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

NCT ID: NCT01469182

Last Updated: 2017-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 914 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2012-04-30

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.

Conditions

Allergy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

SCH 39641

Intervention Type: BIOLOGICAL

Rapidly dissolving tablet sublingually once daily

Placebo

Matching placebo tablet, sublingual, once daily.

Group Type: PLACEBO_COMPARATOR

Placebo for SCH 39641

Intervention Type: DRUG

Rapidly dissolving tablet sublingually once daily

Interventions

SCH 39641

Rapidly dissolving tablet sublingually once daily

Intervention Type: BIOLOGICAL

Placebo for SCH 39641

Rapidly dissolving tablet sublingually once daily

Intervention Type: DRUG

Other Intervention Names

MK-3641

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ALK-Abelló A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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.

Reference Type: DERIVED

PMID: 24836393 (View on PubMed)

Other Identifiers

MK-3641

Identifier Type: OTHER

Identifier Source: secondary_id

P05751

Identifier Type: -

Identifier Source: org_study_id