Safety Study of Ragweed Allergy Immunotherapy Tablet in Subjects 50 Years of Age and Older (Study P06081)

ALK-Abelló

Status and phase: Completed; Phase 2

Conditions: Conjunctivitis; Rhinoconjunctivitis; Rhinitis; Allergy

Treatments: Biological: SCH 39641; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00978029

P06081

MK-3641-004 (Other Identifier)

Details and patient eligibility

About

The purpose of this study was to assess the safety and tolerability of a ragweed allergy immunotherapy tablet (AIT) administered sublingually (under-the tongue) in subjects 50 years of age and older with ragweed-induced rhinoconjunctivitis, with or without asthma.

Enrollment: 203 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject must be 50 years of age or older, of either sex, and of any race/ethnicity.
• Subject must have a clinical history of ragweed-induced allergic rhinoconjunctivitis with or without asthma.
• Subject must have a positive skin prick test response to Ambrosia artemisiifolia at the Screening Visit
• Subject must have a forced expiratory volume in 1 second (FEV1) of at least 70% of predicted value at the Screening Visit and at Randomization.
• A subject's clinical laboratory tests, electrocardiogram (ECG) and vital signs conducted at the Screening Visit must be within normal limits or clinically acceptable to the investigator.

Exclusion criteria

• Subject with asthma who requires inhaled corticosteroids for the treatment of their asthma during the study period.
• Subject requiring anti-allergy medications during the time period from randomization to study completion.
• Subject who has received an immunosuppressive treatment within 3 months prior to the Screening Visit (except steroids for allergic and asthma symptoms).
• Subject with a history of anaphylaxis with cardiorespiratory symptoms.
• Subject with a history of chronic urticaria or angioedema.
• Subject with current severe atopic dermatitis.
• Female subject who is breastfeeding, pregnant, or intending to become pregnant.
• Subject with a history of allergy, hypersensitivity or intolerance to the ingredients of the investigational medicinal products (IMPs) (except for Ambrosia artemisiifolia), or self-injectable epinephrine.
• Subject with a history of self-injectable epinephrine use.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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203 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Matching placebo tablet sublingual, once daily

Treatment:

Drug: Placebo

SCH 39641 6 Amb a 1-U

Experimental group

Description:

6 Units Short Ragweed (Ambrosia artemisiifolia) Major Allergen 1 (Amb a 1-U) in an AIT, sublingual, once daily

Treatment:

Biological: SCH 39641

Biological: SCH 39641

SCH 39641 12 Amb a 1-U

Experimental group

Description:

12 Amb a 1-U in an AIT, sublingual, once daily

Treatment:

Biological: SCH 39641

Biological: SCH 39641