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)

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.

Study Overview

• Status: Completed
• Conditions: Allergy; Rhinitis; Conjunctivitis; Rhinoconjunctivitis
• Intervention / Treatment: Drug: Placebo; Biological: SCH 39641

• Study Type: Interventional
• Enrollment (Actual): 203
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Matching placebo tablet sublingual, once daily	Drug: Placebo; Placebo sublingual tablet, once daily
Experimental: SCH 39641 6 Amb a 1-U; 6 Units Short Ragweed (Ambrosia artemisiifolia) Major Allergen 1 (Amb a 1-U) in an AIT, sublingual, once daily	Biological: SCH 39641; Allergy immunotherapy tablet (sublingual); Other Names: MK-3641
Experimental: SCH 39641 12 Amb a 1-U; 12 Amb a 1-U in an AIT, sublingual, once daily	Biological: SCH 39641; Allergy immunotherapy tablet (sublingual); Other Names: MK-3641

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to Day 42

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to Day 42
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.	Up to Day 42
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.	Up to Day 42
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.	Up to Day 42
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.	Up to Day 28

Collaborators and Investigators

• Sponsor: ALK-Abelló A/S

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): February 1, 2010
• Study Completion (Actual): February 1, 2010

Study Registration Dates

• First Submitted: September 11, 2009
• First Submitted That Met QC Criteria: September 15, 2009
• First Posted (Estimate): September 16, 2009

Study Record Updates

• Last Update Posted (Actual): March 3, 2017
• Last Update Submitted That Met QC Criteria: January 18, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: immunotherapy
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Eye Diseases; Otorhinolaryngologic Diseases; Nose Diseases; Conjunctival Diseases; Hypersensitivity; Rhinitis; Conjunctivitis
• Other Study ID Numbers: P06081; MK-3641-004 (Other Identifier: Merck)