Safety and Efficacy of STALORAL® Birch 300 IR in a Paediatric Population With Birch Pollen-induced ARC w/o Asthma

NCT05668390 | Completed Phase 3 DMC

• 1 other identifier: SL79.22
• Study Type: interventional
• Target: 553
• Locations: 12 countries
• Sites: 62

Brief Summary

Allergic rhinoconjunctivitis due to birch pollen is a seasonal problem which manifests as a combination of nasal symptoms (such as congestion, runny nose, sneezing, itching of the nose) and ocular symptoms (such as red, itchy and watery eyes). For several birch-allergic patients, allergic rhinoconjunctivitis occurs with an oral allergy syndrome. The purpose of this study is to demonstrate the safety and efficacy of the study drug (STALORAL Birch 300 IR) in children and adolescents with birch pollen-induced allergic rhinoconjunctivitis, with or without asthma, when treated before and during the pollen season. Approximately 699 children will participate in this study. The study will be conducted worldwide in approximately 80 medical sites in about 12 countries. The total duration of the study will be approximately 20 months.

Conditions

Allergic Rhinoconjunctivitis; Birch Pollen Allergy

Outcome Measures

Primary Outcomes (1)

• The primary efficacy endpoint will be the average ARC Total Combined Score (TCS) (TCS0-38) over the entire Birch Pollen Season (BPS) 2.

  The Average Adjusted Symptom Score (AadSS(0-18)) a score based on the daily Rhino-conjunctivitis Total Symptom Scores (RTSS) and adjusted for the daily rescue medication (RM) usage, while on treatment during the BPS2.

  Following visits after starting the study: at 16 months, 18 months

Secondary Outcomes (5)

• The average CSMS (CSMS0-6)

  Following visits after starting the study: at 16 months, 18 months

• The average ARC DSS (DSS0-18)

  Following visits after starting the study: at 16 months, 18 months

• The average ARC DMS (DMS0-20)

  Following visits after starting the study: at 16 months, 18 months

• The overall RQLQ(S) score

  Following visits after starting the study: at 16 months, 18 months

• The overall PRQLQ score

  Following visits after starting the study: at 16 months, 18 months

Study Arms (2)

STALORAL® Birch 300 IR

EXPERIMENTAL

1. Escalation Phase: The escalation phase starts with 10 IR/mL solution the first 5 days (daily increase from 1 to 5 actuations) and switching to 300 IR/mL solution the next 5 days (daily increase from 1 to 5 actuations). 2. Maintenance Phase: The maintenance phase takes place with 5 actuations of the active 300 IR/mL solution from Day 11 onwards

Drug: STALORAL® Birch 300 IR

Placebo

PLACEBO COMPARATOR

1. Escalation Phase: The escalation phase starts with 10 IR/mL Placebo solution the first 5 days (daily increase from 1 to 5 actuations) and switching to 300 IR/mL Placebo solution the next 5 days (daily increase from 1 to 5 actuations). 2. Maintenance Phase: The maintenance phase takes place with 5 actuations of the active 300 IR/mL Placebo solution from Day 11 onwards

Drug: STALORAL® Birch 300 IR

Interventions

STALORAL® Birch 300 IR DRUG

2 treatment periods will consist of 2 steps: an escalation phase, where the treatment dose will gradually increase, followed by a maintenance phase.

Placebo; STALORAL® Birch 300 IR

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Able to sign and date the informed consent/assent form prior to any trial-specific procedure. Patients may check a box on the assent form if they are unable to provide a signature.
• (Parents and/or authorised legal representative(s) will have to give written informed consent for minors in their custody)
• Covered by a health insurance system as per local regulation.
• Demographics and Medical History
• Aged ≥5 to ≤17 years old at the randomisation visit.
• Documented, physician diagnosed, clinically relevant history of moderate to severe ARC induced by birch pollen (with or without asthma) despite having received treatment with symptom-relieving medication during at least 1 previous birch pollen season for ages 4 through 6 or at least 2 previous birch pollen seasons for ages 7 through 17 years at screening.
• A Retrospective ARC Total Symptom Score (TSS) based on the previous birch pollen season at least 12 out of a maximum possible score of 18 AND a retrospective score of at least 30 on a general Visual Analog Scale (VAS) (0-100) on the severity of symptoms as evaluated by the patient or by the parent/authorised legal representative if the patient is not able to perform the assessment, at screening.
• Retrospective ARC TSS (0-18) is rated the same way as Daily Symptom Score (DSS) (0-18)
• Screening Tests and Evaluations
• Positive Skin Prick Test (SPT) to Betula pendula at screening visit (the SPT is considered positive if it results in a wheal diameter ≥ 3.0 mm \[with positive control (histamine) ≥ 3.0 mm and negative control = 0 mm\]). The Sponsor will accept to include patients who have a documented positive SPT in their medical records if this SPT was performed during the previous 6 months preceding the screening visit at the same investigational site in which they are enrolled.
• Positive specific Immunoglobulin E (IgE) to pollen allergens of Betula pendula at screening (CAP-RAST birch pollen allergens specific IgE ≥ 0.7 kU/L).
• Negative urine pregnancy test on all female patients of childbearing potential or who have had their first menarche prior to randomisation.
• Lifestyle Considerations
• Internet access at home or via a portable device so that patients or the parent/authorised legal representative can complete the e-Diary in a dedicated application on a mobile phone daily via internet. Patients will start scoring at randomisation, i.e., 4 months before the pollen season.

