Trial Outcomes & Findings for Adolescent Mite Allergy Safety Evaluation (NCT NCT04541004)
NCT ID: NCT04541004
Last Updated: 2023-07-03
Results Overview
At least one TEAE
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
253 participants
Primary outcome timeframe
From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
Results posted on
2023-07-03
Participant Flow
Participant milestones
| Measure |
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)
|
|---|---|
|
Overall Study
STARTED
|
253
|
|
Overall Study
COMPLETED
|
251
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
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)
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
Baseline Characteristics
Adolescent Mite Allergy Safety Evaluation
Baseline characteristics by cohort
| Measure |
HDM SLIT Tablet
n=253 Participants
House dust mite (HDM) Sublingual allergy immunotherapy tablet
HDM SLIT-tablet: Sublingual allergy immunotherapy tablet, for daily administration (1 tablet per day)
|
|---|---|
|
Age, Categorical
<=18 years
|
253 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
101 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
152 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
229 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
18 Participants
n=93 Participants
|
|
Region of Enrollment
Czechia
|
87 Participants
n=93 Participants
|
|
Region of Enrollment
Slovakia
|
137 Participants
n=93 Participants
|
|
Region of Enrollment
Germany
|
29 Participants
n=93 Participants
|
|
Height
|
166.3 cm
STANDARD_DEVIATION 10.6 • n=93 Participants
|
|
Weight
|
61 kg
STANDARD_DEVIATION 15.1 • n=93 Participants
|
|
BMI
|
21.9 kg/m^2
STANDARD_DEVIATION 4.38 • n=93 Participants
|
|
Smoking history
Current
|
3 Participants
n=93 Participants
|
|
Smoking history
Never
|
250 Participants
n=93 Participants
|
|
Regularly exposed to tobacco smoke
No
|
246 Participants
n=93 Participants
|
|
Regularly exposed to tobacco smoke
Yes
|
4 Participants
n=93 Participants
|
|
Regularly exposed to tobacco smoke
Not applicable (current smokers)
|
3 Participants
n=93 Participants
|
|
Baseline sensitisations
HDM only
|
112 Participants
n=93 Participants
|
|
Baseline sensitisations
HDM and others
|
141 Participants
n=93 Participants
|
|
Duration of HDM allergic rhinitis/rhinoconjunctivitis
|
5.9 years
STANDARD_DEVIATION 3.5 • n=93 Participants
|
|
Asthma status
No
|
144 Participants
n=93 Participants
|
|
Asthma status
Yes
|
109 Participants
n=93 Participants
|
|
Inhaled corticosteroids
No
|
180 Participants
n=93 Participants
|
|
Inhaled corticosteroids
Yes
|
73 Participants
n=93 Participants
|
|
Duration of asthma
|
6.7 years
STANDARD_DEVIATION 3.9 • n=93 Participants
|
|
FEV1 (percentage predicted)
|
96.10 percentage predicted FEV1
STANDARD_DEVIATION 12.84 • n=93 Participants
|
|
FEV1 (L)
|
3.26 liters
STANDARD_DEVIATION 0.78 • n=93 Participants
|
PRIMARY outcome
Timeframe: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.At least one TEAE
Outcome measures
| Measure |
HDM SLIT Tablet
n=253 Participants
House dust mite (HDM) Sublingual allergy immunotherapy tablet
HDM SLIT-tablet: Sublingual allergy immunotherapy tablet, for daily administration (1 tablet per day)
|
|---|---|
|
Number of Subjects With at Least One Treatment-emergent Adverse Event (TEAE)
|
223 subjects
|
PRIMARY outcome
Timeframe: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.At least one TEAE
Outcome measures
| Measure |
HDM SLIT Tablet
n=253 Participants
House dust mite (HDM) Sublingual allergy immunotherapy tablet
HDM SLIT-tablet: Sublingual allergy immunotherapy tablet, for daily administration (1 tablet per day)
|
|---|---|
|
Proportion of Subjects With at Least One Treatment-emergent Adverse Event (TEAE)
|
88.1 percent
Interval 84.3 to 91.3
|
PRIMARY outcome
Timeframe: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.At least one TEAE
Outcome measures
| Measure |
HDM SLIT Tablet
n=253 Participants
House dust mite (HDM) Sublingual allergy immunotherapy tablet
HDM SLIT-tablet: Sublingual allergy immunotherapy tablet, for daily administration (1 tablet per day)
|
|---|---|
|
Number of Treatment-emergent Adverse Events (TEAEs)
