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

A 28-Day Study Evaluating the Safety of Ragweed (Ambrosia Artemisiifolia) Sublingual Tablet (SCH 39641) in Adult Subjects 50 Years of Age and Older With Ragweed-Induced Rhinoconjunctivitis (Protocol No. P06081)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00978029

Enrollment

203

Registered

2009-09-16

Start date

2009-11-30

Completion date

2010-02-28

Last updated

2017-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergy, Conjunctivitis, Rhinitis, Rhinoconjunctivitis

Keywords

immunotherapy

Brief summary

The purpose of this study was to assess the safety and tolerability of a ragweed allergy immunotherapy tablet (AIT) administered sublingually (under-the tongue) in subjects 50 years of age and older with ragweed-induced rhinoconjunctivitis, with or without asthma.

Interventions

DRUGPlacebo

Placebo sublingual tablet, once daily

BIOLOGICALSCH 39641

Allergy immunotherapy tablet (sublingual)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

Inclusion criteria

* Subject must be 50 years of age or older, of either sex, and of any race/ethnicity. * Subject must have a clinical history of ragweed-induced allergic rhinoconjunctivitis with or without asthma. * Subject must have a positive skin prick test response to Ambrosia artemisiifolia at the Screening Visit * Subject must have a forced expiratory volume in 1 second (FEV1) of at least 70% of predicted value at the Screening Visit and at Randomization. * A subject's clinical laboratory tests, electrocardiogram (ECG) and vital signs conducted at the Screening Visit must be within normal limits or clinically acceptable to the investigator.

Exclusion criteria

* Subject with asthma who requires inhaled corticosteroids for the treatment of their asthma during the study period. * Subject requiring anti-allergy medications during the time period from randomization to study completion. * Subject who has received an immunosuppressive treatment within 3 months prior to the Screening Visit (except steroids for allergic and asthma symptoms). * Subject with a history of anaphylaxis with cardiorespiratory symptoms. * Subject with a history of chronic urticaria or angioedema. * Subject with current severe atopic dermatitis. * Female subject who is breastfeeding, pregnant, or intending to become pregnant. * Subject with a history of allergy, hypersensitivity or intolerance to the ingredients of the investigational medicinal products (IMPs) (except for Ambrosia artemisiifolia), or self-injectable epinephrine. * Subject with a history of self-injectable epinephrine use.

Design outcomes

Primary

Measure	Time frame	Description
The Proportion of Participants Reporting Treatment-emergent Adverse Events (AEs)	Up to Day 42	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.

Secondary

Measure	Time frame	Description
Proportion of Participants Reporting Oral Pruritus	Up to Day 42	Participants were treated for 28 days with either 6 or 12 Units of SCH 39641 or placebo, and the proportion with oral pruritus were reported.
Proportion of Participants Reporting Ear Pruritus	Up to Day 42	Participants were treated for 28 days with either 6 or 12 Units of SCH 39641 or placebo, and the proportion with ear pruritus were reported.
Proportion of Participants Reporting Throat Irritation	Up to Day 42	Participants were treated for 28 days with either 6 or 12 Units of SCH 39641 or placebo, and the proportion with throat irritation were reported.
Proportion of Participants Reporting Mouth Oedema	Up to Day 42	Participants were treated for 28 days with either 6 or 12 Units of SCH 39641 or placebo, and the proportion with mouth oedema were reported.
Proportion of Participants Who Discontinued Due to Adverse Events.	Up to Day 28	Participants were treated for 28 days with either 6 or 12 Units of SCH 39641 or placebo, and the proportion with AEs leading to study discontinuation were reported. 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.

Participant flow

Pre-assignment details

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

Participants by arm

Arm	Count
Placebo Matching placebo tablet sublingual, once daily	65
SCH 39641 6 Amb a 1-U 6 Amb a 1-U in an AIT, sublingual, once daily	66
SCH 39641 12 Amb a 1-U 12 Amb a 1-U in an AIT, sublingual, once daily	65
Total	196

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Adverse Event	1	2	5
Overall Study	Protocol Violation	0	1	0
Overall Study	Withdrawal by Subject	0	0	1

Baseline characteristics

Characteristic	Placebo	SCH 39641 6 Amb a 1-U	SCH 39641 12 Amb a 1-U	Total
Age, Continuous	56.4 Years STANDARD_DEVIATION 4.7	56.4 Years STANDARD_DEVIATION 5.4	56.2 Years STANDARD_DEVIATION 5.7	56.3 Years STANDARD_DEVIATION 5.3
Gender Female	38 Participants	43 Participants	40 Participants	121 Participants
Gender Male	27 Participants	23 Participants	25 Participants	75 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —
other Total, other adverse events	11 / 65	23 / 66	23 / 65
serious Total, serious adverse events	0 / 65	0 / 66	1 / 65

Outcome results

Primary

The Proportion of Participants Reporting Treatment-emergent Adverse Events (AEs)

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.

Time frame: 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.

Arm	Measure	Value (NUMBER)
Placebo	The Proportion of Participants Reporting Treatment-emergent Adverse Events (AEs)	0.446 Proportion of Participants
SCH 39641 6 Amb a 1-U	The Proportion of Participants Reporting Treatment-emergent Adverse Events (AEs)	0.515 Proportion of Participants
SCH 39641 12 Amb a 1-U	The Proportion of Participants Reporting Treatment-emergent Adverse Events (AEs)	0.615 Proportion of Participants

p-value: 0.48695% CI: [-10.17, 23.97]Fisher Exact

p-value: 0.07895% CI: [0.01, 33.83]Fisher Exact

Secondary

Proportion of Participants Reporting Ear Pruritus

Participants were treated for 28 days with either 6 or 12 Units of SCH 39641 or placebo, and the proportion with ear pruritus were reported.

Time frame: Up to Day 42