Phase II study to assess the tolerability, safety and efficacy of sublingual immunotherapy in patients suffering from birch pollen allergy

Phase II study to assess the tolerability, safety and efficacy of sublingual immunotherapy in patients suffering from birch pollen allergy - Phase II study of birch SLIT

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-002319-27-DE

Enrollment

165

Registered

2020-06-15

Start date

2021-02-01

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Birch pollen-related allergic rhinitis / rhino-conjunctivitis MedDRA version: 21.1 Level: LLT Classification code 10001723 Term: Allergic rhinitis System Organ Class: 100000004855 MedDRA version: 20.0 Level: LLT Classification code 10001726 Term: Allergic rhinitis due to pollen System Organ Class: 100000004870 MedDRA version: 20.0 Level: LLT Classification code 10001728 Term: Allergic rhinoconjunctivitis System Organ Class: 100000004853 MedDRA version: 20.1 Level: LLT Classification code 100

Interventions

Product Name: SULGEN Spray Birke Product Code: V01AA05 Pharmaceutical Form: Sublingual spray, solution INN or Proposed INN: Birch pollen extract CAS Number: 8000045-25-2 Current Sponsor code: SULGEN S

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Patients who signed and dated the informed consent form obtained prior to any study specific examination • Female or male patients between 18 and 65 years of age at the time of signing the informed consent form • Patients with moderate-to-severe allergic rhinitis/rhinoconjunctivitis due to birch pollen for at least two years according to the Allergic Rhinitis and its Impact on Asthma (ARIA) guideline • Patients with or without well controlled mild-to-moderate asthma defined in GINA guideline (Global Initiative for Asthma, 2017). • Forced expiratory volume (FEV1) in one second > 70 % of predicted normal value (only for asthmatic patients) • Sensitization to birch pollen, verified by: positive skin prick test (wheal diameter = 3 mm and negative control =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Previous immunotherapy with tree pollen allergen extracts according to the homologous group of tree pollen of the “birch group” / “fagales group”, as defined in Annex 1 in the Guideline on allergen products: production and quality issues (EMEA/CHMP/BWP/304831), within the last 5 years • Patients with co-sensitizations to any perennial or seasonal allergen with clinical manifestations or co-allergies, whose allergic symptoms interfere with the conduct of the study (e. g. with the tNPT) • Simultaneous participation in other clinical trials • Simultaneous specific immunotherapy with other allergens • Participation in a clinical trial in the last three months before enrolment • Asthmatic patients with forced expiratory volume (FEV1) = 70 % of predicted normal value • Partly controlled or uncontrolled asthma according to GINA guideline (Global Initiative for Asthma, 2017) • Severe acute or chronic inflammatory or infectious diseases • Diseases of the immune system such as autoimmune and immune deficiencies (with exception to well controlled Hashimoto thyroiditis and type-1 diabetes mellitus) • Chronic or acute diseases of the heart, kidney or liver with severe impairment of their function • Hypersensitivity to excipients of the IMP • Any severe or unstable lung disease e. g. active tuberculosis, cystic fibrosis, COPD • Chronic or severe acute diseases of nose or eyes • Irreversible secondary disorders of the target organs (e. g. emphysema, bronchiectasis) • Therapy with immunoglobulins • Completed or ongoing treatment with anti-IgE-antibody • Malignancy within the previous 5 years • Alcohol, drug, or medication abuse within the past year and/or during the study • Use of non-allowed medication (see section 5.3.1) • Contraindications for SPT • Contraindications for NPT • Relationship or dependence with the sponsor and/or investigator • Legal incapacity • Patients who are jurisdictional or governmentally institutionalized • Serious systemic reactions to allergen-specific immunotherapy in the past • Active chronic urticaria • Active severe atopic eczema • Existing or intended pregnancy, lactation or inadequate contraceptive measures for woman with child-bearing potential or a positive pregnancy test at screening • Severe psychiatric, psychological, or neurological disorders; completed or ongoing long-term treatment with tranquilizers or psychactive drugs (including tricyclic antidepressants) • Risk of non-compliance by the patient with study procedures

