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

Primary Purpose

Rhinoconjunctivitis, Rhinitis, Conjunctivitis

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Placebo

SCH 39641

About this trial

This is an interventional treatment trial for Rhinoconjunctivitis focused on measuring immunotherapy

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

SCH 39641 6 Amb a 1-U

SCH 39641 12 Amb a 1-U

Arm Description

Matching placebo tablet sublingual, once daily

6 Units Short Ragweed (Ambrosia artemisiifolia) Major Allergen 1 (Amb a 1-U) in an AIT, sublingual, once daily

12 Amb a 1-U in an AIT, sublingual, once daily

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Proportion of Participants Reporting Oral Pruritus

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

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

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

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.

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.

Full Information

NCT ID

NCT00978029

First Posted

September 11, 2009

Last Updated

January 18, 2017

Sponsor

ALK-Abelló A/S

1. Study Identification

Unique Protocol Identification Number

NCT00978029

Brief Title

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

Official Title

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)

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

November 2009 (undefined)

Primary Completion Date

February 2010 (Actual)

Study Completion Date

February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ALK-Abelló A/S

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rhinoconjunctivitis, Rhinitis, Conjunctivitis, Allergy

Keywords

immunotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

203 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Matching placebo tablet sublingual, once daily

Arm Title

SCH 39641 6 Amb a 1-U

Arm Type

Experimental

Arm Description

6 Units Short Ragweed (Ambrosia artemisiifolia) Major Allergen 1 (Amb a 1-U) in an AIT, sublingual, once daily

Arm Title

SCH 39641 12 Amb a 1-U

Arm Type

Experimental

Arm Description

12 Amb a 1-U in an AIT, sublingual, once daily

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo sublingual tablet, once daily

Intervention Type

Biological

Intervention Name(s)

SCH 39641

Other Intervention Name(s)

MK-3641

Intervention Description

Allergy immunotherapy tablet (sublingual)

Intervention Type

Biological

Intervention Name(s)

SCH 39641

Other Intervention Name(s)

MK-3641

Intervention Description

Allergy immunotherapy tablet (sublingual)

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Up to Day 42

Secondary Outcome Measure Information:

Title

Proportion of Participants Reporting Oral Pruritus

Description

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.

Time Frame

Up to Day 42

Title

Proportion of Participants Reporting Ear Pruritus

Description

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

Title

Proportion of Participants Reporting Throat Irritation

Description

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.

Time Frame

Up to Day 42

Title

Proportion of Participants Reporting Mouth Oedema

Description

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.

Time Frame

Up to Day 42

Title

Proportion of Participants Who Discontinued Due to Adverse Events.

Description

Time Frame

Up to Day 28

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

12. IPD Sharing Statement

Citations:

PubMed Identifier

24836393

Citation

Nolte H, Amar N, Bernstein DI, Lanier BQ, Creticos P, Berman G, Kaur A, Hebert J, Maloney J. Safety and tolerability of a short ragweed sublingual immunotherapy tablet. Ann Allergy Asthma Immunol. 2014 Jul;113(1):93-100.e3. doi: 10.1016/j.anai.2014.04.018. Epub 2014 May 14.

Results Reference

derived

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

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