You may not qualify if:

• Medical History
• Any clinical deterioration of asthma (i.e., asthma exacerbation) that resulted in emergency procedure/treatment or treatment with systemic corticosteroids within 3 months prior to randomisation.
• For patients ≥7 years old:
• Reduced lung function at randomisation defined as Forced Expiratory Volume in 1 second (FEV1) \< 70% of the predicted value. For patients with asthma, this is assessed on the patient's usual asthma controller medication\*. The following wash-out periods apply for as-needed asthma reliever medication: at least a 6-hour wash-out of Short-Acting Beta Agonists (SABAs), a 12-hour wash-out of Long-Acting Beta Agonists (LABAs),a 24-hour wash-out for ultra-LABAs and 5 days or 5 half-lives for inhaled corticosteroids.
• \*In order to ensure that the asthmatic patients with a mild to moderate asthma status are controlled by treatment steps 1, 2 or 3 in accordance with the Global Initiative for Asthma (GINA 2022), the proper continuous asthma treatment i.e., "controller" is maintained. Only the asthma "reliever" medications must be stopped before performing spirometry. If an asthma medication is used as both "controller" and "reliever", such as inhaled corticosteroids (in combination with formoterol \[LABA\]), it must not be stopped before performing spirometry.
• Note: This criterion does not need to be fulfilled if the patient is \<7 years old, as s/he cannot perform reproducible FEV1 manoeuvres despite coaching and is not considered as having a diagnosis of asthma.
• Server or uncontrolled asthma with asthmatic therapies consistent with steps 4 or 5 as defined by Global Initiative for Asthma (GINA) 2022 received within 12 months prior to entry in the trial. Asthmatic patients with asthmatic therapies consistent with steps 1, 2 or 3 must be controlled (i.e. patients with controlled, mild and moderate asthma are eligible).
• Severe oral inflammations such as oral lichen planus, oral ulcerations or oral mycosis.
• Acute or chronic inflammatory or infectious upper airway diseases (excepted mild to moderate asthma) including recurrent acute or chronic sinusitis.
• Note: Patients with fever, flu or an upper respiratory tract infection at Visit 1 (screening visit) must be treated appropriately. They can be randomised at Visit 2 (randomisation visit) only if the infectious episode is resolved.
• History of eosinophilic oesophagitis or with current severe or persistent gastroesophageal symptoms including dysphagia or chest pain that, in the opinion of the investigator, may constitute an increased safety concern.
• 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.
• Any disease that prohibits the use of adrenaline (e.g., hyperthyroidism).
• Any severe, uncontrolled disease that, upon Investigator judgment, could increase the risk for trial patients (including but not limited to cardiovascular insufficiency, any severe or unstable lung diseases, endocrine diseases, clinically significant renal or hepatic diseases, haematological disorders, diseases of the immune system including autoimmune diseases \[upon the Investigator's judgment based on the benefit/risk assessment\] and immune deficiencies of current clinical relevance, active malignancies).
• Screening Tests and Evaluations

Sponsors & Collaborators

• Stallergenes Greer: lead

Study Sites (62)

VIENNA GENERAL HOSPITAL / Medical University of Vienna

Vienna, 1090, Austria

Location

Allergie Ambulatorium

Vienna, 1100, Austria

Location

Allergie Zentrum Wien West

Vienna, 1150, Austria

Location

UMHAT Sveti Georgi EAD

Plovdiv, 4000, Bulgaria

Location

Acibadem City Clinic Tokuda Hospital

Sofia, 1407, Bulgaria

Location

DCC NeoClinic

Sofia, 1431, Bulgaria

Location

MC Hera

Sofia, 1510, Bulgaria

Location

Terveystalo Jyvaskyla

Jyväskylä, 40100, Finland

Location

Terveystalo Hospital

Tampere, 33100, Finland

Location

Alyatec

Strasbourg, 67000, France

Location

Universitaesklinikum Augsburg

Augsburg, 86154, Germany

Location

FA f. Hals-Nasen-Ohrenheilkunde Berlin

Berlin, 10629, Germany

Location

HNO Praxis Dreieich

Dreieich, 63303, Germany

Location

Praxisklinik am Altmarkt / Studienzentrum Dresden

Dresden, 1067, Germany

Location

Yarin Yury, Dr.med.

