Phase 3
N=914
A Study of Ragweed (Ambrosia Artemisiifolia) Allergy Immunotherapy Tablet in Adults With Ragweed Allergies (P05751)
Allergy
Bottom Line
View on ClinicalTrials.gov: NCT01469182 ↗Enrolled (actual)
914
Serious AEs
0.4%
Results posted
Jun 2014
Primary outcome: Primary: Number of Participants With Treatment-emergent Adverse Events (AEs) — 321; 130 Participants — p=0.005
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- SCH 39641 (Biological); Placebo for SCH 39641 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- ALK-Abelló A/S
- Primary completion
- Apr 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-emergent Adverse Events (AEs) |
321; 130 | 0.005 sig |
| SECONDARY Number of Participants Reporting Oral Pruritus. |
44; 5 | <0.001 sig |
| SECONDARY Number of Participants Reporting Ear Pruritus |
52; 2 | <0.001 sig |
| SECONDARY Number of Participants Reporting Throat Irritation |
82; 10 | <0.001 sig |
| SECONDARY Number of Participants Reporting Mouth Oedema |
34; 1 | <0.001 sig |
| SECONDARY Number of Participants Reporting Eye Pruritus |
11; 5 | 0.861 |
| SECONDARY Number of Participants Reporting Nasal Passage Irritation |
21; 7 | 0.344 |
| SECONDARY Number of Participants Reporting Skin Pruritus |
18; 6 | 0.382 |
| SECONDARY Number of Participants Who Discontinued Due to Treatment-emergent AEs |
21; 3 | 0.029 sig |
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
Data sourced from ClinicalTrials.gov (NCT01469182). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.