Allergic Rhinitis, Allergic Rhinoconjunctivitis
Conditions
Keywords
Allergic rhinitis, House dust mite, Adolescent, Pediatric
Brief summary
This is a 28-day clinical trial studying the safety of the house dust mite tablet in adolescents with allergic rhinitis/rhinoconjunctivitis. The purpose of this trial is to collect additional safety information about a tablet used to treat house dust mite allergies, when used to treat adolescents who have these allergies. The trial medication used is already approved to treat allergic rhinitis caused by house dust mite in adults and adolescents (12-17 years old) in several countries.
Detailed description
This trial is a 28-day, single-arm open-label phase III trial to evaluate safety of the house dust mite SLIT-tablet in adolescents (12-17 years of age) with HDM allergic rhinitis/rhinoconjunctivitis with or without asthma. Approximately 250 adolescents will be enrolled in the trial and will receive the house dust mite SLIT tablet. The trial is conducted in several European countries.
Interventions
BIOLOGICALHDM SLIT-tablet
Sublingual allergy immunotherapy tablet, for daily administration (1 tablet per day)
Sponsors
Syneos Health
ALK-Abelló A/S
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Non applicable
Intervention model description
single-armed
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Written informed consent * Male or female subjects aged ≥12 to ≤17 years * A clinical history of allergic rhinitis/rhinoconjunctivitis (AR/C) when exposed to HDM * Positive skin prick test (SPT) to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae at screening * Lung function measured by Forced expiratory volume in 1 second (FEV1) ≥ 70% of predicted value or according to local requirements while on subject's usual asthma medication * The subject must be willing and able to comply with trial protocol and adhere to IMP treatment Main
Exclusion criteria
* A subject who has previously been included in studies with the HDM SLIT-tablet, or otherwise being treated with the marketed HDM SLIT-tablet (e.g. ACARIZAX, ODACTRA) * Any SLIT or SCIT treatment with D. pteronyssinus or D. farinae reaching the maintenance dose within the last 5 years. In addition, any SLIT or SCIT treatment with D. pteronyssinus or D. farinae within the previous 12 months prior to visit 1 * Ongoing treatment with any allergy immunotherapy product at screening * Severe chronic oral inflammation * A diagnosis or history of eosinophilic oesophagitis * Any clinical deterioration of asthma that resulted in emergency treatment, hospitalisation or treatment with systemic corticosteroids within 3 months prior to first tablet administration * Female with positive urine pregnancy test, breastfeeding, pregnant or planning to become pregnant within the projected duration of the trial * Sexually active female of childbearing potential without medically accepted contraceptive method
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With at Least One Treatment-emergent Adverse Event (TEAE) | From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days. | At least one TEAE |
| Proportion of Subjects With at Least One Treatment-emergent Adverse Event (TEAE) | From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days. | At least one TEAE |
| Number of Treatment-emergent Adverse Events (TEAEs) | From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days. | At least one TEAE |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With at Least One IMP-related Adverse Event (AE) | From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days. | At least one IMP-related AE |
| Proportion of Subjects With at Least One IMP-related Adverse Event (AE) | From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days. | At least one IMP-related AE |
| Number of IMP-related Adverse Events (AEs) | From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days. | At least one IMP-related AE |
| Number of Subjects With at Least One Solicited Treatment-emergent Adverse Event (TEAE) | From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days. | At least one solicited TEAE |
| Proportion of Subjects With At Least One Treatment-emergent Serious Adverse Event (SAE) | From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days. | At least one treatment-emergent SAE |
| Number of Treatment-emergent Serious Adverse Events (SAEs) | From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days. | At least one treatment-emergent SAE |
| Number of Subjects With At Least One Treatment-emergent Serious Adverse Event (SAE) | From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days. | At least one treatment-emergent SAE |
| Proportion of Subjects With at Least One Solicited Treatment-emergent Adverse Event (TEAE) | From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days. | At least one solicited TEAE |
| Number of Solicited Treatment-emergent Adverse Events (TEAEs) | From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days. | At least one solicited TEAE |
Countries
Czechia, Germany, Slovakia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| HDM SLIT Tablet House dust mite (HDM) Sublingual allergy immunotherapy tablet