Dresden, 1139, Germany

Location

HNO-Praxisgemeinschaft Dr. med. Frank Bohm/ Marcus Hochhaus

Hannoversch Münden, 34346, Germany

Location

Universitätsklinikum Marburg

Marburg, 35043, Germany

Location

Hno-Praxis Dr. Med. Sonja Runge

Neuenhagen, 15366, Germany

Location

HNO research GmbH / HNO im Norden MVZ

Rendsburg, 25524, Germany

Location

Zentrum fuer Rhinologie und Allergologie - Wiesbaden

Wiesbaden, 65193, Germany

Location

DRC Gyogyszervizsgalo Kozpont Kft.

Balatonfüred, 8230, Hungary

Location

Clinexpert Kft.

Budapest, 1033, Hungary

Location

Debreceni Egyetem Klinikai Kozpont Infektologiai Klinika

Debrecen, 4031, Hungary

Location

Somogy Megyei KAposi Mor Oktato Korhaz

Kaposvár, 7400, Hungary

Location

Association of Balvu and Gulbene Hospitals

Balvi, 4501, Latvia

Location

Private practice of pneimology and alergology

Rēzekne, LV-4601, Latvia

Location

The Centre of Investigation and Treatment of Allergyc Diseases

Riga, 1003, Latvia

Location

Children CUH

Riga, 1004, Latvia

Location

LOR Clinic

Riga, 1004, Latvia

Location

CD-8 Clinic Kaunas

Kaunas, 44158, Lithuania

Location

Vsj Respublikine Siauliu Ligonine

Šiauliai, 78170, Lithuania

Location

Mama, As Sergu

Vilnius, 10305, Lithuania

Location

Inovatyvios Alergologijos Centras

Vilnius, 6256, Lithuania

Location

JSC, Center for Diagnosis and Treatment of Allergic Diseases

Vilnius, 8109, Lithuania

Location

SEIMOS GYDYTOJAS Vaiku ligonine Vsl Vilniaus universiteto ligonines Santariskiu kliniku filialas

Vilnius, 8406, Lithuania

Location

Ausveja Uab

Vilnius, LT-01118, Lithuania

Location

Allergy Clinic Homeo Medicus

Bialystok, 15-687, Poland

Location

Clinical Trials Medical Practice

Bialystok, 15010, Poland

Location

Gabinet Prywatna Praktyka Lekarska

Bialystok, 15430, Poland

Location

Clinica Vitae

Gdansk, 80344, Poland

Location

Indywidualna Specjalistyczna Praktyka Lekarska Elzbieta Matusz

Gryfice, 72-300, Poland

Location

Vita Longa Sp. z o.o.

Katowice, 40-748, Poland

Location

Centrum Medyczne PLEJADY

Krakow, 30363, Poland

Location

ETG Lodz

Lodz, 90302, Poland

Location

Alergotest 5C. Specjalistyczne Centrum Medyczne

Lublin, 20095, Poland

Location

Makowskie Centrum Medyczne Hamernia

Maków, 34-220, Poland

Location

Centrum Alergologii w Poznaniu

Poznan, 60214, Poland

Location

SNZOZ AlergologaPlus

Poznan, 60693, Poland

Location

Irmed Centrum Alergologii

Warsaw, 1157, Poland

Location

All-Med Specjalistyczna Opieka Medyczna. Medyczny Instytut Badawczy

Wroclaw, 53-201, Poland

Location

PROXIMUM

Wroclaw, 53-428, Poland

Location

Spitalul Clinic de Urgenta pentru Copii Grigore Alexandrescu

Bucharest, 11743, Romania

Location

Alergoimuno centrum s.r.o.

Kežmarok, 6001, Slovakia

Location

Alersa s.r.o.

Košice, 04011, Slovakia

Location

Pneumoimunoalergologicka ambulancia Klinika deti a dorastu Martinska fakultna nemocnica

Martin, 4248, Slovakia

Location

ProbarE Lund

Prešov, 8001, Slovakia

Location

Zoll - Med - s.r.o

Rimavská Sobota, 97901, Slovakia

Location

Ambulancia klinickej imunologie a alergologie

Šurany, 94201, Slovakia

Location

Delta Health Care SRL

Linköping, 58185, Sweden

Location

Delta Health Care SRL

Lund, 22222, Sweden

Location

Delta Health Care SRL

Stockholm, 11329, Sweden

Location

Delta Health Care SRL

Stockholm, 11883, Sweden

Location

Study Officials

• Oliver Pfarr, MD

  Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital Marburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2022
• First Posted: December 29, 2022
• Study Start: September 20, 2023
• Primary Completion: August 6, 2025
• Study Completion: August 6, 2025
• Last Updated: November 26, 2025

Record last verified: 2025-11

Locations

DE (10); AU (3); RO (1); LI (7); SE (4); BU (4); PL (15); LA (5); SL (6); FI (2); HU (4); FR (1)