Trial Outcomes & Findings for Efficacy and Safety of Sublingual Tablets of Grass Pollen Allergen Extract (NCT NCT00619827)

Results Overview

The primary efficacy variable was the Average of Rhinoconjunctivitis Total Symptom Score (ARTSS) during the four-hour (\]0-4\] hours) grass pollen allergen challenge at end point (after four months of treatment) of the 6 rhinoconjunctivitis symptoms (sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes). The severity of each symptom was evaluated by the subject, before allergen exposure and every 15 minutes during allergen challenge on a scale of 0 to 3; 0: no symptoms, 1: mild symptoms, 2: moderate symptoms, 3: severe symptoms, total score range was 0 to 18. The ARTSS \]0-4\] hours was calculated as the mean of the RTSSs at each timepoint during the allergen challenge (i.e., 16 timepoints from 15 minutes to 4 hours) after 4 months of treatment (endpoint). The lower the score, the better the outcome.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

89 participants

Primary outcome timeframe

4 months

Results posted on

2016-05-23

Participant Flow

First Patient First Visit 17 SEP 2007, Last Patient Last Visit 10 MAR 2008

Participant milestones

Participant milestones
Measure	300 IR 300 IR grass pollen allergen extract tablet	Placebo Placebo tablet
Overall Study STARTED	45	44
Overall Study COMPLETED	42	40
Overall Study NOT COMPLETED	3	4

Reasons for withdrawal

Reasons for withdrawal
Measure	300 IR 300 IR grass pollen allergen extract tablet	Placebo Placebo tablet
Overall Study Adverse Event	1	2
Overall Study Withdrawal by Subject	2	2

Baseline Characteristics

Efficacy and Safety of Sublingual Tablets of Grass Pollen Allergen Extract

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	300 IR n=45 Participants 300 IR grass pollen allergen extract tablet	Placebo n=44 Participants Placebo tablet	Total n=89 Participants Total of all reporting groups
Age, Continuous	27.46 years STANDARD_DEVIATION 6.577 • n=5 Participants	27.12 years STANDARD_DEVIATION 5.807 • n=7 Participants	27.29 years STANDARD_DEVIATION 6.175 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	28 Participants n=7 Participants	52 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	16 Participants n=7 Participants	37 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4 months

Population: The Intent-to-treat (ITT) population included all randomised subjects who received at least one dose of the investigational product.

The primary efficacy variable was the Average of Rhinoconjunctivitis Total Symptom Score (ARTSS) during the four-hour (\]0-4\] hours) grass pollen allergen challenge at end point (after four months of treatment) of the 6 rhinoconjunctivitis symptoms (sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes). The severity of each symptom was evaluated by the subject, before allergen exposure and every 15 minutes during allergen challenge on a scale of 0 to 3; 0: no symptoms, 1: mild symptoms, 2: moderate symptoms, 3: severe symptoms, total score range was 0 to 18. The ARTSS \]0-4\] hours was calculated as the mean of the RTSSs at each timepoint during the allergen challenge (i.e., 16 timepoints from 15 minutes to 4 hours) after 4 months of treatment (endpoint). The lower the score, the better the outcome.

Outcome measures

Outcome measures
Measure	300 IR n=45 Participants 300 IR grass pollen allergen extract tablet	Placebo n=44 Participants Placebo tablet
Average of Rhinoconjunctivitis Total Symptom Score (ARTSS) ]0-4] Hours	4.88 Units on a scale (range: 0 to 18) Standard Error 0.363	6.84 Units on a scale (range: 0 to 18) Standard Error 0.367

Adverse Events

300 IR

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	300 IR n=45 participants at risk 300 IR grass pollen allergen extract tablet	Placebo n=44 participants at risk Placebo tablet
Ear and labyrinth disorders Ear pruritus	6.7% 3/45 • 4 months. A Treatment Emergent Adverse Event (TEAE) is defined as any adverse event that started on or after the first intake of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publication.	0.00% 0/44 • 4 months. A Treatment Emergent Adverse Event (TEAE) is defined as any adverse event that started on or after the first intake of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publication.
Gastrointestinal disorders Oral pruritus	35.6% 16/45 • 4 months. A Treatment Emergent Adverse Event (TEAE) is defined as any adverse event that started on or after the first intake of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publication.	0.00% 0/44 • 4 months. A Treatment Emergent Adverse Event (TEAE) is defined as any adverse event that started on or after the first intake of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publication.
Respiratory, thoracic and mediastinal disorders Throat irritation	35.6% 16/45 • 4 months. A Treatment Emergent Adverse Event (TEAE) is defined as any adverse event that started on or after the first intake of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publication.	0.00% 0/44 • 4 months. A Treatment Emergent Adverse Event (TEAE) is defined as any adverse event that started on or after the first intake of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publication.
Nervous system disorders Headache	17.8% 8/45 • 4 months. A Treatment Emergent Adverse Event (TEAE) is defined as any adverse event that started on or after the first intake of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publication.	18.2% 8/44 • 4 months. A Treatment Emergent Adverse Event (TEAE) is defined as any adverse event that started on or after the first intake of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publication.
Infections and infestations Nasopharyngitis	4.4% 2/45 • 4 months. A Treatment Emergent Adverse Event (TEAE) is defined as any adverse event that started on or after the first intake of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publication.	9.1% 4/44 • 4 months. A Treatment Emergent Adverse Event (TEAE) is defined as any adverse event that started on or after the first intake of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publication.

Additional Information

Laurence Paolozzi, Medical Director

Stallergenes

Phone: +33 (0) 1 55 59 26 33

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place