HDM SLIT-tablet: Sublingual allergy immunotherapy tablet, for daily administration (1 tablet per day) | 253 |
| Total | 253 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
Baseline characteristics
| Characteristic | HDM SLIT Tablet |
|---|---|
| Age, Categorical <=18 years | 253 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Asthma status No | 144 Participants |
| Asthma status Yes | 109 Participants |
| Baseline sensitisations HDM and others | 141 Participants |
| Baseline sensitisations HDM only | 112 Participants |
| BMI | 21.9 kg/m^2 STANDARD_DEVIATION 4.38 |
| Duration of asthma | 6.7 years STANDARD_DEVIATION 3.9 |
| Duration of HDM allergic rhinitis/rhinoconjunctivitis | 5.9 years STANDARD_DEVIATION 3.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 229 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 18 Participants |
| FEV1 (L) | 3.26 liters STANDARD_DEVIATION 0.78 |
| FEV1 (percentage predicted) | 96.10 percentage predicted FEV1 STANDARD_DEVIATION 12.84 |
| Height | 166.3 cm STANDARD_DEVIATION 10.6 |
| Inhaled corticosteroids No | 180 Participants |
| Inhaled corticosteroids Yes | 73 Participants |
| Region of Enrollment Czechia | 87 Participants |
| Region of Enrollment Germany | 29 Participants |
| Region of Enrollment Slovakia | 137 Participants |
| Regularly exposed to tobacco smoke No | 246 Participants |
| Regularly exposed to tobacco smoke Not applicable (current smokers) | 3 Participants |
| Regularly exposed to tobacco smoke Yes | 4 Participants |
| Sex: Female, Male Female | 101 Participants |
| Sex: Female, Male Male | 152 Participants |
| Smoking history Current | 3 Participants |
| Smoking history Never | 250 Participants |
| Weight | 61 kg STANDARD_DEVIATION 15.1 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 253 |
| other Total, other adverse events | 223 / 253 |
| serious Total, serious adverse events | 0 / 253 |
Outcome results
Primary
Number of Subjects With at Least One Treatment-emergent Adverse Event (TEAE)
At least one TEAE
Time frame: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HDM SLIT Tablet | Number of Subjects With at Least One Treatment-emergent Adverse Event (TEAE) | 223 subjects |
Primary
Number of Treatment-emergent Adverse Events (TEAEs)
At least one TEAE
Time frame: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HDM SLIT Tablet | Number of Treatment-emergent Adverse Events (TEAEs) | 1940 events |
Primary
Proportion of Subjects With at Least One Treatment-emergent Adverse Event (TEAE)
At least one TEAE
Time frame: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HDM SLIT Tablet | Proportion of Subjects With at Least One Treatment-emergent Adverse Event (TEAE) | 88.1 percent |
Secondary
Number of IMP-related Adverse Events (AEs)
At least one IMP-related AE
Time frame: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HDM SLIT Tablet | Number of IMP-related Adverse Events (AEs) | 1863 events |
Secondary
Number of Solicited Treatment-emergent Adverse Events (TEAEs)
At least one solicited TEAE
Time frame: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HDM SLIT Tablet | Number of Solicited Treatment-emergent Adverse Events (TEAEs) | 1796 events |
Secondary
Number of Subjects With at Least One IMP-related Adverse Event (AE)
At least one IMP-related AE
Time frame: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HDM SLIT Tablet | Number of Subjects With at Least One IMP-related Adverse Event (AE) | 218 subjects |
Secondary
Number of Subjects With at Least One Solicited Treatment-emergent Adverse Event (TEAE)
At least one solicited TEAE
Time frame: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HDM SLIT Tablet | Number of Subjects With at Least One Solicited Treatment-emergent Adverse Event (TEAE) | 216 subjects |
Secondary
Number of Subjects With At Least One Treatment-emergent Serious Adverse Event (SAE)
At least one treatment-emergent SAE
Time frame: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HDM SLIT Tablet | Number of Subjects With At Least One Treatment-emergent Serious Adverse Event (SAE) | 0 subjects |
Secondary
Number of Treatment-emergent Serious Adverse Events (SAEs)
At least one treatment-emergent SAE
Time frame: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HDM SLIT Tablet | Number of Treatment-emergent Serious Adverse Events (SAEs) | 0 events |
Secondary
Proportion of Subjects With at Least One IMP-related Adverse Event (AE)
At least one IMP-related AE
Time frame: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HDM SLIT Tablet | Proportion of Subjects With at Least One IMP-related Adverse Event (AE) | 86.2 percent |
Secondary
Proportion of Subjects With at Least One Solicited Treatment-emergent Adverse Event (TEAE)
At least one solicited TEAE
Time frame: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HDM SLIT Tablet | Proportion of Subjects With at Least One Solicited Treatment-emergent Adverse Event (TEAE) | 85.4 percent |
Secondary
Proportion of Subjects With At Least One Treatment-emergent Serious Adverse Event (SAE)
At least one treatment-emergent SAE
Time frame: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HDM SLIT Tablet | Proportion of Subjects With At Least One Treatment-emergent Serious Adverse Event (SAE) | 0 percent |