Efficacy and Long-Term Safety of Ragweed (Ambrosia Artemisiifolia) Sublingual Tablet in Adults With a History of Ragweed-Induced Rhinoconjunctivitis With or Without Asthma (Study P05233)(COMPLETED)

NCT ID: NCT00783198

Last Updated: 2017-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 565 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2011-05-31

Brief Summary

This study will evaluate the efficacy and safety of ragweed sublingual tablet (SCH 39641/MK-3641) compared with placebo in participants with ragweed-induced rhinoconjunctivitis over a one-year period. It is expected that ragweed allergic participants on one of the active arms of the trial will have decreased allergic rhinoconjunctivitis symptoms and require less allergy rescue medications during ragweed pollen season.

Conditions

Rhinitis; Allergic, With Asthma; Conjunctivitis

Study Design

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

Study Groups

SCH 39641 6 Amb a 1-U

Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 6 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks

Group Type: EXPERIMENTAL

SCH 39641 6 Amb a 1-U

Intervention Type: BIOLOGICAL

SCH 39641 6 Amb a 1-U sublingual tablets administered once daily

SCH 39641 12 Amb a 1-U

Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 12 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks

Group Type: EXPERIMENTAL

SCH 39641 12 Amb a 1-U

Intervention Type: BIOLOGICAL

SCH 39641 12 Amb a 1-U sublingual tablets administered once daily

Placebo

Participants receive placebo matching ambrosia artemisiifolia allergen extract, rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

matching placebo sublingual tablets administered once daily

Interventions

SCH 39641 6 Amb a 1-U

SCH 39641 6 Amb a 1-U sublingual tablets administered once daily

Intervention Type: BIOLOGICAL

SCH 39641 12 Amb a 1-U

SCH 39641 12 Amb a 1-U sublingual tablets administered once daily

Intervention Type: BIOLOGICAL

Placebo

matching placebo sublingual tablets administered once daily

Intervention Type: BIOLOGICAL

Other Intervention Names

MK-3641; MK-3641

Eligibility Criteria

Inclusion Criteria

• Must have a clinical history of significant ragweed-induced allergic rhinoconjunctivitis of at least 2 years duration, with or without asthma and have received treatment during the previous RS.
• Must have a positive skin prick test response to Ambrosia artemisiifolia at Screening Visit.
• Must be positive for specific immunoglobulin E (IgE) against Ambrosia artemisiifolia at Screening Visit.
• Must have an forced expiratory volume in 1 second (FEV1) of at least 70% of predicted at Screening Visit.
• Safety laboratory tests and vital signs conducted at the Screening Visit must be within normal limits or clinically acceptable to the investigator/sponsor

Exclusion Criteria

• Clinical history of symptomatic seasonal allergic rhinitis and/or asthma having received regular medication, due to another allergen during or potentially overlapping the RS.
• Clinical history of significant symptomatic perennial allergic rhinitis and/or asthma due to an allergen to which the participant is regularly exposed.
• Receipt of an immunosuppressive treatment within 3 months prior to the Screening Visit (except steroids for allergic and asthma symptoms).
• Clinical history of severe asthma.
• Asthma requiring medium or high dose inhaled corticosteroids.
• History of anaphylaxis with cardiorespiratory symptoms.
• History of chronic urticaria and angioedema.
• Clinical history of chronic sinusitis 2 years prior to the Screening Visit.
• Current severe atopic dermatitis.
• Breast-feeding, pregnant, or intending to become pregnant.
• Had previous treatment by immunotherapy with ragweed allergen or any other allergen 5 years prior to Screening Visit.
• History of allergy, hypersensitivity or intolerance to the ingredients of the investigational medicinal products (except for Ambrosia artemisiifolia), rescue medications, or self-injectable epinephrine.
• History of self-injectable epinephrine use.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ALK-Abelló A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Christensen LH, Ipsen H, Nolte H, Maloney J, Nelson HS, Weber R, Lund K. Short ragweeds is highly cross-reactive with other ragweeds. Ann Allergy Asthma Immunol. 2015 Dec;115(6):490-495.e1. doi: 10.1016/j.anai.2015.09.016. Epub 2015 Oct 21.

Reference Type: DERIVED

PMID: 26507708 (View on PubMed)

Kim H, Waserman S, Hebert J, Blaiss M, Nelson H, Creticos P, Kaur A, Maloney J, Li Z, Nolte H. Efficacy and safety of ragweed sublingual immunotherapy in Canadian patients with allergic rhinoconjunctivitis. Allergy Asthma Clin Immunol. 2014 Nov 10;10(1):55. doi: 10.1186/1710-1492-10-55. eCollection 2014.

Reference Type: DERIVED

PMID: 25788949 (View on PubMed)

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)

Nolte H, Hebert J, Berman G, Gawchik S, White M, Kaur A, Liu N, Lumry W, Maloney J. Randomized controlled trial of ragweed allergy immunotherapy tablet efficacy and safety in North American adults. Ann Allergy Asthma Immunol. 2013 Jun;110(6):450-456.e4. doi: 10.1016/j.anai.2013.03.013. Epub 2013 May 2.

Reference Type: DERIVED

PMID: 23706715 (View on PubMed)

Other Identifiers

2008-003863-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MK-3641-002

Identifier Type: OTHER

Identifier Source: secondary_id

P05233

Identifier Type: -

Identifier Source: org_study_id