Safety Study of MK-3641 and MK-7243 Co-administered in Adult Participants With Ragweed and Grass Pollen Induced Allergic Rhinitis (P08607, MK-3641-006)
A Phase IV, Open-label, Safety and Tolerability Trial of MK-3641 and MK-7243 Coadministered in Subjects At Least 18 Years of Age With Ragweed and Grass Pollen Induced Allergic Rhinitis With or Without Conjunctivitis
1 other identifier
interventional
102
0 countries
N/A
Brief Summary
The purpose of this study is to assess the safety and tolerability of MK-3641 (short ragweed \[Ambrosia artemisiifolia\] extract, SCH 039641, RAGWITEK®) sublingual tablets and MK-7243 (Timothy grass \[Phleum pratense\] extract, SCH 697243, GRASTEK®) sublingual tablets co-administered in participants 18 through 65 years of age with both ragweed- and grass polled-induced allergic rhinitis, with or without conjunctivitis and with or without asthma. The primary endpoint is the percentage of participants who experience at least one event of local swelling after co-administration of MK-3641 and MK-7243 sublingual tablets.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Oct 2014
Shorter than P25 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 1, 2014
CompletedStudy Start
First participant enrolled
October 1, 2014
CompletedFirst Posted
Study publicly available on registry
October 3, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedResults Posted
Study results publicly available
January 18, 2016
CompletedMarch 3, 2017
January 1, 2017
4 months
October 1, 2014
December 7, 2015
January 18, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Who Experienced at Least One Event of Local Swelling
Events of local swelling included pharyngeal edema, laryngeal edema, mouth edema, oropharyngeal swelling, palatal edema, tongue swelling/edema, or throat tightness. Events that occurred during in-clinic dosing were to be monitored and recorded by clinic staff. A Side Effect Report Card was used in Periods I-III to collect information on adverse events identified by the World Allergy Organization (WAO) as local side effects of sublingual immunotherapy (SLIT) that occurred within the first 60 minutes after study drug intake. During Period I, participants were to complete the report card once a day after MK-7243 was administered. During Period II, participants were to complete the report card twice a day, once after each tablet was administered. During Period III, participants were to complete the report card once a day after both tablets were administered.
During Period I, Period II and Period III (Up to 6 weeks)
Secondary Outcomes (3)
Percentage of Participants Who Experienced at Least One Event of Local Application Site Reaction
During Period I, Period II and Period III (Up to 6 weeks)
Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (AE)
During Period I, Period II and Period III (Up to 6 weeks)
Percentage of Participants Who Experienced at Least One Local Application Site Reaction That Required Symptomatic Treatment
During Period I, Period II and Period III (Up to 6 weeks)
Study Arms (1)
MK-3641+ MK-7243
EXPERIMENTALParticipants receive one MK-7243 tablet, SL QD in the evening for 14 days during Period I; one MK-3641 tablet, SL QD in the morning and one MK-7243 tablet, SL QD in the evening for 14 days during Period II; and one MK-3641 tablet, SL QD, and one MK-7243 tablet, SL QD, within 5 minutes of each other for 14 days during Period III.
Interventions
12 units of Ambrosia artemisiifolia major allergen number 1 (Amb a 1-U) extract sublingual tablets
2800 bioequivalent allergen units (BAU) of Phleum pratense extract sublingual tablets
Self-injectable epinephrine, to be administered for an anaphylactic reaction, including symptoms/signs of upper airway obstruction.
Eligibility Criteria
You may qualify if:
- Clinical history of physician-diagnosed ragweed- and grass pollen-induced rhinitis with or without conjunctivitis of \>1 year duration, with or without asthma
- Female participants of childbearing potential must have a negative urine pregnancy test at Screening and Randomization Visits and must agree to remain abstinent or use (or have their partner use) any one of the acceptable methods of birth control within the projected duration of the study. Acceptable methods of birth control are: intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condom, vasectomy, hormonal contraception.
You may not qualify if:
- Unstable, uncontrolled or severe asthma treated with long-acting beta agonists (LABAs) at the time of Screening
- Received immunosuppressive treatment within 3 months prior to Randomization (except steroids for allergic reactions other than asthma)
- History of anaphylaxis with cardiorespiratory symptoms with prior immunotherapy, unknown cause, or inhalant allergen
- Diagnosis of eosinophilic esophagitis
- History of any severe systemic allergic reaction or any severe local reaction to sublingual allergen immunotherapy
- Female and breastfeeding, pregnant or intending to become pregnant
- Received another form of allergen immunotherapy with the past month
- Previously exposed to MK-3641 (RAGWITEK®) or other sublingual ragweed immunotherapy
- Previously exposed to MK-7243 (GRASTEK®) or other sublingual grass immunotherapy
- Known history of allergy, hypersensitivity, or intolerance to the excipient ingredients of the study drug (except for Ambrosia artemisiifolia and/or Phleum pratense), or self-injectable epinephrine
- Unable to or will not comply with the use of self-injectable epinephrine
- Used an investigational drug within 30 days prior to Screening Visit, or plans to participate in another interventional clinical trial during the duration of this trial
- Family member of the investigational or sponsor staff involved in this trial
- Participating in this same trial at another investigational site.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ALK-Abelló A/Slead
Related Publications (1)
Maloney J, Berman G, Gagnon R, Bernstein DI, Nelson HS, Kleine-Tebbe J, Kaur A, Li Q, Nolte H. Sequential Treatment Initiation with Timothy Grass and Ragweed Sublingual Immunotherapy Tablets Followed by Simultaneous Treatment Is Well Tolerated. J Allergy Clin Immunol Pract. 2016 Mar-Apr;4(2):301-9.e2. doi: 10.1016/j.jaip.2015.11.004. Epub 2016 Jan 2.
PMID: 26755098RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme Corp.
Study Officials
- STUDY DIRECTOR
Medical Director
Merck Sharp & Dohme LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 1, 2014
First Posted
October 3, 2014
Study Start
October 1, 2014
Primary Completion
February 1, 2015
Study Completion
February 1, 2015
Last Updated
March 3, 2017
Results First Posted
January 18, 2016
Record last verified: 2017-01