. Med.
Principal Investigator Affiliation Evangelisches Krankenhaus Düsseldorf
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

IndustryIndustry
Overall Status Recruiting
Countries Hungary, Lithuania, Poland, Slovakia
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Allergy
Additional Details

This is a phase III, parallel-group, double-blind, placebo-controlled study to evaluate efficacy and safety of the tree SLIT-tablet in children and adolescents (5-17 years) who have rhinoconjunctivitis (with or without asthma) induced by pollen from birch trees or by trees belonging to the birch homologous group. Approximately 1000 children and adolescents will be enrolled in the trial and will receive either the tree SLIT-tablet or placebo. The trial consists of 3 periods: a screening period, a treatment period, which includes pre-seasonal and co seasonal treatment, and a follow-up period. The duration is up to 13 months for each participant. The trial is conducted in several European countries and in Canada.

Arms & Interventions

Arms

Placebo Comparator: Placebo

Gelatine (fish source), mannitol and sodium hydroxide

Experimental: Intervention/treatment

Sublingual allergy immunotherapy tablet, for daily administration SQ tree SLIT-tablet

Interventions

Drug: - SQ tree SLIT-tablet

Sublingual allergy immunotherapy tablets

Drug: - Placebo

Placebo

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Aranyklinika Kft, Szeged, Csongrád, Hungary

Status

Recruiting

Address

Aranyklinika Kft

Szeged, Csongrád, 6720

Site Contact

Zoltan Novak, MD

novak.zoltan@med.u-szeged.hu

3662317238

"Medicum centrum" JSC, Taurage, Tauragės Apskritis, Lithuania

Status

Recruiting

Address

"Medicum centrum" JSC

Taurage, Tauragės Apskritis, LT-72250

Site Contact

Iveta Skurvydiene, MD

skurvydiene.i@gmail.com

37069939903

"Inlita" JSC Santara CTC, Vilnius, Vilniaus Apskritis, Lithuania

Status

Recruiting

Address

"Inlita" JSC Santara CTC

Vilnius, Vilniaus Apskritis, LT-08406

Site Contact

Kestutis Cerniauskas, MD

kestas.cernis@gmail.com

37061237923

Allergy clinic "Perspektyvos" JSC, Vilnius, Vilniaus Apskritis, Lithuania

Status

Recruiting

Address

Allergy clinic "Perspektyvos" JSC

Vilnius, Vilniaus Apskritis, LT-08465

Site Contact

Ruta Dubakiene, MD

ruta.dubakiene@mf.vu.lt

37065433825

"Center of Innovative Allergology" JSC, Vilnius, Lithuania

Status

Recruiting

Address

"Center of Innovative Allergology" JSC

Vilnius, , LT-06256

Site Contact

Violeta Kvedariene, MD

kv.violeta@gmail.com

+370 655 22932

"Inlita" JSC Santara CTC, Vilnius, Lithuania

Status

Recruiting

Address

"Inlita" JSC Santara CTC

Vilnius, , LT-08406

Site Contact

Kestutis Cerniauskas

kestas.cernis@gmail.com

+37061237923

Malopolskie Centrum Alergologii, Krakow, Małopolskie, Poland

Status

Recruiting

Address

Malopolskie Centrum Alergologii

Krakow, Małopolskie, 31-411

Site Contact

Małgorzata Bederska, MD

malgorzatabederska@gmail.com

48600876555

ETG Kielce, Kielce, Poland

Status

Recruiting

Address

ETG Kielce

Kielce, , 25-355

Site Contact

Anna Latos, MD

a.latos@etg-network.com

48 41-345-31-44

ETG Skierniewice, Skierniewice, Łódzkie, Poland

Status

Recruiting

Address

ETG Skierniewice

Skierniewice, Łódzkie, 96-100

Site Contact

Bozena Kucinska, MD

b.kucinska@etg-network.com

48 46 833 47 56

MedKol, s.r.o., Nové Zámky, Slovakia

Status

Recruiting

Address

MedKol, s.r.o.

Nové Zámky, , 940 01

Site Contact

Monika Kolejakova, MD

medkolnz@gmail.com

+421 918 114 580

Rimavska Sobota, Slovakia

Status

Recruiting

Address

Zoll-Med s.r.o., Ambulancia klinickej imunologie a alergologie

Rimavska Sobota, , 979 01

Site Contact

Lubica Zollerova, MD

zollerova@gmail.com

+421 475 424 382

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