|
1940 events
|
SECONDARY outcome
Timeframe: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.At least one solicited TEAE
Outcome measures
| Measure |
HDM SLIT Tablet
n=253 Participants
House dust mite (HDM) Sublingual allergy immunotherapy tablet
HDM SLIT-tablet: Sublingual allergy immunotherapy tablet, for daily administration (1 tablet per day)
|
|---|---|
|
Number of Subjects With at Least One Solicited Treatment-emergent Adverse Event (TEAE)
|
216 subjects
|
SECONDARY outcome
Timeframe: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.At least one solicited TEAE
Outcome measures
| Measure |
HDM SLIT Tablet
n=253 Participants
House dust mite (HDM) Sublingual allergy immunotherapy tablet
HDM SLIT-tablet: Sublingual allergy immunotherapy tablet, for daily administration (1 tablet per day)
|
|---|---|
|
Proportion of Subjects With at Least One Solicited Treatment-emergent Adverse Event (TEAE)
|
85.4 percent
Interval 81.2 to 88.9
|
SECONDARY outcome
Timeframe: From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.At least one solicited TEAE
Outcome measures
| Measure |
HDM SLIT Tablet
n=253 Participants
House dust mite (HDM) Sublingual allergy immunotherapy tablet
HDM SLIT-tablet: Sublingual allergy immunotherapy tablet, for daily administration (1 tablet per day)
|
|---|---|
|
Number of Solicited Treatment-emergent Adverse Events (TEAEs)
|
1796 events
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
HDM SLIT Tablet
n=253 Participants
House dust mite (HDM) Sublingual allergy immunotherapy tablet
HDM SLIT-tablet: Sublingual allergy immunotherapy tablet, for daily administration (1 tablet per day)
|
|---|---|
|
Number of Subjects With at Least One IMP-related Adverse Event (AE)
|
218 subjects
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
HDM SLIT Tablet
n=253 Participants
House dust mite (HDM) Sublingual allergy immunotherapy tablet
HDM SLIT-tablet: Sublingual allergy immunotherapy tablet, for daily administration (1 tablet per day)
|
|---|---|
|
Proportion of Subjects With at Least One IMP-related Adverse Event (AE)
|
86.2 percent
Interval 82.1 to 89.6
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
HDM SLIT Tablet
n=253 Participants
House dust mite (HDM) Sublingual allergy immunotherapy tablet
HDM SLIT-tablet: Sublingual allergy immunotherapy tablet, for daily administration (1 tablet per day)
|
|---|---|
|
Number of IMP-related Adverse Events (AEs)
|
1863 events
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
HDM SLIT Tablet
n=253 Participants
House dust mite (HDM) Sublingual allergy immunotherapy tablet
HDM SLIT-tablet: Sublingual allergy immunotherapy tablet, for daily administration (1 tablet per day)
|
|---|---|
|
Number of Subjects With At Least One Treatment-emergent Serious Adverse Event (SAE)
|
0 subjects
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
HDM SLIT Tablet
n=253 Participants
House dust mite (HDM) Sublingual allergy immunotherapy tablet
HDM SLIT-tablet: Sublingual allergy immunotherapy tablet, for daily administration (1 tablet per day)
|
|---|---|
|
Proportion of Subjects With At Least One Treatment-emergent Serious Adverse Event (SAE)
|
0 percent
Interval 0.0 to 1.18
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
HDM SLIT Tablet
n=253 Participants
House dust mite (HDM) Sublingual allergy immunotherapy tablet
HDM SLIT-tablet: Sublingual allergy immunotherapy tablet, for daily administration (1 tablet per day)
|
|---|---|
|
Number of Treatment-emergent Serious Adverse Events (SAEs)
|
0 events
|
Adverse Events
HDM SLIT Tablet
Serious events: 0 serious events
Other events: 223 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
HDM SLIT Tablet
n=253 participants at risk
House dust mite (HDM) Sublingual allergy immunotherapy tablet
HDM SLIT-tablet: Sublingual allergy immunotherapy tablet, for daily administration (1 tablet per day)
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal paraesthesia
|
6.7%
17/253 • Number of events 34 • AEs were collected from consent to 7 days after end-of-trial or discontinuation (from first IMP intake to 7 days after end-of-trial or discontinuation, up to 35 days).
