Trial Outcomes & Findings for Study Immunology and Safety of 60-day Treatment of SQ Grass SLIT (Sublingual Immunotherapy)-Tablet in Adult Subjects With Grass Pollen-induced Allergic Rhinoconjunctivitis (NCT NCT02245360)
NCT ID: NCT02245360
Last Updated: 2016-01-11
Results Overview
measurement of IgG4 in serum
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
107 participants
Primary outcome timeframe
baseline versus end of treatment (approx. 60 days)
Results posted on
2016-01-11
Participant Flow
Participant milestones
| Measure |
Grass Tablet 75,000 SQ-T
Grass tablet 75,000 Standardized Quality units Tablet (SQ-T)
Phleum pratense grass pollen allergen extract: Allergy Immunotherapy grass tablet 75,000 SQ-T given once daily over 60 days
|
Placebo
Placebo
placebo: placebo tablet given once daily over 60 days
|
|---|---|---|
|
Overall Study
STARTED
|
53
|
54
|
|
Overall Study
COMPLETED
|
48
|
52
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study Immunology and Safety of 60-day Treatment of SQ Grass SLIT (Sublingual Immunotherapy)-Tablet in Adult Subjects With Grass Pollen-induced Allergic Rhinoconjunctivitis
Baseline characteristics by cohort
| Measure |
Grass Tablet 75,000 SQ-T
n=53 Participants
Grass tablet 75,000 Standardized Quality units Tablet (SQ-T)
Phleum pratense grass pollen allergen extract: Allergy Immunotherapy grass tablet 75,000 SQ-T given once daily over 60 days
|
Placebo
n=54 Participants
Placebo
placebo: placebo tablet given once daily over 60 days
|
Total
n=107 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
53 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
35.8 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
34.1 years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
34.9 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Region of Enrollment
Russian Federation
|
53 participants
n=5 Participants
|
54 participants
n=7 Participants
|
107 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline versus end of treatment (approx. 60 days)Population: In each treatment arm/group 1 subject was excluded from the analyzed sample due to missing post-baseline efficacy data.
measurement of IgG4 in serum
Outcome measures
| Measure |
Grass Tablet 75,000 SQ-T
n=52 Participants
Grass tablet 75,000 Standardized Quality units Tablet (SQ-T)
Phleum pratense grass pollen allergen extract: Allergy Immunotherapy grass tablet 75,000 SQ-T given once daily over 60 days
|
Placebo
n=53 Participants
Placebo
placebo: placebo tablet given once daily over 60 days
|
|---|---|---|
|
The Primary Efficacy Endpoint is Change From Baseline to End of Treatment of Phleum Pratense Specific Immunoglobulin G4 (IgG4) in Serum
|
0.684 mgA/L
Standard Deviation 1.691
|
0.050 mgA/L
Standard Deviation 0.588
|
SECONDARY outcome
Timeframe: baseline versus end of treatment (approx. 60 days)Population: In each treatment arm/group 1 subject was excluded from the analyzed sample due to missing post-baseline efficacy data.
measurement of IgE in serum
Outcome measures
| Measure |
Grass Tablet 75,000 SQ-T
n=52 Participants
Grass tablet 75,000 Standardized Quality units Tablet (SQ-T)
Phleum pratense grass pollen allergen extract: Allergy Immunotherapy grass tablet 75,000 SQ-T given once daily over 60 days
|
Placebo
n=53 Participants
Placebo
placebo: placebo tablet given once daily over 60 days
|
|---|---|---|
|
Change of Phleum Pratense Specific Immunoglobulin E (IgE) From Baseline to End of Treatment
|
22.751 UA/ml
Standard Deviation 29.364
|
-2.756 UA/ml
Standard Deviation 16.933
|
Adverse Events
Grass Tablet 75,000 SQ-T
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Grass Tablet 75,000 SQ-T
n=53 participants at risk
Grass tablet 75,000 Standardized Quality units Tablet (SQ-T)
Phleum pratense grass pollen allergen extract: Allergy Immunotherapy grass tablet 75,000 SQ-T given once daily over 60 days
|
Placebo
n=54 participants at risk
Placebo
placebo: placebo tablet given once daily over 60 days
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
32.1%
17/53 • Number of events 17
|
7.4%
4/54 • Number of events 4
|
|
Gastrointestinal disorders
Oral pruritus
|
13.2%
7/53 • Number of events 7
|
3.7%
2/54 • Number of events 2
|
|
Gastrointestinal disorders
Tongue oedema
|
5.7%
3/53 • Number of events 3
|
0.00%
0/54
|
|
Infections and infestations
Respiratory tract infection viral
|
5.7%
3/53 • Number of events 3
|
11.1%
6/54 • Number of events 6
|
|
Ear and labyrinth disorders
Ear pruritus
|
5.7%
3/53 • Number of events 3
|
0.00%
0/54
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place