Efficacy and Long-Term Safety of Ragweed (Ambrosia Artemisiifolia) Sublingual Tablet (SCH 039641) in Adults With a History of Ragweed-Induced Rhinoconjunctivitis With or Without Asthma (Study P05234 AM4)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00770315
First received: October 9, 2008
Last updated: September 17, 2013
Last verified: September 2013
  Purpose

This study will evaluate the efficacy and safety of ragweed sublingual tablet (SCH 039641/Amb a 1-U) compared with placebo in subjects with ragweed-induced rhinoconjunctivitis over a one year period. It is expected that ragweed allergic subjects 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.


Condition Intervention Phase
Rhinitis, Allergic
Conjunctivitis
Biological: Ambrosia artemisiifolia allergen extract (Amb a 1-U)
Biological: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy and Long-Term Safety of Ragweed (Ambrosia Artemisiifolia) Sublingual Tablet (SCH 39641) in Adult Subjects With a History of Ragweed-Induced Rhinoconjunctivitis With or Without Asthma

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Combined (sum of) rhinoconjunctivitis daily symptom score (DSS) and daily medication score (DMS) averaged over the peak ragweed season (RS) [ Time Frame: The period during the ragweed season with the highest moving pollen average ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Average combined rhinoconjunctivitis DSS and DMS over the entire RS [ Time Frame: Approximately 5 weeks ] [ Designated as safety issue: No ]
  • Average rhinoconjunctivitis DSS for the peak RS [ Time Frame: The period during the ragweed season with the highest moving pollen average ] [ Designated as safety issue: No ]
  • Average rhinoconjunctivitis DSS for the entire RS [ Time Frame: Approximately 5 weeks ] [ Designated as safety issue: No ]
  • Average rhinoconjunctivitis DMS for the peak RS [ Time Frame: The period during the ragweed season with the highest moving pollen average ] [ Designated as safety issue: No ]

Enrollment: 778
Study Start Date: September 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1.5 Amb a 1-U Biological: Ambrosia artemisiifolia allergen extract (Amb a 1-U)
1 rapidly dissolving tablet, sublingually, once daily, at a dose of 1.5, 6 or 12 units.
Other Name: SCH 039641
Experimental: 6 Amb a 1-U Biological: Ambrosia artemisiifolia allergen extract (Amb a 1-U)
1 rapidly dissolving tablet, sublingually, once daily, at a dose of 1.5, 6 or 12 units.
Other Name: SCH 039641
Experimental: 12 Amb a 1-U Biological: Ambrosia artemisiifolia allergen extract (Amb a 1-U)
1 rapidly dissolving tablet, sublingually, once daily, at a dose of 1.5, 6 or 12 units.
Other Name: SCH 039641
Placebo Comparator: Placebo Biological: placebo
Placebo matching Ambrosia artemisiifolia allergen extract, rapidly dissolving tablet, administered once daily, sublingually

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 IgE against Ambrosia artemisiifolia at Screening Visit.
  • Must have an 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.

Exclusion Criteria:

  • 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 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 IMPs (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.
  • Being a family member of the study staff.
  • Inability to meet medication washout requirements.
  • Unlikely to be able to complete the trial, or likely to travel for an extended time during the RS.
  • Clinically significant abnormal vital sign or lab value.
  • Participation in this same study at another site.
  • Randomized into this study more than once.
  • Inability to or will not comply with the use of self-injectable epinephrine.
  • Greater risk of developing adverse reactions after epinephrine administration.
  • History of self-injectable epinephrine use
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00770315     History of Changes
Other Study ID Numbers: P05234, 3810249
Study First Received: October 9, 2008
Last Updated: September 17, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Conjunctivitis
Rhinitis
Conjunctival Diseases
Eye Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on April 17, 2014