An AE is any untoward medical occurrence in a clinical trial subject, and which does not necessarily have a causal relationship with the administered IMP. An AE can therefore be any unfavourable and unintended sign (including e.g. a medication error), symptom, or disease, whether considered related to the IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal swelling
|
13.0%
33/253 • Number of events 59 • AEs were collected from consent to 7 days after end-of-trial or discontinuation (from first IMP intake to 7 days after end-of-trial or discontinuation, up to 35 days).
An AE is any untoward medical occurrence in a clinical trial subject, and which does not necessarily have a causal relationship with the administered IMP. An AE can therefore be any unfavourable and unintended sign (including e.g. a medication error), symptom, or disease, whether considered related to the IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
52.2%
132/253 • Number of events 323 • AEs were collected from consent to 7 days after end-of-trial or discontinuation (from first IMP intake to 7 days after end-of-trial or discontinuation, up to 35 days).
An AE is any untoward medical occurrence in a clinical trial subject, and which does not necessarily have a causal relationship with the administered IMP. An AE can therefore be any unfavourable and unintended sign (including e.g. a medication error), symptom, or disease, whether considered related to the IMP.
|
|
Nervous system disorders
Dysgeusia
|
6.3%
16/253 • Number of events 24 • AEs were collected from consent to 7 days after end-of-trial or discontinuation (from first IMP intake to 7 days after end-of-trial or discontinuation, up to 35 days).
An AE is any untoward medical occurrence in a clinical trial subject, and which does not necessarily have a causal relationship with the administered IMP. An AE can therefore be any unfavourable and unintended sign (including e.g. a medication error), symptom, or disease, whether considered related to the IMP.
|
|
Ear and labyrinth disorders
Ear pruritus
|
39.9%
101/253 • Number of events 270 • AEs were collected from consent to 7 days after end-of-trial or discontinuation (from first IMP intake to 7 days after end-of-trial or discontinuation, up to 35 days).
An AE is any untoward medical occurrence in a clinical trial subject, and which does not necessarily have a causal relationship with the administered IMP. An AE can therefore be any unfavourable and unintended sign (including e.g. a medication error), symptom, or disease, whether considered related to the IMP.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
15.8%
40/253 • Number of events 77 • AEs were collected from consent to 7 days after end-of-trial or discontinuation (from first IMP intake to 7 days after end-of-trial or discontinuation, up to 35 days).
An AE is any untoward medical occurrence in a clinical trial subject, and which does not necessarily have a causal relationship with the administered IMP. An AE can therefore be any unfavourable and unintended sign (including e.g. a medication error), symptom, or disease, whether considered related to the IMP.
|
|
Gastrointestinal disorders
Diarrhoea
|
9.5%
24/253 • Number of events 30 • AEs were collected from consent to 7 days after end-of-trial or discontinuation (from first IMP intake to 7 days after end-of-trial or discontinuation, up to 35 days).
