Trial Outcomes & Findings for Grass Pollen Allergen Immunotherapy Tablet (AIT) Time Course Study (NCT NCT02005627)

NCT ID: NCT02005627

Last Updated: 2019-12-04

Results Overview

The total nasal symptom score at one hour after grass pollen nasal allergen challenge in active versus placebo treated participants after treatment period. Score ranges from minimum 0 point to maximum of 12 points. Higher score is more severe symptoms.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 46 participants
• Primary outcome timeframe: 60 minutes post-challenge after 12 months of treatment
• Results posted on: 2019-12-04

Participant Flow

Participant milestones

Measure	Grazax The active treatment arm received active grass pollen immunotherapy tablet (AIT), Grazax Oral Lyophilisate 75,000 standardised quality units tablet (SQ-T) once daily. Grazax: The active treatment arm will receive active grass pollen immunotherapy tablet (AIT), Grazax Oral Lyophilisate 75,000 SQ-T once daily.	Grazax Placebo This arm received Grazax placebo once daily which contains the same composition as in the active Grazax tablet with the only difference being the exclusion of the grass pollen allergen extract. Grazax Placebo: This arm will receive Grazax placebo once daily which contains the same composition as in the active Grazax tablet with the only difference being the exclusion of the grass pollen allergen extract.
Overall Study STARTED	23	23
Overall Study COMPLETED	21	19
Overall Study NOT COMPLETED	2	4

Reasons for withdrawal

Measure	Grazax The active treatment arm received active grass pollen immunotherapy tablet (AIT), Grazax Oral Lyophilisate 75,000 standardised quality units tablet (SQ-T) once daily. Grazax: The active treatment arm will receive active grass pollen immunotherapy tablet (AIT), Grazax Oral Lyophilisate 75,000 SQ-T once daily.	Grazax Placebo This arm received Grazax placebo once daily which contains the same composition as in the active Grazax tablet with the only difference being the exclusion of the grass pollen allergen extract. Grazax Placebo: This arm will receive Grazax placebo once daily which contains the same composition as in the active Grazax tablet with the only difference being the exclusion of the grass pollen allergen extract.
Overall Study Lost to Follow-up	1	2
Overall Study Withdrawal by Subject	1	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Grazax n=23 Participants The active treatment arm received active grass pollen immunotherapy tablet, Grazax Oral Lyophilisate 75,000 standardised quality units tablet once daily.	Grazax Placebo n=23 Participants This arm received Grazax placebo once daily which contains the same composition as in the active Grazax tablet with the only difference being the exclusion of the grass pollen allergen extract.	Total n=46 Participants Total of all reporting groups
Age, Continuous	31.5 years STANDARD_DEVIATION 2.12 • n=23 Participants	36.9 years STANDARD_DEVIATION 1.97 • n=23 Participants	34.2 years STANDARD_DEVIATION 2.04 • n=46 Participants
Sex: Female, Male Female	10 Participants n=23 Participants	5 Participants n=23 Participants	15 Participants n=46 Participants
Sex: Female, Male Male	13 Participants n=23 Participants	18 Participants n=23 Participants	31 Participants n=46 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United Kingdom	23 participants n=23 Participants	23 participants n=23 Participants	46 participants n=46 Participants
Specific Immunoglobulin E (IgE)	14.4 kU/l STANDARD_DEVIATION 3.12 • n=23 Participants	14.17 kU/l STANDARD_DEVIATION 2.81 • n=23 Participants	14.28 kU/l STANDARD_DEVIATION 2.96 • n=46 Participants

PRIMARY outcome

Timeframe: 60 minutes post-challenge after 12 months of treatment

The total nasal symptom score at one hour after grass pollen nasal allergen challenge in active versus placebo treated participants after treatment period. Score ranges from minimum 0 point to maximum of 12 points. Higher score is more severe symptoms.

Outcome measures

Measure	Grazax n=23 Participants The active treatment arm received active grass pollen immunotherapy tablet, Grazax Oral Lyophilisate 75,000 standardised quality units tablet once daily.	Grazax Placebo n=23 Participants This arm received Grazax placebo once daily which contains the same composition as in the active Grazax tablet with the only difference being the exclusion of the grass pollen allergen extract.
Total Nasal Symptom Score After Nasal Allergen Challenge (NAC)	3.37 score on a scale Interval 2.7 to 4.05	4.71 score on a scale Interval 4.0 to 5.4

SECONDARY outcome

Timeframe: after 12 months of treatment

Mean Diameter in millimetre of EPR skin responses to intradermal grass pollen allergen injection at 12 months in active versus placebo treated participants. The larger the diameter the worst symptoms.

