Clinical trial NCT01469182: A Study of Ragweed (Ambrosia Artemisiifolia) Allergy Immunotherapy Tablet in Adults With Ragweed Allergies (P05751)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergy
Keywords: Immunology
Lead sponsor: ALK-Abelló A/S
Sponsor class: INDUSTRY
First posted: 2011-11-10
Enrollment: 914
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Number of Participants With Treatment-emergent Adverse Events (AEs)
timeFrame: Up to Day 35
Secondary outcomes:
measure: Number of Participants Reporting Oral Pruritus.
timeFrame: Up to Day 35
measure: Number of Participants Reporting Ear Pruritus
timeFrame: Up to Day 35
measure: Number of Participants Reporting Throat Irritation
timeFrame: Up to Day 35
measure: Number of Participants Reporting Mouth Oedema
timeFrame: Up to Day 35
measure: Number of Participants Reporting Eye Pruritus
timeFrame: Up to Day 35
measure: Number of Participants Reporting Nasal Passage Irritation
timeFrame: Up to Day 35
measure: Number of Participants Reporting Skin Pruritus
timeFrame: Up to Day 35
measure: Number of Participants Who Discontinued Due to Treatment-emergent AEs
timeFrame: Up to Day 28
Other outcomes:
Locations:
Study officials:
References:
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.