A Study of Ragweed (Ambrosia Artemisiifolia) Allergy Immunotherapy Tablet in Adults With Ragweed Allergies (P05751)

A 28-Day Study Evaluating the Safety of Ragweed (Ambrosia Artemisiifolia) Allergy Immunotherapy Tablet (SCH 39641/MK-3641) Treatment in Ragweed Allergic Adults (Phase 3, Protocol No.P05751)

This study assessed the safety profile of short ragweed (Ambrosia artemisiifolia) in participants with ragweed-induced rhinoconjunctivitis with or without asthma. The primary objective was to compare treatment-emergent adverse events (AEs) for participants treated with short ragweed allergy immunotherapy tablet (AIT) with those treated with placebo.

Study Overview

• Status: Completed
• Conditions: Allergy
• Intervention / Treatment: Biological: SCH 39641; Drug: Placebo for SCH 39641

• Study Type: Interventional
• Enrollment (Actual): 914
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Clinical history of physician-diagnosed ragweed-induced allergic rhinoconjunctivitis of 2 years duration or more, with or without asthma
• Must have a positive skin prick test response to Ambrosia artemisiifolia
• Must have a forced expiratory volume in 1 second (FEV1) of at least 70% of predicted value
• Clinical laboratory tests, electrocardiogram (ECG) and vital signs conducted at the Screening Visit must be within normal limits or clinically acceptable to the investigator/sponsor
• Females of child-bearing potential must agree to use medically accepted methods of contraception

Exclusion Criteria:

• Unstable asthma or has experienced an occurrence of any clinical deterioration of asthma that resulted in emergency treatment, hospitalization due to asthma, or treatment with systemic corticosteroids in previous 3 months
• Received an immunosuppressive treatment within 3 months
• History of anaphylaxis with cardio-respiratory symptoms.
• History of chronic urticaria or angioedema
• Current severe atopic dermatitis
• Female subject who is breastfeeding, pregnant, or intending to become pregnant
• Has received maintenance doses of immunotherapy with ragweed extract for ≥1 month within the last 5 years
• History of allergy, hypersensitivity or intolerance to the ingredients of the investigational medicinal products (IMPs) (except for Ambrosia artemisiifolia), or self-injectable epinephrine
• Unable to or will not comply with the use of self-injectable epinephrine
• Participating in any other clinical trial

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SCH 39641 12 Amb a 1-U; 12 Units short ragweed (Ambrosia artemisiifolia) Major Allergen 1 (Amb a 1-U) extract in an AIT, sublingual, once daily.	Biological: SCH 39641; Rapidly dissolving tablet sublingually once daily; Other Names: MK-3641
Placebo Comparator: Placebo; Matching placebo tablet, sublingual, once daily.	Drug: Placebo for SCH 39641; Rapidly dissolving tablet sublingually once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment-emergent Adverse Events (AEs)	Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number 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 35

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Reporting Oral Pruritus.	Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with oral pruritus were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported.	Up to Day 35
Number of Participants Reporting Ear Pruritus	Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with ear pruritus were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported.	Up to Day 35
Number of Participants Reporting Throat Irritation	Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with throat irritation were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported.	Up to Day 35
Number of Participants Reporting Mouth Oedema	Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with mouth oedema were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported.	Up to Day 35
Number of Participants Reporting Eye Pruritus	Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with eye pruritus were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported.	Up to Day 35
Number of Participants Reporting Nasal Passage Irritation	Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with nasal passage irritation were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported.	Up to Day 35
Number of Participants Reporting Skin Pruritus	Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with skin pruritus were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported.	Up to Day 35
Number of Participants Who Discontinued Due to Treatment-emergent AEs	Participants were treated with either SCH 39641 12 Amb a 1-U or placebo for 28 days, and the number who discontinued due to 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 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, 2011
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: October 21, 2011
• First Submitted That Met QC Criteria: November 9, 2011
• First Posted (Estimate): November 10, 2011

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: Immunology
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: P05751; MK-3641 (Other Identifier: Merck)