Outcome measures

Measure	Grazax n=23 Participants The active treatment arm received active grass pollen immunotherapy tablet, Grazax Oral Lyophilisate 75,000 standardised quality units tablet once daily.	Grazax Placebo n=23 Participants This arm received Grazax placebo once daily which contains the same composition as in the active Grazax tablet with the only difference being the exclusion of the grass pollen allergen extract.
Early Phase Intradermal Test	15.3 Millimiters Standard Error 1.1	20.2 Millimiters Standard Error 1.1

SECONDARY outcome

Timeframe: after 12 months of treatment

Mean Diameter in millimetre of LPR skin responses to intradermal grass pollen allergen injection at 12 months in active versus placebo treated participants. The larger the diameter the worst symptoms

Outcome measures

Measure	Grazax n=23 Participants The active treatment arm received active grass pollen immunotherapy tablet, Grazax Oral Lyophilisate 75,000 standardised quality units tablet once daily.	Grazax Placebo n=23 Participants This arm received Grazax placebo once daily which contains the same composition as in the active Grazax tablet with the only difference being the exclusion of the grass pollen allergen extract.
Late Phase Intradermal Test	52.6 millimeters Standard Error 3.4	74.6 millimeters Standard Error 3.4

SECONDARY outcome

Timeframe: 60 minutes post-challenge after 12 months of treatment

Nasal patency assessed at 60 minutes after nasal allergen challenge 12 months after treatment. The lower the peak nasal inspiratory flow the blockage nasal patency is.

Outcome measures

Measure	Grazax n=23 Participants The active treatment arm received active grass pollen immunotherapy tablet, Grazax Oral Lyophilisate 75,000 standardised quality units tablet once daily.	Grazax Placebo n=23 Participants This arm received Grazax placebo once daily which contains the same composition as in the active Grazax tablet with the only difference being the exclusion of the grass pollen allergen extract.
Change From Baseline in Delta Peak Nasal Inspiratory Flow in L/Min	-29.2 L/min Interval -44.8 to -13.5	-72.5 L/min Interval -88.8 to -56.1

SECONDARY outcome

Timeframe: after treatment at 12 months

Hayfever symptoms during last pollen season after start of treatment. Score on a scale ranges from minimum 0 point to maximum of 100 points. Higher score is more severe symptoms.

Outcome measures

Measure	Grazax n=23 Participants The active treatment arm received active grass pollen immunotherapy tablet, Grazax Oral Lyophilisate 75,000 standardised quality units tablet once daily.	Grazax Placebo n=23 Participants This arm received Grazax placebo once daily which contains the same composition as in the active Grazax tablet with the only difference being the exclusion of the grass pollen allergen extract.
End of Season Global Rhinitis Symptoms	40.4 score on a scale Standard Error 5.18	54.97 score on a scale Standard Error 5.43

Adverse Events

Grazax

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Grazax Placebo

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Grazax n=23 participants at risk The active treatment arm received active grass pollen immunotherapy tablet (AIT), Grazax Oral Lyophilisate 75,000 standardised quality units tablet (SQ-T) once daily. Grazax: The active treatment arm will receive active grass pollen immunotherapy tablet (AIT), Grazax Oral Lyophilisate 75,000 SQ-T once daily.	Grazax Placebo n=23 participants at risk This arm received Grazax placebo once daily which contains the same composition as in the active Grazax tablet with the only difference being the exclusion of the grass pollen allergen extract. Grazax Placebo: This arm will receive Grazax placebo once daily which contains the same composition as in the active Grazax tablet with the only difference being the exclusion of the grass pollen allergen extract.
Gastrointestinal disorders Dyspepsia	26.1% 6/23 • Number of events 8 • 1 year	0.00% 0/23 • 1 year
Gastrointestinal disorders Abdominal pain	4.3% 1/23 • Number of events 1 • 1 year	0.00% 0/23 • 1 year
Gastrointestinal disorders Mucositis oral	4.3% 1/23 • Number of events 1 • 1 year	4.3% 1/23 • Number of events 1 • 1 year
Immune system disorders Allergic Reaction	82.6% 19/23 • Number of events 23 • 1 year	13.0% 3/23 • Number of events 3 • 1 year
General disorders Tooth ache	8.7% 2/23 • Number of events 2 • 1 year	0.00% 0/23 • 1 year
Gastrointestinal disorders Vomiting	17.4% 4/23 • Number of events 4 • 1 year	0.00% 0/23 • 1 year
Infections and infestations Common cold/URTI	65.2% 15/23 • Number of events 88 • 1 year	87.0% 20/23 • Number of events 60 • 1 year
Nervous system disorders Headache	21.7% 5/23 • Number of events 38 • 1 year	21.7% 5/23 • Number of events 66 • 1 year

Additional Information

Stephen R Durham

Imperial College London

Phone: +44207-351-8024

Email: s.durham@imperial.ac.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place