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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

699

Participants

Timeline

Start Date

November 14, 2023

Primary Completion Date

July 31, 2025

Study Completion Date

November 30, 2025

Conditions
Allergic RhinoconjunctivitisBirch Pollen Allergy
Interventions
DRUG

STALORAL® Birch 300 IR

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

Trial Locations (62)

1003

The Centre of Investigation and Treatment of Allergyc Diseases, Riga

1004

Children CUH, Riga

LOR Clinic, Riga

1033

Clinexpert Kft., Budapest

1067

Praxisklinik am Altmarkt / Studienzentrum Dresden, Dresden

1090

VIENNA GENERAL HOSPITAL / Medical University of Vienna, Vienna

1100

Allergie Ambulatorium, Vienna

1139

Yarin Yury, Dr.med., Dresden

1150

Allergie Zentrum Wien West, Vienna

1157

Irmed Centrum Alergologii, Warsaw

1407

Acibadem City Clinic Tokuda Hospital, Sofia

1431

DCC NeoClinic, Sofia

1510

MC Hera, Sofia

4000

UMHAT Sveti Georgi EAD, Plovdiv

4031

Debreceni Egyetem Klinikai Kozpont Infektologiai Klinika, Debrecen

4248

Pneumoimunoalergologicka ambulancia Klinika deti a dorastu Martinska fakultna nemocnica, Martin

4501

Association of Balvu and Gulbene Hospitals, Balvi

6001

Alergoimuno centrum s.r.o., Kežmarok

6256

Inovatyvios Alergologijos Centras, Vilnius

7400

Somogy Megyei KAposi Mor Oktato Korhaz, Kaposvár

8001

ProbarE Lund, Prešov

8109

JSC, Center for Diagnosis and Treatment of Allergic Diseases, Vilnius

8230

DRC Gyogyszervizsgalo Kozpont Kft., Balatonfüred

8406

SEIMOS GYDYTOJAS Vaiku ligonine Vsl Vilniaus universiteto ligonines Santariskiu kliniku filialas, Vilnius

10305

Mama, As Sergu, Vilnius

10629

FA f. Hals-Nasen-Ohrenheilkunde Berlin, Berlin

11329

Delta Health Care SRL, Stockholm

11743

Spitalul Clinic de Urgenta pentru Copii Grigore Alexandrescu, Bucharest

11883

Delta Health Care SRL, Stockholm

15010

Clinical Trials Medical Practice, Bialystok

15366

Hno-Praxis Dr. Med. Sonja Runge, Neuenhagen

15430

Gabinet Prywatna Praktyka Lekarska, Bialystok

20095

Alergotest 5C. Specjalistyczne Centrum Medyczne, Lublin

22222

Delta Health Care SRL, Lund

25524

HNO research GmbH / HNO im Norden MVZ, Rendsburg

30363

Centrum Medyczne PLEJADY, Krakow

33100

Terveystalo Hospital, Tampere

34346

HNO-Praxisgemeinschaft Dr. med. Frank Bohm/ Marcus Hochhaus, Hannoversch Münden

35043

Universitätsklinikum Marburg, Marburg

40100

Terveystalo Jyvaskyla, Jyväskylä

44158

CD-8 Clinic Kaunas, Kaunas

58185

Delta Health Care SRL, Linköping

60214

Centrum Alergologii w Poznaniu, Poznan

60693

SNZOZ AlergologaPlus, Poznan

63303

HNO Praxis Dreieich, Dreieich

65193

Zentrum fuer Rhinologie und Allergologie - Wiesbaden, Wiesbaden

67000

Alyatec, Strasbourg

78170

Vsj Respublikine Siauliu Ligonine, Šiauliai

80344

Clinica Vitae, Gdansk

86154

Universitaesklinikum Augsburg, Augsburg

90302

ETG Lodz, Lodz

94201

Ambulancia klinickej imunologie a alergologie, Šurany

97901

Zoll - Med - s.r.o, Rimavská Sobota

LV-4601

Private practice of pneimology and alergology, Rēzekne

LT-01118

Ausveja Uab, Vilnius

15-687

Allergy Clinic Homeo Medicus, Bialystok

72-300

Indywidualna Specjalistyczna Praktyka Lekarska Elzbieta Matusz, Gryfice

40-748

Vita Longa Sp. z o.o., Katowice

34-220

Makowskie Centrum Medyczne Hamernia, Maków

53-201

All-Med Specjalistyczna Opieka Medyczna. Medyczny Instytut Badawczy, Wroclaw

53-428

PROXIMUM, Wroclaw

04011

Alersa s.r.o., Košice

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Stallergenes Greer

INDUSTRY

NCT05668390 - Safety and Efficacy of STALORAL® Birch 300 IR in a Paediatric Population With Birch Pollen-induced ARC w/o Asthma | Biotech Hunter | Biotech Hunter