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

ALK-Abelló

Status and phase: Completed; Phase 3

Conditions: Allergy

Treatments: Drug: Placebo for SCH 39641; Biological: SCH 39641

Study type: Interventional

Funder types: Industry

Identifiers

NCT01469182

MK-3641 (Other Identifier)

P05751

Details and patient eligibility

About

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.

Enrollment: 914 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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914 participants in 2 patient groups, including a placebo group

SCH 39641 12 Amb a 1-U

Experimental group

Description:

12 Units short ragweed (Ambrosia artemisiifolia) Major Allergen 1 (Amb a 1-U) extract in an AIT, sublingual, once daily.

Treatment:

Biological: SCH 39641

Placebo

Placebo Comparator group

Description:

Matching placebo tablet, sublingual, once daily.

Treatment:

Drug: Placebo for SCH 39641