Phase 3
N=952
A Study in Children and Adolescents With Birch Pollen-induced Rhinoconjunctivitis
Allergy
Bottom Line
View on ClinicalTrials.gov: NCT04878354 ↗Enrolled (actual)
952
Serious AEs
1.2%
Results posted
Jan 2025
Primary outcome: Primary: Average Total Combined Score (TCS) During the Birch Pollen Season (BPS) — 5.88; 4.60 score on a scale — p=0.0004
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Tree SLIT-tablet (Drug); Placebo SLIT-tablet (Drug)
- Age
- Pediatric · 5+ yrs
- Sex
- All
- Sponsor
- ALK-Abelló A/S
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Total Combined Score (TCS) During the Birch Pollen Season (BPS) |
5.88; 4.60 | 0.0004 sig |
| SECONDARY Average Total Combined Score (TCS) During the Tree Pollen Season (TPS) |
4.51; 3.66 | 0.0010 sig |
| SECONDARY Average Daily Symptoms Score (DSS) During the Birch Pollen Season (BPS) |
2.75; 2.39 | 0.0354 sig |
| SECONDARY Average Daily Symptoms Score (DSS) During the Tree Pollen Season (TPS) |
2.28; 2.04 | 0.0734 |
| SECONDARY Average Daily Medication Score (DMS) During the Birch Pollen Season (BPS) |
2.42; 1.55 | <0.0001 sig |
| SECONDARY Average Daily Medication Score (DMS) During the Tree Pollen Season (TPS) |
1.72; 1.18 | 0.0002 sig |
| SECONDARY Average Total Combined Score (TCS) During the Alder Hazel Pollen Season (AHPS) |
2.83; 2.51 | 0.1516 |
| SECONDARY Average Daily Symptoms Score (DSS) During the Alder Hazel Pollen Season (AHPS) |
1.57; 1.56 | 0.9709 |
| SECONDARY Average Daily Medication Score (DMS) During the Alder Hazel Pollen Season (AHPS) |
0.80; 0.59 | 0.0499 sig |
| SECONDARY Average Total Combined Score (TCS) During the Oak Pollen Season (OPS) |
5.67; 4.22 | <0.0001 sig |
| SECONDARY Average Daily Symptoms Score (DSS) During the Oak Pollen Season (OPS) |
2.68; 2.20 | 0.0075 sig |
| SECONDARY Average Daily Medication Score (DMS) During the Oak Pollen Season (OPS) |
2.18; 1.31 | <0.0001 sig |
| SECONDARY Number of Severe Days During the Birch Pollen Season (BPS) |
0.23; 0.20 | <0.0001 sig |
| SECONDARY Number of Severe Days During the Tree Pollen Season (TPS) |
0.11; 0.11 | 0.9124 |
| SECONDARY Number of Well Days During the Birch Pollen Season (BPS) |
0.36; 0.43 | <0.0001 sig |
| SECONDARY Number of Well Days During the Tree Pollen Season (TPS) |
0.50; 0.53 | <0.0001 sig |
| SECONDARY Number of Symptom-free Days During the Birch Pollen Season (BPS) |
0.24; 0.29 | <0.0001 sig |
| SECONDARY Number of Symptom-free Days During the Tree Pollen Season (TPS) |
0.28; 0.30 | 0.0001 sig |
| SECONDARY Percentage of Patients Free of Symptoms and With no Use of Rescue Medication During the Birch Pollen Season (BPS) |
19; 18; 21; 20; 439; 435 | — |
| SECONDARY Percentage of Patients Free of Symptoms and With no Use of Rescue Medication During the Tree Pollen Season (TPS) |
15; 16; 10; 4; 454; 453 | — |
| SECONDARY Average Total Combined Score (TCS) (EAACI Scoring) During Birch Pollen Season (BPS) |
0.95; 0.77 | 0.0015 sig |
| SECONDARY Average Total Combined Score (TCS) (EAACI Scoring) During Tree Pollen Season (TPS) |
0.74; 0.62 | 0.0032 sig |
| SECONDARY Average Weekly Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score During the Birch Pollen Season (BPS) (12-17 Years Only) |
0.98; 0.97 | 0.9277 |
| SECONDARY Average Weekly Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score During the Tree Pollen Season (TPS) (12-17 Years Only) |
0.85; 0.86 | 0.9643 |
| SECONDARY Overall Paediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Score During the Birch Pollen Season (BPS) (5-11 Years Only) |
1.30; 1.12 | 0.0287 sig |
| SECONDARY Treatment Satisfaction (TSQM-9) |
79.6; 78.2; 59.8; 67.6; 62.1; 69.9 | — |
| SECONDARY Patient-rated Global Evaluation of Treatment Efficacy |
0.70; 0.85 | <0.0001 sig |
| SECONDARY Change From Baseline in Birch Specific IgE |
-0.21; 0.22; 0.10; 0.06 | <0.0001 sig |
| SECONDARY Change From Baseline in Birch Specific IgG4 |
-0.09; 0.43; 0.05; 0.54 | <0.0001 sig |
| SECONDARY Change From Baseline in Birch Specific IgE-Blocking Factor (IgE-BF) |
-0.01; 0.28; 0.04; 0.35 | <0.0001 sig |
| SECONDARY Change From Baseline in Alder, Hazel and Oak Specific IgE |
-0.22; 0.17; 0.18; 0.10; -0.22; 0.15 | — |
| SECONDARY Change From Baseline in Alder, Hazel and Oak Specific IgG4 |
-0.08; 0.38; 0.13; 0.51; -0.08; 0.35 | — |
| SECONDARY Change From Baseline in Alder and Hazel Specific IgE- Blocking Factor (IgE-BF) |
-0.03; 0.20; 0.04; 0.21; -0.03; 0.15 | — |
Summary
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?.
Eligibility 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:
- Sleep disturbance
- Impairment of daily activities, leisure and/or sport
- Impairment of school or work
- 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
Data sourced from ClinicalTrials.gov (NCT04878354). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.