Efficacy and Long-Term Safety of Ragweed (Ambrosia Artemisiifolia) Sublingual Tablet (SCH 39641) in Adults With a History of Ragweed-Induced Rhinoconjunctivitis With or Without Asthma (Study P05234)

NCT00770315 | Completed Phase 2 Results DMC

• 4 other identifiers: P0523438102492008-003864-20MK-3641-002
• Study Type: interventional
• Target: 784
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will evaluate the efficacy and safety of ragweed sublingual tablet (SCH 39641/MK-3641/Amb a 1-U) 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; Conjunctivitis

Outcome Measures

Primary Outcomes (1)

• Combined (Sum of) Rhinoconjunctivitis Daily Symptom Score (DSS) and Daily Medication Score (DMS) Averaged Over the Peak Ragweed Season (RS)

  The total combined score is a composite endpoint that combines the rhinoconjuntivitis DSS and the rhinoconjunctivitis DMS. The rhinoconjunctivitis DSS consisted of a total of 6 symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes and watery eyes) that were measured on a scale of 0 to 3 (0=no symptoms, 3=severe symptoms; score range: 0-18), with a lower score indicating less rhinoconjunctivitis symptoms. Rhinoconjunctivitis DMS was based on use of specific study-provided rescue medication, with different rescue medications being assigned different scores/dose unit (score range: 0-36), with a lower score indicating less rhinconjunctivitis medication use. The sum of the rhinoconjunctivitis DSS+DMS could range from 0 to 54, with a lower score indicating less rhinoconjuntivitis symptoms and medication use. Raw means were converted to adjusted means using an ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects.

  The 15-day period during the ragweed season with the highest moving pollen average

Secondary Outcomes (4)

• Average Combined Rhinoconjunctivitis DSS and DMS Over the Entire RS

  Approximately 5 weeks

• Average Rhinoconjunctivitis DSS for the Peak RS

  The 15-day period during the ragweed season with the highest moving pollen average

• Average Rhinoconjunctivitis DSS for the Entire RS

  Approximately 5 weeks

• Average Rhinoconjunctivitis DMS for the Peak RS

  The 15-day period during the ragweed season with the highest moving pollen average

Study Arms (4)

SCH 39641 1.5 Amb a 1-U

EXPERIMENTAL

Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 1.5 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks

Biological: Ambrosia artemisiifolia allergen extract (Amb a 1-U)

SCH 39641 6 Amb a 1-U

EXPERIMENTAL

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

Biological: Ambrosia artemisiifolia allergen extract (Amb a 1-U)

SCH 39641 12 Amb a 1-U

EXPERIMENTAL

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

Biological: Ambrosia artemisiifolia allergen extract (Amb a 1-U)

Placebo

PLACEBO COMPARATOR

Participants receive matching placebo rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks

Biological: Placebo

Interventions

Ambrosia artemisiifolia allergen extract (Amb a 1-U) BIOLOGICAL

Rapidly dissolving tablet administered sublingually once daily, at a dose of 1.5, 6 or 12 units.

Also known as: SCH 39641, MK-3641

SCH 39641 1.5 Amb a 1-U; SCH 39641 12 Amb a 1-U; SCH 39641 6 Amb a 1-U

Placebo BIOLOGICAL

Placebo matching Ambrosia artemisiifolia allergen extract rapidly dissolving tablet, administered sublingually once daily

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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 ragweed season (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 one 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.
• Must be willing to give written informed consent and be able to adhere to dose and visit schedules.
• Female participants of childbearing potential must be using a medically acceptable and adequate form of birth control. These include: hormonal contraceptives as prescribed by a physician (oral, hormonal vaginal ring, hormonal implant or depot injectable); medically prescribed intra-uterine device; medically prescribed topically-applied transdermal contraceptive patch; double-barrier method (eg, condom in combination with a spermicide).
• Female participants of childbearing potential should be counseled in the appropriate use of birth control while in the study. Female participants who are not currently sexually active must and consent to use one of the above-mentioned methods if she becomes sexually active during the study.
• Female participants of childbearing potential must have a negative urine pregnancy test at Screening Visit. Women who have been surgically sterilized or at least 1 year postmenopausal are not considered to be of childbearing potential.

You may not qualify if:

• Clinical history of symptomatic seasonal allergic rhinitis and/or asthma having received regular medication, due to another 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 (ICS).
• 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, pregnancy, 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.
• Any clinically significant condition or situation, other than the condition being studied that, in the opinion of the investigator, would interfere with the study evaluations or optimal participation in the study.
• Use of any investigational drugs within 30 days of Screening Visit.
• Participation in any other clinical study.

Sponsors & Collaborators

• ALK-Abelló A/S: lead

Related Publications (4)

• Creticos PS, Maloney J, Bernstein DI, Casale T, Kaur A, Fisher R, Liu N, Murphy K, Nekam K, Nolte H. Randomized controlled trial of a ragweed allergy immunotherapy tablet in North American and European adults. J Allergy Clin Immunol. 2013 May;131(5):1342-9.e6. doi: 10.1016/j.jaci.2013.03.019.

  PMID: 23622121 RESULT

• 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.

  PMID: 26507708 DERIVED

• 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.

  PMID: 25788949 DERIVED

• 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.

  PMID: 24836393 DERIVED

MeSH Terms

Conditions

Rhinitis, Allergic; Conjunctivitis

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Conjunctival Diseases; Eye Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2008
• First Posted: October 10, 2008
• Study Start: September 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: March 3, 2017
• Results First Posted: July 3, 2014

Record last verified: 2017-01