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

• ClinicalTrials.gov Identifier: NCT01469182
• Recruitment Status: Completed
• First Posted: November 10, 2011
• Results First Posted: June 5, 2014
• Last Update Posted: March 3, 2017
• Sponsor: ALK-Abelló A/S
• Information provided by (Responsible Party): ALK-Abelló A/S

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Allergy	Biological: SCH 39641; Drug: Placebo for SCH 39641	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 914 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: 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)
• Study Start Date: November 2011
• Actual Primary Completion Date: April 2012
• Actual Study Completion Date: April 2012

Arms and Interventions

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 Name: MK-3641
Placebo Comparator: Placebo; Matching placebo tablet, sublingual, once daily.	Drug: Placebo for SCH 39641; Rapidly dissolving tablet sublingually once daily

Outcome Measures

Primary Outcome Measures :

1. Number of Participants With Treatment-emergent Adverse Events (AEs) [ Time Frame: Up to Day 35 ]
   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.

Secondary Outcome Measures :

1. Number of Participants Reporting Oral Pruritus. [ Time Frame: Up to Day 35 ]
   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.
2. Number of Participants Reporting Ear Pruritus [ Time Frame: Up to Day 35 ]
   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.
3. Number of Participants Reporting Throat Irritation [ Time Frame: Up to Day 35 ]
   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.
4. Number of Participants Reporting Mouth Oedema [ Time Frame: Up to Day 35 ]
   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.
5. Number of Participants Reporting Eye Pruritus [ Time Frame: Up to Day 35 ]
   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.
6. Number of Participants Reporting Nasal Passage Irritation [ Time Frame: Up to Day 35 ]
   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.
7. Number of Participants Reporting Skin Pruritus [ Time Frame: Up to Day 35 ]
   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.
8. Number of Participants Who Discontinued Due to Treatment-emergent AEs [ Time Frame: Up to Day 28 ]
   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.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

No Contacts or Locations Provided

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Nolte H, Amar N, Bernstein DI, Lanier BQ, Creticos P, Berman G, Kaur A, Hébert 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.

• Responsible Party: ALK-Abelló A/S
• ClinicalTrials.gov Identifier: NCT01469182
• Other Study ID Numbers: P05751; MK-3641 ( Other Identifier: Merck )
• First Posted: November 10, 2011
• Results First Posted: June 5, 2014
• Last Update Posted: March 3, 2017
• Last Verified: January 2017

Keywords provided by ALK-Abelló A/S:

Immunology

Additional relevant MeSH terms:

Hypersensitivity; Immune System Diseases