Efficacy and Safety Study of RAGWITEK™ (MK-3641) in Children With Ragweed-Induced Rhinoconjunctivitis With or Without Asthma (MK-3641-008)



Status:Recruiting
Conditions:Allergy
Therapuetic Areas:Otolaryngology
Healthy:No
Age Range:4 - 17
Updated:5/27/2018
Start Date:July 20, 2015
End Date:November 30, 2018
Contact:Toll Free Number
Phone:1-888-577-8839

Use our guide to learn which trials are right for you!

A Phase III, Randomized, Placebo-Controlled Clinical Trial to Study the Efficacy and Safety of MK-3641, a Ragweed (Ambrosia Artemisiifolia) Sublingual Immunotherapy Tablet, in Children With a History of Ragweed-Induced Rhinoconjunctivitis With or Without Asthma

The purpose of this study is to assess the efficacy and safety of MK-3641 (short ragweed
[Ambrosia artemisiifolia] extract, MK-3641, SCH 039641, RAGWITEK™) sublingual immunotherapy
tablets in children aged 5 to 17 years with ragweed-induced allergic
rhinitis/rhinoconjunctivitis with or without asthma. The primary hypothesis of this study is
that administration of MK-3641 sublingual immunotherapy tablets to children 5 to 17 years of
age, compared with placebo, will result in a significant reduction in rhinoconjunctivitis
symptoms and medication use over the peak ragweed season (RS).


Inclusion Criteria:

- Is between the ages of 4 and 17 years (inclusive) at enrollment in this study and is
at least 5 years old at randomization

- Has a clinical history of significant ragweed pollen-induced allergic
rhinitis/rhinoconjunctivitis of ≥1 year (at least 1 season for ages 4 to 6 years) or
≥2 years (at least 2 seasons for ages 7 to 17 years) duration diagnosed by a physician
(with or without asthma) and have received treatment for the condition during the
previous ragweed season

- If female, agrees to remain abstinent or use (or have their partner use) an acceptable
method of birth control within the projected duration of the study.

Exclusion Criteria:

- Has a clinical history of symptomatic seasonal allergic rhinitis (and/or asthma) due
to another allergen, which has required regular medication during, or potentially
overlapping, the ragweed season

- Has a clinical history of significant symptomatic perennial allergic rhinitis and/or
asthma due to an allergen to which the subject is regularly exposed during the ragweed
season which would interfere with assessment of the treatment effect

- Has any nasal condition that could confound the efficacy or safety assessments (e.g.,
nasal polyposis).

- Has asthma requiring high daily doses of inhaled corticosteroids within the 6 months
prior to the Screening Visit

- Has severe, unstable, or uncontrolled asthma, as judged by the clinical investigator,
or has experienced a life-threatening asthma attack or an occurrence of any clinical
deterioration of asthma that resulted in emergency treatment, hospitalization due to
asthma, or treatment with systemic corticosteroids (but allowing short-acting beta
agonists) at any time within the last 3 months prior to the Screening or Randomization
Visits

- Has a history of anaphylaxis with cardiorespiratory symptoms with prior immunotherapy,
unknown cause, or inhalant allergen

- Has a diagnosis of eosinophilic esophagitis

- Has a history of chronic urticaria and/or chronic angioedema

- Has a clinical history of chronic sinusitis during the 2 years prior to the Screening
or Randomization Visits

- Has current severe atopic dermatitis

- Has a history of allergy, hypersensitivity, or intolerance to the ingredients of the
study drug (except for Ambrosia artemisiifolia), rescue medications, or
self-injectable epinephrine

- Has previously received MK-3641

- Has previously been randomized into this study

- Is participating in any other clinical study or plans to participate in another
clinical study during the duration of this study
We found this trial at
20
sites
533
mi
from 43215
Waterbury, CT
Click here to add this to my saved trials
1131
mi
from 43215
Boerne, TX
Click here to add this to my saved trials
Budapest,
Phone: 36 1 888 5300
4737
mi
from 43215
Budapest,
Click here to add this to my saved trials
907
mi
from 43215
Carrollton, TX
Click here to add this to my saved trials
278
mi
from 43215
Charlottesville, VA
Click here to add this to my saved trials
98
mi
from 43215
Cincinnati, OH
Click here to add this to my saved trials
910
mi
from 43215
Dallas, TX
Click here to add this to my saved trials
103
mi
from 43215
Fort Mitchell, KY
Click here to add this to my saved trials
Greenville, South Carolina 29605
358
mi
from 43215
Greenville, SC
Click here to add this to my saved trials
335
mi
from 43215
Lanham, MD
Click here to add this to my saved trials
154
mi
from 43215
Lexington, KY
Click here to add this to my saved trials
624
mi
from 43215
Minneapolis, MN
Click here to add this to my saved trials
266
mi
from 43215
Owensboro, KY
Click here to add this to my saved trials
635
mi
from 43215
Plymouth, MN
Click here to add this to my saved trials
355
mi
from 43215
Rochester, NY
Click here to add this to my saved trials
355
mi
from 43215
Rochester, NY
Click here to add this to my saved trials
561
mi
from 43215
Savannah, GA
Click here to add this to my saved trials
789
mi
from 43215
Shreveport, LA
Click here to add this to my saved trials
980
mi
from 43215
Waco, TX
Click here to add this to my saved trials
615
mi
from 43215
Warwick, RI
Click here to add this to my saved trials