An AE is any untoward medical occurrence in a clinical trial subject, and which does not necessarily have a causal relationship with the administered IMP. An AE can therefore be any unfavourable and unintended sign (including e.g. a medication error), symptom, or disease, whether considered related to the IMP.
|
|
Gastrointestinal disorders
Enlarged uvula
|
5.5%
14/253 • Number of events 38 • AEs were collected from consent to 7 days after end-of-trial or discontinuation (from first IMP intake to 7 days after end-of-trial or discontinuation, up to 35 days).
An AE is any untoward medical occurrence in a clinical trial subject, and which does not necessarily have a causal relationship with the administered IMP. An AE can therefore be any unfavourable and unintended sign (including e.g. a medication error), symptom, or disease, whether considered related to the IMP.
|
|
Gastrointestinal disorders
Glossodynia
|
16.2%
41/253 • Number of events 87 • AEs were collected from consent to 7 days after end-of-trial or discontinuation (from first IMP intake to 7 days after end-of-trial or discontinuation, up to 35 days).
An AE is any untoward medical occurrence in a clinical trial subject, and which does not necessarily have a causal relationship with the administered IMP. An AE can therefore be any unfavourable and unintended sign (including e.g. a medication error), symptom, or disease, whether considered related to the IMP.
|
|
Gastrointestinal disorders
Lip oedema
|
4.3%
11/253 • Number of events 15 • AEs were collected from consent to 7 days after end-of-trial or discontinuation (from first IMP intake to 7 days after end-of-trial or discontinuation, up to 35 days).
An AE is any untoward medical occurrence in a clinical trial subject, and which does not necessarily have a causal relationship with the administered IMP. An AE can therefore be any unfavourable and unintended sign (including e.g. a medication error), symptom, or disease, whether considered related to the IMP.
|
|
Gastrointestinal disorders
Lip swelling
|
15.8%
40/253 • Number of events 89 • AEs were collected from consent to 7 days after end-of-trial or discontinuation (from first IMP intake to 7 days after end-of-trial or discontinuation, up to 35 days).
An AE is any untoward medical occurrence in a clinical trial subject, and which does not necessarily have a causal relationship with the administered IMP. An AE can therefore be any unfavourable and unintended sign (including e.g. a medication error), symptom, or disease, whether considered related to the IMP.
|
|
Gastrointestinal disorders
Mouth swelling
|
5.5%
14/253 • Number of events 32 • AEs were collected from consent to 7 days after end-of-trial or discontinuation (from first IMP intake to 7 days after end-of-trial or discontinuation, up to 35 days).
An AE is any untoward medical occurrence in a clinical trial subject, and which does not necessarily have a causal relationship with the administered IMP. An AE can therefore be any unfavourable and unintended sign (including e.g. a medication error), symptom, or disease, whether considered related to the IMP.
|
|
Gastrointestinal disorders
Mouth ulceration
|
15.0%
38/253 • Number of events 68 • AEs were collected from consent to 7 days after end-of-trial or discontinuation (from first IMP intake to 7 days after end-of-trial or discontinuation, up to 35 days).
An AE is any untoward medical occurrence in a clinical trial subject, and which does not necessarily have a causal relationship with the administered IMP. An AE can therefore be any unfavourable and unintended sign (including e.g. a medication error), symptom, or disease, whether considered related to the IMP.
|
|
Gastrointestinal disorders
Nausea
|
15.8%
40/253 • Number of events 83 • AEs were collected from consent to 7 days after end-of-trial or discontinuation (from first IMP intake to 7 days after end-of-trial or discontinuation, up to 35 days).
An AE is any untoward medical occurrence in a clinical trial subject, and which does not necessarily have a causal relationship with the administered IMP. An AE can therefore be any unfavourable and unintended sign (including e.g. a medication error), symptom, or disease, whether considered related to the IMP.
|
|
Gastrointestinal disorders
Oedema mouth
|
8.3%
21/253 • Number of events 35 • AEs were collected from consent to 7 days after end-of-trial or discontinuation (from first IMP intake to 7 days after end-of-trial or discontinuation, up to 35 days).
