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: September 17, 2013
Last verified: September 2013
  Purpose

This study will assess the safety profile of the short ragweed (Ambrosia artemisiifolia) in participants with ragweed-induced rhinoconjunctivitis with or without asthma.


Condition Intervention Phase
Allergy
Drug: SCH 39641 (MK-3641)
Drug: Placebo for SCH 39641 (MK-3641)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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 who Report Treatment-emergent Adverse Events (AEs) [ Time Frame: Up to Day 35 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of Participants Reporting Local AEs (oral pruritus, ear pruritus, throat irritation, mouth edema, eye pruritus, nasal passage irritation, and skin pruritus) [ Time Frame: Up to Day 35 ] [ Designated as safety issue: Yes ]
  • Number of Discontinuations due to Treatment-emergent AEs [ Time Frame: Up to Day 35 ] [ Designated as safety issue: Yes ]

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 (MK-3641) Drug: SCH 39641 (MK-3641)
Rapidly dissolving tablet sublingually once daily
Other Name: Short ragweed (Ambrosia artemisiifolia) pollen allergen extract
Placebo Comparator: Placebo Drug: Placebo for SCH 39641 (MK-3641)
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
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01469182     History of Changes
Other Study ID Numbers: P05751
Study First Received: October 21, 2011
Last Updated: September 17, 2013
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 April 21, 2014