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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01469182
First received: October 21, 2011
Last updated: October 24, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Allergy
Biological: SCH 39641
Drug: Placebo for SCH 39641
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A 28-Day Study Evaluating the Safety of Ragweed (Ambrosia Artemisiifolia) Allergy Immunotherapy Tablet (SCH 39641/MK-3641) Treatment in Ragweed Allergic Adults (Phase 3, Protocol No.P05751)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Number of Participants With Treatment-emergent Adverse Events (AEs) [ Time Frame: Up to Day 35 ] [ Designated as safety issue: Yes ]
    Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with treatment-emergent AEs were recorded. An AE is any unfavorable and unintended sign, symptom or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. Treatment-emergent AEs are new AEs that occur after participants have been randomized into the trial, or existing AEs that occurred during Screening that increase in severity after randomization.


Secondary Outcome Measures:
  • Number of Participants Reporting Oral Pruritus. [ Time Frame: Up to Day 35 ] [ Designated as safety issue: Yes ]
    Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with oral pruritus were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported.

  • Number of Participants Reporting Ear Pruritus [ Time Frame: Up to Day 35 ] [ Designated as safety issue: Yes ]
    Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with ear pruritus were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported.

  • Number of Participants Reporting Throat Irritation [ Time Frame: Up to Day 35 ] [ Designated as safety issue: Yes ]
    Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with throat irritation were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported.

  • Number of Participants Reporting Mouth Oedema [ Time Frame: Up to Day 35 ] [ Designated as safety issue: Yes ]
    Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with mouth oedema were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported.

  • Number of Participants Reporting Eye Pruritus [ Time Frame: Up to Day 35 ] [ Designated as safety issue: Yes ]
    Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with eye pruritus were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported.

  • Number of Participants Reporting Nasal Passage Irritation [ Time Frame: Up to Day 35 ] [ Designated as safety issue: Yes ]
    Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with nasal passage irritation were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported.

  • Number of Participants Reporting Skin Pruritus [ Time Frame: Up to Day 35 ] [ Designated as safety issue: Yes ]
    Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with skin pruritus were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported.

  • Number of Participants Who Discontinued Due to Treatment-emergent AEs [ Time Frame: Up to Day 28 ] [ Designated as safety issue: Yes ]
    Participants were treated with either SCH 39641 12 Amb a 1-U or placebo for 28 days, and the number who discontinued due to treatment emergent-AEs were recorded. An AE is any unfavorable and unintended sign, symptom or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. Treatment-emergent AEs are new AEs that occur after participants have been randomized into the trial, or existing AEs that occurred during Screening that increase in severity after randomization.


Enrollment: 914
Study Start Date: November 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Biological: SCH 39641
Rapidly dissolving tablet sublingually once daily
Other Name: MK-3641
Placebo Comparator: Placebo
Matching placebo tablet, sublingual, once daily.
Drug: Placebo for SCH 39641
Rapidly dissolving tablet sublingually once daily

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided by Merck Sharp & Dohme Corp.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01469182     History of Changes
Other Study ID Numbers: P05751, MK-3641
Study First Received: October 21, 2011
Results First Received: April 25, 2014
Last Updated: October 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
Immunology

Additional relevant MeSH terms:
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on November 20, 2014