An AE is any untoward medical occurrence in a clinical trial subject, and which does not necessarily have a causal relationship with the administered IMP. An AE can therefore be any unfavourable and unintended sign (including e.g. a medication error), symptom, or disease, whether considered related to the IMP.
|
|
Gastrointestinal disorders
Oral pain
|
4.0%
10/253 • Number of events 19 • AEs were collected from consent to 7 days after end-of-trial or discontinuation (from first IMP intake to 7 days after end-of-trial or discontinuation, up to 35 days).
An AE is any untoward medical occurrence in a clinical trial subject, and which does not necessarily have a causal relationship with the administered IMP. An AE can therefore be any unfavourable and unintended sign (including e.g. a medication error), symptom, or disease, whether considered related to the IMP.
|
|
Gastrointestinal disorders
Oral pruritus
|
66.8%
169/253 • Number of events 421 • AEs were collected from consent to 7 days after end-of-trial or discontinuation (from first IMP intake to 7 days after end-of-trial or discontinuation, up to 35 days).
An AE is any untoward medical occurrence in a clinical trial subject, and which does not necessarily have a causal relationship with the administered IMP. An AE can therefore be any unfavourable and unintended sign (including e.g. a medication error), symptom, or disease, whether considered related to the IMP.
|
|
Gastrointestinal disorders
Swollen tongue
|
11.5%
29/253 • Number of events 51 • AEs were collected from consent to 7 days after end-of-trial or discontinuation (from first IMP intake to 7 days after end-of-trial or discontinuation, up to 35 days).
An AE is any untoward medical occurrence in a clinical trial subject, and which does not necessarily have a causal relationship with the administered IMP. An AE can therefore be any unfavourable and unintended sign (including e.g. a medication error), symptom, or disease, whether considered related to the IMP.
|
|
Gastrointestinal disorders
Tongue eruption
|
2.4%
6/253 • Number of events 16 • AEs were collected from consent to 7 days after end-of-trial or discontinuation (from first IMP intake to 7 days after end-of-trial or discontinuation, up to 35 days).
An AE is any untoward medical occurrence in a clinical trial subject, and which does not necessarily have a causal relationship with the administered IMP. An AE can therefore be any unfavourable and unintended sign (including e.g. a medication error), symptom, or disease, whether considered related to the IMP.
|
|
Gastrointestinal disorders
Tongue ulceration
|
16.6%
42/253 • Number of events 79 • AEs were collected from consent to 7 days after end-of-trial or discontinuation (from first IMP intake to 7 days after end-of-trial or discontinuation, up to 35 days).
An AE is any untoward medical occurrence in a clinical trial subject, and which does not necessarily have a causal relationship with the administered IMP. An AE can therefore be any unfavourable and unintended sign (including e.g. a medication error), symptom, or disease, whether considered related to the IMP.
|
|
Gastrointestinal disorders
Vomiting
|
2.4%
6/253 • Number of events 9 • AEs were collected from consent to 7 days after end-of-trial or discontinuation (from first IMP intake to 7 days after end-of-trial or discontinuation, up to 35 days).
An AE is any untoward medical occurrence in a clinical trial subject, and which does not necessarily have a causal relationship with the administered IMP. An AE can therefore be any unfavourable and unintended sign (including e.g. a medication error), symptom, or disease, whether considered related to the IMP.
|
|
Infections and infestations
Rhinitis
|
2.4%
6/253 • Number of events 10 • AEs were collected from consent to 7 days after end-of-trial or discontinuation (from first IMP intake to 7 days after end-of-trial or discontinuation, up to 35 days).
An AE is any untoward medical occurrence in a clinical trial subject, and which does not necessarily have a causal relationship with the administered IMP. An AE can therefore be any unfavourable and unintended sign (including e.g. a medication error), symptom, or disease, whether considered related to the IMP.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60