Design outcomes

Primary

Measure	Time frame
Main Objective: The purpose of this trial is to establish the optimal dose of SULGEN® Spray Birke in terms of benefit-risk balance. To assess the efficacy of four different doses of SULGEN® Spray Birke compared between each other and to placebo. The primary efficacy endpoint is defined as percentage of patients with an increased dosing step needed to provoke a positive response in the titrated nasal provocation test (tNPT) post-treatment compared with pre-treatment (i. e. any improvement) in each of the five study groups. This is based on the change of the response to tNPT with incremental concentrations of an allergen extract of Betula verrucosa from baseline to end of treatment. ;Secondary Objective: To assess the efficacy of four different doses of SULGEN® Spray Birke compared between each other and to placebo by the change in the number of dosing steps (pre-post difference) needed to provoke a positive response in the tNPT from baseline to end of treatment in each of the five study groups. To analyse the safety and tolerability of four different doses of SULGEN® Spray Birke compared between each other and to placebo by number of treatment-emergent adverse drug reactions and number of patients affected in each group. ;Primary end point(s): To assess the efficacy of four different doses of SULGEN® Spray Birke compared between each other and to placebo. The primary efficacy endpoint is defined as percentage of patients with an increased dosing step needed to provoke a positive response in the titrated nasal provocation test (tNPT) post-treatment compared with pre-treatment (i. e. any improvement) in each of the five study groups. This is based on the change of the response to tNPT with incremental concentrations of an allergen extract of Betula verrucosa from baseline to end of treatment. ;Timepoint(s) of evaluation of this end point: 9 months after start of trial	—

Measure

Time frame

Main Objective: The purpose of this trial is to establish the optimal dose of SULGEN® Spray Birke in terms of benefit-risk balance. To assess the efficacy of four different doses of SULGEN® Spray Birke compared between each other and to placebo. The primary efficacy endpoint is defined as percentage of patients with an increased dosing step needed to provoke a positive response in the titrated nasal provocation test (tNPT) post-treatment compared with pre-treatment (i. e. any improvement) in each of the five study groups. This is based on the change of the response to tNPT with incremental concentrations of an allergen extract of Betula verrucosa from baseline to end of treatment. ;Secondary Objective: To assess the efficacy of four different doses of SULGEN® Spray Birke compared between each other and to placebo by the change in the number of dosing steps (pre-post difference) needed to provoke a positive response in the tNPT from baseline to end of treatment in each of the five study groups. To analyse the safety and tolerability of four different doses of SULGEN® Spray Birke compared between each other and to placebo by number of treatment-emergent adverse drug reactions and number of patients affected in each group. ;Primary end point(s): To assess the efficacy of four different doses of SULGEN® Spray Birke compared between each other and to placebo. The primary efficacy endpoint is defined as percentage of patients with an increased dosing step needed to provoke a positive response in the titrated nasal provocation test (tNPT) post-treatment compared with pre-treatment (i. e. any improvement) in each of the five study groups. This is based on the change of the response to tNPT with incremental concentrations of an allergen extract of Betula verrucosa from baseline to end of treatment. ;Timepoint(s) of evaluation of this end point: 9 months after start of trial

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Secondary

Measure	Time frame
Secondary end point(s): To assess the efficacy of four different doses of SULGEN® Spray Birke compared between each other and to placebo by the change in the number of dosing steps (pre-post difference) needed to provoke a positive response in the tNPT from baseline to end of treatment in each of the five study groups. To analyse the safety and tolerability of four different doses of SULGEN® Spray Birke compared between each other and to placebo by number of treatment-emergent adverse drug reactions and number of patients affected in each group.;Timepoint(s) of evaluation of this end point: 9 months after start of trial	—

Measure

Time frame

Secondary end point(s): To assess the efficacy of four different doses of SULGEN® Spray Birke compared between each other and to placebo by the change in the number of dosing steps (pre-post difference) needed to provoke a positive response in the tNPT from baseline to end of treatment in each of the five study groups. To analyse the safety and tolerability of four different doses of SULGEN® Spray Birke compared between each other and to placebo by number of treatment-emergent adverse drug reactions and number of patients affected in each group.;Timepoint(s) of evaluation of this end point: 9 months after start of trial

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Countries

Germany

Contacts

Public ContactROXALL Medizin GmbH

ROXALL Medizin GmbH

ct@roxall.de0049408972520

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026