Trial Outcomes & Findings for Safety Study of Ragweed Allergy Immunotherapy Tablet in Subjects 50 Years of Age and Older (Study P06081) (NCT NCT00978029)

Results Overview

Participants were treated for 28 days with either 6 or 12 Units of SCH 39641 or placebo, and the proportion with treatment-emergent AEs were recorded. An AE is any unfavorable and unintended sign, symptom or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. Treatment-emergent AEs are new AEs that occur after participants have been randomized into the trial, or existing AEs that occurred during Screening that increase in severity after randomization.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

203 participants

Primary outcome timeframe

Up to Day 42

Results posted on

2017-03-03

Participant Flow

Due to non-compliance with Good Clinical Practice (GCP) 7 randomized participants who completed treatment were excluded from all subsequent analysis.

Participant milestones

Participant milestones
Measure	Placebo Matching placebo tablet sublingual, once daily	SCH 39641 6 Amb a 1-U 6 Units Short Ragweed (Ambrosia artemisiifolia) Major Allergen 1 (Amb a 1-U) in an Allergy Immunotherapy Tablet (AIT) sublingual, once daily	SCH 39641 12 Amb a 1-U 12 Amb a 1-U in an AIT, sublingual, once daily
Overall Study STARTED	65	66	65
Overall Study COMPLETED	64	63	59
Overall Study NOT COMPLETED	1	3	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Matching placebo tablet sublingual, once daily	SCH 39641 6 Amb a 1-U 6 Units Short Ragweed (Ambrosia artemisiifolia) Major Allergen 1 (Amb a 1-U) in an Allergy Immunotherapy Tablet (AIT) sublingual, once daily	SCH 39641 12 Amb a 1-U 12 Amb a 1-U in an AIT, sublingual, once daily
Overall Study Adverse Event	1	2	5
Overall Study Withdrawal by Subject	0	0	1
Overall Study Protocol Violation	0	1	0

Baseline Characteristics

Safety Study of Ragweed Allergy Immunotherapy Tablet in Subjects 50 Years of Age and Older (Study P06081)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=65 Participants Matching placebo tablet sublingual, once daily	SCH 39641 6 Amb a 1-U n=66 Participants 6 Amb a 1-U in an AIT, sublingual, once daily	SCH 39641 12 Amb a 1-U n=65 Participants 12 Amb a 1-U in an AIT, sublingual, once daily	Total n=196 Participants Total of all reporting groups
Age, Continuous	56.4 Years STANDARD_DEVIATION 4.7 • n=93 Participants	56.4 Years STANDARD_DEVIATION 5.4 • n=4 Participants	56.2 Years STANDARD_DEVIATION 5.7 • n=27 Participants	56.3 Years STANDARD_DEVIATION 5.3 • n=483 Participants
Gender Female	38 Participants n=93 Participants	43 Participants n=4 Participants	40 Participants n=27 Participants	121 Participants n=483 Participants
Gender Male	27 Participants n=93 Participants	23 Participants n=4 Participants	25 Participants n=27 Participants	75 Participants n=483 Participants

PRIMARY outcome

Timeframe: Up to Day 42

Population: All subjects as treated (ASAT) consisting of all randomized participants who received at least one dose of study treatment. Due to non-compliance with GCP 7 participants were excluded from this analysis.

Participants were treated for 28 days with either 6 or 12 Units of SCH 39641 or placebo, and the proportion with treatment-emergent AEs were recorded. An AE is any unfavorable and unintended sign, symptom or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. Treatment-emergent AEs are new AEs that occur after participants have been randomized into the trial, or existing AEs that occurred during Screening that increase in severity after randomization.